Evidence-based digital support during 1 year after an Interdisciplinary Pain Rehabilitation Programme for persons with chronic musculoskeletal pain to facilitate a sustainable return to work: a study protocol for a registry-based multicentre randomised controlled trial

Christina Turesson, Gunilla Liedberg, Linda Vixner, Monika Lofgren, Mathilda Björk, Christina Turesson, Gunilla Liedberg, Linda Vixner, Monika Lofgren, Mathilda Björk

Abstract

Introduction: Chronic musculoskeletal pain (CMSP) severely affects the individual's quality of life, functioning and ability to work, and comes with significant societal costs for sick leave and productivity loss. After rehabilitation, patients with CMSP often experience lack of support when responsibility for the return-to-work process is taken over by the employer. Therefore, we aim to evaluate the effectiveness of a digital support (Sustainable WorkEr digital support for Persons with chronic Pain and their Employers (SWEPPE)) for promoting a sustainable return-to-work for persons with CMSP and to facilitate the employers' supportive role and responsibilities in the process.

Methods and analysis: In this registry-based multicentre randomised controlled trial, 360 patients with CMSP will be randomised to either receive the smartphone application SWEPPE (n=180) or to a control group (n=180). The intervention group will use SWEPPE for 1 year and the control group will not receive any intervention for return to work (RTW). Participants will be recruited from approximately 10 specialist and primary care level units connected to the Swedish National Quality Registry for Pain Rehabilitation providing Interdisciplinary Pain Rehabilitation Programmes (IPRP) for CMSP. Eligibility criteria are age 18-65 years and a need for support in RTW or continued support at work for creating a sustainable work situation. Baseline data will be collected when the participants have completed the IPRP. Final assessment will be performed after 12 months. The primary outcome will be a number of days with sickness cash benefit. Secondary outcomes and explanatory variables including important domains affected by CMSP such as health-related quality of life, functioning and work ability will be collected.

Ethics and dissemination: The Swedish Ethics Review Board approved the study (Dnr 2020-01593, Dnr 2021-01854). The study findings will be disseminated through publication, national and international conferences, and meetings to be available for patients, healthcare providers or stakeholders.

Trial registration number: NCT05058547.

Keywords: Clinical trials; PAIN MANAGEMENT; REHABILITATION MEDICINE.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Time schedule of enrolment, interventions and assessments. IPRP, Interdisciplinary Pain Rehabilitation Programmes; SWEPPE, Sustainable WorkEr digital support for Persons with chronic Pain and their Employers.

