Effects of a trunk exoskeleton on pain during functional activities: a crossover randomized clinical trial.

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Vincent Tiffreau, Nicolas OLLIVIER, melissa moulart, Gwendoline Schulz, and 2 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-6177905/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Purpose Chronic lower back pain is a multifactorial health problem that can involve the intervertebral discs. The objective of the present clinical trial was to describe the effect of a trunk exoskeleton on the level of pain experienced during a standardized activity track. Materials and Methods Thirty-one patients with chronic lower back pain agreed to wear the device daily and perform a standardized activity track as part of a hospital-based multidisciplinary rehabilitation programme. The participants were randomized to use the device on day 4 but not on day 5, or vice versa. Blinding was not applicable because the patient and investigators could not be blinded to the intervention ( wearing or not wearing the device) Results The mean ± standard deviation (SD) pain visual analogue scale (VAS) score in the standardized activity track was 4.6 ± 1.6 mm lower with the device (albeit not significantly) than without the device. The reduction in the pain VAS score after wearing the device for an hour ranged from 12 ± 21 to 15±21 mm. The percentage of pain-free patients (i.e. with a pain VAS score ≤ 30 mm) was similar in the two groups. Seventeen (54.8%) of the 31 participants showed a decrease in the pain level >20 mm when wearing the device; this proportion was significant lower when the device was not worn. Conclusion Although the study did not evidence a significance difference in the primary endpoint, use of the device was associated with a higher proportion of patients experiencing a reduction in pain levels. Exoskeleton Low back Pain assistive device Figures Figure 1 Introduction Musculoskeletal pain is one of the main causes of invalidity[ 1 , 2 ]. Epidemiological studies have confirmed that industrialized countries have similar prevalences of lower back pain [3,4.Chronic lower back pain concerns around 20% of these patients, most of whom are aged between 35 and 45[ 5 ]. The management of lower back pain generates very significant direct and indirect costs 6,7 . The direct costs are related to care consumption and account for only 40% of the total. The indirect costs are incurred when lower back pain interferes with work activities [ 6 , 7 ]. Many studies have highlighted the intervertebral disc as the primary factor [ 8 , 9 ]. Several risk factors have been evidenced, including smoking, overweight, sedentariness, and the repeated carrying of heavy loads [ 10 ]. Despite the high prevalence and major socioeconomic impact of chronic lower back pain, there is no consensus on the treatment of this condition [ 11 ]. Surgery has shown a lack of efficacy, except in cases of nerve root pain and some other very specific situations [ 12 , 13 ]. Non-surgical management is currently recommended [ 11 ]; multidisciplinary rehabilitation programmes seek to counter muscle deconditioning, fear of movement, and other fears and beliefs about lower back pain [ 5 ]. Several techniques have been developed for decompression of the intervertebral discs, including vertebral traction techniques on a table [ 14 – 16 ]. The analgesic effect of certain medical devices (such as the flexible lumbar support belts) has been demonstrated by Calmels et al. and reported as a change in the pain VAS score [ 41.5 ± 21.4 vs. 32.0 ± 20; P = 0.002 ) 17 . The Japet.W+ (Japet Medical Devices, Loos, France) is a newly developed, wearable medical device. The device’s mechanical traction effect has been demonstrated in a biomechanical study [ 18 ]. The Japet.W + trunk exoskeleton is fitted with actuators that exert a traction force on the lumbar spine via two belts: one fastened around the lower thorax and the other fastened around the pelvis [ 19 ]. The Japet.W + complies with the IEC 60601-1-2:2014 standard. The primary objective of the present study was to assess the effect of the Japet.W + device on the pain level experienced by patients when performing standardized activity . Material and Methods This was a single-centre, prospective, randomized, controlled trial with a 2x2 (two periods, two treatments) crossover design. The study protocol was approved by an independent ethics committee ( CPP Nord-Ouest IV , Lille, France; reference: CPP18046) and registered at ClinicalTrials.gov (NCT0380194).. The study participants were patients with chronic lower back pain enrolled in a 4-week, hospital-based, multidisciplinary rehabilitation program. For the participants, the study period corresponded to the first week of the 4-week rehabilitation programme (i.e. from day D1 to D5; Fig. 1). The inclusion criteria were (i) admission to the 4-week rehabilitation program, (ii) chronic back pain for more than 3 months, (iii) a pain VAS score ≥ 30 mm on admission, (iv) a body mass index (BMI) < 30 kg/m², (v) age between 18 and 75, (vi) the provision of written, informed consent, and (vii) a Hospital Anxiety and Depression Scale score < 11 21,22 . The non-inclusion criteria were (i) a neurological impairment of the nerve root and/or spinal cord, (ii) a skin disorder affecting the trunk, (iii) a history of arthrodesis surgery, (iv) treatment with an implanted neurostimulator, (v) a BMI > 30 kg/m², (vi) respiratory insufficiency, and (vii) recent rib fracture (within the previous 3 months). Randomization Included patients were randomized 1:1 into two groups. In the first group, the participants wore the Japet.W + device when performing the activity track on the Thursday (D4) but not when performing the same activity track on the following day (Friday, D5). In the second group, the participants did not wear the device during the standardized activity track on D4 but did wear it on D5. Participants were randomized using a list of computer-generated random numbers with a block size of four. To ensure centralized, real-time randomization, the randomization list was implemented in an electronic case report form developed with Clinsight® software (ENNOV SAS, Paris, France). Procedure On D1 (i.e. just after admission to the rehabilitation program), the pain experienced by patients in daily life was rated on a VAS; this value is referred to hereafter as VAS T 0 . Next, patients performed the activity track without wearing the Japet.W + device. The activity track comprised five standardized tasks: (i) lying down on a bed and then getting up, (ii) sweeping under a bed, (iii) carrying a 6 kg weight, (iv) kneeling on one knee, as if to tie a shoelace, and (v) sorting objects of various weights on shelves at various heights. The pain VAS score was rated just after each task. The functional impact of lower back pain was evaluated by filling out the Roland-Morris Disability Questionnaire (21] and the Dallas Pain Questionnaire [ 22 ], Trunk muscle endurance was evaluated in the Shirado test[ 23 ]. . All participants wore the device for one hour on D1, D2 and D3. The pain VAS score was rated immediately before putting the device on and immediately after taking it off. Depending on their randomization group, the patients performed theactivity track wearing the Japet.W + device on D4 and without it on D5, or vice versa. The intervention The intervention consisted in wearing the Japet.W + device during a standardized activity track [ 24 ]. This standardized activity has been described by Vanderthommen et al. and consists of five simple daily activities involving the spine, such as moving objects from a shelf to a work surface, and sweeping under a bed [ 24 ]. Outcomes The primary outcome was the pain VAS score experienced after performing the most painful task (determined at baseline) in the activity track. The first of the three secondary outcomes was the change in the intensity of pain from VAS T 0 to the VAS score measured just after the Japet.W + device had been worn for an hour on D1, D2 and D3. The second secondary outcome was the percentage of patients showing an improvement, defined as a decrease of 20 mm or more between the baseline pain VAS score for the patient’s most painful task at baseline and the pain VAS score measured after performing the same task in the two conditions during the crossover phase. The last secondary outcome was the proportion of “pain-free” patients (i.e. those with a pain VAS score of less than 30 mm) after performing the task that was most painful at baseline. Statistical analysis The sample size calculation was based on the effect size (standardized mean difference) expected for the pain VAS score when wearing the Japet.W + device during the activity track. The estimated mean ± standard deviation pain VAS score in patients with lower back pain was 47 ± 22.8 mm 25 . According to Cohen, values of 0.2, 0.5 and 0.8 are considered to indicate small, medium and large effects, respectively. We expected a medium or large effect and set it to 0.7. This corresponds to a pain VAS score difference between the two groups of 16 mm. To detect this difference with a two-sided Student’s t test, a power of 80%, a type I error of 5% and balanced parallel-group study design, 34 participants per group