Effect of a Digital Pain Education Material on Beliefs and Attitudes about Low Back Pain in the General Community: Study Protocol for a Web-Based Randomised Controlled Trial

Effect of a Digital Pain Education Material on Beliefs and Attitudes about Low Back Pain in the General Community: Study Protocol for a Web-Based Randomised Controlled Trial | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Method Article Effect of a Digital Pain Education Material on Beliefs and Attitudes about Low Back Pain in the General Community: Study Protocol for a Web-Based Randomised Controlled Trial Viviane Rocha Celedonio, Ana Carla Lima Nunes, Rafael Z. Pinto, and 2 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-8584307/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Background Promoting appropriate beliefs and attitudes about low back pain (LBP) in the community is a promising component of an educational strategy to aid the management of LBP. Objective We aim to investigate whether a digital pain education material improved LBP beliefs and attitudes of community consumers; to identify whether e-health literacy and pain self-efficacy are associated with changes in beliefs; to verify whether this exposure generates changes in pain self-efficacy in people with LBP. Methods The study was approved by the Human Research Ethics Committee from the Federal University of Ceara (5.336.455/2022) and registered at The Brazilian Registry of Clinical Trials (ReBEC - RBR-10kpgx78). We projected the conduction of a web-based randomised controlled trial with adults, randomised to one of two digital educational content packages: 1) digital LBP education materials; 2) general health information. The primary outcome was beliefs and attitudes about LBP (Back Pain Attitude Questionnaire); secondary outcomes were e-health literacy (eHealth Literacy Scale) and self-efficacy (Pain Self-Efficacy Questionnaire). Outcomes were measured at baseline, immediate and eight weeks post-exposure. Mixed linear models will be used to estimate between-group differences. Recruitment started in December 2022 and data collection was completed in December 2023. Conclusion The study is innovative because the design allows the investigation of the effect of digital material on the beliefs about LBP in Brazilian people. The results can contribute to exploring the potential of digital mass health campaigns about LBP. Physical Medicine & Rehab Orthopedics Low Back Pain Health Knowledge Attitudes Practice Self Efficacy Health Education Controlled Clinical Trial Figures Figure 1 1 Introduction The age standardised prevalence of low back pain (LBP) decreased by 10.4% between 1990 and 2020, but population growth and population ageing contributed to an increase of 60.4% in the absolute number of individuals affected by LBP at the same time. This is not different in Brazil, where there are 22.3 millions of people with LBP in 2020 and a projected increase to 2050, primarily due to population ageing ( 1 ). The economic burden of LBP care in low and middle-income countries such as Brazil is greater than that in high-income countries. There is a limited amount of resources available for publicly funded health care in Brazil, and these resources are wasted if used to support low-value care approaches ( 2 ). Moreover, the impact of related disability on absenteeism, early retirement, and productivity losses at work is substantial, leading to a reduction in income and a challenge in economic and social management due to LBP ( 3 ). The Lancet Low Back Pain series, published in 2018, recommends promoting educational actions and strengthening beliefs about LBP as a way of reducing disease burden by encouraging self-management ( 4 – 6 ). International guidelines emphasise the importance of incorporating such recommendations for the management of acute and chronic LBP care ( 7 ). An update from the Lancet Low Back Pain series advises to disseminate such strategies among health professionals, patients, and people from the general community ( 8 ). Considering the high prevalence of LBP, and the expectation that the absolute number of people suffering from LBP will be larger by 2050 ( 1 ), it is essential to improve health literacy of the community so that they better placed to self-manage their LBP. Previous research has shown that improving beliefs through pain education may explain the improvement on self-efficacy, kinesiophobia, pain and disability ( 9 – 11 ); and face-to-face delivery of education is not superior to online delivery ( 10 ). Personalised materials on LBP education are recommended, as well as their adaptation to the context in which they are disseminated ( 12 ). It is known that changes in beliefs can improve self-management ( 12 , 13 ), and this outcome is of particular benefit to low and middle-income countries by reducing the burden on the health system and socio-economic deficits. We have only found nonrandomised studies conducted in high-income countries that investigated the impact of educational mass media campaigns on the general population's beliefs about LBP ( 14 – 16 ). To our knowledge, a randomised controlled trial has not yet been conducted with that purpose, neither in high nor middle and low-income countries. This manuscript describes the protocol for a web-based, two-arm, parallel group, randomised controlled trial of an educational intervention for the Brazilian general community. We aim to identify the effect of exposure to a set of evidence-based digital LBP education materials on the beliefs and attitudes about LBP of consumers from the general community (compared to general health and hygiene habits information from the government website). This type of control intervention is called attention control which is normally used in trials testing education or advice interventions, where the participants receive the same amount of interaction, but the material has no specific therapeutic purpose for the health condition being evaluated ( 17 ). Furthermore, we want to check whether the changes obtained in beliefs and attitudes about LBP after exposure to a package of digital pain education materials are associated with e-health literacy and self-efficacy to cope with pain; and to investigate the effects of intervention on the self-efficacy of individuals with LBP. 2 Methods 2.1 Study design We are conducting a web-based, two-arm, parallel, randomised controlled trial (RCT) investigating the effects of digital pain education material on beliefs and attitudes about LBP among adults from the community at immediate and 8-week follow-ups. This trial has been designed and reported according to the Consolidated Standards of Reporting Trials of Electronic and Mobile HEalth Applications and onLine TeleHealth (CONSORT-EHEALTH) statement ( 18 ), and this protocol follows the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) statement ( 19 ). The RCT was approved by the Human Research Ethics Committee from the Federal University of Ceara (5.336.455/2022) and it was prospectively registered at the Brazilian Registry of Clinical Trials (RBR-10kpgx78) ( Table 1 ) . Table 1 Trial registration data Data Category Information Primary registry and trial identifying number Registro Brasileiro de Ensaios Clínicos (ReBEC - RBR-10kpgx78) Date of registration in primary registry 28 September, 2022 Secondary identifying numbers Universal Trial Number U1111-1279-5533 Source(s) of monetary or material support Sponsors (below) Primary sponsor Federal University of Ceara Secondary sponsor Federal University of Ceara Contact for public queries VRC ( [email protected] ) Contact for scientific queries FRJM ( [email protected] ) Public title A package of social media material targeting low back pain beliefs in the general community: a randomized controlled trial Scientific title Effect of a digital pain education material on beliefs and attitudes about low back pain in the general community: a randomized controlled trial Countries of recruitment Brazil Health condition or problem studied Low back pain Intervention Exhibition to a digital material on pain education targeting changes in low back pain beliefs and attitudes in Brazilian community at immediate and 8-weeks follow-up. Key inclusion and exclusion criteria Inclusion criteria: Adults residing in Brazil; aged 18 years old or over; able to speak Portuguese; know how to read and understand reading in the Portuguese language; have access to the internet. Exclusion criteria: not applicable Study type Randomized controlled trial, parallel groups, statistical analyst blinding Date of first enrollment 15 December, 2022 Target sample size 440 Recruitment status Recruiting Primary outcome(s) Beliefs and attitudes about low back pain - Back Pain Attitudes Questionnaire Key secondary outcomes Electronic literacy in health - eHealth Literacy Scale Pain self-efficacy - Pain Self-Efficacy Questionnaire Insert Table 1 2.2 Study setting This is a web-based community trial. Participants were recruited via social media advertising. 2.3 Participants and eligibility criteria Adults with or without LBP who reside in Brazil were recruited. For this study, individuals had to be over 18 years old, speak Portuguese, be able to read and understand the Portuguese language, and have access to the internet. The individual was required to read and sign the informed consent in Portuguese language, electronically. 2.4 Recruitment Our research team recruited participants through WhatsApp messages and social media, including online advertisements that were monitored by the research team through the Ads Manager App. We also used local advertisements, with posters placed in places of great circulation of people. Through this nationwide advertisement, the user was invited to participate in the research by accessing a link that led them to the Research Electronic Data Capture (REDCap) web platform, where all stages of the research were conducted, from consent to final data collection. The use of the Ads Manager App was linked to the @dorlombardigital Instagram profile and Facebook page Dorlombardigital. This profile and page were developed by the research team with a friendly visual and communication style. 2.5 Blinding The researcher was unaware of the allocation of participants. A second blinded researcher extracted the data from the digital platform. All data analysis will be conducted by a statistician who is blind to group allocation. All questionnaires were self-reported and the participants were not blind as they had access to the digital material and they were aware of its content. 2.6 Procedures Participants accessed the trial through a link that directed them to the web platform REDCap. Potential participants had filled in preliminary information related to an online informed consent. Upon acceptance, they were required to provide sociodemographic and pain status data, as well as to complete baseline questionnaires and scales related to beliefs and attitudes regarding LBP, electronic health (e-health) literacy, pain-related self-efficacy (when in the presence of LBP in the previous 30 days and/or in the previous 12 months), and pain intensity (when in the presence of LBP in the previous 30 days). 