Efficacy of capacitive resistive monopolar radiofrequency in the physiotherapeutic treatment of chronic pelvic pain syndrome: study protocol for a Randomized Controlled Trial

Efficacy of capacitive resistive monopolar radiofrequency in the physiotherapeutic treatment of chronic pelvic pain syndrome: study protocol for a Randomized 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 Study protocol Efficacy of capacitive resistive monopolar radiofrequency in the physiotherapeutic treatment of chronic pelvic pain syndrome: study protocol for a Randomized Controlled Trial Andrea Carralero-Martínez, Miguel Ángel Muñoz Pérez, Regina Pané-Alemany, and 3 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-194630/v1 This work is licensed under a CC BY 4.0 License Status: Under Review Version 1 posted 13 You are reading this latest preprint version Abstract Background Chronic Pelvic Pain Syndrome (CPPS) is a multifactorial disorder that affects 5.7–26.6% of women and 2.2–9.7% of men, characterized by a hypersensitivity of the central and peripheral nervous system affecting bladder and genital function. People with CPPS have much higher rates of psychological disorders (anxiety, depression, and catastrophizing) that increase the severity of chronic pain and worsen quality of life. Myofascial therapy, manual therapy, and treatment of trigger points are proven therapeutic options for this syndrome. The aim of this study is to evaluate the efficacy of capacitive resistive monopolar radiofrequency (CRMRF) at 448 KHz as an adjunct treatment to the other physiotherapeutic techniques for reducing pain and improving the quality of life of patients with CPPS. Methods This triple-blind (1:1) randomized controlled trial will include 80 women and men with CPPS. Participants will be randomized into CRMRF activated group or CRMRF deactivated group, together with physiotherapeutic techniques and pain education. The groups will receive treatment for 10 consecutive weeks. Pain intensity (with the VAS), quality of life (with the SF-12), kinesiophobia (with the TSK-11) and catastrophism (with the PCS) will be evaluated at the beginning, at the sixth and the tenth session. Discussion The results of this study will make it possible to prove that CRMRF benefits the treatment of patients with CPPS together with physiotherapeutic techniques and pain education. These results could offer another conservative treatment option for these patients. Trial registration: ClinicalTrials.gov Identifier: NCT03797911. Registered 8 January 2019, https://clinicaltrials.gov/ct2/show/NCT03797911 Orthopedics Chronic pelvic pain syndrome musculoskeletal pain physical therapy therapeutic interventions capacitive resistive monopolar radiofrequency Randomized Controlled Trial gynecology urology Background Chronic Pelvic Pain Syndrome (CPPS) is defined as “pain of non-oncological cause, intermittent or constant, in the lower part of the abdomen or pelvis, in both men and women, lasting at least 6 months, and with negative consequences that can be cognitive, behavioral, sexual and emotional" [ 1 – 2 ]. It is a multifactorial disorder serious enough to cause urinary and genital functional disability and with a high prevalence (5.7–26.6% of women, and 2.2–9.7% of men) [ 3 – 8 ]. People with CPPS have much higher rates of psychological distress. The prevalence of anxiety ranges between 39–73% compared to the general population (12%), as the prevalence of depression is 26–52% compared to 5–10% of the general population [ 9 – 13 ]. These conditions, along with catastrophizing, are associated with an increased severity of chronic pain and reduction of quality of life [ 4 , 14 – 18 ]. In addition, people with CPPS tend to have central and peripheral nervous system hypersensitivity, with dysfunctional pain modulation that tends to aggravate pain [ 19 – 24 ]. In physical therapy consultations, there are a variety of therapeutic options with sufficient evidence to guide physical therapy for patients with CPPS [ 25 ]. The most widely used is myofascial therapy, although this group of patients should be treated from a multidisciplinary approach along with other therapies such as psychology, medication or surgery when other treatments have failed [ 26 , 27 ]. One of these options in clinical practice is capacitive resistive monopolar radiofrequency (CRMRF) at 448 KHz, which consists of a non-invasive strategy that increases the temperature of deep organs or tissues through the action of radiofrequency electrical currents with the aim of reducing pain and inflammation and increasing tissue repair [ 28 – 35 ]. There are few recent studies that evaluate its clinical efficacy despite the fact that its practice has been common for the last 20 years [ 36 ]. Current studies report promising results in terms of pain reduction and improved function in musculoskeletal pathologies (such as low back pain) [ 37 ] and tendinopathies (such as plantar fasciitis) [ 38 – 40 ]. In spite of its demonstrated efficacy in other musculoskeletal pathologies, there is currently insufficient scientific evidence regarding its role in the management of CPPS. Methods The aim The study hypothesizes that the application of CRMRF associated with physiotherapy techniques and health education provides benefits in reducing pain compared to physiotherapy and health education techniques alone in the management of patients with CPPS. The specific aims are to evaluate the efficacy of the CRMRF according to the intensity of pain, quality of life, kinesiophobia and catastrophism of the patients participating in the study. In addition, sociodemographic and clinical data, adherence to treatment and possible adverse effects during treatment will be recorded in both groups. Study design This manuscript describes a research protocol for a triple blind, randomized controlled clinical trial. Participants will be equal (1:1) randomly allocated into activate capacitive resistive monopolar radiofrequency group (intervention group, IG) and deactivate capacitive resistive monopolar radiofrequency (control group, CG). Both groups will receive pain education and physiotherapeutic techniques (myofascial therapy, trigger point therapy, and/or manual therapy). Participants, the investigators performing the intervention and the statistical analyses will be blinded. An analysis of the results will be carried out at six and ten weeks of treatment. Study locations This trial will take place at RAPbarcelona pelvic floor specialized physiotherapy center in Barcelona. Study population Patients who consult in the center for a first visit or who are derived from other health professionals who know the protocol of this study, will be invited to participate in this study. To be eligible, participants must meet the following criteria. Inclusion criteria: Being of legal age, suffering from CPPS for 6 months or more (etiologies will include: Myofascial Syndrome, Endometriosis, Adenomyosis, Abacterial Prostatitis, Interstitial Cystitis, Levator Ani Syndrome, Pudendal Nerve Syndrome, Nonspecific CPPS) and accepting to participate in the study granting signed informed consent. Exclusion criteria: undergoing other conservative treatments during the study, having undergone treatment with chemotherapy or radiotherapy in the pelvic area, having recently undergone an oncological process, being pregnant, having undergone surgery in the pelvic area in the last 3 months, presenting fibromyalgia or chronic fatigue, suffering serious psyche disorders, presenting hypersensitivity in the skin that may be in contact with the treatment, and suffering neuromuscular diseases. Investigations Patients who agree to participate in the study will be given an appointment by telephone and will receive CRMRF therapy for 30 minutes once a week (except for the first session, which will last 45–60 minutes to deliver the patient information and sign the informed consent, to resolve doubts about the study, about the questionnaires and, finally, to explain the theory of pain and health education). At baseline, participants will undergo an initial assessment where data on age, medical history, surgical history and clinical data will be collected. According to criteria used in previous similar studies [ 41 , 42 ] a palpation of the abdominal, lumbosacral, and perineal region will be performed, followed by internal palpation using the index finger at the vaginal and/or anal level to palpate the pelvic floor muscles, tissue connective and internal organs, and localize pain. The Visual Analogic Scale (VAS) to measure the intensity of pain, the health questionnaire Short Form 12 (SF-12) to assess their quality of life, the Tampa Scale for Kinesiophobia (TSK-11) to assess kinesiophobia, and the Pain Catastrophizing Scale (PCS) to assess catastrophism will be evaluated at first visit. The same tests will be re-evaluated at 6 and 10 sessions. Also, in each session, treatment adherence and possible adverse effects of the therapy will be identified and recorded in a database designed for the project. A total of ten treatment physiotherapy sessions will be held on a weekly basis (Table 1 ). Both groups will follow the same protocol that will consist of applying the CRMRF (INDIBA Activ CT8 → ) at 2% to induce an electrical and athermic effect, along with pain education and physiotherapeutic techniques [ 43 , 44 ] according to the location of the pain (Table 2 ) that will be applied at the same time as the CRMRF. Participants will be placed comfortably in a supine or prone position (depending on the area to be treated) with a pillow under their heads, without pants or underwear. The plate will be placed on the abdomen or lower back depending on the patient's position on the stretcher, and the 32 mm resistive electrode will be used to apply the CRMRF to the painful area. Table 1 Treatment sessions Intervention group (IG) Control group (CG) SESSION 1 Delivery of the information sheet and signing of the informed consent. Collection and recording of baseline data (age, sociodemographic data, clinical data, and medical and surgical history). Self-completion of tests (VAS, SF-12, TSK-11 and PCS). Application of physiotherapeutic techniques with activated CRMRF. Explanation of the theory of pain and health education. Application of physiotherapeutic techniques with deactivated CRMRF. Explanation of the theory of pain and health education. SESSION 2–5 Session protocol: • Registration of possible discomfort or adverse effects perceived by the patient. • Application of physiotherapeutic techniques with activated CRMRF. • Pain education clarifications Session protocol: • Registration of possible discomfort or adverse effects perceived by the patient. • Application of physiotherapeutic techniques with deactivated CRMRF. • Pain education clarifications SESSION 6 Collection of VAS, SF-12, TSK-11 and PCS tests. Session protocol (as described in session 2–5) SESSION 7–9 Session protocol (as described