would be needed. Assuming a correlation of 0.2 between repeated measurements of the pain VAS score and assuming that 10% of the data would not analysable, we planned to recruit a total of 32 participants into the crossover trial. All statistical analyses were performed independently in Lille University Hospital’s Methodology, Biostatistics and Data Management Unit, using SAS software (version 9.4, SAS Institute, Inc., Cary, NC, USA). All statistical tests were two-sided. The threshold for statistical significance was set to p < 0.05. The two conditions (wearing the Japet.W + device vs. not wearing the device) were compared with regard to the primary efficacy outcome using a linear mixed model, with period and condition as fixed effects and subjects as a random effect to take account of the 2x2 crossover design. The mean difference in the pain VAS score with its 95% confidence interval (CI) was derived from the model as the treatment effect size. The change in the VAS score from VAS T 0 to VAS after the Japet.W + device had been worn for an hour on D1, D2 and D3 (the first secondary outcome) was tested for each of the three days by applying a linear mixed model, with time (T 0 /after wearing the Japet.W + device) as a fixed effect and the participant as a random effect (to take account of the paired data). The mean difference in the change in the pain VAS score [95%CI] was derived from the model as the effect size. The two conditions (wearing the Japet.W + device vs. not wearing the device) were compared with regard to the proportion of patients showing an improvement using a generalized linear mixed model (GLMM), with a binomial distribution, a logit link function, the period and condition as fixed effects, and the participant as a random effect. The condition x period interaction was not significant and so was removed from the model. The relative risk (wearing the Japet.W + device vs. not wearing device) was derived from this GLMM model as a relative effect size. Furthermore, the absolute risk difference was calculated in the GLMM model by replacing the log link function with an identity link function. For the third secondary endpoint (namely the proportion of patients with a VAS score below 30 mm after performing the most painful task in the standardized activity track; ( the two conditions were compared using the GLMM model). Results Characteristics of the study population The study participants were recruited between April 1st, 2019, and June 21st, 2021. Inclusions were suspended during the COVID-19 epidemic (from January 2020 to January 2021). 31 were included in the study (Fig. 1). One participant was excluded from the study after inclusion but before randomization because he withdrew his consent.. On inclusion, 22 (71%) of the 31 participants stated that they were taking analgesics. There were no major differences between the two crossover sequences with regard to the patients’ main clinical and sociodemographic characteristics (Table 1 ). Insert Table 1 Table 1 The main clinical and sociodemographic characteristics of the study population on inclusion. BMI: body mass Index; HADS: Hospital Anxiety and Depression Scale; VAS: visual analogue scale; EIFEL: Échelle d'Incapacité Fonctionnelle pour l'Evaluation des Lombalgies (the validated French version of the Roland-Morris Disability Questionnaire). n Mean SD Median Min Max Age ( y) 31 43 11 41 19 67 BMI (kg/m 2 ) 31 26 3 24 21 34 HADS anxiety score 31 7 2 7 3 12 HADS depression score 31 5 2 5 1 11 VAS on inclusion (mm) 31 39 20 40 30 72 EIFEL 31 10 5 11 2 18 Dallas Pain Questionnaire, daily activities (%) 31 56 12 57 33 81 Dallas Pain Questionnaire, work activities (%) 31 61 18 65 20 95 Dallas Pain Questionnaire, anxiety depression (%) 31 30 21 25 0 70 Dallas Pain Questionnaire, sociability (%) 31 35 21 30 0 80 Endurance, spinal flexors (s) 31 69 44 55 8 180 Endurance, spinal extensors (s) 31 61 40 51 0 180 Endurance, quadriceps (s) 31 48 24 47 10 125 Endurance, quadratus lumborum (s) 31 43 27 36 8 109 Insert Fig. 1 Primary outcome The mean ± standard deviation VAS measured after each patient’s most painful task in the activity track was 24.6 ± 23.5 with the Japet.W + device and 29.2 ± 22.9 without it. This difference was not statistically significant (p = 0.18), and the mean difference [95%CI] was 4.6 [-2.3 to 11.5] (Tables 2 and 3 ). Table 2 Mean changes in the pain VAS scores in the two groups Group A with the device Group B without the device Day 4 n 16 15 Pain VAS score, mean ± SD (mm) 24.2 ± 24.3 29.5 ± 22.6 Pain VAS score, median (IQR] (mm) 17.5 (1.5; 43.5) 20 (10; 50) Pain VAS score, range (mm) 0–74 0–60 Group A without the device Group B with the device Day 5 n 16 15 Pain VAS score, mean ± SD (mm) 28.9 ± 23.8 25.1 ± 22.9 Pain VAS score, median (IQR] (mm) 22.5(12.5; 47) 20(5;50) Pain VAS score, range (mm) 0–75 0–64 Table 3 The pain VAS score, by treatment. Mean t value p* Alpha Min Max Score without the device 29 6.94 < 0.0001 0.05 20.715 37.756 Score with the device 24 5.85 < 0.0001 0.05 16.14 33.181 Difference 4 1.36 0.184 0.05 -2.299 11.449 * in Student’s t test Insert Table 2 and Table 3 Secondary endpoints Decrease in the daily pain VAS score The mean ± standard deviation pain VAS score T 0 (measured on D1) was 38.9 ± 20.3 mm. The mean change in the pain VAS score between T 0 and the timepoint just after the Japet.W + device had been worn ranged from 12.3 to 16.0 mm and evidenced a significant reduction in pain during the hour of device use (Table 4 ). Table 4 The daily pain VAS score after removal of the device and the difference vs. the pain VAS score on inclusion. Period Mean ± standard deviation pain VAS score Mean ± standard deviation difference vs. inclusion P value Day 1 24 ± 21.5 -14.9 ± 21.4 0.0002 Day 2 26.7 ± 21.4 -12.2 ± 21.3 0.0022 Day 3 23.2 ± 20.8 -15.7 ± 20.7 0.0002 Day 4 24.3 ± 20.7 -14.6 ± 20.6 0.0005 Day 5 25 ± 18.9 -14 ± 18.8 0.0064 Patients showing an improvement The proportion of participants showing an improvement in the pain VAS score was higher (54.8%, 17 out of 31) when they were wearing the Japet.W + device during the standardized activity track than when they were not (5.5%, 11 out of 31; p = 0.03). After adjustment for the period effect, this difference corresponded to a relative risk [95%CI] of 1.5 [1.03 to 2.30] and an absolute difference [95%CI] of 19.4% [2.98–35.78%]. The proportion of participants considered to be pain-free (i.e. those with a pain VAS score below 30 mm during the activity track) was 61.3% (19 out of 31) when they were wearing the Japet.W device and 54.8% (17 out of 31) when they were not (p = 0.41). Discussion In this crossover randomized clinical trial, we did not observe a significant effect of the Japet.W + device on the primary endpoint, i.e. a lower mean pain VAS during the activity track with the device vs. without the device. Nevertheless, the level of pain experienced when patients performed activities of daily living with the Japet.W + device was significantly lower than the level recorded on inclusion in the study. Moreover, the proportion of patients with an improvement was significantly higher when they wore the Japet.W + device than when they did not. We did not observe a significant effect of the device on the proportion of patients considered to be pain-free. This lack of effect was probably due to the low overall level of pain on inclusion, which prevented the observation of a sufficiently large decrease. In fact, the study participants’ pain levels were not very high with regard to the functional impact. None of the participants withdrew their consent because of problems encountered during the study. We observed only a few (non-serious) device-related adverse events; most were due to minor technical problems that were resolved by an engineer from the Japet development team. A few adverse events were related to pain at the device’s point of contact with the body but were rapidly resolved by adjusting the set-up. Our decision to include patients participating in a physical activity programme facilitated the study procedures. However, these patients were suffering from multifactorial chronic lower back pain; in general, traction treatment is known to be less effective in “multifactorial” patients than in patients with subacute lumbar sciatica. The predetermined activity track was based on the literature [ 24 ], and the tasks only lasted a short time. Advantageously, this activity track was standardized and ecological; however, it was mainly designed for qualitative application by therapists with a view to improving posture and movements, rather than for an overall evaluation of pain in a functional situation. The track was too short for the participants to say whether they had difficulty performing the activities. It would be interesting to include the specific activities of daily living that the participants had trouble performing and then compare these activities with vs. without device. This type of personalized goal attainment scale usefully targets the tasks of concern, which may differ from one participant to another [ 25 ]. Some of the patients were taking painkillers at the time of the study; these treatments might have modified the pain levels evaluated during the study. In our study, the overall pain level on inclusion was low (38.94 ± 20.34 mm), which made it more difficult to evidence an effect of treatment. Furthermore, the pain level experienced varied greatly from one study participants to another. It would be more appropriate to observe the effect of the device in patients with higher pain levels (e.g. in the acute or subacute phases of lower back pain). It should be borne in mind that the Japet.W + device’s current applications essentially concern people whose work involves particularly intense mechanical constraints, which can cause lower back pain to intensify during the working day.