2.6.1 Stratification After completing the baseline questionnaires, participants were stratified into two groups according to the presence or absence of LBP in the previous 30 days. 2.6.2 Randomization and Allocation After stratification, the participants were automatically assigned to one of two groups, intervention or control, using the REDCap randomization function (1:1 ratio). The researcher developed a randomization model and an allocation table was imported from the RStudio software (2023.03.0 Build 386) ( 20 ). In order to maintain the sizes of the treatment groups similar, the random allocation was made in blocks sizes of 40 and 20, respectively ( Fig. 1 ) . Participants were advised to watch or read the specific health educational material designated for their group. Insert Fig. 1 2.6.3 Intervention group The intervention is described according to the Template for Intervention Description and Replication (TIDieR) guidance ( 21 ). Participants allocated to the intervention group accessed to pain education content provided by the Community-based University Extension project called ‘Movimento’. The Project Movement is linked to the Federal University of Ceara and provides primary care assistance to people with musculoskeletal pain in the community. A group of researchers from this project developed a series of educational strategies with the support of the "IASP Developing Countries Project: Initiative for Improving Pain Education", including a package of an educational booklet for chronic LBP, interactive and non-interactive infographics, and animated video for the general community, customised to the Brazilian scenario. The material contains information on the LBP course and prognosis, associated factors, first line care advice, and self-management strategies to cope with the complaint. Access to the pain education material was free and individualised. The participants could choose to view or watch the material as many times as they wished, accessing it at their convenience until they pressed the “Send” button on the platform page. The intervention was web-based and involved self-assessment. Data collection continued with the immediate follow-up, which is explained later. 2.6.4 Control group Participants allocated to the control group had accessed to health information related to hygiene and health habits in general that do not deal with LBP (a booklet, an infographic and a brief educational video), made available by the Brazilian government on the web at https://repositorio.butantan.gov.br/bitstream/butantan/3111/2/cartilha-higiene.pdf , https://www.inca.gov.br/publicacoes/infograficos/promover-ambientes-saudaveis-e-uma-das-formas-de-se-proteger-do-cancer and https://www.youtube.com/watch?app=desktop&v=Wu8A8k0JsPU&t=2s . 2.7 Data collection All data were collected online using REDCap at three distinct stages: at baseline, by answering questionnaires and scales related to beliefs and attitudes regarding LBP, e-health literacy, pain-related self-efficacy (when in the presence of LBP in the previous 30 days and/or in the previous 12 months), and pain intensity (when in the presence of LBP in the previous 30 days); at post-intervention and 8-week follow-ups. After the participants had completed the baseline instruments, they were exposed to the digital material, followed by two rounds of data collection: right after the intervention with a period of up to one week after exposure to the digital material (i.e., post-intervention), and another eight weeks after the exposure (8-week follow-up). The participant could answer the instrument at post-intervention immediately after reading or watching the digital educational materials, while remaining on the REDCap through the same access. Alternatively, the participant was required to return to the survey at another time, thus reminder messages were sent along with the individual access link automatically via email by REDCap and/or WhatsApp and social media through a manual system. Contacts were established every one day to complete the data collection. We continued sending reminders for up to seven weeks through emails and messages, to those who failed to complete the immediate follow-up. The same procedures were followed for data collection at the 8-week follow-up. After a period of eight weeks, the researchers contacted the participants again through the same means mentioned above, sending a link to return to the survey. The follow-up instrument contained some of the questions that were already asked at the beginning (such as beliefs and attitudes about LBP and pain-related self-efficacy - when in the presence of LBP in the previous 30 days and/or in the previous 12 months). Reminder messages were sent along with the individual access link automatically via email by REDCap and/or WhatsApp and other social media platforms manually by one of the research team members. The contact was established every three days to complete the data collection. We continued sending reminders up to 12 weeks, through emails and text messages, to those who failed to complete the 8-week follow-up. The outcome assessment was identical in the intervention and control groups. All outcome measures were self-reported. 2.8 Data management and storage All data will be stored in the REDCap server at Federal University of Ceara, and will be available for the investigators only. We de-identified the data and included email address and telephone numbers for reminders to complete the protocol. Prior to the commencement of the study, we developed a codebook for the survey and ran pilot tests for readability and clarity of the steps associated with its use. The participants were provided with a unique trial identification number, and any identifiers were concealed to guarantee the confidentiality of identity. Each participant was restricted to a single-entry permission for the survey only once, limited by the email address field. Using REDCap enabled us to monitor the completeness, accuracy and quality of data collection. The platform is secure for the storage and management of large databases. All data is being stored at the Federal University of Ceara REDCap login for 10 years and is available to investigators only, under login and password access. Researchers investigated and resolved any inconsistencies in the data. The master investigator will download, store and back up the data on the hard drive and on a secure cloud. The statistician will access the data contained in spreadsheets. 2.9 Outcomes 2.9.1 Primary outcome Beliefs and attitudes about low back pain The primary outcome measure was the Back Pain Attitudes Questionnaire - Back-PAQ in its Brazilian version (Back Pain Attitudes Questionnaire - Back-PAQ-Br). This questionnaire has been translated and validated into Brazilian Portuguese with excellent internal consistency (Cronbach’s 𝝰 = 0.92, ranging from 0.917 to 0.925) and test-retest reliability (Intraclass Correlation Coefficient = 0.94, ranging from 0.89 to 0.97–95% CI). The instrument consists of 34 items related to beliefs and attitudes about LBP. Each item is assessed using a 5-point Likert scale, with the options of “False”, “Possibly False”, “Uncertain”, “Possibly True” and “True”. The answers are scored from − 2 (True) to 2 (False), and there are 11 items that are scored in reverse (items 1, 2, 3, 15, 16, 17, 27, 28, 29, 30 and 31). The scores range from − 68 to 68, with negative scores indicating unhelpful beliefs, whereas positive scores indicate helpful beliefs ( 22 ). This outcome was collected at baseline, immediate follow-up and 8-week follow-up of the research in order to determine the immediate and short-term effects of the intervention on changes in beliefs and attitudes about LBP. 2.9.2 Secondary Outcome Self-efficacy for pain If a participant has already experienced pain in the previous 30 days and/or in the previous 12 months, self-efficacy to deal with pain was also collected. We used the Pain Self-Efficacy Questionnaire - PSEQ in its adapted and validated version for Portuguese in Brazil. It has adequate internal consistency (Cronbach's of 0.90) and a p value considered significant (p ≤ 0.008) after adjustment with the Bonferroni test ( 23 ). The instrument contains 10 items related to the individual's self-efficacy for pain. Each item is rated using a 7-point Likert scale (0–6), with 0 representing “Not Completely Confident” and 6 representing “Completely Confident”. The scores range from 0 to 60, and the greater the sum, the greater the self-efficacy belief ( 24 ). This outcome was collected at baseline, immediate follow-up and 8-week follow-up of the research. 2.9.3 Additional measures 2.9.3.1 Demographic data. Demographic data was collected at baseline, following the National Institutes of Health (NIH) task force research recommendations for LBP ( 25 ), such as gender (male or female), age (in years), marital status (married, living together, divorced, single, widowed) ( 26 ), academic level (illiterate or incomplete primary education, complete primary education or incomplete secondary education, complete secondary education or incomplete tertiary education, complete tertiary education), occupation (farming; industry; construction; commerce; accommodation and food; domestic services; financial information and other professional activities; public administrative, education, health and social services; transport, storage and mail; other services; student; retirees; unemployed), state where lives and social class according to the minimum wage ranges of the Brazilian Institute of Geography and Statistics average income household (A - more than twenty minimum wages, B - more than ten to twenty minimum wages, C - more than four to ten minimum wages, D - more than two to four minimum wages, E - until two minimum wages), estimated by the Brazilian Economic Classification Criteria ( 27 ). 2.9.3.2 Electronic health literacy. The eHealth Literacy Scale - eHEALS was used in its Brazilian version. This scale was translated and validated for Brazilian Portuguese with good internal consistency (Cronbach's 𝝰 of 0.89, ranging from 0.086 to 0.88), with a mean of 28.02 (± 5.53, 8–40) with a variation of 30.60. The scale proved to be valid and reliable to measure literacy levels in electronic health in Brazil. The instrument consists of 8 items, and each item is rated using a 5-point Likert scale, with options for “Completely Disagree”, “Disagree”, “Undecided”, “Agree” and “Strongly Agree.” The items are scored from 1 to 5, with the total score range being from 8 to 40. Lower scores correspond to a lower level of literacy in electronic health, while higher scores correspond to a higher level of literacy ( 28 , 29 ). This outcome was collected at baseline only. 2.9.3.3 Pain intensity. Furthermore, in the presence of LBP in the previous 30 days, pain intensity was assessed using the Numerical Pain Scale, which has been validated for both acute and chronic pain ( 30 ). It consists of a scale with 11 discrete numbers (0–10), wherein lower scores indicate a low level of pain, while higher scores indicate a high level of pain. The participant should report the presence of LBP in the previous 30 days preceding the data collection. The measurement of pain intensity was conducted at baseline if the participant has already experienced pain in the previous 30 days (see Table 2 for a comprehensive overview of the data collected at baseline, immediate and 8-week follow-ups). Table 2 Overview of the information collected at baseline and at immediate and 8-week follow-ups Characteristics Screening / Consent Baseline Allocation Immediate Follow-up 8-week Follow-up Descriptive Variables Participant Screening / Consent Form X Participant Characteristics X Sociodemographic X Randomization X Primary Outcome Back Pain Attitudes Questionnaire X X X Secondary Outcome Pain Self-Efficacy Questionnaire (if applicable) X X X Additional Measures eHEALS X Pain Status (Stratification) X Pain Intensity (if applicable) X eHEALS - Electronic Health Literacy Scale Insert Table 2 2.10 Statistical methods 2.10.1 Sample size calculations The sample size was estimated at 366 participants (183 per group) and considering a loss of 20% during the follow-up, we needed 220 participants per group. We anticipated needing to approach double this number, presuming that 50% of those invited will consent to participate. Statistical parameters based on previous studies were used, namely: minimum expected mean difference of 10% for the selected primary outcome (1.0 point), assumed standard deviation of 3.4, effect size of 0.30, power of 80% and a significance level of 0.05 (95% CI), considering a normal (two-tailed) distribution hypothesis ( 14 , 31 ). 