in session 2–5) SESSION 10 Session protocol (as described in session 2–5) Assessment of VAS, SF-12, TSK-11, PCS tests, evolution of the pathology and referral (if required). Participants in the IG will receive the treatment with the activated CRMRF (emitting electrical signal) and the participants in the CG will receive the same treatment with the deactivated CRMRF (without emitting electrical signal). This CRMRF equipment is designed to perform the conventional treatment (IG) and a placebo treatment (CG) without being visible to either the therapist or the participant. The team produces an automatic randomization for each participant according to the order of study assignment. Pain education will consist of a basic theory about gate control [ 45 ], concepts of pain and central sensitization, and a basic explanation of the neurotransmitters that influence the increase or decrease in pain [ 46 – 48 ]. The physiotherapeutic techniques that will be performed in each session will always be the same in all individualized treatment sessions for each patient that will be assigned according to the location of the pain (Table 2 ). These will be those recommended by the literature for the treatment of CPPS, which will consist of myofascial induction techniques, trigger point therapy, and manual therapy with the aim of improving the elasticity of the musculature and fascial tissue and improving blood flow. These techniques will be performed with smooth and slow movements, and always from more indirect to more direct, and from more distal to more local [ 49 ]. Table 2 Physiotherapeutic techniques and position of the patient during treatment sessions, depending on the location of the pain Previous location (abdomen, pubis, groin, perineum, vagina, penis, testicles) Posterior location (lumbar, sacrum, coccyx, buttocks, anus, rectum) Position: Patient in supine position. CRMRF plate in lower back Patient in the prone position. CRMRF plate in abdomen Techniques: • Abdominal area: - Lift techniques of the peritoneum - Liberation of the urachus • Groin area: - Stretching the inguinal ligament - Myotensive techniques of the internal obturator • Vulvar, perineal and vaginal area: - Relaxation of the superficial fascia of the perineum - Stretching the prevesical ligament - Uterine release techniques - Stretching of the round ligament - Stretching of the wide ligament - Relaxation of the sacrorectogenitopubian laminae - Release of the pudendal nerve in Alcock’s canal • Penis and testicular area: - Relaxation of the superficial fascia of the perineum - Relaxation of the deep fascia of the perineum - Testicular drainage • Lumbosacral area: - Relaxation of the quadratus lumbar - Relaxation of the paravertebral muscles • Gluteal area: - Decompression of the pudendal nerve in the greater sciatic foramen - Stretching of the sacrociatic ligament - Stretching of the sacrotuberous ligament - Release of the pudendal nerve in the ischiorectal fossa - Myotensive techniques of the pyramidal - Myotensive techniques of the external obturator • Anorectal area: - Sacral plexus release techniques - Relaxation of the sacrorectogenitopubian laminae - Stretching the Denonvilliers fascia - Prostate release techniques If there is a scar, manual scar work is performed and the 35mm resistive electrode is applied over it. As this is a study with multiple tests and interventions, several physical therapists will be needed to be able to carry it out. For this reason, to avoid errors due to lack of standardization, there will be a training period in the application of the therapy and data collection for all the physiotherapists who will participate in the study. Outcome measures Participants will complete three study assessments: baseline, 6 and 10 weeks after first session. Primary outcome: Intensity of pain: According to the VAS score, evaluated in the first, sixth and tenth sessions of the study. This quantitative and subjective variable consists of marking the degree of intensity of pain in a straight horizontal line of fixed length of 10cm. The ends are defined as the extreme limits of the parameter to be measured orientated from the left (worst) to the right (best) [ 50 , 51 ]. Secondary outcomes: Quality of life related to health: Measured with the SF-12 Quality of Life health questionnaire. Is a generic questionnaire that we will use the Spanish adaptation done by Alonso et al [ 52 , 53 ] of the SF-12 Health Survey [ 54 , 55 ]. The SF-12 is a reduced version of the SF-36 Health Questionnaire designed for cases in which this is too long. The SF-12 is answered in an average of ≤ 2 min and the SF-36 needs between 5 and 10 min. It consists of 12 items from the 8 dimensions of the SF-36 (physical function, social function, physical role, emotional role, mental health, vitality, body pain and general health status). Higher score means better quality of life. Kinesiophobia: Fear of movement will be measured by Tampa Scale for Kinesiophobia (TSK-11). This questionnaire created by Miller et al [ 56 ] quantifies the intensity of kinesiophobia suffered by the patient, and we will use the reduced version and adaptation to Spanish by Gómez-Pérez et al [ 57 ]. It consists of 11 statements that the patient must answer using a Likert-type scale from 1 (totally disagree) to 4 (totally agree). Higher score means higher degree of kinesiophobia. Catastrophizing: Measured with the Pain Catastrophizing Scale (PCS) [ 58 ]. This 13-item questionnaire assesses the patient's catastrophic thoughts using a five-point Likert scale. It consists of three subscales (rumination, magnification, hopelessness). Higher score means higher degree of catastrophizing. The Spanish adaptation validated by García Campayo et al [ 59 ] will be used. Sociodemographic variables, pathological history and clinical history: Assessed in the first session of the treatment, collected through a standardized clinical history. Adverse effects: Recorded in each of the treatment sessions through the patient references about his status and evolution. Adherence to treatment: Assessed in each of the treatment sessions, collected through a compliance from designed for the project. Schedule Table 3 The different schedule phases are shown in italics. Recruitment Session 1 Sessions 2–5 Session 6 Sessions 7–9 Session 10 Recruitment : Selection screening X Informed consent X Allocation X Interventions : Intervention CG (deactivated CRMRF X X X X X Intervention IG (activated CRMRF) X X X X X Evaluations : Descriptive variables X Clinical variables X VAS X X X SF-12 X X X TSK-11 X X X PCS X X X Compliance form X X X X X Recording of adverse effects X X X X X Sample size To estimate the sample size, we use the sample size calculator of the “GRANMO” program. This version 7.12 of April 2012 can be obtained at the following link on the website https://www.imim.es/ofertadeserveis/software-public/granmo/ . For this estimate, alpha values of 5% and beta of 20% (power of 80%) were taken into account. Based on data published in the literature [ 60 ] and applying a common standard deviation of 3 and a difference equal to or greater than 2 in the VAS, 40 patients are needed in each arm of the study, assuming a maximum percentage of follow-up losses/dropouts of 10%. Selection of the sample The selection of the sample will be done by sampling of consecutive cases, from RAPbarcelona clinic in Barcelona. Health professionals from other institutions will be contacted to increase referrals to the center, and an advertising campaign will be carried out on social networks. In physiotherapists appointments, patients with CPPS will be referred to the principal investigator. The protocol will be clearly explained to each of the interested patients who meet all the selection criteria, and he will be asked to sign the informed consent if accept participation. After the signature the patient will be allocated to one of the two study groups. Random allocation of groups Once the participants are included in the study, they will be identified from the number of the computerized Medical Record, and they will be ordered sequentially and consecutively from 1 to 80 according to the order of recruitment. To assign interventions, CRMRF team engineers will enter into the software the randomized sequence corresponding to each number from 1 to 80 to designate the CG and IG participants. In order to keep the assigned study group hidden from the patient, the physiotherapist and the main researcher, the following four indications will be taken into account: 1) No parameter will appear at any time on the visible screen of the CRMRF team that can reflect if the machine performs any activity. 2) The current intensity parameter will be 2% in all participants, to prevent the intervention group patients from perceiving any thermal effect. 3) The physiotherapists will perform the application of the CRMRF by manipulating the equipment with the handle and never with the electrode to avoid any sensation. They will be trained before starting the study. 4) The sequence of randomization and allocation will be kept hidden at all times for all patients, professionals and for the main researcher, until the statistical analysis once the entire intervention is finished. Collection, management and data analysis The data will be collected in a specific database coded for this study, which will only be available to the main researcher. The database and statistical analysis will be performed with IBM SPSS Statistics 24.0 software. First, a descriptive analysis of the characteristics of the patients included in both study groups, as well as the outcome variables will be carried out. To do this, absolute and relative frequencies (percentages) will be estimated for qualitative variables, and mean or median and standard deviation or range, respectively, depending on the normality of the distribution, for quantitative variables. Afterwards, the comparative analysis of the two treatment groups will be carried out using the Chi-square test for qualitative variables, and with the Student's t test for quantitative variables. Additionally, different associations between diverse variables will be analyzed. To check for the efficacy of the study treatments, intention to treat (ITT) and by protocol (PP) analysis will be performed. The comparison of results will be done by estimating the differences in a timely manner and with their corresponding 95% confidence intervals (95% CI). Additionally, the adjusted differences will be calculated, following the indications of the CONSORT document [ 61 ]. In all cases, the level of statistical significance established will be the usual (5%); therefore, statistically significant differences will be considered when p values are less than 0.05. Discussion The results of this study will make it possible to prove that CRMRF benefits the treatment of patients with CPPS together with physiotherapeutic techniques and pain education. These results could offer