[ 19 ] Conclusion Use of the Japet.W + device was not associated with significantly lower pain levels in in patients with lower back pain performing a standardized activity track. However, wearing the device for an hour while doing everyday activities reduced the level of pain. Although the activity track studied here had the advantage of being standardized, it would be interesting to assess the device’s effects in situations that are more restrictive that those studied here. Declarations Authors contribution Vincent TIFFREAU wrote the protocole Quentin HANOT and Gwendoline SCHULZ participated as investigators André THEVENON supervised the investigation as chief of the medical Unit Melissa MOULART gave technical support with the device Vincent TIFREAU and Nicolas OLIVIER wrote the study report Acknowledgement We give acknowlegement tu Japet Medical Devics for providing the device and giving technical support References Nicol V, Verdaguer C, Daste C, Bisseriex H, Lapeyre É, Lefèvre-Colau MM et al (2023) Chronic Low Back Pain: A Narrative Review of Recent International Guidelines for Diagnosis and Conservative Treatment. J Clin Med. 20 févr. ;12(4):1685 Knezevic NN, Candido KD, Vlaeyen JWS, Van Zundert J, Cohen SP (2021) Low back pain. Lancet Lond Engl 3 juill 398(10294):78–92 Cieza A, Causey K, Kamenov K, Hanson SW, Chatterji S, Vos T (2021) Global estimates of the need for rehabilitation based on the Global Burden of Disease study 2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet Lond Engl 19 déc 396(10267):2006–2017 Chou R, Deyo R, Friedly J, Skelly A, Hashimoto R, Weimer M et al Noninvasive Treatments for Low Back Pain (Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2016 (cité 5 févr 2017]. (AHRQ Comparative Effectiveness Reviews). Disponible sur: http://www.ncbi.nlm.nih.gov/books/NBK350276/ Chou R, Deyo R, Friedly J, Skelly A, Hashimoto R, Weimer M et al (2017) Nonpharmacologic Therapies for Low Back Pain: A Systematic Review for an American College of Physicians Clinical Practice Guideline. Ann Intern Med. 4 avr. ;166(7):493–505 Fatoye F, Gebrye T, Ryan CG, Useh U, Mbada C (2023) Global and regional estimates of clinical and economic burden of low back pain in high-income countries: a systematic review and meta-analysis. Front Public Health 11:1098100 Perrot S, Doane MJ, Jaffe DH, Dragon E, Abraham L, Viktrup L et al (2022) Burden of chronic low back pain: Association with pain severity and prescription medication use in five large European countries. Pain Pract Off J World Inst Pain mars 22(3):359–371 Borenstein D (2013) Mechanical low back pain–a rheumatologist’s view. Nat Rev Rheumatol nov 9(11):643–653 Bogduk N (2009) On the definitions and physiology of back pain, referred pain, and radicular pain. Pain 15 déc 147(1–3):17–19 Maher C, Underwood M, Buchbinder R (2017) Non-specific low back pain. Lancet 18 févr 389(10070):736–747 Oliveira CB, Maher CG, Pinto RZ, Traeger AC, Lin CWC, Chenot JF et al (2018) Clinical practice guidelines for the management of non-specific low back pain in primary care: an updated overview. Eur Spine J Off Publ Eur Spine Soc Eur Spinal Deform Soc Eur Sect Cerv Spine Res Soc nov 27(11):2791–2803 Copeland B (sept 2007) Surgical versus nonsurgical treatment for back pain. N Engl J Med 20(12):1255 author reply 1255–1256 Gaudin D, Krafcik BM, Mansour TR, Alnemari A (2017) Considerations in Spinal Fusion Surgery for Chronic Lumbar Pain: Psychosocial Factors, Rating Scales, and Perioperative Patient Education-A Review of the Literature. World Neurosurg févr 98:21–27 Leonel FJF, de Paula L, Raab Ferreira GC, do Nascimento DMDR, Gnoato Zotz TG, de Melo JM et al (2023) Effect of two suspension training programs on pain and musculoskeletal function in chronic low back pain: study protocol. Pain Manag. 17 juill Vanti C, Panizzolo A, Turone L, Guccione AA, Violante FS, Pillastrini P et al (2021) Effectiveness of Mechanical Traction for Lumbar Radiculopathy: A Systematic Review and Meta-Analysis. Phys Ther 3 mars 101(3):pzaa231 Clarke J, van Tulder M, Blomberg S, de Vet H, van der Heijden G, Bronfort G (2006) Traction for low back pain with or without sciatica: an updated systematic review within the framework of the Cochrane collaboration. Spine 15 juin 31(14):1591–1599 Calmels P, Queneau P, Hamonet C, Le Pen C, Maurel F, Lerouvreur C et al (2009) Effectiveness of a lumbar belt in subacute low back pain: an open, multicentric, and randomized clinical study. Spine 1 févr 34(3):215–220 Zaïri F, Moulart M, Fontaine C, Zaïri F, Tiffreau V, Logier R Relevance of a novel external dynamic distraction device for treating back pain. Proc Inst Mech Eng (H] 27 nov 2020;954411920971401. Moulart M, Olivier N, Giovanelli Y, Marin F (2022) Subjective assessment of a lumbar exoskeleton’s impact on lower back pain in a real work situation. Heliyon nov 8(11):e11420 Roberge P, Doré I, Menear M, Chartrand É, Ciampi A, Duhoux A et al (2013) A psychometric evaluation of the French Canadian version of the Hospital Anxiety and Depression Scale in a large primary care population. J Affect Disord 1 mai 147(1):171–179 Coste J, Le Parc JM, Berge E, Delecoeuillerie G, Paolaggi JB (1993) (French validation of a disability rating scale for the evaluation of low back pain (EIFEL questionnaire)]. Rev Rhum Ed Francaise 1993. mai ;60(5):335–41 Marty M, Blotman F, Avouac B, Rozenberg S, Valat JP (1998) Validation of the French version of the Dallas Pain Questionnaire in chronic low back pain patients. Rev Rhum Engl Ed févr 65(2):126–134 Gagnon S, Lensel-Corbeil G, Duquesnoy B (2009) Multicenter multidisciplinary training program for chronic low back pain: French experience of the Renodos back pain network (Réseau Nord-Pas-de-Calais du DOS). Ann Phys Rehabil Med 1 févr 52(1):3–16 Vanderthommen M, Defaweux M, Tomasella M, Crielaard JM (1999) Le comportement gestuel du patient lombalgique fréquentant une école du dos: analyse préliminaire d’un test d’évaluation. Ann Réadapt Médecine Phys 1 nov 42(8):485–492 Kang E, Kim MY, Lipsey KL, Foster ER Person-Centered Goal Setting: A systematic review of intervention components and level of active engagement in rehabilitation goal setting interventions. Arch Phys Med Rehabil (Internet] 8 août 2021 [cité 1 sept 2021]; Disponible sur: https://www.sciencedirect.com/science/article/pii/S0003999321013472 Additional Declarations No competing interests reported. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-6177905","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":428155485,"identity":"24a775e4-36a9-4134-bbdf-092bbe83d62e","order_by":0,"name":"Vincent Tiffreau","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAABFklEQVRIie3PMUvDQBTA8Xcc5JbXZr2gxq+QEAid9Kt4FJxEHAOKXijESbrGbyEUimPLQbOce8f2G8RRqOKlabt46exw/yF3PPjxLgAu13+MHi5kVTenD2i+d/y0b466m0SAlMZlcw1kQyKOHgApu3cZAjsSzbAddJGo6s3rz/cNXDJKRll2ISbVx4JDNECPSTOxENUfBq96+zCSaz0UU317zbcPw5mZ/CXBCFPaKxriV+u8oGK6xPRk0xB+xdayg3wXuy35z5OYlJi2W85XJLcQnxpCDkQq8cb3hEMXSYKXIkFUhshFlZT6Jhm0/yJyG/F8HddfRRiysTLk4f5s/KzjJWSPoc/U3Eb2oW1IjgCXy+VyHesXDoZS1zQjqOMAAAAASUVORK5CYII=","orcid":"","institution":"Centre Hospitalier Universitaire de Lille","correspondingAuthor":true,"prefix":"","firstName":"Vincent","middleName":"","lastName":"Tiffreau","suffix":""},{"id":428155486,"identity":"45f8a39a-29dd-438f-9cb4-b739aa7bae63","order_by":1,"name":"Nicolas OLLIVIER","email":"","orcid":"","institution":"University of Lille","correspondingAuthor":false,"prefix":"","firstName":"Nicolas","middleName":"","lastName":"OLLIVIER","suffix":""},{"id":428155489,"identity":"35d4fbbe-9ce8-448b-87e4-68271af24afa","order_by":2,"name":"melissa moulart","email":"","orcid":"","institution":"University of Technology of Compiègne","correspondingAuthor":false,"prefix":"","firstName":"melissa","middleName":"","lastName":"moulart","suffix":""},{"id":428155494,"identity":"96b61979-5f18-42cb-9179-305e6ba584fb","order_by":3,"name":"Gwendoline Schulz","email":"","orcid":"","institution":"Centre Hospitalier Universitaire de Lille","correspondingAuthor":false,"prefix":"","firstName":"Gwendoline","middleName":"","lastName":"Schulz","suffix":""},{"id":428155496,"identity":"ebdc1df6-54e4-4cc9-8d27-44e56eb7071c","order_by":4,"name":"Quentin HANOT","email":"","orcid":"","institution":"Centre Hospitalier Universitaire de Lille","correspondingAuthor":false,"prefix":"","firstName":"Quentin","middleName":"","lastName":"HANOT","suffix":""},{"id":428155497,"identity":"828fdad1-528e-4232-8e37-15bfe9ddb792","order_by":5,"name":"André Thevenon","email":"","orcid":"","institution":"Centre Hospitalier Universitaire de Lille","correspondingAuthor":false,"prefix":"","firstName":"André","middleName":"","lastName":"Thevenon","suffix":""}],"badges":[],"createdAt":"2025-03-07 11:38:13","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-6177905/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-6177905/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":78732453,"identity":"d7c4b745-0824-4b06-be43-fe5ddc61dbfb","added_by":"auto","created_at":"2025-03-18 07:47:38","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":121398,"visible":true,"origin":"","legend":"\u003cp\u003eSee image above for figure legend.