2.10.2 Statistical analysis plan Analyses will be performed by a blind statistician utilising intention-to-treat principles. Data will be analysed with JAMOVI version 1.6.23 and RStudio software (2023.03.0 Build 386) with a significance level of p ≤ 0.05 (95% CI), considering a normal two-tailed distribution hypothesis. We will use the Shapiro-Wilk normality test to analyse data distribution. The data referring to the characterisation of the sample at baseline will be reported through descriptive statistics, incorporating measures of frequencies for categorical variables, mean and standard deviation for normally distributed continuous variables, and median and interquartile range otherwise. We will use the Mixed Linear Model Two-Way ANOVA to calculate the difference between groups on the beliefs and attitudes regarding LBP and self-efficacy for pain outcomes at follow-up, considering that each construct will be measured at different time points (baseline, immediate follow-up and 8-week follow-up) and in two groups, intervention and control. We will examine the effects considering the presence of pain in the previous 30 days or in the past 12 months on the primary outcome of beliefs and attitudes about LBP. The model will be adjusted by the covariates e-health literacy, self-efficacy for pain, age, education level, occupation and family income. To assess the association between e-health literacy and the difference in mean beliefs and attitudes, and the association between pain-related self-efficacy and the difference in mean beliefs and attitudes, we will perform Pearson's or Spearman's Coefficient. Later, we will use Multivariate Linear Regression to investigate the relationship between these variables and changes in the primary outcome, adjusting the model for age, education level, occupation, family income and pain occurrence. 2.11 Patient and Public involvement Individuals with LBP were actively involved during the development of the digital content material delivered for the intervention group. They were asked to provide their comprehension, and preferences for each of the proposed materials. Members from the general public were consulted regarding the usability and accessibility of the project on the REDCap platform, through a pilot study. 2.12 Ethics and dissemination The RCT was approved by the Human Research Ethics Committee from the Federal University of Ceara (5.336.455/2022) and it was prospectively registered at The Brazilian Registry of Clinical Trials (ReBEC RBR-10kpgx78). Current protocol is version 1 (28 September 2022) and no modifications were registered on ReBEC and the Ethics Committee. We requested informed consent from all individuals before participation. All participants were informed about the objectives, benefits and harms of the study, and they were free to withdraw from it at any time without consequences. The methods for safeguarding all databases were elucidated, while ensuring the privacy and confidentiality of the participants. The findings of the study will be published in peer-reviewed international journals, as well as presented at national and international conferences. 3 Discussion High and low-income countries have already carried out observational studies characterizing beliefs and attitudes about LBP in their populations ( 32 – 34 ). Quasi-experimental, nonrandomised studies were conducted in high-income countries, with the intervention being a multimedia campaign on open television ( 14 , 16 , 35 ), rather than an RCT. A trial can contribute to exploring the potential of mass digital health campaigns about LBP. There was a gap in this field of investigation, which was the development of an RCT to analyse the specific effect of educational material on changes in beliefs and attitudes about LBP in the world. The protocol presented here outlines the steps of this investigation and describes the intervention material used, including its formats and central messages based on the Lancet Series (2018). It is personalised to the intervention scenario. The intervention is being implemented in Brazil, a country in the middle and low-income block, where the impact of LBP on individual and social disability is even greater, considering the association of disability with lower socioeconomic levels and the occupational demand experienced ( 36 , 37 ). We are not solely focusing on characterizing the population's beliefs and attitudes about LBP, but also testing a specific digital health education material that has the potential to change beliefs and reduce the impact due to LBP in the community. The project's development in REDCap is a strength of our trial. The project was carefully designed, with the implementation of varied functions, so that the platform had a friendly presentation and clear communication with the respondent. The platform explained each stage of the process throughout the survey and sought participant autonomy when following the research. We implemented functionalities to the project that enabled the inclusion of conditional eligibility criteria; digital ethical acceptance; transcription of self-reported questionnaires; stratification according to LBP status; plotting of digital intervention material; randomisation; allocation into intervention and control groups; and creation of QR Code and link for recruitment. Another advantage is that the study intervention comprises a collection of materials with diverse presentation styles, and in this sense, each of the models can interest diverse consumers. Some people will be more prone to the infographics, the video, or the booklet. This is potentially advantageous as it aims to engage individuals with diverse behavioural profiles using accessible language and format, in Portuguese. If we can demonstrate that this package of educational digital material can enhance beliefs and attitudes regarding the confrontation and self-management of LBP, we can improve the dissemination of this digital material through social media. Public policy makers would be asked to increase the dissemination of this material, in order to improve public health across the country. As this is an electronic designed intervention, it implied that its participants had a cell phone or a computer and internet access, which can limit generalising findings for those with lower socioeconomic status or less familiar with technology. To minimise this limitation, materials were conceived in formats that could be seen in either computers or mobile phones, and REDCap was pilot tested to allow its visualisation for either electronic mode. Declarations Funding This research did not receive any specific grants from funding agencies in the public, comercial or non-profit sectors. Acknowledgments To the scholarships holders and volunteers involved in this project (APSB, FBP, LCF, MIAC). This work is supported by the “Programa Institucional de Bolsas de Iniciação Científica” from the Federal University of Ceara. The development of the intervention digital material was supported by the IASP Developing Countries Project: Initiative for Improving Pain Education. The development of the web platform REDCap project was supported by the “Núcleo de Apoio ao Pesquisador da Unidade de Pesquisa Clínica do Complexo de Hospitais Universitários da UFC/EBSERH” Researcher Support Center of the Clinical Research Unit of the University Hospitals Complex UFC/EBSERH. References Ferreira ML, De Luca K, Haile LM, Steinmetz JD, Culbreth GT, Cross M et al (2023) Global, regional, and national burden of low back pain, 1990–2020, its attributable risk factors, and projections to 2050: a systematic analysis of the Global Burden of Disease Study 2021. Lancet Rheumatol 5(6):e316–e329 Carregaro RL, da Silva EN, van Tulder M (2019) Direct healthcare costs of spinal disorders in Brazil. Int J Public Health 64(6):965–974 Carregaro RL, Tottoli CR, da Silva Rodrigues D, Bosmans JE, da Silva EN, van Tulder M (2020) Low back pain should be considered a health and research priority in Brazil: Lost productivity and healthcare costs between 2012 to 2016. PLoS ONE. ;15(4) Buchbinder R, van Tulder M, Öberg B, Costa LM, Woolf A, Schoene M et al (2018) Low back pain: a call for action. Lancet 391(10137):2384–2388 Foster NE, Anema JR, Cherkin D, Chou R, Cohen SP, Gross DP et al (2018) Prevention and treatment of low back pain: evidence, challenges, and promising directions. Lancet 391(10137):2368–2383 Hartvigsen J, Hancock MJ, Kongsted A, Louw Q, Ferreira ML, Genevay S et al (2018) What low back pain is and why we need to pay attention. Lancet 391(10137):2356–2367 George SZ, Fritz JM, Silfies SP, Schneider MJ, Beneciuk JM, Lentz TA et al (2021) Interventions for the Management of Acute and Chronic Low Back Pain: Revision 2021. J Orthop Sports Phys Ther 51(11):CPG1–60 Buchbinder R, Underwood M, Hartvigsen J, Maher CG (2020) The Lancet Series call to action to reduce low value care for low back pain: an update. Pain 161(9):S57–64 Barbari V, Storari L, Ciuro A, Testa M (2020) Effectiveness of communicative and educative strategies in chronic low back pain patients: A systematic review. Patient Educ Couns 103(5):908–929 Du S, Hu L, Dong J, Xu G, Chen X, Jin S et al (2017) Self-management program for chronic low back pain: A systematic review and meta-analysis. Patient Educ Couns 100(1):37–49 Pincus T, Holt N, Vogel S, Underwood M, Savage R, Walsh DA et al (2013) Cognitive and affective reassurance and patient outcomes in primary care: A systematic review. Pain 154(11):2407–2416 Hodges PW, Hall L, Setchell J, French S, Kasza J, Bennell K et al (2021) Effect of a consumer-focused website for low back pain on health literacy, Treatment choices, and clinical outcomes: Randomized controlled trial. J Med Internet Res 23(6):e27860 Lee H, Moseley GL, Hübscher M, Kamper SJ, Traeger AC, Skinner IW et al (2015) Understanding how pain education causes changes in pain and disability: Protocol for a causal mediation analysis of the PREVENT trial. J Physiother 61(3):156 Buchbinder R, Jolley D, Wyatt M (2001) Volvo award winner in clinical studies: Effects of a media campaign on back pain beliefs and its potential influence on management of low back pain in general practice. Spine (Phila Pa 1976). 2001;26(23):2535–42 Gross DP, Russell AS, Ferrari R, Battié MC, Schopflocher D, Hu R et al (2010) Evaluation of a Canadian Back Pain Mass Media Campaign. Eur Spine J 35(8):906–913 Werner EL, Ihlebæk C, Lærum E, Wormgoor MEA, Indahl A (2008) Low back pain media campaign: No effect on sickness behaviour. Patient Educ Couns 71(2):198–203 Kamper SJ (2018) Control Groups: Linking Evidence to Practice. J Orthop Sports Phys Ther 48(11):905–906 Eysenbach G, Group C (2011) ehealth. CONSORT-EHEALTH: Improving and Standardizing Evaluation Reports of Web-based and Mobile Health Interventions Corresponding Author : J Med Internet Res. ;13(4):e126 Chan Awen, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K et al (2016) SPIRIT 2013 Statement: Defining Standard Protocol Items for Clinical Trials. Ann Intern Med 158(3):200–207 Silveira F (2016) Guia RedCap [Internet]. São Paulo: Núcleo de Tecnologia da Informação. Faculdade de Ciências Médica. Unicamp.; Available from: https://wiki.fcm.unicamp.br/images/Manual_Redcap.pdf Hoffmann TC, Glasziou PP, Boutron I, Milne R, Perera R, Moher D et al (2014) Better reporting of interventions: Template for intervention description and replication (TIDieR) checklist and guide. BMJ 348:g1687 Krug RC, Carneiro J, Ribeiro DC, Darlow B, Silva MF, Loss JF (2019) Back Pain attitudes questionnaire: Cross-cultural adaptation to brazilian-portuguese and measurement properties. Rev Bras Psiquiatr 41(1):1–2 Sardá J, Nicholas MK, Pimenta CAM, Asghari A (2007) Pain-related self-efficacy beliefs in a Brazilian chronic pain patient sample: A psychometric analysis. Stress Heal 23(3):185–190 Bonafé FSS, Marôco J, Campos JADB (2018) Pain self-efficacy questionnaire and its use in samples with different pain duration time. Brazilian J Pain 1(1):33–39 Deyo RA, Dworkin SF, Amtmann D, Andersson G, Borenstein D, Carragee E et al (2014) Report of the NIH task force on research standards for chronic low back pain. J Pain 15(6):569–585 Tartuce F (2019) Direito Civil: direito de família, 14th edn. Forense, Rio de Janeiro IBGE - Instituto Brasileiro de Geografia e Estatística. Síntese de Indicadores Sociais: uma análise das condições de vida da população brasileira 2020 [Internet]. Rio de Janeiro: Estudos e Pesquisas. Informação Demográfica e Socioeconômica, ISSN 1516–3296; n. 43 (2020) 148p. Available from: https://biblioteca.ibge.gov.br/visualizacao/livros/liv101760.pdf MASCHIO KF, SILVA KiK da (2019) the Ehealth Literacy Scale (Eheals) – Tradução E Validação Da Versão Brasileira De Uma Escala De Alfabetização Em Saúde Eletrônica [Internet]. Trabalho de conclusão de curso. Available from: https://rd.uffs.edu.br/handle/prefix/3704 Mialhe FL, Moraes KL, Sampaio HA, de Brasil C, Vila VV, Soares VdaSC (2022) Evaluating the psychometric properties of the eHealth Literacy Scale in Brazilian adults. Rev Bras Enferm 75(1):1–8 Bijur PE, Latimer CT, Gallagher EJ (2003) Validation of a verbally administered numerical rating scale of acute pain for use in the emergency department. Acad Emerg Med 10(4):390–392 Sharma S, Traeger AC, O’Keeffe M, Copp T, Freeman A, Hoffmann T et al (2021) Effect of information format on intentions and beliefs regarding diagnostic imaging for non-specific low back pain: A randomised controlled trial in members of the public. Patient Educ Couns 104(3):595–602 Christe G, Pizzolato V, Meyer M, Nzamba J, Pichonnaz C (2021) Unhelpful beliefs and attitudes about low back pain in the general population: A cross-sectional survey. Musculoskelet Sci Pract [Internet] 52:102342 Ho-A-Tham N, Ting-A-Kee B, Struyf N, Vanlandewijck Y, Dankaerts W (2021) Low back pain prevalence, beliefs and treatment-seeking behaviour in multi-ethnic Suriname. Rheumatol Adv Pract 5(3):1–10 Pierobon A, Policastro PO, Soliño S, Andreu M, Novoa G, Raguzzi I et al (2020) Beliefs and attitudes about low back pain in Argentina: A cross-sectional survey using social media. Musculoskelet Sci Pract 49:102183 Waddell G, O’Connor M, Boorman S, Torsney B (2007) Working backs Scotland: A public and professional health education campaign for back pain. Spine (Phila Pa 1976) 32(19):2139–2143 Sharma S, Mcauley JH (2022) Low Back Pain in Low- and Middle-Income Countries, Part 1: The Problem. J Orthop Sports Phys Ther 52(5):233–235 Fatoye F, Gebrye T, Mbada CE, Useh U (2023) Clinical and economic burden of low back pain in low- and middle-income countries: a systematic review. BMJ Open 13(4):1–7 Additional Declarations The authors declare no competing interests. Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-8584307","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Method Article","associatedPublications":[],"authors":[{"id":573450423,"identity":"a3775540-e753-4276-9f5c-536456b5ad3b","order_by":0,"name":"Viviane Rocha Celedonio","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAABDElEQVRIiWNgGAWjYDACZgaGA2AGOwODBAjxgzgJBcRoYYZqkWwAaTEg0joJEG0ANgGPFoPjPIYHfu6wkednZj544+MOCznj86sTPzwwYJDnFzuAXcthHoODvWfSDGc2syVbzjwjYWx24+1mCaDDDGfOTsCqRbKZLeEAb9vhBKBeM2neNonEbTfObgBpSTC4jVvLwb9t/xPsD/N/A2vZPOPs5h/4tAC9cOAwb9uBBANmHjawlg38vdvw2gLWItuWbDjjMJux5cw2CWOJG7zbLBIMJHD6hY3/YPPHt2128vztzQ9vfGyrk+PvP7v55o8KYBhKY9eCBUiAVUoQqxzs1gOkqB4Fo2AUjIIRAAB+jVrTAHoojwAAAABJRU5ErkJggg==","orcid":"https://orcid.org/0000-0001-8176-5133","institution":"Federal University of Ceara","correspondingAuthor":true,"prefix":"","firstName":"Viviane","middleName":"Rocha","lastName":"Celedonio","suffix":""},{"id":573450424,"identity":"1fa433b5-c4e2-43ef-b7b3-b0605c68aef1","order_by":1,"name":"Ana Carla Lima Nunes","email":"","orcid":"https://orcid.org/0000-0002-7380-6537","institution":"Federal University of Ceara","correspondingAuthor":false,"prefix":"","firstName":"Ana","middleName":"Carla Lima","lastName":"Nunes","suffix":""},{"id":573450425,"identity":"cf4c9645-0052-44cc-a2f2-ca6cb7d0c59a","order_by":2,"name":"Rafael Z. Pinto","email":"","orcid":"https://orcid.org/0000-0002-2775-860X","institution":"Federal University of Minas Gerais","correspondingAuthor":false,"prefix":"","firstName":"Rafael","middleName":"Z.","lastName":"Pinto","suffix":""},{"id":573450426,"identity":"705fcf9a-c10d-484e-abe4-2c33a60b9e4a","order_by":3,"name":"Chris G. Maher","email":"","orcid":"https://orcid.org/0000-0002-1628-7857","institution":"The University of Sydney","correspondingAuthor":false,"prefix":"","firstName":"Chris","middleName":"G.","lastName":"Maher","suffix":""},{"id":573450427,"identity":"d17ddff7-256a-41d0-8be3-98ffa326ac4c","order_by":4,"name":"Fabianna Resende de Jesus-Moraleida","email":"","orcid":"https://orcid.org/0000-0002-3797-949X","institution":"Federal University of Ceara","correspondingAuthor":false,"prefix":"","firstName":"Fabianna","middleName":"Resende","lastName":"de Jesus-Moraleida","suffix":""}],"badges":[],"createdAt":"2026-01-12 17:24:06","currentVersionCode":1,"declarations":{"humanSubjects":true,"vertebrateSubjects":false,"conflictsOfInterestStatement":false,"humanSubjectEthicalGuidelines":true,"humanSubjectConsent":true,"humanSubjectClinicalTrial":true,"humanSubjectCaseReport":false,"vertebrateSubjectEthicalGuidelines":false},"doi":"10.21203/rs.3.rs-8584307/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-8584307/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":100260404,"identity":"dd20b3f8-2c2a-4923-962a-d9788d05e4ed","added_by":"auto","created_at":"2026-01-14 16:53:54","extension":"docx","order_by":0,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":2556215,"visible":true,"origin":"","legend":"","description":"","filename":"ManuscriptFileresearchsquare.docx","url":"https://assets-eu.researchsquare.com/files/rs-8584307/v1/7d51ab26c6b7ad9daa992826.docx"},{"id":100260401,"identity":"07845dfa-7be4-4baf-85eb-af457eb6f43c","added_by":"auto","created_at":"2026-01-14 16:53:54","extension":"json","order_by":1,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":342,"visible":true,"origin":"","legend":"","description":"","filename":"rs8584307.json","url":"https://assets-eu.researchsquare.com/files/rs-8584307/v1/d7deb86f686e93e5f2b48700.json"},{"id":100372534,"identity":"291b20c1-7eac-477a-bae5-9bd7f40aead0","added_by":"auto","created_at":"2026-01-16 08:12:38","extension":"xml","order_by":2,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":98703,"visible":true,"origin":"","legend":"","description":"","filename":"rs85843072enriched.xml","url":"https://assets-eu.researchsquare.com/files/rs-8584307/v1/8140e7b9e7362e2273f1b682.xml"},{"id":100260405,"identity":"8f31f562-8feb-4193-85e4-b0ce5c9bccdf","added_by":"auto","created_at":"2026-01-14 16:53:54","extension":"xml","order_by":3,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":95355,"visible":true,"origin":"","legend":"","description":"","filename":"rs85843072structuring.xml","url":"https://assets-eu.researchsquare.com/files/rs-8584307/v1/2ac94fd5d5541cda64fd77bd.xml"},{"id":100260403,"identity":"c96a6ea5-cfc6-48ee-af27-407d99fe42b7","added_by":"auto","created_at":"2026-01-14 16:53:54","extension":"html","order_by":4,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":106637,"visible":true,"origin":"","legend":"","description":"","filename":"earlyproof.html","url":"https://assets-eu.researchsquare.com/files/rs-8584307/v1/2e376d592512a02301d84a23.html"},{"id":100260402,"identity":"a0bf7b2e-69fd-45f4-addd-929009a0bcf6","added_by":"auto","created_at":"2026-01-14 16:53:54","extension":"jpg","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":396461,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eFigure 1 \u003c/strong\u003e- Study flowchart according to CONSORT recommendations\u003c/p\u003e","description":"","filename":"Figure1researchsquarejpg.jpg","url":"https://assets-eu.researchsquare.com/files/rs-8584307/v1/293d9422fffc45c561c19ef7.jpg"},{"id":100383881,"identity":"73b5f754-21c9-465f-936b-6db367d2c270","added_by":"auto","created_at":"2026-01-16 10:48:42","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1199477,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-8584307/v1/d3fe2c49-16db-49f3-a45c-95901591807a.pdf"}],"financialInterests":"The authors declare no competing interests.","formattedTitle":"\u003cp\u003e\u003cstrong\u003eEffect of a Digital Pain Education Material on Beliefs and Attitudes about Low Back Pain in the General Community: Study Protocol for a Web-Based Randomised Controlled Trial\u003c/strong\u003e\u003c/p\u003e","fulltext":[{"header":"1 Introduction","content":"\u003cp\u003eThe age standardised prevalence of low back pain (LBP) decreased by 10.4% between 1990 and 2020, but population growth and population ageing contributed to an increase of 60.4% in the absolute number of individuals affected by LBP at the same time. This is not different in Brazil, where there are 22.3 millions of people with LBP in 2020 and a projected increase to 2050, primarily due to population ageing (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e). The economic burden of LBP care in low and middle-income countries such as Brazil is greater than that in high-income countries. There is a limited amount of resources available for publicly funded health care in Brazil, and these resources are wasted if used to support low-value care approaches (\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e). Moreover, the impact of related disability on absenteeism, early retirement, and productivity losses at work is substantial, leading to a reduction in income and a challenge in economic and social management due to LBP (\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eThe Lancet Low Back Pain series, published in 2018, recommends promoting educational actions and strengthening beliefs about LBP as a way of reducing disease burden by encouraging self-management (\u003cspan additionalcitationids=\"CR5\" citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e). International guidelines emphasise the importance of incorporating such recommendations for the management of acute and chronic LBP care (\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e). An update from the Lancet Low Back Pain series advises to disseminate such strategies among health professionals, patients, and people from the general community (\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e). Considering the high prevalence of LBP, and the expectation that the absolute number of people suffering from LBP will be larger by 2050 (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e), it is essential to improve health literacy of the community so that they better placed to self-manage their LBP.\u003c/p\u003e \u003cp\u003ePrevious research has shown that improving beliefs through pain education may explain the improvement on self-efficacy, kinesiophobia, pain and disability (\u003cspan additionalcitationids=\"CR10\" citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e); and face-to-face delivery of education is not superior to online delivery (\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e). Personalised materials on LBP education are recommended, as well as their adaptation to the context in which they are disseminated (\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e). It is known that changes in beliefs can improve self-management (\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e, \u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e), and this outcome is of particular benefit to low and middle-income countries by reducing the burden on the health system and socio-economic deficits.\u003c/p\u003e \u003cp\u003eWe have only found nonrandomised studies conducted in high-income countries that investigated the impact of educational mass media campaigns on the general population's beliefs about LBP (\u003cspan additionalcitationids=\"CR15\" citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e). To our knowledge, a randomised controlled trial has not yet been conducted with that purpose, neither in high nor middle and low-income countries.\u003c/p\u003e \u003cp\u003eThis manuscript describes the protocol for a web-based, two-arm, parallel group, randomised controlled trial of an educational intervention for the Brazilian general community. We aim to identify the effect of exposure to a set of evidence-based digital LBP education materials on the beliefs and attitudes about LBP of consumers from the general community (compared to general health and hygiene habits information from the government website). This type of control intervention is called attention control which is normally used in trials testing education or advice interventions, where the participants receive the same amount of interaction, but the material has no specific therapeutic purpose for the health condition being evaluated (\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e). Furthermore, we want to check whether the changes obtained in beliefs and attitudes about LBP after exposure to a package of digital pain education materials are associated with e-health literacy and self-efficacy to cope with pain; and to investigate the effects of intervention on the self-efficacy of individuals with LBP.