another conservative treatment option for these patients. Trial Status This is the first version of the protocol (January 28, 2021). Recruitment began in April 2019 and the intervention has had to stop due to the coronavirus crisis. For this reason, the completion is expected for next April. Declarations Ethics approval and consent to participate This protocol has been evaluated and approved by the Research Ethics Committee of the Vall d'Hebron University Hospital (Comité de Ética de Investigación con Medicamentos y comisión de proyectos de investigación del Hospital Universitari Vall d’Hebron) (PR(RAP)361/2018). The development of the project is based on following and respecting the bioethical principles of beneficence, nonmaleficence, autonomy, justice, dignity and privacy, the Declaration of Human Rights, the Belmont Report and the International Declaration on Bioethics and Human Rights of UNESCO. It is also grounded on the statements of the World Medical Association of Helsinki, the Deontological Code of the Association of Medical Colleges of Spain and the Deontological Code of Physiotherapists of Catalonia and Spain. All patients will be informed verbally and via an information sheet and will sign the informed consent. Participation in the study may be interrupted by the patient at any time, if desired, and without negative consequences for him. All data collected will be confidential, respecting the Spanish data protection law (LOPD Ley Orgánica 3/2018, de 5 de diciembre, de Protección de Datos Personales y garantía de los derechos digitales). Likewise, the privacy of each of the participants will be respected at all times. Only the principal investigator, the physiotherapists who performed the interventions and the statistical analyst will have access to the final data set. The aim is to publish the results in the form of doctoral thesis of the principal investigator. Consent for publish Not applicable Availability of data and materials Not applicable Competing interests The authors declare that they have no competing interests. Funding Not funding. Authors' contributions ACM and IRG were responsible for the study conception and design. MAMP collaboratively conceptualized the study objectives and methodology and provided a critical revision of the manuscript. RPA, SK and LBR helped conceptualize and design the study. All authors read and approved the final manuscript. The authors declared that INDIBA SAU (ES) has no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Acknowledgements We want to thank Mr. Sebastià Sendrós and his staff (INDIBA SAU, ES) who have voluntarily given their technical support to helping us with the randomization of the equipment (INDIBA Activ CT8â) to be used for this study. And thanks to Dr. Emilia Sánchez and Mr. Gary Gibson for their support in reviewing this article. Authors’ information Andrea Carralero Martínez a,b , Miguel Ángel Muñoz Pérez c,d,e , Regina Pané Alemany a , Laia Blanco Ratto a,f , Stephannie Kauffmann a,f,g , Inés Ramírez García a,h,i,j a Rehabilitación Abdomino-Pelviana (RAPbarcelona SL), Barcelona, España. b Servicio de Ginecología, Instituto Clínic de Ginecología, Obstetricia y Neonatología, Hospital Clínic de Barcelona, España. c Institut Universitari d’Investigació en Atenció Primària Jordi Gol (IDIAP-Jordi Gol), Barcelona, España. d Institut Català de la Salut (ICS), Barcelona, España. e Departament de Pediatria, Obstetricia i Ginecologia i Medicina Preventiva, Universitat Autònoma de Barcelona (UAB), Bellaterra, España. f Fundació Universitària del Bages (FUB), Barcelona, España. g Servicio de Fisioterapia, Womens Salud y Bienestar de la Mujer SL, Barcelona, España. h Servicio de Fisioterapia, Instituto Médico Tecnológico SL, Barcelona, España. i Blanquerna School of Health Science-Universitat Ramon Llull, Barcelona, España. j Universidad Internacional de Catalunya (UIC), Barcelona, España. 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Short term efficacy of capacitive-resistive diathermy therapy in patients with low back pain: A prospective randomized controlled trial. J Biol Regul Homeost Agents 2017;31: 509–515. Wiegerinck JI, Kerkhoffs GM, van Sterkenburg MN, et al. Treatment for insertional Achilles tendinopathy: A systematic review. Knee Surg Sports Traumatol Arthrosc 2013;21:1345–1355. Costantino C, Vulpiani MC, Romiti D, et al. Cryoultrasound therapy in the treatment of chronic plantar fasciitis with heel spurs. A randomized controlled clinical study. Eur J Phys Rehabil Med 2014;50:39–47. Lideo L, Milan R. Ultrasound monitoring of shortwave diathermic treatment of gastrocnemius strain in a dog. J Ultrasound 2013;16:231–234. Bonder JH, Chi M, Rispoli L. Myofascial pelvic pain and related disorders. Phys Med Rehabil Clin N Am. 2017;28:501-515. Simons DG, Travell JG (2010). Dolor y disfunción miofascial: El manual de los puntos gatillo (vol.2): extremidades inferiores. Panamericana. Charles D, Hudgins T, MacNaughton J, Newman E, Tan J, Wigger M. A systematic review of manual therapy techniques, dry cupping and dry needling in the reduction of myofascial pain and myofascial trigger points. J Bodyw Mov Ther. 2019 Jul;23(3):539-546. Montenegro ML, Braz CA, Rosa-e-Silva JC, Candido-dos-Reis FJ, Nogueira AA, Poli-Neto OB. Anaesthetic injection versus ischemic compression for the pain relief of abdominal wall trigger points in women with chronic pelvic pain. BMC Anesthesiol. 2015 Dec 1;15:175. Melzack R, Wall P. Pain mechanisms: a new theory. Science 1965 Nov;150(3699):971-979. Aredo JV, Heyrana KJ, Karp BI, Shah JP, Stratton P. Relating Chronic Pelvic Pain and Endometriosis to Signs of Sensitization and Myofascial Pain and Dysfunction. Semin Reprod Med. 2017 Jan;35(1):88-97. Kaya S, Hermans L, Willems T, Roussel N, Meeus M. Central sensitization in urogynecological chronic pelvic pain: a systematic literature review. Pain Physician. 2013 Jul-Aug;16(4):291-308. Nijs J, Meeus M, Versijpt J, Moens M, Bos I, Knaepen K, Meeusen R. Brain-derived neurotrophic factor as a driving force behind neuroplasticity in neuropathic and central sensitization pain: a new therapeutic target? Expert Opin Ther Targets. 2015 Apr;19(4):565-76. Laimi K, Mäkila A, Bärlund E, Katajapuu N, Oksanen A, Seikkula V et al. Effectiveness of myofascial release in treatment of chronic musculoskeletal pain: a systematic review. Clin 2018 Apr;32(4):440-450. Gould et al. Visual Analogue Scale (VAS). Journal of Clinical Nursing 2001; 10:697-706. Streiner DL,Norman GR. Health measurement scales: a practical guide to their development and use. New York; Oxford University Press,1989. Vilagut G, Ferrer M, Rajmil M, Rebollo P, Permanyer-Miralda G, Quintana J. M, Santed R, Valderas J. M, Ribera A, Domingo-Salvany A, and Alonso J. El cuestionario de salud SF-36 espa.ol: una d.cada de experiencia y nuevos desarrollos. Gac Sanit. 2005; 19 (2):135-50. Alonso J, Regidor E, Barrio G, Prieto L, Rodr.guez C y de la Fuente L. Valores poblacionales de referencia de la versi.n espa.ola del Cuestionario de Salud SF- 36. Med Clin (Barc). 1998; 111:410-416. Ware JE Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996;34:220-33. Gandek B, Ware JE, Aaronson NK, Apolone G, Bjorner JB, Brazier JE, et al. Crossvalidation of item selection and scoring for the SF-12 Health Survey in nine countries: results from the IQOLA Project. International Quality of Life Assessment. J Clin Epidemiol. 1998;51:1171-8. Miller R, Kori S, Todd D. The Tampa Scale: a measure of kinesiophobia. Clin J Pain. 1991;7(1):51. Gómez-Pérez L, López-Martínez AE, Ruiz-Párraga GT. Psychometric properties of the Spanish version of the Tampa Scale for Kinesiophobia (TSK). Journal of Pain. 2011; 12(4):425-35. Sullivan M, Bishop S, Pivik J. The pain catastrophizing scale: development and validation. Physchological Assessment 1995;7(4):524-532. García Campayo J, Rodero B, Alda M, Sobradiel N, Montero J, Moreno S. Validation of the spanish version of the pain catastrophizing scale in fibromyalgia. Med Clin 2008 Oct;131(13):487-493. Parker SL, Adogwa O, Paul AR, Anderson WN, Aaronson O, Cheng JS, McGirt MJ. Utility of minimum clinically important difference in assessing pain, disability, and health state after transforaminal lumbar interbody fusion for degenerative lumbar J Neurosurg Spine. 2011 May;14(5):598-604. Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG. CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trials .BMJ. 2010;340:c869. 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Research Institute","correspondingAuthor":false,"prefix":"","firstName":"Miguel","middleName":"Ángel Muñoz","lastName":"Pérez","suffix":""},{"id":15056341,"identity":"58b20b4b-ef43-43fa-9d4e-3c1e02f056c9","order_by":2,"name":"Regina Pané-Alemany","email":"","orcid":"","institution":"RAPbarcelona S.L.","correspondingAuthor":false,"prefix":"","firstName":"Regina","middleName":"","lastName":"Pané-Alemany","suffix":""},{"id":15056342,"identity":"1eb37630-fbf3-41ce-b99d-42d67b71e0c4","order_by":3,"name":"Laia Blanco-Ratto","email":"","orcid":"","institution":"RAPbarcelona S.L.","correspondingAuthor":false,"prefix":"","firstName":"Laia","middleName":"","lastName":"Blanco-Ratto","suffix":""},{"id":15056343,"identity":"e2a9e3e0-9431-410f-9497-e75411b93aff","order_by":4,"name":"Stephanie Kauffmann","email":"","orcid":"","institution":"RAPbarcelona 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17:09:14","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-194630/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-194630/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":13677904,"identity":"2f0f970f-4fbe-4c2e-90c3-c7b468e97bb8","added_by":"auto","created_at":"2021-09-17 11:37:11","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":424009,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-194630/v1/f9ea66ef-7257-469c-a130-23184dafcdff.pdf"},{"id":6773053,"identity":"67fbe4ef-e572-4660-b545-0b6dc8ce391f","added_by":"auto","created_at":"2021-03-10 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Pain Syndrome (CPPS) is defined as \u0026ldquo;pain of non-oncological cause, intermittent or constant, in the lower part of the abdomen or pelvis, in both men and women, lasting at least 6 months, and with negative consequences that can be cognitive, behavioral, sexual and emotional\" [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e]. It is a multifactorial disorder serious enough to cause urinary and genital functional disability and with a high prevalence (5.7\u0026ndash;26.6% of women, and 2.2\u0026ndash;9.7% of men) [\u003cspan additionalcitationids=\"CR4 CR5 CR6 CR7\" citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e].