\u003c/p\u003e","description":"","filename":"Figure1.png","url":"https://assets-eu.researchsquare.com/files/rs-6177905/v1/beafc41716bf6e171d650e65.png"},{"id":84073746,"identity":"5ccbd8e2-60ab-4bd2-90bd-877eec448533","added_by":"auto","created_at":"2025-06-06 12:46:54","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":794562,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-6177905/v1/6fc134bd-5938-497b-bf92-0539e6ee15b2.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"Effects of a trunk exoskeleton on pain during functional activities: a crossover randomized clinical trial.","fulltext":[{"header":"Introduction","content":"\u003cp\u003eMusculoskeletal pain is one of the main causes of invalidity[\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e, \u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e]. Epidemiological studies have confirmed that industrialized countries have similar prevalences of lower back pain [3,4.Chronic lower back pain concerns around 20% of these patients, most of whom are aged between 35 and 45[\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e]. The management of lower back pain generates very significant direct and indirect costs \u003csup\u003e6,7\u003c/sup\u003e. The direct costs are related to care consumption and account for only 40% of the total. The indirect costs are incurred when lower back pain interferes with work activities [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e, \u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eMany studies have highlighted the intervertebral disc as the primary factor [\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e, \u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e]. Several risk factors have been evidenced, including smoking, overweight, sedentariness, and the repeated carrying of heavy loads [\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e]. Despite the high prevalence and major socioeconomic impact of chronic lower back pain, there is no consensus on the treatment of this condition [\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e]. Surgery has shown a lack of efficacy, except in cases of nerve root pain and some other very specific situations [\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e, \u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eNon-surgical management is currently recommended [\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e]; multidisciplinary rehabilitation programmes seek to counter muscle deconditioning, fear of movement, and other fears and beliefs about lower back pain [\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e]. Several techniques have been developed for decompression of the intervertebral discs, including vertebral traction techniques on a table [\u003cspan additionalcitationids=\"CR15\" citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e]. The analgesic effect of certain medical devices (such as the flexible lumbar support belts) has been demonstrated by Calmels et al. and reported as a change in the pain VAS score [ 41.5\u0026thinsp;\u0026plusmn;\u0026thinsp;21.4 \u003cem\u003evs.\u003c/em\u003e 32.0\u0026thinsp;\u0026plusmn;\u0026thinsp;20; \u003cem\u003eP\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.002 )\u003csup\u003e17\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eThe Japet.W+ (Japet Medical Devices, Loos, France) is a newly developed, wearable medical device. The device\u0026rsquo;s mechanical traction effect has been demonstrated in a biomechanical study [\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e]. The Japet.W\u0026thinsp;+\u0026thinsp;trunk exoskeleton is fitted with actuators that exert a traction force on the lumbar spine via two belts: one fastened around the lower thorax and the other fastened around the pelvis [\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e]. The Japet.W\u0026thinsp;+\u0026thinsp;complies with the IEC 60601-1-2:2014 standard.\u003c/p\u003e \u003cp\u003eThe primary objective of the present study was to assess the effect of the Japet.W\u0026thinsp;+\u0026thinsp;device on the pain level experienced by patients when performing standardized activity .\u003c/p\u003e"},{"header":"Material and Methods","content":"\u003cp\u003eThis was a single-centre, prospective, randomized, controlled trial with a 2x2 (two periods, two treatments) crossover design. The study protocol was approved by an independent ethics committee (\u003cem\u003eCPP Nord-Ouest IV\u003c/em\u003e, Lille, France; reference: CPP18046) and registered at ClinicalTrials.gov (NCT0380194).. The study participants were patients with chronic lower back pain enrolled in a 4-week, hospital-based, multidisciplinary rehabilitation program.\u003c/p\u003e \u003cp\u003eFor the participants, the study period corresponded to the first week of the 4-week rehabilitation programme (i.e. from day D1 to D5; Fig.\u0026nbsp;1). The inclusion criteria were (i) admission to the 4-week rehabilitation program, (ii) chronic back pain for more than 3 months, (iii) a pain VAS score\u0026thinsp;\u0026ge;\u0026thinsp;30 mm on admission, (iv) a body mass index (BMI)\u0026thinsp;\u0026lt;\u0026thinsp;30 kg/m\u0026sup2;, (v) age between 18 and 75, (vi) the provision of written, informed consent, and (vii) a Hospital Anxiety and Depression Scale score\u0026thinsp;\u0026lt;\u0026thinsp;11 \u003csup\u003e21,22\u003c/sup\u003e. The non-inclusion criteria were (i) a neurological impairment of the nerve root and/or spinal cord, (ii) a skin disorder affecting the trunk, (iii) a history of arthrodesis surgery, (iv) treatment with an implanted neurostimulator, (v) a BMI\u0026thinsp;\u0026gt;\u0026thinsp;30 kg/m\u0026sup2;, (vi) respiratory insufficiency, and (vii) recent rib fracture (within the previous 3 months).\u003c/p\u003e \u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eRandomization\u003c/h2\u003e \u003cp\u003eIncluded patients were randomized 1:1 into two groups. In the first group, the participants wore the Japet.W\u0026thinsp;+\u0026thinsp;device when performing the activity track on the Thursday (D4) but not when performing the same activity track on the following day (Friday, D5). In the second group, the participants did not wear the device during the standardized activity track on D4 but did wear it on D5. Participants were randomized using a list of computer-generated random numbers with a block size of four. To ensure centralized, real-time randomization, the randomization list was implemented in an electronic case report form developed with Clinsight\u0026reg; software (ENNOV SAS, Paris, France).\u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003eProcedure\u003c/h3\u003e\n\u003cp\u003eOn D1 (i.e. just after admission to the rehabilitation program), the pain experienced by patients in daily life was rated on a VAS; this value is referred to hereafter as VAS T\u003csub\u003e0\u003c/sub\u003e. Next, patients performed the activity track without wearing the Japet.W\u0026thinsp;+\u0026thinsp;device. The activity track comprised five standardized tasks: (i) lying down on a bed and then getting up, (ii) sweeping under a bed, (iii) carrying a 6 kg weight, (iv) kneeling on one knee, as if to tie a shoelace, and (v) sorting objects of various weights on shelves at various heights. The pain VAS score was rated just after each task.\u003c/p\u003e \u003cp\u003eThe functional impact of lower back pain was evaluated by filling out the Roland-Morris Disability Questionnaire (21] and the Dallas Pain Questionnaire [\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e], Trunk muscle endurance was evaluated in the Shirado test[\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e]. .\u003c/p\u003e \u003cp\u003eAll participants wore the device for one hour on D1, D2 and D3. The pain VAS score was rated immediately before putting the device on and immediately after taking it off. Depending on their randomization group, the patients performed theactivity track wearing the Japet.W\u0026thinsp;+\u0026thinsp;device on D4 and without it on D5, or vice versa.\u003c/p\u003e\n\u003ch3\u003eThe intervention\u003c/h3\u003e\n\u003cp\u003eThe intervention consisted in wearing the Japet.W\u0026thinsp;+\u0026thinsp;device during a standardized activity track [\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e]. This standardized activity has been described by Vanderthommen et al. and consists of five simple daily activities involving the spine, such as moving objects from a shelf to a work surface, and sweeping under a bed [\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e].