\u003c/p\u003e"},{"header":"2 Methods","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003e2.1 Study design\u003c/h2\u003e \u003cp\u003eWe are conducting a web-based, two-arm, parallel, randomised controlled trial (RCT) investigating the effects of digital pain education material on beliefs and attitudes about LBP among adults from the community at immediate and 8-week follow-ups. This trial has been designed and reported according to the Consolidated Standards of Reporting Trials of Electronic and Mobile HEalth Applications and onLine TeleHealth (CONSORT-EHEALTH) statement (\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e), and this protocol follows the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) statement (\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e). The RCT was approved by the Human Research Ethics Committee from the Federal University of Ceara (5.336.455/2022) and it was prospectively registered at the Brazilian Registry of Clinical Trials (RBR-10kpgx78) \u003cb\u003e(\u003c/b\u003eTable\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e\u003cb\u003e)\u003c/b\u003e.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eTrial registration data\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"2\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eData Category\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eInformation\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePrimary registry and trial identifying number\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eRegistro Brasileiro de Ensaios Cl\u0026iacute;nicos (ReBEC - RBR-10kpgx78)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDate of registration in primary registry\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e28 September, 2022\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSecondary identifying numbers\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eUniversal Trial Number U1111-1279-5533\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSource(s) of monetary or material support\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eSponsors (below)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePrimary sponsor\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eFederal University of Ceara\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSecondary sponsor\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eFederal University of Ceara\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eContact for public queries\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eVRC ([email protected])\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eContact for scientific queries\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eFRJM ([email protected])\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePublic title\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eA package of social media material targeting low back pain beliefs in the general community: a randomized controlled trial\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eScientific title\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eEffect of a digital pain education material on beliefs and attitudes about low back pain in the general community: a randomized controlled trial\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCountries of recruitment\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eBrazil\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHealth condition or problem studied\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eLow back pain\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eIntervention\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eExhibition to a digital material on pain education targeting changes in low back pain beliefs and attitudes in Brazilian community at immediate and 8-weeks follow-up.\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eKey inclusion and exclusion criteria\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eInclusion criteria: Adults residing in Brazil; aged 18 years old or over; able to speak Portuguese; know how to read and understand reading in the Portuguese language; have access to the internet.\u003c/p\u003e \u003cp\u003eExclusion criteria: not applicable\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eStudy type\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eRandomized controlled trial, parallel groups, statistical analyst blinding\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDate of first enrollment\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e15 December, 2022\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eTarget sample size\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e440\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eRecruitment status\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eRecruiting\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePrimary outcome(s)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eBeliefs and attitudes about low back pain - Back Pain Attitudes Questionnaire\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eKey secondary outcomes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eElectronic literacy in health - eHealth Literacy Scale\u003c/p\u003e \u003cp\u003ePain self-efficacy - Pain Self-Efficacy Questionnaire\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003e \u003cb\u003eInsert\u003c/b\u003e Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec4\" class=\"Section2\"\u003e \u003ch2\u003e2.2 Study setting\u003c/h2\u003e \u003cp\u003eThis is a web-based community trial. Participants were recruited via social media advertising.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec5\" class=\"Section2\"\u003e \u003ch2\u003e2.3 Participants and eligibility criteria\u003c/h2\u003e \u003cp\u003eAdults with or without LBP who reside in Brazil were recruited. For this study, individuals had to be over 18 years old, speak Portuguese, be able to read and understand the Portuguese language, and have access to the internet. The individual was required to read and sign the informed consent in Portuguese language, electronically.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec6\" class=\"Section2\"\u003e \u003ch2\u003e2.4 Recruitment\u003c/h2\u003e \u003cp\u003eOur research team recruited participants through WhatsApp messages and social media, including online advertisements that were monitored by the research team through the Ads Manager App. We also used local advertisements, with posters placed in places of great circulation of people. Through this nationwide advertisement, the user was invited to participate in the research by accessing a link that led them to the Research Electronic Data Capture (REDCap) web platform, where all stages of the research were conducted, from consent to final data collection. The use of the Ads Manager App was linked to the @dorlombardigital Instagram profile and Facebook page Dorlombardigital. This profile and page were developed by the research team with a friendly visual and communication style.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec7\" class=\"Section2\"\u003e \u003ch2\u003e2.5 Blinding\u003c/h2\u003e \u003cp\u003eThe researcher was unaware of the allocation of participants. A second blinded researcher extracted the data from the digital platform. All data analysis will be conducted by a statistician who is blind to group allocation. All questionnaires were self-reported and the participants were not blind as they had access to the digital material and they were aware of its content.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec8\" class=\"Section2\"\u003e \u003ch2\u003e2.6 Procedures\u003c/h2\u003e \u003cp\u003eParticipants accessed the trial through a link that directed them to the web platform REDCap. Potential participants had filled in preliminary information related to an online informed consent. Upon acceptance, they were required to provide sociodemographic and pain status data, as well as to complete baseline questionnaires and scales related to beliefs and attitudes regarding LBP, electronic health (e-health) literacy, pain-related self-efficacy (when in the presence of LBP in the previous 30 days and/or in the previous 12 months), and pain intensity (when in the presence of LBP in the previous 30 days).\u003c/p\u003e \u003cdiv id=\"Sec9\" class=\"Section3\"\u003e \u003ch2\u003e2.6.1 Stratification\u003c/h2\u003e \u003cp\u003eAfter completing the baseline questionnaires, participants were stratified into two groups according to the presence or absence of LBP in the previous 30 days.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec10\" class=\"Section3\"\u003e \u003ch2\u003e2.6.2 Randomization and Allocation\u003c/h2\u003e \u003cp\u003eAfter stratification, the participants were automatically assigned to one of two groups, intervention or control, using the REDCap randomization function (1:1 ratio). The researcher developed a randomization model and an allocation table was imported from the RStudio software (2023.03.0 Build 386) (\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e). In order to maintain the sizes of the treatment groups similar, the random allocation was made in blocks sizes of 40 and 20, respectively \u003cb\u003e(\u003c/b\u003eFig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e\u003cb\u003e)\u003c/b\u003e. Participants were advised to watch or read the specific health educational material designated for their group.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003e \u003cb\u003eInsert\u003c/b\u003e Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec11\" class=\"Section3\"\u003e \u003ch2\u003e2.6.3 Intervention group\u003c/h2\u003e \u003cp\u003eThe intervention is described according to the Template for Intervention Description and Replication (TIDieR) guidance (\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e). Participants allocated to the intervention group accessed to pain education content provided by the Community-based University Extension project called \u0026lsquo;Movimento\u0026rsquo;. The Project Movement is linked to the Federal University of Ceara and provides primary care assistance to people with musculoskeletal pain in the community. A group of researchers from this project developed a series of educational strategies with the support of the \"IASP Developing Countries Project: Initiative for Improving Pain Education\", including a package of an educational booklet for chronic LBP, interactive and non-interactive infographics, and animated video for the general community, customised to the Brazilian scenario. The material contains information on the LBP course and prognosis, associated factors, first line care advice, and self-management strategies to cope with the complaint. Access to the pain education material was free and individualised. The participants could choose to view or watch the material as many times as they wished, accessing it at their convenience until they pressed the \u0026ldquo;Send\u0026rdquo; button on the platform page. The intervention was web-based and involved self-assessment. Data collection continued with the immediate follow-up, which is explained later.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec12\" class=\"Section3\"\u003e \u003ch2\u003e2.6.4 Control group\u003c/h2\u003e \u003cp\u003eParticipants allocated to the control group had accessed to health information related to hygiene and health habits in general that do not deal with LBP (a booklet, an infographic and a brief educational video), made available by the Brazilian government on the web at \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://repositorio.butantan.gov.br/bitstream/butantan/3111/2/cartilha-higiene.pdf\u003c/span\u003e\u003cspan address=\"https://repositorio.butantan.gov.br/bitstream/butantan/3111/2/cartilha-higiene.pdf\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e, \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://www.inca.gov.br/publicacoes/infograficos/promover-ambientes-saudaveis-e-uma-das-formas-de-se-proteger-do-cancer\u003c/span\u003e\u003cspan address=\"https://www.inca.gov.br/publicacoes/infograficos/promover-ambientes-saudaveis-e-uma-das-formas-de-se-proteger-do-cancer\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e and \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://www.youtube.com/watch?app=desktop\u0026amp;v=Wu8A8k0JsPU\u0026amp;t=2s\u003c/span\u003e\u003cspan address=\"https://www.youtube.com/watch?app=desktop\u0026amp;v=Wu8A8k0JsPU\u0026amp;t=2s\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e .