\u003c/p\u003e \u003cp\u003ePeople with CPPS have much higher rates of psychological distress. The prevalence of anxiety ranges between 39\u0026ndash;73% compared to the general population (12%), as the prevalence of depression is 26\u0026ndash;52% compared to 5\u0026ndash;10% of the general population [\u003cspan additionalcitationids=\"CR10 CR11 CR12\" citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e]. These conditions, along with catastrophizing, are associated with an increased severity of chronic pain and reduction of quality of life [\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e, \u003cspan additionalcitationids=\"CR15 CR16 CR17\" citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eIn addition, people with CPPS tend to have central and peripheral nervous system hypersensitivity, with dysfunctional pain modulation that tends to aggravate pain [\u003cspan additionalcitationids=\"CR20 CR21 CR22 CR23\" citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eIn physical therapy consultations, there are a variety of therapeutic options with sufficient evidence to guide physical therapy for patients with CPPS [\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e]. The most widely used is myofascial therapy, although this group of patients should be treated from a multidisciplinary approach along with other therapies such as psychology, medication or surgery when other treatments have failed [\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e, \u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e]. One of these options in clinical practice is capacitive resistive monopolar radiofrequency (CRMRF) at 448 KHz, which consists of a non-invasive strategy that increases the temperature of deep organs or tissues through the action of radiofrequency electrical currents with the aim of reducing pain and inflammation and increasing tissue repair [\u003cspan additionalcitationids=\"CR29 CR30 CR31 CR32 CR33 CR34\" citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR35\" class=\"CitationRef\"\u003e35\u003c/span\u003e]. There are few recent studies that evaluate its clinical efficacy despite the fact that its practice has been common for the last 20 years [\u003cspan citationid=\"CR36\" class=\"CitationRef\"\u003e36\u003c/span\u003e]. Current studies report promising results in terms of pain reduction and improved function in musculoskeletal pathologies (such as low back pain) [\u003cspan citationid=\"CR37\" class=\"CitationRef\"\u003e37\u003c/span\u003e] and tendinopathies (such as plantar fasciitis) [\u003cspan additionalcitationids=\"CR39\" citationid=\"CR38\" class=\"CitationRef\"\u003e38\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR40\" class=\"CitationRef\"\u003e40\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eIn spite of its demonstrated efficacy in other musculoskeletal pathologies, there is currently insufficient scientific evidence regarding its role in the management of CPPS.\u003c/p\u003e "},{"header":"Methods","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e\u003ch2\u003eThe aim\u003c/h2\u003e\u003cp\u003eThe study hypothesizes that the application of CRMRF associated with physiotherapy techniques and health education provides benefits in reducing pain compared to physiotherapy and health education techniques alone in the management of patients with CPPS.\u003c/p\u003e\u003cp\u003eThe specific aims are to evaluate the efficacy of the CRMRF according to the intensity of pain, quality of life, kinesiophobia and catastrophism of the patients participating in the study. In addition, sociodemographic and clinical data, adherence to treatment and possible adverse effects during treatment will be recorded in both groups.\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec4\" class=\"Section2\"\u003e\u003ch2\u003eStudy design\u003c/h2\u003e\u003cp\u003eThis manuscript describes a research protocol for a triple blind, randomized controlled clinical trial. Participants will be equal (1:1) randomly allocated into activate capacitive resistive monopolar radiofrequency group (intervention group, IG) and deactivate capacitive resistive monopolar radiofrequency (control group, CG). Both groups will receive pain education and physiotherapeutic techniques (myofascial therapy, trigger point therapy, and/or manual therapy). Participants, the investigators performing the intervention and the statistical analyses will be blinded.\u003c/p\u003e\u003cp\u003eAn analysis of the results will be carried out at six and ten weeks of treatment.\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec5\" class=\"Section2\"\u003e\u003ch2\u003eStudy locations\u003c/h2\u003e\u003cp\u003eThis trial will take place at RAPbarcelona pelvic floor specialized physiotherapy center in Barcelona.\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec6\" class=\"Section2\"\u003e\u003ch2\u003eStudy population\u003c/h2\u003e\u003cp\u003ePatients who consult in the center for a first visit or who are derived from other health professionals who know the protocol of this study, will be invited to participate in this study.\u003c/p\u003e\u003cp\u003eTo be eligible, participants must meet the following criteria. Inclusion criteria: Being of legal age, suffering from CPPS for 6 months or more (etiologies will include: Myofascial Syndrome, Endometriosis, Adenomyosis, Abacterial Prostatitis, Interstitial Cystitis, Levator Ani Syndrome, Pudendal Nerve Syndrome, Nonspecific CPPS) and accepting to participate in the study granting signed informed consent. Exclusion criteria: undergoing other conservative treatments during the study, having undergone treatment with chemotherapy or radiotherapy in the pelvic area, having recently undergone an oncological process, being pregnant, having undergone surgery in the pelvic area in the last 3 months, presenting fibromyalgia or chronic fatigue, suffering serious psyche disorders, presenting hypersensitivity in the skin that may be in contact with the treatment, and suffering neuromuscular diseases.\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec7\" class=\"Section2\"\u003e\u003ch2\u003eInvestigations\u003c/h2\u003e\u003cp\u003ePatients who agree to participate in the study will be given an appointment by telephone and will receive CRMRF therapy for 30 minutes once a week (except for the first session, which will last 45\u0026ndash;60 minutes to deliver the patient information and sign the informed consent, to resolve doubts about the study, about the questionnaires and, finally, to explain the theory of pain and health education).\u003c/p\u003e\u003cp\u003eAt baseline, participants will undergo an initial assessment where data on age, medical history, surgical history and clinical data will be collected. According to criteria used in previous similar studies [\u003cspan citationid=\"CR41\" class=\"CitationRef\"\u003e41\u003c/span\u003e, \u003cspan citationid=\"CR42\" class=\"CitationRef\"\u003e42\u003c/span\u003e] a palpation of the abdominal, lumbosacral, and perineal region will be performed, followed by internal palpation using the index finger at the vaginal and/or anal level to palpate the pelvic floor muscles, tissue connective and internal organs, and localize pain. The Visual Analogic Scale (VAS) to measure the intensity of pain, the health questionnaire Short Form 12 (SF-12) to assess their quality of life, the Tampa Scale for Kinesiophobia (TSK-11) to assess kinesiophobia, and the Pain Catastrophizing Scale (PCS) to assess catastrophism will be evaluated at first visit. The same tests will be re-evaluated at 6 and 10 sessions. Also, in each session, treatment adherence and possible adverse effects of the therapy will be identified and recorded in a database designed for the project.\u003c/p\u003e\u003cp\u003eA total of ten treatment physiotherapy sessions will be held on a weekly basis (Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e).\u003c/p\u003e\u003cp\u003eBoth groups will follow the same protocol that will consist of applying the CRMRF (INDIBA Activ CT8\u003csup\u003e\u0026rarr;\u003c/sup\u003e) at 2% to induce an electrical and athermic effect, along with pain education and physiotherapeutic techniques [\u003cspan citationid=\"CR43\" class=\"CitationRef\"\u003e43\u003c/span\u003e, \u003cspan citationid=\"CR44\" class=\"CitationRef\"\u003e44\u003c/span\u003e] according to the location of the pain (Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e) that will be applied at the same time as the CRMRF. Participants will be placed comfortably in a supine or prone position (depending on the area to be treated) with a pillow under their heads, without pants or underwear. The plate will be placed on the abdomen or lower back depending on the patient's position on the stretcher, and the 32 mm resistive electrode will be used to apply the CRMRF to the painful area.\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\u003eTreatment sessions\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"3\"\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003eIntervention group (IG)\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u003cp\u003eControl group (CG)\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e\u003cp\u003eSESSION 1\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c3\" namest=\"c2\"\u003e\u003cp\u003eDelivery of the information sheet and signing of the informed consent.\u003c/p\u003e\u003cp\u003eCollection and recording of baseline data (age, sociodemographic data, clinical data, and medical and surgical history). Self-completion of tests (VAS, SF-12, TSK-11 and PCS).\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eApplication of physiotherapeutic techniques with activated CRMRF.\u003c/p\u003e\u003cp\u003eExplanation of the theory of pain and health education.\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eApplication of physiotherapeutic techniques with deactivated CRMRF.\u003c/p\u003e\u003cp\u003eExplanation of the theory of pain and health education.\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eSESSION 2\u0026ndash;5\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eSession protocol:\u003c/p\u003e\u003cp\u003e\u0026bull; Registration of possible discomfort or adverse effects perceived by the patient.\u003c/p\u003e\u003cp\u003e\u0026bull; Application of physiotherapeutic techniques with activated CRMRF.\u003c/p\u003e\u003cp\u003e\u0026bull; Pain education clarifications\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eSession protocol:\u003c/p\u003e\u003cp\u003e\u0026bull; Registration of possible discomfort or adverse effects perceived by the patient.\u003c/p\u003e\u003cp\u003e\u0026bull; Application of physiotherapeutic techniques with deactivated CRMRF.\u003c/p\u003e\u003cp\u003e\u0026bull; Pain education clarifications\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eSESSION 6\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c3\" namest=\"c2\"\u003e\u003cp\u003eCollection of VAS, SF-12, TSK-11 and PCS tests.