\u003c/p\u003e\n\u003ch3\u003eOutcomes\u003c/h3\u003e\n\u003cp\u003eThe primary outcome was the pain VAS score experienced after performing the most painful task (determined at baseline) in the activity track. The first of the three secondary outcomes was the change in the intensity of pain from VAS T\u003csub\u003e0\u003c/sub\u003e to the VAS score measured just after the Japet.W\u0026thinsp;+\u0026thinsp;device had been worn for an hour on D1, D2 and D3. The second secondary outcome was the percentage of patients showing an improvement, defined as a decrease of 20 mm or more between the baseline pain VAS score for the patient\u0026rsquo;s most painful task at baseline and the pain VAS score measured after performing the same task in the two conditions during the crossover phase. The last secondary outcome was the proportion of \u0026ldquo;pain-free\u0026rdquo; patients (i.e. those with a pain VAS score of less than 30 mm) after performing the task that was most painful at baseline.\u003c/p\u003e \u003cdiv id=\"Sec7\" class=\"Section2\"\u003e \u003ch2\u003eStatistical analysis\u003c/h2\u003e \u003cp\u003eThe sample size calculation was based on the effect size (standardized mean difference) expected for the pain VAS score when wearing the Japet.W\u0026thinsp;+\u0026thinsp;device during the activity track. The estimated mean\u0026thinsp;\u0026plusmn;\u0026thinsp;standard deviation pain VAS score in patients with lower back pain was 47\u0026thinsp;\u0026plusmn;\u0026thinsp;22.8 mm \u003csup\u003e25\u003c/sup\u003e. According to Cohen, values of 0.2, 0.5 and 0.8 are considered to indicate small, medium and large effects, respectively. We expected a medium or large effect and set it to 0.7. This corresponds to a pain VAS score difference between the two groups of 16 mm. To detect this difference with a two-sided Student\u0026rsquo;s t test, a power of 80%, a type I error of 5% and balanced parallel-group study design, 34 participants per group would be needed. Assuming a correlation of 0.2 between repeated measurements of the pain VAS score and assuming that 10% of the data would not analysable, we planned to recruit a total of 32 participants into the crossover trial.\u003c/p\u003e \u003cp\u003eAll statistical analyses were performed independently in Lille University Hospital\u0026rsquo;s Methodology, Biostatistics and Data Management Unit, using SAS software (version 9.4, SAS Institute, Inc., Cary, NC, USA). All statistical tests were two-sided. The threshold for statistical significance was set to p\u0026thinsp;\u0026lt;\u0026thinsp;0.05.\u003c/p\u003e \u003cp\u003eThe two conditions (wearing the Japet.W\u0026thinsp;+\u0026thinsp;device vs. not wearing the device) were compared with regard to the primary efficacy outcome using a linear mixed model, with period and condition as fixed effects and subjects as a random effect to take account of the 2x2 crossover design. The mean difference in the pain VAS score with its 95% confidence interval (CI) was derived from the model as the treatment effect size.\u003c/p\u003e \u003cp\u003eThe change in the VAS score from VAS T\u003csub\u003e0\u003c/sub\u003e to VAS after the Japet.W\u0026thinsp;+\u0026thinsp;device had been worn for an hour on D1, D2 and D3 (the first secondary outcome) was tested for each of the three days by applying a linear mixed model, with time (T\u003csub\u003e0\u003c/sub\u003e/after wearing the Japet.W\u0026thinsp;+\u0026thinsp;device) as a fixed effect and the participant as a random effect (to take account of the paired data). The mean difference in the change in the pain VAS score [95%CI] was derived from the model as the effect size. The two conditions (wearing the Japet.W\u0026thinsp;+\u0026thinsp;device vs. not wearing the device) were compared with regard to the proportion of patients showing an improvement using a generalized linear mixed model (GLMM), with a binomial distribution, a logit link function, the period and condition as fixed effects, and the participant as a random effect. The condition x period interaction was not significant and so was removed from the model. The relative risk (wearing the Japet.W\u0026thinsp;+\u0026thinsp;device vs. not wearing device) was derived from this GLMM model as a relative effect size. Furthermore, the absolute risk difference was calculated in the GLMM model by replacing the log link function with an identity link function. For the third secondary endpoint (namely the proportion of patients with a VAS score below 30 mm after performing the most painful task in the standardized activity track; ( the two conditions were compared using the GLMM model).\u003c/p\u003e \u003c/div\u003e"},{"header":"Results","content":"\u003cdiv id=\"Sec9\" class=\"Section2\"\u003e \u003ch2\u003eCharacteristics of the study population\u003c/h2\u003e \u003cp\u003eThe study participants were recruited between April 1st, 2019, and June 21st, 2021. Inclusions were suspended during the COVID-19 epidemic (from January 2020 to January 2021). 31 were included in the study (Fig.\u0026nbsp;1). One participant was excluded from the study after inclusion but before randomization because he withdrew his consent.. On inclusion, 22 (71%) of the 31 participants stated that they were taking analgesics. There were no major differences between the two crossover sequences with regard to the patients\u0026rsquo; main clinical and sociodemographic characteristics (Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e). \u003cb\u003eInsert\u003c/b\u003e Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eThe main clinical and sociodemographic characteristics of the study population on inclusion. BMI: body mass Index; HADS: Hospital Anxiety and Depression Scale; VAS: visual analogue scale; EIFEL: \u003cem\u003e\u0026Eacute;chelle d'Incapacit\u0026eacute; Fonctionnelle pour l'Evaluation des Lombalgies\u003c/em\u003e (the validated French version of the Roland-Morris Disability Questionnaire).\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"7\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c7\" colnum=\"7\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cem\u003en\u003c/em\u003e\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u003cem\u003eMean\u003c/em\u003e\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u003cem\u003eSD\u003c/em\u003e\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003e\u003cem\u003eMedian\u003c/em\u003e\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c6\"\u003e \u003cp\u003e\u003cem\u003eMin\u003c/em\u003e\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c7\"\u003e \u003cp\u003e\u003cem\u003eMax\u003c/em\u003e\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAge ( y)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e31\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e43\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e11\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e41\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e19\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e \u003cp\u003e67\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eBMI (kg/m\u003csup\u003e2\u003c/sup\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e31\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e26\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e24\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e21\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e \u003cp\u003e34\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHADS anxiety score\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e31\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e7\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e7\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e \u003cp\u003e12\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHADS depression score\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e31\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e \u003cp\u003e11\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eVAS on inclusion (mm)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e31\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e39\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e20\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e40\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e30\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e \u003cp\u003e72\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eEIFEL\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e31\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e10\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e11\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e \u003cp\u003e18\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDallas Pain Questionnaire, daily activities (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e31\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e56\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e12\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e57\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e33\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e \u003cp\u003e81\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDallas Pain Questionnaire, work activities (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e31\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e61\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e18\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e65\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e20\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e \u003cp\u003e95\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDallas Pain Questionnaire, anxiety depression (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e31\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e30\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e21\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e25\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e \u003cp\u003e70\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDallas Pain Questionnaire, sociability (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e31\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e35\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e21\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e30\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e \u003cp\u003e80\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eEndurance, spinal flexors (s)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e31\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e69\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e44\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e55\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e8\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e \u003cp\u003e180\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eEndurance, spinal extensors (s)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e31\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e61\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e40\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e51\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e \u003cp\u003e180\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eEndurance, quadriceps (s)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e31\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e48\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e24\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e47\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e10\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e \u003cp\u003e125\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eEndurance, quadratus lumborum (s)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e31\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e43\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e27\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e36\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e8\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e \u003cp\u003e109\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\n\u003ch3\u003eInsert Fig. 1\u003c/h3\u003e\n\u003cdiv id=\"Sec11\" class=\"Section2\"\u003e \u003ch2\u003ePrimary outcome\u003c/h2\u003e \u003cp\u003eThe mean\u0026thinsp;\u0026plusmn;\u0026thinsp;standard deviation VAS measured after each patient\u0026rsquo;s most painful task in the activity track was 24.6\u0026thinsp;\u0026plusmn;\u0026thinsp;23.5 with the Japet.W\u0026thinsp;+\u0026thinsp;device and 29.2\u0026thinsp;\u0026plusmn;\u0026thinsp;22.9 without it. This difference was not statistically significant (p\u0026thinsp;=\u0026thinsp;0.18), and the mean difference [95%CI] was 4.6 [-2.3 to 11.5] (Tables\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e and \u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\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\u003eMean changes in the pain VAS scores in the two groups\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"4\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eGroup A with the device\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eGroup B without the device\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDay 4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003en\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e16\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e15\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003ePain VAS score, mean\u0026thinsp;\u0026plusmn;\u0026thinsp;SD (mm)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e24.2\u0026thinsp;\u0026plusmn;\u0026thinsp;24.3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e29.5\u0026thinsp;\u0026plusmn;\u0026thinsp;22.6\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003ePain VAS score, median (IQR] (mm)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e17.5 (1.5; 43.5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e20 (10; 50)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003ePain VAS score, range (mm)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0\u0026ndash;74\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0\u0026ndash;60\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eGroup A without the device\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eGroup B with the device\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDay 5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003en\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e16\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e15\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003ePain VAS score, mean\u0026thinsp;\u0026plusmn;\u0026thinsp;SD (mm)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e28.9\u0026thinsp;\u0026plusmn;\u0026thinsp;23.8\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e25.1\u0026thinsp;\u0026plusmn;\u0026thinsp;22.9\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003ePain VAS score, median (IQR] (mm)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e22.5(12.5; 47)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e20(5;50)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003ePain VAS score, range (mm)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0\u0026ndash;75\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0\u0026ndash;64\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003e \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 pain VAS score, by treatment. \u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"7\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c7\" colnum=\"7\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eMean\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003et value\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003ep*\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003eAlpha\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c6\"\u003e \u003cp\u003eMin\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c7\"\u003e \u003cp\u003eMax\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\u003eScore without the device\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e29\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e6.94\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.0001\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.05\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e20.715\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e \u003cp\u003e37.756\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eScore with the device\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e24\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e5.85\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.0001\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.05\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e16.14\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e \u003cp\u003e33.181\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eDifference\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e1.36\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.184\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.05\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e-2.299\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e \u003cp\u003e11.449\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \n\u003cp\u003e* in Student\u0026rsquo;s t test\u003c/p\u003e\u003cp\u003eInsert Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e and Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec12\" class=\"Section2\"\u003e \u003ch2\u003eSecondary endpoints\u003c/h2\u003e \u003cdiv id=\"Sec13\" class=\"Section3\"\u003e \u003ch2\u003eDecrease in the daily pain VAS score\u003c/h2\u003e \u003cp\u003eThe mean\u0026thinsp;\u0026plusmn;\u0026thinsp;standard deviation pain VAS score T\u003csub\u003e0\u003c/sub\u003e (measured on D1) was 38.9\u0026thinsp;\u0026plusmn;\u0026thinsp;20.3 mm. The mean change in the pain VAS score between T\u003csub\u003e0\u003c/sub\u003e and the timepoint just after the Japet.W\u0026thinsp;+\u0026thinsp;device had been worn ranged from 12.3 to 16.0 mm and evidenced a significant reduction in pain during the hour of device use (Table\u0026nbsp;\u003cspan refid=\"Tab4\" class=\"InternalRef\"\u003e4\u003c/span\u003e).\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab4\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 4\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eThe daily pain VAS score after removal of the device and the difference vs. the pain VAS score on inclusion.