\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv id=\"Sec13\" class=\"Section2\"\u003e \u003ch2\u003e2.7 Data collection\u003c/h2\u003e \u003cp\u003eAll data were collected online using REDCap at three distinct stages: at baseline, by answering questionnaires and scales related to beliefs and attitudes regarding LBP, e-health literacy, pain-related self-efficacy (when in the presence of LBP in the previous 30 days and/or in the previous 12 months), and pain intensity (when in the presence of LBP in the previous 30 days); at post-intervention and 8-week follow-ups.\u003c/p\u003e \u003cp\u003eAfter the participants had completed the baseline instruments, they were exposed to the digital material, followed by two rounds of data collection: right after the intervention with a period of up to one week after exposure to the digital material (i.e., post-intervention), and another eight weeks after the exposure (8-week follow-up). The participant could answer the instrument at post-intervention immediately after reading or watching the digital educational materials, while remaining on the REDCap through the same access. Alternatively, the participant was required to return to the survey at another time, thus reminder messages were sent along with the individual access link automatically via email by REDCap and/or WhatsApp and social media through a manual system. Contacts were established every one day to complete the data collection. We continued sending reminders for up to seven weeks through emails and messages, to those who failed to complete the immediate follow-up.\u003c/p\u003e \u003cp\u003eThe same procedures were followed for data collection at the 8-week follow-up. After a period of eight weeks, the researchers contacted the participants again through the same means mentioned above, sending a link to return to the survey. The follow-up instrument contained some of the questions that were already asked at the beginning (such as beliefs and attitudes about LBP and pain-related self-efficacy - when in the presence of LBP in the previous 30 days and/or in the previous 12 months). Reminder messages were sent along with the individual access link automatically via email by REDCap and/or WhatsApp and other social media platforms manually by one of the research team members. The contact was established every three days to complete the data collection. We continued sending reminders up to 12 weeks, through emails and text messages, to those who failed to complete the 8-week follow-up. The outcome assessment was identical in the intervention and control groups. All outcome measures were self-reported.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec14\" class=\"Section2\"\u003e \u003ch2\u003e2.8 Data management and storage\u003c/h2\u003e \u003cp\u003eAll data will be stored in the REDCap server at Federal University of Ceara, and will be available for the investigators only. We de-identified the data and included email address and telephone numbers for reminders to complete the protocol. Prior to the commencement of the study, we developed a codebook for the survey and ran pilot tests for readability and clarity of the steps associated with its use. The participants were provided with a unique trial identification number, and any identifiers were concealed to guarantee the confidentiality of identity. Each participant was restricted to a single-entry permission for the survey only once, limited by the email address field. Using REDCap enabled us to monitor the completeness, accuracy and quality of data collection.\u003c/p\u003e \u003cp\u003eThe platform is secure for the storage and management of large databases. All data is being stored at the Federal University of Ceara REDCap login for 10 years and is available to investigators only, under login and password access. Researchers investigated and resolved any inconsistencies in the data. The master investigator will download, store and back up the data on the hard drive and on a secure cloud. The statistician will access the data contained in spreadsheets.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec15\" class=\"Section2\"\u003e \u003ch2\u003e2.9 Outcomes\u003c/h2\u003e \u003cdiv id=\"Sec16\" class=\"Section3\"\u003e \u003ch2\u003e2.9.1 Primary outcome\u003c/h2\u003e \u003cp\u003eBeliefs and attitudes about low back pain\u003c/p\u003e \u003cp\u003eThe primary outcome measure was the Back Pain Attitudes Questionnaire - Back-PAQ in its Brazilian version (Back Pain Attitudes Questionnaire - Back-PAQ-Br). This questionnaire has been translated and validated into Brazilian Portuguese with excellent internal consistency (Cronbach\u0026rsquo;s \u0026#120688; = 0.92, ranging from 0.917 to 0.925) and test-retest reliability (Intraclass Correlation Coefficient\u0026thinsp;=\u0026thinsp;0.94, ranging from 0.89 to 0.97\u0026ndash;95% CI). The instrument consists of 34 items related to beliefs and attitudes about LBP. Each item is assessed using a 5-point Likert scale, with the options of \u0026ldquo;False\u0026rdquo;, \u0026ldquo;Possibly False\u0026rdquo;, \u0026ldquo;Uncertain\u0026rdquo;, \u0026ldquo;Possibly True\u0026rdquo; and \u0026ldquo;True\u0026rdquo;. The answers are scored from \u0026minus;\u0026thinsp;2 (True) to 2 (False), and there are 11 items that are scored in reverse (items 1, 2, 3, 15, 16, 17, 27, 28, 29, 30 and 31). The scores range from \u0026minus;\u0026thinsp;68 to 68, with negative scores indicating unhelpful beliefs, whereas positive scores indicate helpful beliefs (\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e). This outcome was collected at baseline, immediate follow-up and 8-week follow-up of the research in order to determine the immediate and short-term effects of the intervention on changes in beliefs and attitudes about LBP.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec17\" class=\"Section3\"\u003e \u003ch2\u003e2.9.2 Secondary Outcome\u003c/h2\u003e \u003cp\u003eSelf-efficacy for pain\u003c/p\u003e \u003cp\u003eIf a participant has already experienced pain in the previous 30 days and/or in the previous 12 months, self-efficacy to deal with pain was also collected. We used the Pain Self-Efficacy Questionnaire - PSEQ in its adapted and validated version for Portuguese in Brazil. It has adequate internal consistency (Cronbach's of 0.90) and a p value considered significant (p\u0026thinsp;\u0026le;\u0026thinsp;0.008) after adjustment with the Bonferroni test (\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e). The instrument contains 10 items related to the individual's self-efficacy for pain. Each item is rated using a 7-point Likert scale (0\u0026ndash;6), with 0 representing \u0026ldquo;Not Completely Confident\u0026rdquo; and 6 representing \u0026ldquo;Completely Confident\u0026rdquo;. The scores range from 0 to 60, and the greater the sum, the greater the self-efficacy belief (\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e). This outcome was collected at baseline, immediate follow-up and 8-week follow-up of the research.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec18\" class=\"Section3\"\u003e \u003ch2\u003e2.9.3 Additional measures\u003c/h2\u003e \u003cp\u003e \u003cem\u003e2.9.3.1 Demographic data.\u003c/em\u003e Demographic data was collected at baseline, following the National Institutes of Health (NIH) task force research recommendations for LBP (\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e), such as gender (male or female), age (in years), marital status (married, living together, divorced, single, widowed) (\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e), academic level (illiterate or incomplete primary education, complete primary education or incomplete secondary education, complete secondary education or incomplete tertiary education, complete tertiary education), occupation (farming; industry; construction; commerce; accommodation and food; domestic services; financial information and other professional activities; public administrative, education, health and social services; transport, storage and mail; other services; student; retirees; unemployed), state where lives and social class according to the minimum wage ranges of the Brazilian Institute of Geography and Statistics average income household (A - more than twenty minimum wages, B - more than ten to twenty minimum wages, C - more than four to ten minimum wages, D - more than two to four minimum wages, E - until two minimum wages), estimated by the Brazilian Economic Classification Criteria (\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e).\u003c/p\u003e \u003cp\u003e \u003cem\u003e2.9.3.2 Electronic health literacy.\u003c/em\u003e The eHealth Literacy Scale - eHEALS was used in its Brazilian version. This scale was translated and validated for Brazilian Portuguese with good internal consistency (Cronbach's \u0026#120688; of 0.89, ranging from 0.086 to 0.88), with a mean of 28.02 (\u0026plusmn;\u0026thinsp;5.53, 8\u0026ndash;40) with a variation of 30.60. The scale proved to be valid and reliable to measure literacy levels in electronic health in Brazil. The instrument consists of 8 items, and each item is rated using a 5-point Likert scale, with options for \u0026ldquo;Completely Disagree\u0026rdquo;, \u0026ldquo;Disagree\u0026rdquo;, \u0026ldquo;Undecided\u0026rdquo;, \u0026ldquo;Agree\u0026rdquo; and \u0026ldquo;Strongly Agree.\u0026rdquo; The items are scored from 1 to 5, with the total score range being from 8 to 40. Lower scores correspond to a lower level of literacy in electronic health, while higher scores correspond to a higher level of literacy (\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e, \u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e). This outcome was collected at baseline only.\u003c/p\u003e \u003cp\u003e \u003cem\u003e2.9.3.3 Pain intensity.\u003c/em\u003e Furthermore, in the presence of LBP in the previous 30 days, pain intensity was assessed using the Numerical Pain Scale, which has been validated for both acute and chronic pain (\u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e). It consists of a scale with 11 discrete numbers (0\u0026ndash;10), wherein lower scores indicate a low level of pain, while higher scores indicate a high level of pain. The participant should report the presence of LBP in the previous 30 days preceding the data collection. The measurement of pain intensity was conducted at baseline if the participant has already experienced pain in the previous 30 days (see Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e for a comprehensive overview of the data collected at baseline, immediate and 8-week follow-ups).