\u003c/p\u003e\u003cp\u003eSession protocol (as described in session 2\u0026ndash;5)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eSESSION 7\u0026ndash;9\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c3\" namest=\"c2\"\u003e\u003cp\u003eSession protocol (as described in session 2\u0026ndash;5)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eSESSION 10\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c3\" namest=\"c2\"\u003e\u003cp\u003eSession protocol (as described in session 2\u0026ndash;5)\u003c/p\u003e\u003cp\u003eAssessment of VAS, SF-12, TSK-11, PCS tests, evolution of the pathology and referral (if required).\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\u003eParticipants in the IG will receive the treatment with the activated CRMRF (emitting electrical signal) and the participants in the CG will receive the same treatment with the deactivated CRMRF (without emitting electrical signal).\u003c/p\u003e\u003cp\u003eThis CRMRF equipment is designed to perform the conventional treatment (IG) and a placebo treatment (CG) without being visible to either the therapist or the participant. The team produces an automatic randomization for each participant according to the order of study assignment.\u003c/p\u003e\u003cp\u003ePain education will consist of a basic theory about gate control [\u003cspan citationid=\"CR45\" class=\"CitationRef\"\u003e45\u003c/span\u003e], concepts of pain and central sensitization, and a basic explanation of the neurotransmitters that influence the increase or decrease in pain [\u003cspan additionalcitationids=\"CR47\" citationid=\"CR46\" class=\"CitationRef\"\u003e46\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR48\" class=\"CitationRef\"\u003e48\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eThe physiotherapeutic techniques that will be performed in each session will always be the same in all individualized treatment sessions for each patient that will be assigned according to the location of the pain (Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e). These will be those recommended by the literature for the treatment of CPPS, which will consist of myofascial induction techniques, trigger point therapy, and manual therapy with the aim of improving the elasticity of the musculature and fascial tissue and improving blood flow. These techniques will be performed with smooth and slow movements, and always from more indirect to more direct, and from more distal to more local [\u003cspan citationid=\"CR49\" class=\"CitationRef\"\u003e49\u003c/span\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\u003ePhysiotherapeutic techniques and position of the patient during treatment sessions, depending on the location of the pain\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"3\"\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003ePrevious location\u003c/p\u003e\u003cp\u003e(abdomen, pubis, groin, perineum, vagina, penis, testicles)\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u003cp\u003ePosterior location\u003c/p\u003e\u003cp\u003e(lumbar, sacrum, coccyx, buttocks, anus, rectum)\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003ePosition:\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003ePatient in supine position. CRMRF plate in lower back\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003ePatient in the prone position. CRMRF plate in abdomen\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e\u003cp\u003eTechniques:\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e\u0026bull; Abdominal area:\u003c/p\u003e\u003cp\u003e- Lift techniques of the peritoneum\u003c/p\u003e\u003cp\u003e- Liberation of the urachus\u003c/p\u003e\u003cp\u003e\u0026bull; Groin area:\u003c/p\u003e\u003cp\u003e- Stretching the inguinal ligament\u003c/p\u003e\u003cp\u003e- Myotensive techniques of the internal obturator\u003c/p\u003e\u003cp\u003e\u0026bull; Vulvar, perineal and vaginal area:\u003c/p\u003e\u003cp\u003e- Relaxation of the superficial fascia of the perineum\u003c/p\u003e\u003cp\u003e- Stretching the prevesical ligament\u003c/p\u003e\u003cp\u003e- Uterine release techniques\u003c/p\u003e\u003cp\u003e- Stretching of the round ligament\u003c/p\u003e\u003cp\u003e- Stretching of the wide ligament\u003c/p\u003e\u003cp\u003e- Relaxation of the sacrorectogenitopubian laminae\u003c/p\u003e\u003cp\u003e- Release of the pudendal nerve in Alcock\u0026rsquo;s canal\u003c/p\u003e\u003cp\u003e\u0026bull; Penis and testicular area:\u003c/p\u003e\u003cp\u003e- Relaxation of the superficial fascia of the perineum\u003c/p\u003e\u003cp\u003e- Relaxation of the deep fascia of the perineum\u003c/p\u003e\u003cp\u003e- Testicular drainage\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e\u0026bull; Lumbosacral area:\u003c/p\u003e\u003cp\u003e- Relaxation of the quadratus lumbar\u003c/p\u003e\u003cp\u003e- Relaxation of the paravertebral muscles\u003c/p\u003e\u003cp\u003e\u0026bull; Gluteal area:\u003c/p\u003e\u003cp\u003e- Decompression of the pudendal nerve in the greater sciatic foramen\u003c/p\u003e\u003cp\u003e- Stretching of the sacrociatic ligament\u003c/p\u003e\u003cp\u003e- Stretching of the sacrotuberous ligament\u003c/p\u003e\u003cp\u003e- Release of the pudendal nerve in the ischiorectal fossa\u003c/p\u003e\u003cp\u003e- Myotensive techniques of the pyramidal\u003c/p\u003e\u003cp\u003e- Myotensive techniques of the external obturator\u003c/p\u003e\u003cp\u003e\u0026bull; Anorectal area:\u003c/p\u003e\u003cp\u003e- Sacral plexus release techniques\u003c/p\u003e\u003cp\u003e- Relaxation of the sacrorectogenitopubian laminae\u003c/p\u003e\u003cp\u003e- Stretching the Denonvilliers fascia\u003c/p\u003e\u003cp\u003e- Prostate release techniques\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c3\" namest=\"c2\"\u003e\u003cp\u003eIf there is a scar, manual scar work is performed and the 35mm resistive electrode is applied over it.\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\u003eAs this is a study with multiple tests and interventions, several physical therapists will be needed to be able to carry it out. For this reason, to avoid errors due to lack of standardization, there will be a training period in the application of the therapy and data collection for all the physiotherapists who will participate in the study.\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec8\" class=\"Section2\"\u003e\u003ch2\u003eOutcome measures\u003c/h2\u003e\u003cp\u003eParticipants will complete three study assessments: baseline, 6 and 10 weeks after first session.\u003c/p\u003e\u003cp\u003ePrimary outcome:\u003c/p\u003e\u003cp\u003e\u003cul\u003e\u003cli\u003e\u003cp\u003eIntensity of pain: According to the VAS score, evaluated in the first, sixth and tenth sessions of the study. This quantitative and subjective variable consists of marking the degree of intensity of pain in a straight horizontal line of fixed length of 10cm. The ends are defined as the extreme limits of the parameter to be measured orientated from the left (worst) to the right (best) [\u003cspan citationid=\"CR50\" class=\"CitationRef\"\u003e50\u003c/span\u003e, \u003cspan citationid=\"CR51\" class=\"CitationRef\"\u003e51\u003c/span\u003e].\u003c/p\u003e\u003c/li\u003e\u003c/ul\u003e\u003c/p\u003e\u003cp\u003eSecondary outcomes:\u003c/p\u003e\u003cp\u003e\u003cul\u003e\u003cli\u003e\u003cp\u003eQuality of life related to health: Measured with the SF-12 Quality of Life health questionnaire. Is a generic questionnaire that we will use the Spanish adaptation done by Alonso et al [\u003cspan citationid=\"CR52\" class=\"CitationRef\"\u003e52\u003c/span\u003e, \u003cspan citationid=\"CR53\" class=\"CitationRef\"\u003e53\u003c/span\u003e] of the SF-12 Health Survey [\u003cspan citationid=\"CR54\" class=\"CitationRef\"\u003e54\u003c/span\u003e, \u003cspan citationid=\"CR55\" class=\"CitationRef\"\u003e55\u003c/span\u003e]. The SF-12 is a reduced version of the SF-36 Health Questionnaire designed for cases in which this is too long. The SF-12 is answered in an average of \u0026le;\u0026thinsp;2 min and the SF-36 needs between 5 and 10 min. It consists of 12 items from the 8 dimensions of the SF-36 (physical function, social function, physical role, emotional role, mental health, vitality, body pain and general health status). Higher score means better quality of life.\u003c/p\u003e\u003c/li\u003e\u003cli\u003e\u003cp\u003eKinesiophobia: Fear of movement will be measured by Tampa Scale for Kinesiophobia (TSK-11). This questionnaire created by Miller et al [\u003cspan citationid=\"CR56\" class=\"CitationRef\"\u003e56\u003c/span\u003e] quantifies the intensity of kinesiophobia suffered by the patient, and we will use the reduced version and adaptation to Spanish by G\u0026oacute;mez-P\u0026eacute;rez et al [\u003cspan citationid=\"CR57\" class=\"CitationRef\"\u003e57\u003c/span\u003e]. It consists of 11 statements that the patient must answer using a Likert-type scale from 1 (totally disagree) to 4 (totally agree). Higher score means higher degree of kinesiophobia.\u003c/p\u003e\u003c/li\u003e\u003cli\u003e\u003cp\u003eCatastrophizing: Measured with the Pain Catastrophizing Scale (PCS) [\u003cspan citationid=\"CR58\" class=\"CitationRef\"\u003e58\u003c/span\u003e]. This 13-item questionnaire assesses the patient's catastrophic thoughts using a five-point Likert scale. It consists of three subscales (rumination, magnification, hopelessness). Higher score means higher degree of catastrophizing. The Spanish adaptation validated by Garc\u0026iacute;a Campayo et al [\u003cspan citationid=\"CR59\" class=\"CitationRef\"\u003e59\u003c/span\u003e] will be used.\u003c/p\u003e\u003c/li\u003e\u003cli\u003e\u003cp\u003eSociodemographic variables, pathological history and clinical history: Assessed in the first session of the treatment, collected through a standardized clinical history.\u003c/p\u003e\u003c/li\u003e\u003cli\u003e\u003cp\u003eAdverse effects: Recorded in each of the treatment sessions through the patient references about his status and evolution.\u003c/p\u003e\u003c/li\u003e\u003cli\u003e\u003cp\u003eAdherence to treatment: Assessed in each of the treatment sessions, collected through a compliance from designed for the project.\u003c/p\u003e\u003c/li\u003e\u003c/ul\u003e\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec9\" class=\"Section2\"\u003e\u003ch2\u003eSchedule\u003c/h2\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab3\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 3\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cp\u003eThe different schedule phases are shown in italics.