\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"4\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\"\u0026plusmn;\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\"\u0026plusmn;\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePeriod\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eMean\u0026thinsp;\u0026plusmn;\u0026thinsp;standard deviation pain VAS score\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eMean\u0026thinsp;\u0026plusmn;\u0026thinsp;standard deviation difference vs. inclusion\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eP value\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\u003eDay 1\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c2\"\u003e \u003cp\u003e24\u0026thinsp;\u0026plusmn;\u0026thinsp;21.5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c3\"\u003e \u003cp\u003e-14.9\u0026thinsp;\u0026plusmn;\u0026thinsp;21.4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.0002\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eDay 2\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c2\"\u003e \u003cp\u003e26.7\u0026thinsp;\u0026plusmn;\u0026thinsp;21.4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c3\"\u003e \u003cp\u003e-12.2\u0026thinsp;\u0026plusmn;\u0026thinsp;21.3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.0022\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eDay 3\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c2\"\u003e \u003cp\u003e23.2\u0026thinsp;\u0026plusmn;\u0026thinsp;20.8\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c3\"\u003e \u003cp\u003e-15.7\u0026thinsp;\u0026plusmn;\u0026thinsp;20.7\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.0002\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eDay 4\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c2\"\u003e \u003cp\u003e24.3\u0026thinsp;\u0026plusmn;\u0026thinsp;20.7\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c3\"\u003e \u003cp\u003e-14.6\u0026thinsp;\u0026plusmn;\u0026thinsp;20.6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.0005\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eDay 5\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c2\"\u003e \u003cp\u003e25\u0026thinsp;\u0026plusmn;\u0026thinsp;18.9\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c3\"\u003e \u003cp\u003e-14\u0026thinsp;\u0026plusmn;\u0026thinsp;18.8\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.0064\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 \u003c/div\u003e \u003cdiv id=\"Sec14\" class=\"Section2\"\u003e \u003ch2\u003ePatients showing an improvement\u003c/h2\u003e \u003cp\u003eThe proportion of participants showing an improvement in the pain VAS score was higher (54.8%, 17 out of 31) when they were wearing the Japet.W\u0026thinsp;+\u0026thinsp;device during the standardized activity track than when they were not (5.5%, 11 out of 31; p\u0026thinsp;=\u0026thinsp;0.03). After adjustment for the period effect, this difference corresponded to a relative risk [95%CI] of 1.5 [1.03 to 2.30] and an absolute difference [95%CI] of 19.4% [2.98\u0026ndash;35.78%].\u003c/p\u003e \u003cp\u003eThe proportion of participants considered to be pain-free (i.e. those with a pain VAS score below 30 mm during the activity track) was 61.3% (19 out of 31) when they were wearing the Japet.W device and 54.8% (17 out of 31) when they were not (p\u0026thinsp;=\u0026thinsp;0.41).\u003c/p\u003e \u003c/div\u003e"},{"header":"Discussion","content":"\u003cp\u003eIn this crossover randomized clinical trial, we did not observe a significant effect of the Japet.W\u0026thinsp;+\u0026thinsp;device on the primary endpoint, i.e. a lower mean pain VAS during the activity track with the device vs. without the device. Nevertheless, the level of pain experienced when patients performed activities of daily living with the Japet.W\u0026thinsp;+\u0026thinsp;device was significantly lower than the level recorded on inclusion in the study. Moreover, the proportion of patients with an improvement was significantly higher when they wore the Japet.W\u0026thinsp;+\u0026thinsp;device than when they did not.\u003c/p\u003e \u003cp\u003eWe did not observe a significant effect of the device on the proportion of patients considered to be pain-free. This lack of effect was probably due to the low overall level of pain on inclusion, which prevented the observation of a sufficiently large decrease. In fact, the study participants\u0026rsquo; pain levels were not very high with regard to the functional impact.\u003c/p\u003e \u003cp\u003eNone of the participants withdrew their consent because of problems encountered during the study. We observed only a few (non-serious) device-related adverse events; most were due to minor technical problems that were resolved by an engineer from the Japet development team. A few adverse events were related to pain at the device\u0026rsquo;s point of contact with the body but were rapidly resolved by adjusting the set-up.\u003c/p\u003e \u003cp\u003eOur decision to include patients participating in a physical activity programme facilitated the study procedures. However, these patients were suffering from multifactorial chronic lower back pain; in general, traction treatment is known to be less effective in \u0026ldquo;multifactorial\u0026rdquo; patients than in patients with subacute lumbar sciatica.\u003c/p\u003e \u003cp\u003eThe predetermined activity track was based on the literature [\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e], and the tasks only lasted a short time. Advantageously, this activity track was standardized and ecological; however, it was mainly designed for qualitative application by therapists with a view to improving posture and movements, rather than for an overall evaluation of pain in a functional situation. The track was too short for the participants to say whether they had difficulty performing the activities. It would be interesting to include the specific activities of daily living that the participants had trouble performing and then compare these activities with vs. without device. This type of personalized goal attainment scale usefully targets the tasks of concern, which may differ from one participant to another [\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eSome of the patients were taking painkillers at the time of the study; these treatments might have modified the pain levels evaluated during the study.\u003c/p\u003e \u003cp\u003eIn our study, the overall pain level on inclusion was low (38.94\u0026thinsp;\u0026plusmn;\u0026thinsp;20.34 mm), which made it more difficult to evidence an effect of treatment. Furthermore, the pain level experienced varied greatly from one study participants to another. It would be more appropriate to observe the effect of the device in patients with higher pain levels (e.g. in the acute or subacute phases of lower back pain).\u003c/p\u003e \u003cp\u003eIt should be borne in mind that the Japet.W\u0026thinsp;+\u0026thinsp;device\u0026rsquo;s current applications essentially concern people whose work involves particularly intense mechanical constraints, which can cause lower back pain to intensify during the working day.[\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e]\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003eUse of the Japet.W\u0026thinsp;+\u0026thinsp;device was not associated with significantly lower pain levels in in patients with lower back pain performing a standardized activity track. However, wearing the device for an hour while doing everyday activities reduced the level of pain. Although the activity track studied here had the advantage of being standardized, it would be interesting to assess the device\u0026rsquo;s effects in situations that are more restrictive that those studied here.\u003c/p\u003e"},{"header":"Declarations","content":"\u003ch2\u003eAuthors contribution \u0026nbsp;\u003c/h2\u003e\n\u003cp\u003eVincent TIFFREAU wrote the protocole\u003c/p\u003e\n\u003cp\u003eQuentin HANOT and Gwendoline SCHULZ participated as investigators\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAndr\u0026eacute; THEVENON supervised the investigation as chief of the medical Unit\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eMelissa MOULART gave technical support with the device\u003c/p\u003e\n\u003cp\u003eVincent TIFREAU and Nicolas OLIVIER wrote the study report\u0026nbsp;\u003c/p\u003e\u003ch2\u003eAcknowledgement\u003c/h2\u003e\u003cp\u003eWe give acknowlegement tu Japet Medical Devics for providing the device and giving technical support\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eNicol V, Verdaguer C, Daste C, Bisseriex H, Lapeyre \u0026Eacute;, Lef\u0026egrave;vre-Colau MM et al (2023) Chronic Low Back Pain: A Narrative Review of Recent International Guidelines for Diagnosis and Conservative Treatment. J Clin Med. 20 f\u0026eacute;vr. ;12(4):1685\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKnezevic NN, Candido KD, Vlaeyen JWS, Van Zundert J, Cohen SP (2021) Low back pain. Lancet Lond Engl 3 juill 398(10294):78\u0026ndash;92\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eCieza A, Causey K, Kamenov K, Hanson SW, Chatterji S, Vos T (2021) Global estimates of the need for rehabilitation based on the Global Burden of Disease study 2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet Lond Engl 19 d\u0026eacute;c 396(10267):2006\u0026ndash;2017\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eChou R, Deyo R, Friedly J, Skelly A, Hashimoto R, Weimer M et al Noninvasive Treatments for Low Back Pain (Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2016 (cit\u0026eacute; 5 f\u0026eacute;vr 2017]. (AHRQ Comparative Effectiveness Reviews). Disponible sur: \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttp://www.ncbi.nlm.nih.gov/books/NBK350276/\u003c/span\u003e\u003cspan address=\"http://www.ncbi.nlm.nih.gov/books/NBK350276/\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eChou R, Deyo R, Friedly J, Skelly A, Hashimoto R, Weimer M et al (2017) Nonpharmacologic Therapies for Low Back Pain: A Systematic Review for an American College of Physicians Clinical Practice Guideline. Ann Intern Med. 4 avr. ;166(7):493\u0026ndash;505\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eFatoye F, Gebrye T, Ryan CG, Useh U, Mbada C (2023) Global and regional estimates of clinical and economic burden of low back pain in high-income countries: a systematic review and meta-analysis. Front Public Health 11:1098100\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003ePerrot S, Doane MJ, Jaffe DH, Dragon E, Abraham L, Viktrup L et al (2022) Burden of chronic low back pain: Association with pain severity and prescription medication use in five large European countries. Pain Pract Off J World Inst Pain mars 22(3):359\u0026ndash;371\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBorenstein D (2013) Mechanical low back pain\u0026ndash;a rheumatologist\u0026rsquo;s view. Nat Rev Rheumatol nov 9(11):643\u0026ndash;653\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBogduk N (2009) On the definitions and physiology of back pain, referred pain, and radicular pain. Pain 15 d\u0026eacute;c 147(1\u0026ndash;3):17\u0026ndash;19\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMaher C, Underwood M, Buchbinder R (2017) Non-specific low back pain. Lancet 18 f\u0026eacute;vr 389(10070):736\u0026ndash;747\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eOliveira CB, Maher CG, Pinto RZ, Traeger AC, Lin CWC, Chenot JF et al (2018) Clinical practice guidelines for the management of non-specific low back pain in primary care: an updated overview. Eur Spine J Off Publ Eur Spine Soc Eur Spinal Deform Soc Eur Sect Cerv Spine Res Soc nov 27(11):2791\u0026ndash;2803\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eCopeland B (sept 2007) Surgical versus nonsurgical treatment for back pain. N Engl J Med 20(12):1255 author reply 1255\u0026ndash;1256\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGaudin D, Krafcik BM, Mansour TR, Alnemari A (2017) Considerations in Spinal Fusion Surgery for Chronic Lumbar Pain: Psychosocial Factors, Rating Scales, and Perioperative Patient Education-A Review of the Literature. World Neurosurg f\u0026eacute;vr 98:21\u0026ndash;27\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eLeonel FJF, de Paula L, Raab Ferreira GC, do Nascimento DMDR, Gnoato Zotz TG, de Melo JM et al (2023) Effect of two suspension training programs on pain and musculoskeletal function in chronic low back pain: study protocol. Pain Manag. 17 juill\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eVanti C, Panizzolo A, Turone L, Guccione AA, Violante FS, Pillastrini P et al (2021) Effectiveness of Mechanical Traction for Lumbar Radiculopathy: A Systematic Review and Meta-Analysis. Phys Ther 3 mars 101(3):pzaa231\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eClarke J, van Tulder M, Blomberg S, de Vet H, van der Heijden G, Bronfort G (2006) Traction for low back pain with or without sciatica: an updated systematic review within the framework of the Cochrane collaboration. Spine 15 juin 31(14):1591\u0026ndash;1599\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eCalmels P, Queneau P, Hamonet C, Le Pen C, Maurel F, Lerouvreur C et al (2009) Effectiveness of a lumbar belt in subacute low back pain: an open, multicentric, and randomized clinical study. Spine 1 f\u0026eacute;vr 34(3):215\u0026ndash;220\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eZa\u0026iuml;ri F, Moulart M, Fontaine C, Za\u0026iuml;ri F, Tiffreau V, Logier R Relevance of a novel external dynamic distraction device for treating back pain. Proc Inst Mech Eng (H] 27 nov 2020;954411920971401.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMoulart M, Olivier N, Giovanelli Y, Marin F (2022) Subjective assessment of a lumbar exoskeleton\u0026rsquo;s impact on lower back pain in a real work situation. Heliyon nov 8(11):e11420\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eRoberge P, Dor\u0026eacute; I, Menear M, Chartrand \u0026Eacute;, Ciampi A, Duhoux A et al (2013) A psychometric evaluation of the French Canadian version of the Hospital Anxiety and Depression Scale in a large primary care population. J Affect Disord 1 mai 147(1):171\u0026ndash;179\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eCoste J, Le Parc JM, Berge E, Delecoeuillerie G, Paolaggi JB (1993) (French validation of a disability rating scale for the evaluation of low back pain (EIFEL questionnaire)]. Rev Rhum Ed Francaise 1993. mai ;60(5):335\u0026ndash;41\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMarty M, Blotman F, Avouac B, Rozenberg S, Valat JP (1998) Validation of the French version of the Dallas Pain Questionnaire in chronic low back pain patients. Rev Rhum Engl Ed f\u0026eacute;vr 65(2):126\u0026ndash;134\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGagnon S, Lensel-Corbeil G, Duquesnoy B (2009) Multicenter multidisciplinary training program for chronic low back pain: French experience of the Renodos back pain network (R\u0026eacute;seau Nord-Pas-de-Calais du DOS). Ann Phys Rehabil Med 1 f\u0026eacute;vr 52(1):3\u0026ndash;16\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eVanderthommen M, Defaweux M, Tomasella M, Crielaard JM (1999) Le comportement gestuel du patient lombalgique fr\u0026eacute;quentant une \u0026eacute;cole du dos: analyse pr\u0026eacute;liminaire d\u0026rsquo;un test d\u0026rsquo;\u0026eacute;valuation. Ann R\u0026eacute;adapt M\u0026eacute;decine Phys 1 nov 42(8):485\u0026ndash;492\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKang E, Kim MY, Lipsey KL, Foster ER Person-Centered Goal Setting: A systematic review of intervention components and level of active engagement in rehabilitation goal setting interventions. Arch Phys Med Rehabil (Internet] 8 ao\u0026ucirc;t 2021 [cit\u0026eacute; 1 sept 2021]; Disponible sur: \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://www.sciencedirect.com/science/article/pii/S0003999321013472\u003c/span\u003e\u003cspan address=\"https://www.sciencedirect.com/science/article/pii/S0003999321013472\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"Exoskeleton, Low back Pain, assistive device","lastPublishedDoi":"10.21203/rs.3.rs-6177905/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-6177905/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003ePurpose\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eChronic lower back pain is a multifactorial health problem that can involve the intervertebral discs. The objective of the present clinical trial was to describe the effect of a trunk exoskeleton on the level of pain experienced during a standardized activity track.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMaterials and Methods\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThirty-one patients with chronic lower back pain agreed to wear the device daily and perform a standardized activity track as part of a hospital-based multidisciplinary rehabilitation programme. The participants were randomized to use the device on day 4 but not on day 5, or vice versa. Blinding was not applicable because the patient and investigators could not be blinded to the intervention ( wearing or not wearing the device)\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eResults\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe mean ± standard deviation (SD) pain visual analogue scale (VAS) score in the standardized activity track was 4.6 ± 1.6 mm lower with the device (albeit not significantly) than without the device. The reduction in the pain VAS score after wearing the device for an hour ranged from 12 ± 21 to 15±21 mm. The percentage of pain-free patients (i.e. with a pain VAS score ≤ 30 mm) was similar in the two groups. Seventeen (54.8%) of the 31 participants showed a decrease in the pain level \u0026gt;20 mm when wearing the device; this proportion was significant lower when the device was not worn.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConclusion\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAlthough the study did not evidence a significance difference in the primary endpoint, use of the device was associated with a higher proportion of patients experiencing a reduction in pain levels.\u003c/p\u003e","manuscriptTitle":"Effects of a trunk exoskeleton on pain during functional activities: a crossover randomized clinical trial.","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-03-18 07:47:34","doi":"10.21203/rs.3.rs-6177905/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"463c3b92-7119-406f-862f-8c1b962ebf90","owner":[],"postedDate":"March 18th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2025-06-06T12:38:47+00:00","versionOfRecord":[],"versionCreatedAt":"2025-03-18 07:47:34","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-6177905","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-6177905","identity":"rs-6177905","version":["v1"]},"buildId":"XKTyCvWXoU3ODBz1xrDgd","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}