\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003c/ol\u003e \u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eOverview of the information collected at baseline and at immediate and 8-week follow-ups\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"6\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCharacteristics\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eScreening / Consent\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eBaseline\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eAllocation\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003eImmediate Follow-up\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c6\"\u003e \u003cp\u003e8-week\u003c/p\u003e \u003cp\u003eFollow-up\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDescriptive Variables\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eParticipant Screening / Consent Form\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eX\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eParticipant Characteristics\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eX\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSociodemographic\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eX\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eRandomization\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eX\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePrimary Outcome\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eBack Pain Attitudes Questionnaire\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eX\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003eX\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003eX\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSecondary Outcome\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePain Self-Efficacy Questionnaire (if applicable)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eX\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003eX\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003eX\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAdditional Measures\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eeHEALS\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eX\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePain Status (Stratification)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eX\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePain Intensity (if applicable)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eX\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"6\"\u003eeHEALS - Electronic Health Literacy Scale\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003e \u003cb\u003eInsert\u003c/b\u003e Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv id=\"Sec19\" class=\"Section2\"\u003e \u003ch2\u003e2.10 Statistical methods\u003c/h2\u003e \u003cdiv id=\"Sec20\" class=\"Section3\"\u003e \u003ch2\u003e2.10.1 Sample size calculations\u003c/h2\u003e \u003cp\u003eThe sample size was estimated at 366 participants (183 per group) and considering a loss of 20% during the follow-up, we needed 220 participants per group. We anticipated needing to approach double this number, presuming that 50% of those invited will consent to participate. Statistical parameters based on previous studies were used, namely: minimum expected mean difference of 10% for the selected primary outcome (1.0 point), assumed standard deviation of 3.4, effect size of 0.30, power of 80% and a significance level of 0.05 (95% CI), considering a normal (two-tailed) distribution hypothesis (\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e, \u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec21\" class=\"Section3\"\u003e \u003ch2\u003e2.10.2 Statistical analysis plan\u003c/h2\u003e \u003cp\u003eAnalyses will be performed by a blind statistician utilising intention-to-treat principles. Data will be analysed with JAMOVI version 1.6.23 and RStudio software (2023.03.0 Build 386) with a significance level of p\u0026thinsp;\u0026le;\u0026thinsp;0.05 (95% CI), considering a normal two-tailed distribution hypothesis. We will use the Shapiro-Wilk normality test to analyse data distribution. The data referring to the characterisation of the sample at baseline will be reported through descriptive statistics, incorporating measures of frequencies for categorical variables, mean and standard deviation for normally distributed continuous variables, and median and interquartile range otherwise.\u003c/p\u003e \u003cp\u003eWe will use the Mixed Linear Model Two-Way ANOVA to calculate the difference between groups on the beliefs and attitudes regarding LBP and self-efficacy for pain outcomes at follow-up, considering that each construct will be measured at different time points (baseline, immediate follow-up and 8-week follow-up) and in two groups, intervention and control. We will examine the effects considering the presence of pain in the previous 30 days or in the past 12 months on the primary outcome of beliefs and attitudes about LBP. The model will be adjusted by the covariates e-health literacy, self-efficacy for pain, age, education level, occupation and family income.\u003c/p\u003e \u003cp\u003eTo assess the association between e-health literacy and the difference in mean beliefs and attitudes, and the association between pain-related self-efficacy and the difference in mean beliefs and attitudes, we will perform Pearson's or Spearman's Coefficient. Later, we will use Multivariate Linear Regression to investigate the relationship between these variables and changes in the primary outcome, adjusting the model for age, education level, occupation, family income and pain occurrence.\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv id=\"Sec22\" class=\"Section2\"\u003e \u003ch2\u003e2.11 Patient and Public involvement\u003c/h2\u003e \u003cp\u003eIndividuals with LBP were actively involved during the development of the digital content material delivered for the intervention group. They were asked to provide their comprehension, and preferences for each of the proposed materials. Members from the general public were consulted regarding the usability and accessibility of the project on the REDCap platform, through a pilot study.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec23\" class=\"Section2\"\u003e \u003ch2\u003e2.12 Ethics and dissemination\u003c/h2\u003e \u003cp\u003e The RCT was approved by the Human Research Ethics Committee from the Federal University of Ceara (5.336.455/2022) and it was prospectively registered at The Brazilian Registry of Clinical Trials (ReBEC RBR-10kpgx78). Current protocol is version 1 (28 September 2022) and no modifications were registered on ReBEC and the Ethics Committee. We requested informed consent from all individuals before participation. All participants were informed about the objectives, benefits and harms of the study, and they were free to withdraw from it at any time without consequences. The methods for safeguarding all databases were elucidated, while ensuring the privacy and confidentiality of the participants. The findings of the study will be published in peer-reviewed international journals, as well as presented at national and international conferences.\u003c/p\u003e \u003c/div\u003e"},{"header":"3 Discussion","content":"\u003cp\u003eHigh and low-income countries have already carried out observational studies characterizing beliefs and attitudes about LBP in their populations (\u003cspan additionalcitationids=\"CR33\" citationid=\"CR32\" class=\"CitationRef\"\u003e32\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR34\" class=\"CitationRef\"\u003e34\u003c/span\u003e). Quasi-experimental, nonrandomised studies were conducted in high-income countries, with the intervention being a multimedia campaign on open television (\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e, \u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e, \u003cspan citationid=\"CR35\" class=\"CitationRef\"\u003e35\u003c/span\u003e), rather than an RCT. A trial can contribute to exploring the potential of mass digital health campaigns about LBP.\u003c/p\u003e \u003cp\u003eThere was a gap in this field of investigation, which was the development of an RCT to analyse the specific effect of educational material on changes in beliefs and attitudes about LBP in the world. The protocol presented here outlines the steps of this investigation and describes the intervention material used, including its formats and central messages based on the Lancet Series (2018). It is personalised to the intervention scenario. The intervention is being implemented in Brazil, a country in the middle and low-income block, where the impact of LBP on individual and social disability is even greater, considering the association of disability with lower socioeconomic levels and the occupational demand experienced (\u003cspan citationid=\"CR36\" class=\"CitationRef\"\u003e36\u003c/span\u003e, \u003cspan citationid=\"CR37\" class=\"CitationRef\"\u003e37\u003c/span\u003e). We are not solely focusing on characterizing the population's beliefs and attitudes about LBP, but also testing a specific digital health education material that has the potential to change beliefs and reduce the impact due to LBP in the community.\u003c/p\u003e \u003cp\u003eThe project's development in REDCap is a strength of our trial. The project was carefully designed, with the implementation of varied functions, so that the platform had a friendly presentation and clear communication with the respondent. The platform explained each stage of the process throughout the survey and sought participant autonomy when following the research. We implemented functionalities to the project that enabled the inclusion of conditional eligibility criteria; digital ethical acceptance; transcription of self-reported questionnaires; stratification according to LBP status; plotting of digital intervention material; randomisation; allocation into intervention and control groups; and creation of QR Code and link for recruitment.\u003c/p\u003e \u003cp\u003eAnother advantage is that the study intervention comprises a collection of materials with diverse presentation styles, and in this sense, each of the models can interest diverse consumers. Some people will be more prone to the infographics, the video, or the booklet. This is potentially advantageous as it aims to engage individuals with diverse behavioural profiles using accessible language and format, in Portuguese.\u003c/p\u003e \u003cp\u003eIf we can demonstrate that this package of educational digital material can enhance beliefs and attitudes regarding the confrontation and self-management of LBP, we can improve the dissemination of this digital material through social media. Public policy makers would be asked to increase the dissemination of this material, in order to improve public health across the country.\u003c/p\u003e \u003cp\u003eAs this is an electronic designed intervention, it implied that its participants had a cell phone or a computer and internet access, which can limit generalising findings for those with lower socioeconomic status or less familiar with technology. To minimise this limitation, materials were conceived in formats that could be seen in either computers or mobile phones, and REDCap was pilot tested to allow its visualisation for either electronic mode.\u003c/p\u003e"},{"header":"Declarations","content":"\u003ch2\u003eFunding\u003c/h2\u003e \u003cp\u003eThis research did not receive any specific grants from funding agencies in the public, comercial or non-profit sectors.\u003c/p\u003e\u003ch2\u003eAcknowledgments\u003c/h2\u003e \u003cp\u003eTo the scholarships holders and volunteers involved in this project (APSB, FBP, LCF, MIAC). This work is supported by the \u0026ldquo;Programa Institucional de Bolsas de Inicia\u0026ccedil;\u0026atilde;o Cient\u0026iacute;fica\u0026rdquo; from the Federal University of Ceara. The development of the intervention digital material was supported by the IASP Developing Countries Project: Initiative for Improving Pain Education. The development of the web platform REDCap project was supported by the \u0026ldquo;N\u0026uacute;cleo de Apoio ao Pesquisador da Unidade de Pesquisa Cl\u0026iacute;nica do Complexo de Hospitais Universit\u0026aacute;rios da UFC/EBSERH\u0026rdquo; Researcher Support Center of the Clinical Research Unit of the University Hospitals Complex UFC/EBSERH.