\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"7\"\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003eRecruitment\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u003cp\u003eSession 1\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c4\"\u003e\u003cp\u003eSessions 2\u0026ndash;5\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c5\"\u003e\u003cp\u003eSession 6\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c6\"\u003e\u003cp\u003eSessions 7\u0026ndash;9\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c7\"\u003e\u003cp\u003eSession 10\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003eRecruitment\u003c/b\u003e:\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\u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eSelection screening\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\u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eInformed consent\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\u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eAllocation\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\u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003eInterventions\u003c/b\u003e:\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\u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eIntervention CG (deactivated CRMRF\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\u003cp\u003eX\u003c/p\u003e\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\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003eX\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eIntervention IG (activated CRMRF)\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\u003cp\u003eX\u003c/p\u003e\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\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003eX\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003eEvaluations\u003c/b\u003e:\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\u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\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\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\u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eClinical variables\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\u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eVAS\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\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003eX\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eSF-12\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\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003eX\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eTSK-11\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\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003eX\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003ePCS\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\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003eX\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eCompliance form\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\u003cp\u003eX\u003c/p\u003e\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\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003eX\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eRecording of adverse effects\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\u003cp\u003eX\u003c/p\u003e\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\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003eX\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec10\" class=\"Section2\"\u003e\u003ch2\u003eSample size\u003c/h2\u003e\u003cp\u003eTo estimate the sample size, we use the sample size calculator of the \u0026ldquo;GRANMO\u0026rdquo; program. This version 7.12 of April 2012 can be obtained at the following link on the website \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://www.imim.es/ofertadeserveis/software-public/granmo/\u003c/span\u003e\u003c/span\u003e.\u003c/p\u003e\u003cp\u003eFor this estimate, alpha values of 5% and beta of 20% (power of 80%) were taken into account. Based on data published in the literature [\u003cspan citationid=\"CR60\" class=\"CitationRef\"\u003e60\u003c/span\u003e] and applying a common standard deviation of 3 and a difference equal to or greater than 2 in the VAS, 40 patients are needed in each arm of the study, assuming a maximum percentage of follow-up losses/dropouts of 10%.\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec11\" class=\"Section2\"\u003e\u003ch2\u003eSelection of the sample\u003c/h2\u003e\u003cp\u003eThe selection of the sample will be done by sampling of consecutive cases, from RAPbarcelona clinic in Barcelona. Health professionals from other institutions will be contacted to increase referrals to the center, and an advertising campaign will be carried out on social networks. In physiotherapists appointments, patients with CPPS will be referred to the principal investigator. The protocol will be clearly explained to each of the interested patients who meet all the selection criteria, and he will be asked to sign the informed consent if accept participation. After the signature the patient will be allocated to one of the two study groups.\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec12\" class=\"Section2\"\u003e\u003ch2\u003eRandom allocation of groups\u003c/h2\u003e\u003cp\u003eOnce the participants are included in the study, they will be identified from the number of the computerized Medical Record, and they will be ordered sequentially and consecutively from 1 to 80 according to the order of recruitment. To assign interventions, CRMRF team engineers will enter into the software the randomized sequence corresponding to each number from 1 to 80 to designate the CG and IG participants. In order to keep the assigned study group hidden from the patient, the physiotherapist and the main researcher, the following four indications will be taken into account: 1) No parameter will appear at any time on the visible screen of the CRMRF team that can reflect if the machine performs any activity. 2) The current intensity parameter will be 2% in all participants, to prevent the intervention group patients from perceiving any thermal effect. 3) The physiotherapists will perform the application of the CRMRF by manipulating the equipment with the handle and never with the electrode to avoid any sensation. They will be trained before starting the study. 4) The sequence of randomization and allocation will be kept hidden at all times for all patients, professionals and for the main researcher, until the statistical analysis once the entire intervention is finished.\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec13\" class=\"Section2\"\u003e\u003ch2\u003eCollection, management and data analysis\u003c/h2\u003e\u003cp\u003eThe data will be collected in a specific database coded for this study, which will only be available to the main researcher. The database and statistical analysis will be performed with IBM SPSS Statistics 24.0 software.\u003c/p\u003e\u003cp\u003eFirst, a descriptive analysis of the characteristics of the patients included in both study groups, as well as the outcome variables will be carried out. To do this, absolute and relative frequencies (percentages) will be estimated for qualitative variables, and mean or median and standard deviation or range, respectively, depending on the normality of the distribution, for quantitative variables. Afterwards, the comparative analysis of the two treatment groups will be carried out using the Chi-square test for qualitative variables, and with the Student's t test for quantitative variables. Additionally, different associations between diverse variables will be analyzed. To check for the efficacy of the study treatments, intention to treat (ITT) and by protocol (PP) analysis will be performed.\u003c/p\u003e\u003cp\u003eThe comparison of results will be done by estimating the differences in a timely manner and with their corresponding 95% confidence intervals (95% CI).\u003c/p\u003e\u003cp\u003eAdditionally, the adjusted differences will be calculated, following the indications of the CONSORT document [\u003cspan citationid=\"CR61\" class=\"CitationRef\"\u003e61\u003c/span\u003e]. In all cases, the level of statistical significance established will be the usual (5%); therefore, statistically significant differences will be considered when p values are less than 0.05.\u003c/p\u003e\u003c/div\u003e"},{"header":"Discussion","content":" \u003cp\u003eThe results of this study will make it possible to prove that CRMRF benefits the treatment of patients with CPPS together with physiotherapeutic techniques and pain education. These results could offer another conservative treatment option for these patients.\u003c/p\u003e "},{"header":"Trial Status","content":" \u003cp\u003eThis is the first version of the protocol (January 28, 2021). Recruitment began in April 2019 and the intervention has had to stop due to the coronavirus crisis. For this reason, the completion is expected for next April.\u003c/p\u003e "},{"header":"Declarations","content":"\u003ch2\u003eEthics approval and consent to participate\u003c/h2\u003e\n\u003cp\u003eThis protocol has been evaluated and approved by the Research Ethics Committee of the Vall d'Hebron University Hospital (Comit\u0026eacute; de \u0026Eacute;tica de Investigaci\u0026oacute;n con Medicamentos y comisi\u0026oacute;n de proyectos de investigaci\u0026oacute;n del Hospital Universitari Vall d\u0026rsquo;Hebron) (PR(RAP)361/2018).\u003c/p\u003e\n\u003cp\u003eThe development of the project is based on following and respecting the bioethical principles of beneficence, nonmaleficence, autonomy, justice, dignity and privacy, the Declaration of Human Rights, the Belmont Report and the International Declaration on Bioethics and Human Rights of UNESCO. It is also grounded on the statements of the World Medical Association of Helsinki, the Deontological Code of the Association of Medical Colleges of Spain and the Deontological Code of Physiotherapists of Catalonia and Spain.\u003c/p\u003e\n\u003cp\u003eAll patients will be informed verbally and via an information sheet and will sign the informed consent. Participation in the study may be interrupted by the patient at any time, if desired, and without negative consequences for him.\u003c/p\u003e\n\u003cp\u003eAll data collected will be confidential, respecting the Spanish data protection law (LOPD Ley Org\u0026aacute;nica 3/2018, de 5 de diciembre, de Protecci\u0026oacute;n de Datos Personales y garant\u0026iacute;a de los derechos digitales). Likewise, the privacy of each of the participants will be respected at all times. Only the principal investigator, the physiotherapists who performed the interventions and the statistical analyst will have access to the final data set.\u003c/p\u003e\n\u003cp\u003eThe aim is to publish the results in the form of doctoral thesis of the principal investigator.\u003c/p\u003e\n\u003ch2\u003eConsent for publish\u003c/h2\u003e\n\u003cp\u003eNot applicable\u003c/p\u003e\n\u003ch2\u003eAvailability of data and materials\u003c/h2\u003e\n\u003cp\u003eNot applicable\u003c/p\u003e\n\u003ch2\u003eCompeting interests\u003c/h2\u003e\n\u003cp\u003eThe authors declare that they have no competing interests.\u003c/p\u003e\n\u003ch2\u003eFunding\u003c/h2\u003e\n\u003cp\u003eNot funding.\u003c/p\u003e\n\u003ch2\u003eAuthors' contributions\u003c/h2\u003e\n\u003cp\u003eACM and IRG were responsible for the study conception and design. MAMP collaboratively conceptualized the study objectives and methodology and provided a critical revision of the manuscript. RPA, SK and LBR helped conceptualize and design the study. All authors read and approved the final manuscript.