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eFerreira ML, De Luca K, Haile LM, Steinmetz JD, Culbreth GT, Cross M et al (2023) Global, regional, and national burden of low back pain, 1990\u0026ndash;2020, its attributable risk factors, and projections to 2050: a systematic analysis of the Global Burden of Disease Study 2021. Lancet Rheumatol 5(6):e316\u0026ndash;e329\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eCarregaro RL, da Silva EN, van Tulder M (2019) Direct healthcare costs of spinal disorders in Brazil. Int J Public Health 64(6):965\u0026ndash;974\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eCarregaro RL, Tottoli CR, da Silva Rodrigues D, Bosmans JE, da Silva EN, van Tulder M (2020) Low back pain should be considered a health and research priority in Brazil: Lost productivity and healthcare costs between 2012 to 2016. PLoS ONE. ;15(4)\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBuchbinder R, van Tulder M, \u0026Ouml;berg B, Costa LM, Woolf A, Schoene M et al (2018) Low back pain: a call for action. Lancet 391(10137):2384\u0026ndash;2388\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eFoster NE, Anema JR, Cherkin D, Chou R, Cohen SP, Gross DP et al (2018) Prevention and treatment of low back pain: evidence, challenges, and promising directions. Lancet 391(10137):2368\u0026ndash;2383\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHartvigsen J, Hancock MJ, Kongsted A, Louw Q, Ferreira ML, Genevay S et al (2018) What low back pain is and why we need to pay attention. Lancet 391(10137):2356\u0026ndash;2367\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGeorge SZ, Fritz JM, Silfies SP, Schneider MJ, Beneciuk JM, Lentz TA et al (2021) Interventions for the Management of Acute and Chronic Low Back Pain: Revision 2021. J Orthop Sports Phys Ther 51(11):CPG1\u0026ndash;60\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBuchbinder R, Underwood M, Hartvigsen J, Maher CG (2020) The Lancet Series call to action to reduce low value care for low back pain: an update. Pain 161(9):S57\u0026ndash;64\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBarbari V, Storari L, Ciuro A, Testa M (2020) Effectiveness of communicative and educative strategies in chronic low back pain patients: A systematic review. Patient Educ Couns 103(5):908\u0026ndash;929\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eDu S, Hu L, Dong J, Xu G, Chen X, Jin S et al (2017) Self-management program for chronic low back pain: A systematic review and meta-analysis. Patient Educ Couns 100(1):37\u0026ndash;49\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003ePincus T, Holt N, Vogel S, Underwood M, Savage R, Walsh DA et al (2013) Cognitive and affective reassurance and patient outcomes in primary care: A systematic review. Pain 154(11):2407\u0026ndash;2416\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHodges PW, Hall L, Setchell J, French S, Kasza J, Bennell K et al (2021) Effect of a consumer-focused website for low back pain on health literacy, Treatment choices, and clinical outcomes: Randomized controlled trial. J Med Internet Res 23(6):e27860\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eLee H, Moseley GL, H\u0026uuml;bscher M, Kamper SJ, Traeger AC, Skinner IW et al (2015) Understanding how pain education causes changes in pain and disability: Protocol for a causal mediation analysis of the PREVENT trial. J Physiother 61(3):156\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBuchbinder R, Jolley D, Wyatt M (2001) Volvo award winner in clinical studies: Effects of a media campaign on back pain beliefs and its potential influence on management of low back pain in general practice. Spine (Phila Pa 1976). 2001;26(23):2535\u0026ndash;42\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGross DP, Russell AS, Ferrari R, Batti\u0026eacute; MC, Schopflocher D, Hu R et al (2010) Evaluation of a Canadian Back Pain Mass Media Campaign. Eur Spine J 35(8):906\u0026ndash;913\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eWerner EL, Ihleb\u0026aelig;k C, L\u0026aelig;rum E, Wormgoor MEA, Indahl A (2008) Low back pain media campaign: No effect on sickness behaviour. Patient Educ Couns 71(2):198\u0026ndash;203\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKamper SJ (2018) Control Groups: Linking Evidence to Practice. J Orthop Sports Phys Ther 48(11):905\u0026ndash;906\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eEysenbach G, Group C (2011) ehealth. CONSORT-EHEALTH: Improving and Standardizing Evaluation Reports of Web-based and Mobile Health Interventions Corresponding Author : J Med Internet Res. ;13(4):e126\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eChan Awen, Tetzlaff JM, Altman DG, Laupacis A, G\u0026oslash;tzsche PC, Krleža-Jerić K et al (2016) SPIRIT 2013 Statement: Defining Standard Protocol Items for Clinical Trials. Ann Intern Med 158(3):200\u0026ndash;207\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSilveira F (2016) Guia RedCap [Internet]. S\u0026atilde;o Paulo: N\u0026uacute;cleo de Tecnologia da Informa\u0026ccedil;\u0026atilde;o. Faculdade de Ci\u0026ecirc;ncias M\u0026eacute;dica. Unicamp.; Available from: \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://wiki.fcm.unicamp.br/images/Manual_Redcap.pdf\u003c/span\u003e\u003cspan address=\"https://wiki.fcm.unicamp.br/images/Manual_Redcap.pdf\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHoffmann TC, Glasziou PP, Boutron I, Milne R, Perera R, Moher D et al (2014) Better reporting of interventions: Template for intervention description and replication (TIDieR) checklist and guide. BMJ 348:g1687\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKrug RC, Carneiro J, Ribeiro DC, Darlow B, Silva MF, Loss JF (2019) Back Pain attitudes questionnaire: Cross-cultural adaptation to brazilian-portuguese and measurement properties. Rev Bras Psiquiatr 41(1):1\u0026ndash;2\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSard\u0026aacute; J, Nicholas MK, Pimenta CAM, Asghari A (2007) Pain-related self-efficacy beliefs in a Brazilian chronic pain patient sample: A psychometric analysis. Stress Heal 23(3):185\u0026ndash;190\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBonaf\u0026eacute; FSS, Mar\u0026ocirc;co J, Campos JADB (2018) Pain self-efficacy questionnaire and its use in samples with different pain duration time. Brazilian J Pain 1(1):33\u0026ndash;39\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eDeyo RA, Dworkin SF, Amtmann D, Andersson G, Borenstein D, Carragee E et al (2014) Report of the NIH task force on research standards for chronic low back pain. J Pain 15(6):569\u0026ndash;585\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eTartuce F (2019) Direito Civil: direito de fam\u0026iacute;lia, 14th edn. Forense, Rio de Janeiro\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eIBGE - Instituto Brasileiro de Geografia e Estat\u0026iacute;stica. S\u0026iacute;ntese de Indicadores Sociais: uma an\u0026aacute;lise das condi\u0026ccedil;\u0026otilde;es de vida da popula\u0026ccedil;\u0026atilde;o brasileira 2020 [Internet]. Rio de Janeiro: Estudos e Pesquisas. Informa\u0026ccedil;\u0026atilde;o Demogr\u0026aacute;fica e Socioecon\u0026ocirc;mica, ISSN 1516\u0026ndash;3296; n. 43 (2020) 148p. Available from: \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://biblioteca.ibge.gov.br/visualizacao/livros/liv101760.pdf\u003c/span\u003e\u003cspan address=\"https://biblioteca.ibge.gov.br/visualizacao/livros/liv101760.pdf\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMASCHIO KF, SILVA KiK da (2019) the Ehealth Literacy Scale (Eheals) \u0026ndash; Tradu\u0026ccedil;\u0026atilde;o E Valida\u0026ccedil;\u0026atilde;o Da Vers\u0026atilde;o Brasileira De Uma Escala De Alfabetiza\u0026ccedil;\u0026atilde;o Em Sa\u0026uacute;de Eletr\u0026ocirc;nica [Internet]. Trabalho de conclus\u0026atilde;o de curso. Available from: \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://rd.uffs.edu.br/handle/prefix/3704\u003c/span\u003e\u003cspan address=\"https://rd.uffs.edu.br/handle/prefix/3704\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMialhe FL, Moraes KL, Sampaio HA, de Brasil C, Vila VV, Soares VdaSC (2022) Evaluating the psychometric properties of the eHealth Literacy Scale in Brazilian adults. Rev Bras Enferm 75(1):1\u0026ndash;8\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBijur PE, Latimer CT, Gallagher EJ (2003) Validation of a verbally administered numerical rating scale of acute pain for use in the emergency department. Acad Emerg Med 10(4):390\u0026ndash;392\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSharma S, Traeger AC, O\u0026rsquo;Keeffe M, Copp T, Freeman A, Hoffmann T et al (2021) Effect of information format on intentions and beliefs regarding diagnostic imaging for non-specific low back pain: A randomised controlled trial in members of the public. Patient Educ Couns 104(3):595\u0026ndash;602\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eChriste G, Pizzolato V, Meyer M, Nzamba J, Pichonnaz C (2021) Unhelpful beliefs and attitudes about low back pain in the general population: A cross-sectional survey. Musculoskelet Sci Pract [Internet] 52:102342\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHo-A-Tham N, Ting-A-Kee B, Struyf N, Vanlandewijck Y, Dankaerts W (2021) Low back pain prevalence, beliefs and treatment-seeking behaviour in multi-ethnic Suriname. Rheumatol Adv Pract 5(3):1\u0026ndash;10\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003ePierobon A, Policastro PO, Soli\u0026ntilde;o S, Andreu M, Novoa G, Raguzzi I et al (2020) Beliefs and attitudes about low back pain in Argentina: A cross-sectional survey using social media. Musculoskelet Sci Pract 49:102183\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eWaddell G, O\u0026rsquo;Connor M, Boorman S, Torsney B (2007) Working backs Scotland: A public and professional health education campaign for back pain. Spine (Phila Pa 1976) 32(19):2139\u0026ndash;2143\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSharma S, Mcauley JH (2022) Low Back Pain in Low- and Middle-Income Countries, Part 1: The Problem. J Orthop Sports Phys Ther 52(5):233\u0026ndash;235\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eFatoye F, Gebrye T, Mbada CE, Useh U (2023) Clinical and economic burden of low back pain in low- and middle-income countries: a systematic review. BMJ Open 13(4):1\u0026ndash;7\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":true,"hideJournal":true,"highlight":"","institution":"Federal University of Ceara","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"Low Back Pain, Health Knowledge, Attitudes, Practice, Self Efficacy, Health Education, Controlled Clinical Trial","lastPublishedDoi":"10.21203/rs.3.rs-8584307/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-8584307/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eBackground\u003c/h2\u003e \u003cp\u003ePromoting appropriate beliefs and attitudes about low back pain (LBP) in the community is a promising component of an educational strategy to aid the management of LBP.\u003c/p\u003e\u003ch2\u003eObjective\u003c/h2\u003e \u003cp\u003eWe aim to investigate whether a digital pain education material improved LBP beliefs and attitudes of community consumers; to identify whether e-health literacy and pain self-efficacy are associated with changes in beliefs; to verify whether this exposure generates changes in pain self-efficacy in people with LBP.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e \u003cp\u003e The study was approved by the Human Research Ethics Committee from the Federal University of Ceara (5.336.455/2022) and registered at The Brazilian Registry of Clinical Trials (ReBEC - RBR-10kpgx78). We projected the conduction of a web-based randomised controlled trial with adults, randomised to one of two digital educational content packages: 1) digital LBP education materials; 2) general health information. The primary outcome was beliefs and attitudes about LBP (Back Pain Attitude Questionnaire); secondary outcomes were e-health literacy (eHealth Literacy Scale) and self-efficacy (Pain Self-Efficacy Questionnaire). Outcomes were measured at baseline, immediate and eight weeks post-exposure. Mixed linear models will be used to estimate between-group differences. Recruitment started in December 2022 and data collection was completed in December 2023.\u003c/p\u003e\u003ch2\u003eConclusion\u003c/h2\u003e \u003cp\u003eThe study is innovative because the design allows the investigation of the effect of digital material on the beliefs about LBP in Brazilian people. The results can contribute to exploring the potential of digital mass health campaigns about LBP.\u003c/p\u003e","manuscriptTitle":"Effect of a Digital Pain Education Material on Beliefs and Attitudes about Low Back Pain in the General Community: Study Protocol for a Web-Based Randomised Controlled Trial","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2026-01-14 16:53:49","doi":"10.21203/rs.3.rs-8584307/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"e0bd47d7-35cd-4a29-b536-0a18c20ed8d2","owner":[],"postedDate":"January 14th, 2026","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[{"id":61016165,"name":"Physical Medicine \u0026 Rehab"},{"id":61016166,"name":"Orthopedics"}],"tags":[],"updatedAt":"2026-01-14T16:53:49+00:00","versionOfRecord":[],"versionCreatedAt":"2026-01-14 16:53:49","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-8584307","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-8584307","identity":"rs-8584307","version":["v1"]},"buildId":"XKTyCvWXoU3ODBz1xrDgd","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}