\u003c/p\u003e\n\u003cp\u003eThe authors declared that INDIBA SAU (ES) has no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.\u003c/p\u003e\n\u003ch2\u003eAcknowledgements\u003c/h2\u003e\n\u003cp\u003eWe want to thank Mr. Sebasti\u0026agrave; Sendr\u0026oacute;s and his staff (INDIBA SAU, ES) who have voluntarily given their technical support to helping us with the randomization of the equipment (INDIBA Activ CT8\u0026acirc;) to be used for this study. And thanks to Dr. Emilia S\u0026aacute;nchez and Mr. Gary Gibson for their support in reviewing this article.\u003c/p\u003e\n\u003ch2\u003eAuthors\u0026rsquo; information\u003c/h2\u003e\n\u003cp\u003eAndrea Carralero Mart\u0026iacute;nez\u003csup\u003ea,b\u003c/sup\u003e, Miguel \u0026Aacute;ngel Mu\u0026ntilde;oz P\u0026eacute;rez\u003csup\u003ec,d,e\u003c/sup\u003e , Regina Pan\u0026eacute; Alemany\u003csup\u003ea\u003c/sup\u003e, Laia Blanco Ratto\u003csup\u003ea,f\u003c/sup\u003e, Stephannie Kauffmann\u003csup\u003ea,f,g\u003c/sup\u003e, In\u0026eacute;s Ram\u0026iacute;rez Garc\u0026iacute;a\u003csup\u003ea,h,i,j\u003c/sup\u003e\u003c/p\u003e\n\u003cp\u003e\u003csup\u003ea\u003c/sup\u003eRehabilitaci\u0026oacute;n Abdomino-Pelviana (RAPbarcelona SL), Barcelona, Espa\u0026ntilde;a.\u003c/p\u003e\n\u003cp\u003e\u003csup\u003eb\u003c/sup\u003eServicio de Ginecolog\u0026iacute;a, Instituto Cl\u0026iacute;nic de Ginecolog\u0026iacute;a, Obstetricia y Neonatolog\u0026iacute;a, Hospital Cl\u0026iacute;nic de Barcelona, Espa\u0026ntilde;a.\u003c/p\u003e\n\u003cp\u003e\u003csup\u003ec\u003c/sup\u003eInstitut Universitari d\u0026rsquo;Investigaci\u0026oacute; en Atenci\u0026oacute; Prim\u0026agrave;ria Jordi Gol (IDIAP-Jordi Gol), Barcelona, Espa\u0026ntilde;a.\u003c/p\u003e\n\u003cp\u003e\u003csup\u003ed\u003c/sup\u003eInstitut Catal\u0026agrave; de la Salut (ICS), Barcelona, Espa\u0026ntilde;a.\u003c/p\u003e\n\u003cp\u003e\u003csup\u003ee\u003c/sup\u003eDepartament de Pediatria, Obstetricia i Ginecologia i Medicina Preventiva, Universitat Aut\u0026ograve;noma de Barcelona (UAB), Bellaterra, Espa\u0026ntilde;a.\u003c/p\u003e\n\u003cp\u003e\u003csup\u003ef\u003c/sup\u003eFundaci\u0026oacute; Universit\u0026agrave;ria del Bages (FUB), Barcelona, Espa\u0026ntilde;a.\u003c/p\u003e\n\u003cp\u003e\u003csup\u003eg\u003c/sup\u003eServicio de Fisioterapia, Womens Salud y Bienestar de la Mujer SL, Barcelona, Espa\u0026ntilde;a.\u003c/p\u003e\n\u003cp\u003e\u003csup\u003eh\u003c/sup\u003eServicio de Fisioterapia, Instituto M\u0026eacute;dico Tecnol\u0026oacute;gico SL, Barcelona, Espa\u0026ntilde;a.\u003c/p\u003e\n\u003cp\u003e\u003csup\u003ei\u003c/sup\u003eBlanquerna School of Health Science-Universitat Ramon Llull, Barcelona, Espa\u0026ntilde;a.\u003c/p\u003e\n\u003cp\u003e\u003csup\u003ej\u003c/sup\u003eUniversidad Internacional de Catalunya (UIC), Barcelona, Espa\u0026ntilde;a.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cp\u003eCG: Control Group\u003c/p\u003e\n\u003cp\u003eCPPS: Chronic Pelvic Pain Syndrome\u003c/p\u003e\n\u003cp\u003eCRMRF: Capacitive Resistive Monopolar Radiofrequency\u003c/p\u003e\n\u003cp\u003eIG: Intervention group\u003c/p\u003e\n\u003cp\u003ePCS: Pain Catastrophizing Scale\u003c/p\u003e\n\u003cp\u003eSF-12: Health Questionnaire Short Form 12\u003c/p\u003e\n\u003cp\u003eTSK-11: Tampa Scale for Kinesiophobia\u003c/p\u003e\n\u003cp\u003eVAS: Visual Analogic Scale\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eEngeler D, Baranowski A.P, Borovicka J, Dinis-Oliveira P, Elneil S, Hughes J, et al. Guidelines on chronic pelvic pain. Eur Urol. 2016.\u003c/li\u003e\n\u003cli\u003eValdivia Jim\u0026eacute;nez M.I. Abordaje del dolor en una unidad de suelo p\u0026eacute;lvico. Necesidad de equipos multidisciplinares. Suelo P\u0026eacute;lvico. 2013;9(1):29-35.\u003c/li\u003e\n\u003cli\u003eAhangari A. Prevalence of chronic pelvic pain among women: an updated review. Pain Physician. 2014 Mar-Apr;17(2):e141-7.\u003c/li\u003e\n\u003cli\u003eGrinberg K, Granot M, Lowenstein L, Abramov L, Weissman-Fogel I. A common pronociceptive pain modulation profile typifying subgroups of chronic pelvic pain syndromes is interrelated with enhanced clinical pain. Pain. 2017 Jun;158(6):1021-1029.\u003c/li\u003e\n\u003cli\u003eSteege JF, Siedhoff MT. Chronic pelvic pain. Obstet Gynecol. 2014 Sep;124(3):616-29.\u003c/li\u003e\n\u003cli\u003eCheong YC, Smotra G, Williams AC. Non-surgical interventions for the management of chronic pelvic pain. 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In: Prentice W, editor. Therapeutic Modalities in Rehabilitation. 4th ed. New York: McGraw-Hill; 2011. p. 433\u0026ndash;62.\u003c/li\u003e\n\u003cli\u003eKumaran B, Watson T. Radiofrequency-based treatment in therapyrelated clinical practice \u0026ndash; a narrative review. Part I: acute conditions. Phys Ther Rev. 2015;20(4):241\u0026ndash;54.\u003c/li\u003e\n\u003cli\u003eFuentes-M\u0026aacute;rquez P, Cabrera-Martos I, Valenza MC. Physiotherapy interventions for patients with chronic pelvic pain: A systematic review of the literature. Physiother Theory Pract. 2019 Dec;35(12):1131-1138.\u003c/li\u003e\n\u003cli\u003eNotarnicola A, Maccagnano G, Gallone MF, et al. Short term efficacy of capacitive-resistive diathermy therapy in patients with low back pain: A prospective randomized controlled trial. J Biol Regul Homeost Agents 2017;31: 509\u0026ndash;515.\u003c/li\u003e\n\u003cli\u003eWiegerinck JI, Kerkhoffs GM, van Sterkenburg MN, et al. Treatment for insertional Achilles tendinopathy: A systematic review. Knee Surg Sports Traumatol Arthrosc 2013;21:1345\u0026ndash;1355.\u003c/li\u003e\n\u003cli\u003eCostantino C, Vulpiani MC, Romiti D, et al. Cryoultrasound therapy in the treatment of chronic plantar fasciitis with heel spurs. A randomized controlled clinical study. Eur J Phys Rehabil Med 2014;50:39\u0026ndash;47.\u003c/li\u003e\n\u003cli\u003eLideo L, Milan R. Ultrasound monitoring of shortwave diathermic treatment of gastrocnemius strain in a dog. J Ultrasound 2013;16:231\u0026ndash;234.\u003c/li\u003e\n\u003cli\u003eBonder JH, Chi M, Rispoli L. Myofascial pelvic pain and related disorders. Phys Med Rehabil Clin N Am. 2017;28:501-515.\u003c/li\u003e\n\u003cli\u003eSimons DG, Travell JG (2010). Dolor y disfunci\u0026oacute;n miofascial: El manual de los puntos gatillo (vol.2): extremidades inferiores. Panamericana.\u003c/li\u003e\n\u003cli\u003eCharles D, Hudgins T, MacNaughton J, Newman E, Tan J, Wigger M. A systematic review of manual therapy techniques, dry cupping and dry needling in the reduction of myofascial pain and myofascial trigger points. J Bodyw Mov Ther. 2019 Jul;23(3):539-546.\u003c/li\u003e\n\u003cli\u003eMontenegro ML, Braz CA, Rosa-e-Silva JC, Candido-dos-Reis FJ, Nogueira AA, Poli-Neto OB. Anaesthetic injection versus ischemic compression for the pain relief of abdominal wall trigger points in women with chronic pelvic pain. BMC Anesthesiol. 2015 Dec 1;15:175.\u003c/li\u003e\n\u003cli\u003eMelzack R, Wall P. Pain mechanisms: a new theory. Science 1965 Nov;150(3699):971-979.\u003c/li\u003e\n\u003cli\u003eAredo JV, Heyrana KJ, Karp BI, Shah JP, Stratton P. Relating Chronic Pelvic Pain and Endometriosis to Signs of Sensitization and Myofascial Pain and Dysfunction. Semin Reprod Med. 2017 Jan;35(1):88-97.\u0026nbsp;\u003c/li\u003e\n\u003cli\u003eKaya S, Hermans L, Willems T, Roussel N, Meeus M. Central sensitization in urogynecological chronic pelvic pain: a systematic literature review. Pain Physician. 2013 Jul-Aug;16(4):291-308.\u003c/li\u003e\n\u003cli\u003eNijs J, Meeus M, Versijpt J, Moens M, Bos I, Knaepen K, Meeusen R. Brain-derived neurotrophic factor as a driving force behind neuroplasticity in neuropathic and central sensitization pain: a new therapeutic target? Expert Opin Ther Targets. 2015 Apr;19(4):565-76.\u003c/li\u003e\n\u003cli\u003eLaimi K, M\u0026auml;kila A, B\u0026auml;rlund E, Katajapuu N, Oksanen A, Seikkula V et al. Effectiveness of myofascial release in treatment of chronic musculoskeletal pain: a systematic review. Clin 2018 Apr;32(4):440-450.\u003c/li\u003e\n\u003cli\u003eGould et al. Visual Analogue Scale (VAS). Journal of Clinical Nursing 2001; 10:697-706.\u003c/li\u003e\n\u003cli\u003eStreiner DL,Norman GR. Health measurement scales: a practical guide to their development and use. 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CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trials .BMJ. 2010;340:c869.\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":true,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"trials","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"trls","sideBox":"Learn more about [Trials](http://trialsjournal.biomedcentral.com/)","snPcode":"13063","submissionUrl":"https://www.editorialmanager.com/trls","title":"Trials","twitterHandle":"MedicalEvidence","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"Chronic pelvic pain syndrome, musculoskeletal pain, physical therapy, therapeutic interventions, capacitive resistive monopolar radiofrequency, Randomized Controlled Trial, gynecology, urology","lastPublishedDoi":"10.21203/rs.3.rs-194630/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-194630/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eBackground\u003c/h2\u003e \u003cp\u003eChronic Pelvic Pain Syndrome (CPPS) is a multifactorial disorder that affects 5.7\u0026ndash;26.6% of women and 2.2\u0026ndash;9.7% of men, characterized by a hypersensitivity of the central and peripheral nervous system affecting bladder and genital function. People with CPPS have much higher rates of psychological disorders (anxiety, depression, and catastrophizing) that increase the severity of chronic pain and worsen quality of life. Myofascial therapy, manual therapy, and treatment of trigger points are proven therapeutic options for this syndrome. The aim of this study is to evaluate the efficacy of capacitive resistive monopolar radiofrequency (CRMRF) at 448 KHz as an adjunct treatment to the other physiotherapeutic techniques for reducing pain and improving the quality of life of patients with CPPS.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e \u003cp\u003eThis triple-blind (1:1) randomized controlled trial will include 80 women and men with CPPS. Participants will be randomized into CRMRF activated group or CRMRF deactivated group, together with physiotherapeutic techniques and pain education. The groups will receive treatment for 10 consecutive weeks. Pain intensity (with the VAS), quality of life (with the SF-12), kinesiophobia (with the TSK-11) and catastrophism (with the PCS) will be evaluated at the beginning, at the sixth and the tenth session.\u003c/p\u003e\u003ch2\u003eDiscussion\u003c/h2\u003e \u003cp\u003eThe results of this study will make it possible to prove that CRMRF benefits the treatment of patients with CPPS together with physiotherapeutic techniques and pain education. These results could offer another conservative treatment option for these patients.\u003c/p\u003e\u003ch2\u003eTrial registration:\u003c/h2\u003e \u003cp\u003eClinicalTrials.gov Identifier: NCT03797911. Registered 8 January 2019, \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://clinicaltrials.gov/ct2/show/NCT03797911\u003c/span\u003e\u003c/span\u003e\u003c/p\u003e","manuscriptTitle":"Efficacy of capacitive resistive monopolar radiofrequency in the physiotherapeutic treatment of chronic pelvic pain syndrome: study protocol for a Randomized Controlled Trial","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2021-03-09 23:58:37","doi":"10.21203/rs.3.rs-194630/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Minor revision","date":"2021-04-14T17:46:30+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2021-04-13T00:00:00+00:00","index":3,"fulltext":"Recommendation: Minor Revision\nForm responses:\n---\n\nComments to Author:\n---\nDear author, the trial seems to me very interesting; however I would like to highlight some aspects that deserve some consideration.\nMethods:\nStudy Population:\nIn line 92 you use the term Interstitial Cystitis. Although it has been widely used and still has some interest in terms of patient's divulgation, the International Continence Society recommended term for this disorder is Bladder Pain Syndrome and it would be better used instead.\nInvestigations:\nThe statement in line 102 it is somehow confusing to me. When you say \"Patients who agree to participate in the study will be given an appointment by telephone…\" probably you mean they are scheduled for a consultation in which they \"…will receive CRMRF…..\". However this could be misunderstood with having a telephone consultation. So that I would rephrase or avoid to detail how they are scheduled in the agenda.\nIn lines 111 (tissue connective) and 116 (adverse effects) I suggest to use connective tissue and adverse events instead.\nIn lines 120-121, please detail the Brand full name, city and country of the manufacturer of the device.\nIn the paragraph in lines 133-136, I wonder if you mean that the CRMRF device is designed by the manufacturer to perform placebo treatment or if it was specifically modified in this way in order to do this study?. Please clarify this aspect.\nIn Table 2 when you divide into Previous location and Posterior location maybe would be clearer use Anterior and Posterior.\nI wonder if In Table 3 the term Descriptive variables are actually describing demographic variables?\n* Publons Reviewer Recognition. Springer Nature can send verification of this review directly to Publons (a subsidiary of Clarivate Analytics). If you would like to take advantage of this service, please click on the “Yes” option below. Your name, email address, title of the reviewed manuscript, name of the journal, and date of your review submission (the “Review Data”) will then be transmitted to Publons after the final decision on the manuscript has been made. If you have already registered at Publons, they will notify you of the receipt of this review and update your profile as per your settings and their policy. If you are not registered with Publons, you will receive an email from them asking you to register in order for them to be able to recognize your review on your new profile page. Publons may use the Review Data to generate derivative metadata for the benefit of Publons and you as a reviewer, carefully considering the sensitivity of such information. For example, Publons may verify your record as a reviewer by updating your profile published on its webservice if you have registered for such service or help editors to identify candidate reviewers. Please find the details of processing in Publons’ privacy policy https://publons.com/about/terms: **No**\n* Level of interest: **An article of importance in its field**\n* Quality of written English: **Needs some language corrections before being published**\n* Quality of figures: **- Acceptable**\n* Statistical review: **- No, the manuscript does not need to be seen by a statistician**\n* Declaration of competing interests: **I declare that I have no competing interests**\n* I agree to the open peer review policy of the journal. I understand that my name will be included on my report to the authors and, if the manuscript is accepted for publication, my named report including any attachments I upload will be posted on the website along with the authors' responses. I agree for my report to be made available under an Open Access Creative Commons CC-BY license (http://creativecommons.org/licenses/by/4.0/). I understand that any comments which I do not wish to be included in my named report can be included as confidential comments to the editors, which will not be published.: **\nI agree to the open peer review policy of the journal**\n* Were you mentored through this peer review?: **No**\n"},{"type":"editorInvitedReview","content":"","date":"2021-04-12T00:00:00+00:00","index":2,"fulltext":"Recommendation: Accept\nForm responses:\n---\n\nComments to Author:\n---\nThis is a very interesting research that can help patients with CPP and their therapist. The research was well conducted and the statistics too.* Publons Reviewer Recognition. Springer Nature can send verification of this review directly to Publons (a subsidiary of Clarivate Analytics). If you would like to take advantage of this service, please click on the “Yes” option below. 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Please find the details of processing in Publons’ privacy policy https://publons.com/about/terms: **Yes**\n* Level of interest: **An article of importance in its field**\n* Quality of written English: **Acceptable**\n* Quality of figures: **- Acceptable**\n* Statistical review: **- Yes, and I have assessed the statistics in my report**\n* Declaration of competing interests: **I declare that I have no competing interests'**\n* I agree to the open peer review policy of the journal. I understand that my name will be included on my report to the authors and, if the manuscript is accepted for publication, my named report including any attachments I upload will be posted on the website along with the authors' responses. I agree for my report to be made available under an Open Access Creative Commons CC-BY license (http://creativecommons.org/licenses/by/4.0/). I understand that any comments which I do not wish to be included in my named report can be included as confidential comments to the editors, which will not be published.: **\nI agree to the open peer review policy of the journal**\n* Were you mentored through this peer review?: **No**\n"},{"type":"reviewerAgreed","content":"","date":"2021-04-01T00:00:00+00:00","index":4,"fulltext":""},{"type":"reviewerAgreed","content":"","date":"2021-03-31T01:00:00+00:00","index":3,"fulltext":""},{"type":"editorInvitedReview","content":"","date":"2021-03-31T00:00:00+00:00","index":0,"fulltext":""},{"type":"reviewerAgreed","content":"","date":"2021-03-31T00:00:00+00:00","index":2,"fulltext":""},{"type":"editorInvitedReview","content":"","date":"2021-03-25T00:00:00+00:00","index":1,"fulltext":"Recommendation: Minor Revision\nForm responses:\n---\n\nComments to Author:\n---\nThanks for an interesting and important protocol. I have a few minor queries and comments. Numbers below refer to items in the SPIRIT checklist:\n8 Can you confirm the framework for the trial is superiority?\n\n11b Adverse events are recorded, but can you describe the criteria and procedure for modifying interventions in the face of adverse events?\n\n11d Is there any concomitant care or intervention that is prohibited during the trial?\n\n12 Is the outcome recorded as an absolute value or a change from baseline?\n\n18b Could you expand on your plans to promote participant retention and to complete follow-up?\n\n21b Will there be an interim analysis for the purposes of stopping the trial early?\n\n22 How will any adverse effects be managed?\n\n25 How will any changes to the protocol be communicated?\n\n\n* Publons Reviewer Recognition. Springer Nature can send verification of this review directly to Publons (a subsidiary of Clarivate Analytics). If you would like to take advantage of this service, please click on the “Yes” option below. 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Please find the details of processing in Publons’ privacy policy https://publons.com/about/terms: **Yes**\n* Level of interest: **An article of importance in its field**\n* Quality of written English: **Acceptable**\n* Quality of figures: **- Acceptable**\n* Statistical review: **- Yes, but I do not feel adequately qualified to assess the statistics**\n* Declaration of competing interests: **I declare that I have no competing interests**\n* I agree to the open peer review policy of the journal. I understand that my name will be included on my report to the authors and, if the manuscript is accepted for publication, my named report including any attachments I upload will be posted on the website along with the authors' responses. I agree for my report to be made available under an Open Access Creative Commons CC-BY license (http://creativecommons.org/licenses/by/4.0/). I understand that any comments which I do not wish to be included in my named report can be included as confidential comments to the editors, which will not be published.: **\nI agree to the open peer review policy of the journal**\n* Were you mentored through this peer review?: **No**\n"},{"type":"reviewerAgreed","content":"","date":"2021-03-21T00:00:00+00:00","index":1,"fulltext":""},{"type":"editorAssigned","content":"","date":"2021-03-20T00:00:00+00:00","index":"","fulltext":""},{"type":"reviewersInvited","content":"","date":"2021-03-20T00:00:00+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2021-03-05T11:38:01+00:00","index":"","fulltext":""},{"type":"submitted","content":"Trials","date":"2021-01-31T12:09:13+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"trials","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"trls","sideBox":"Learn more about [Trials](http://trialsjournal.biomedcentral.com/)","snPcode":"13063","submissionUrl":"https://www.editorialmanager.com/trls","title":"Trials","twitterHandle":"MedicalEvidence","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"669362fa-1dfe-4058-8e4f-178bc4a90f52","owner":[],"postedDate":"March 9th, 2021","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"under-review","subjectAreas":[{"id":2864987,"name":"Orthopedics"}],"tags":[],"updatedAt":"2021-06-03T13:17:24+00:00","versionOfRecord":[],"versionCreatedAt":"2021-03-09 23:58:37","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-194630","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-194630","identity":"rs-194630","version":["v1"]},"buildId":"B-jG_2CBjPDmsCi4Wdhf-","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}