References

    1. Harker J, Reid KJ, Bekkering GE, et al. . Epidemiology of chronic pain in Denmark and Sweden. Pain Res Treat 2012;2012:37124810.1155/2012/371248
    1. Reid KJ, Harker J, Bala MM, et al. . Epidemiology of chronic non-cancer pain in Europe: narrative review of prevalence, pain treatments and pain impact. Curr Med Res Opin 2011;27:449–62. 10.1185/03007995.2010.545813
    1. Dahlhamer J, Lucas J, Zelaya C, et al. . Prevalence of Chronic Pain and High-Impact Chronic Pain Among Adults - United States, 2016. MMWR Morb Mortal Wkly Rep 2018;67:1001–6. 10.15585/mmwr.mm6736a2
    1. Pérez C, Margarit C, Sánchez-Magro I, et al. . Chronic pain features relate to quality of life more than physiopathology: a cross-sectional evaluation in pain clinics. Pain Pract 2017;17:866–78. 10.1111/papr.12533
    1. Gerdle B, Björk J, Henriksson C, et al. . Prevalence of current and chronic pain and their influences upon work and healthcare-seeking: a population study. J Rheumatol 2004;31:1399–406.
    1. Cáceres-Matos R, Gil-García E, Barrientos-Trigo S, et al. . Consequences of chronic non-cancer pain in adulthood. scoping review. Rev Saude Publica 2020;54:39. 10.11606/s1518-8787.2020054001675
    1. Asmundson GJG, Katz J. Understanding the co-occurrence of anxiety disorders and chronic pain: state-of-the-art. Depress Anxiety 2009;26:888–901. 10.1002/da.20600
    1. Shupler MS, Kramer JK, Cragg JJ, et al. . Pan-Canadian estimates of chronic pain prevalence from 2000 to 2014: a repeated cross-sectional survey analysis. J Pain 2019;20:557–65. 10.1016/j.jpain.2018.10.010
    1. Kamper SJ, Apeldoorn AT, Chiarotto A, et al. . Multidisciplinary biopsychosocial rehabilitation for chronic low back pain: cochrane systematic review and meta-analysis. BMJ 2015;350:h444. 10.1136/bmj.h444
    1. Waterschoot FPC, Dijkstra PU, Geertzen JHB. Dose or content? effectiveness of pain rehabilitation programs for patients with chronic low back pain: a systematic review. Author reply. Pain 2014;155:1902–3.
    1. Scascighini L, Toma V, Dober-Spielmann S, et al. . Multidisciplinary treatment for chronic pain: a systematic review of interventions and outcomes. Rheumatology 2008;47:670–8. 10.1093/rheumatology/ken021
    1. Svanholm F, Liedberg GM, Löfgren M, et al. . Factors of importance for return to work, experienced by patients with chronic pain that have completed a multimodal rehabilitation program - a focus group study. Disabil Rehabil 2022;44:1–9. 10.1080/09638288.2020.1780479
    1. Toye F, Seers K, Allcock N, et al. . A synthesis of qualitative research exploring the barriers to staying in work with chronic musculoskeletal pain. Disabil Rehabil 2016;38:566–72. 10.3109/09638288.2015.1049377
    1. Liedberg GM, Björk M, Dragioti E, et al. . Qualitative evidence from studies of interventions aimed at return to work and staying at work for persons with chronic musculoskeletal pain. J Clin Med 2021;10:1247:1247. 10.3390/jcm10061247
    1. Wilkie R, Bjork M, Costa-Black KM, et al. . Managing work participation for people with rheumatic and musculoskeletal diseases. Best Pract Res Clin Rheumatol 2020;34:101517. 10.1016/j.berh.2020.101517
    1. Glavare M, Löfgren M, Schult M-L. Between unemployment and employment: experience of unemployed long-term pain sufferers. Work 2012;43:475–85. 10.3233/WOR-2012-1394
    1. Saunders SL, Nedelec B. What work means to people with work disability: a scoping review. J Occup Rehabil 2014;24:100–10. 10.1007/s10926-013-9436-y
    1. Grant M, O-Beirne-Elliman J, Froud R, et al. . The work of return to work. challenges of returning to work when you have chronic pain: a meta-ethnography. BMJ Open 2019;9:e025743. 10.1136/bmjopen-2018-025743
    1. Magalhães L, Chan C, Chapman AC, et al. . Successful return to work of individuals with chronic pain according to health care providers: a meta-synthesis. Cadernos Brasileiros de Terapia Ocupacional 2017;25:825–37. 10.4322/2526-8910.ctoAR2063
    1. Cohen D, Allen J, Rhydderch M, et al. . The return to work discussion: a qualitative study of the line manager conversation about return to work and the development of an educational programme. J Rehabil Med 2012;44:677–83. 10.2340/16501977-0996
    1. Scott W, Chilcot J, Guildford B, et al. . Feasibility randomized-controlled trial of online acceptance and commitment therapy for patients with complex chronic pain in the United Kingdom. Eur J Pain 2018;22:1473–84. 10.1002/ejp.1236
    1. Coutu M-F, Légaré F, Durand M-J, et al. . Acceptability and feasibility of a shared decision-making model in work rehabilitation: a mixed-methods study of stakeholders' perspectives. J Occup Rehabil 2019;29:128–39. 10.1007/s10926-018-9770-1
    1. Turesson C, Liedberg G, Björk M. Development of a digital support application with evidence-based content for sustainable return to work for persons with chronic pain and their employers: a user-centered agile design approach. JMIR Hum Factors 2022;9:e33571. 10.2196/33571
    1. Brhel M, Meth H, Maedche A, et al. . Exploring principles of user-centered agile software development: a literature review. Inf Softw Technol 2015;61:163–81. 10.1016/j.infsof.2015.01.004
    1. Braillard O, Cedraschi C, Jesaimani A, et al. . [Chronic noncancer pain and patient education: a place for e-learning?]. Rev Med Suisse 2015;11:1400:2–5.
    1. Solem IKL, Varsi C, Eide H. A user-centered approach to an evidence-based electronic health pain management intervention for people with chronic pain: design and development of EPIO. JMIR 2020;22.
    1. Kristjánsdóttir Ólöf Birna, Fors EA, Eide E, et al. . A smartphone-based intervention with diaries and therapist feedback to reduce catastrophizing and increase functioning in women with chronic widespread pain. Part 2: 11-month follow-up results of a randomized trial. J Med Internet Res 2013;15:e72. 10.2196/jmir.2442
    1. Thurnheer SE, Gravestock I, Pichierri G, et al. . Benefits of mobile apps in pain management: systematic review. JMIR Mhealth Uhealth 2018;6:e11231. 10.2196/11231
    1. Garg S, Garg D, Turin TC, et al. . Web-based interventions for chronic back pain: a systematic review. J Med Internet Res 2016;18:e139. 10.2196/jmir.4932
    1. Slattery BW, Haugh S, O'Connor L, et al. . An evaluation of the effectiveness of the modalities used to deliver electronic health interventions for chronic pain: systematic review with network meta-analysis. J Med Internet Res 2019;21:e11086. 10.2196/11086
    1. Ledel Solem IK, Varsi C, Eide H, et al. . Patients' needs and requirements for eHealth pain management interventions: qualitative study. J Med Internet Res 2019;21:e13205. 10.2196/13205
    1. Timmers T, Janssen L, Kool RB, et al. . Educating patients by providing timely information using smartphone and tablet apps: systematic review. J Med Internet Res 2020;22:e17342. 10.2196/17342
    1. Granja C, Janssen W, Johansen MA. Factors determining the success and failure of eHealth interventions: systematic review of the literature. J Med Internet Res 2018;20:e10235. 10.2196/10235
    1. Devan H, Hale L, Hempel D, et al. . What works and does not work in a self-management intervention for people with chronic pain? qualitative systematic review and meta-synthesis. Phys Ther 2018;98:381–97. 10.1093/ptj/pzy029
    1. Devan H, Farmery D, Peebles L, et al. . Evaluation of self-management support functions in apps for people with persistent pain: systematic review. JMIR Mhealth Uhealth 2019;7:e13080. 10.2196/13080
    1. Ruckenstein M. Visualized and interacted life: personal analytics and Engagements with data doubles. Societies 2014;4:68–84. 10.3390/soc4010068
    1. Mamykina L, Smaldone AM, Bakken SR. Adopting the sensemaking perspective for chronic disease self-management. J Biomed Inform 2015;56:406–17. 10.1016/j.jbi.2015.06.006
    1. Morton K, Dennison L, May C, et al. . Using digital interventions for self-management of chronic physical health conditions: a meta-ethnography review of published studies. Patient Educ Couns 2017;100:616–35. 10.1016/j.pec.2016.10.019
    1. Machado GC, Pinheiro MB, Lee H, et al. . Smartphone apps for the self-management of low back pain: A systematic review. Best Pract Res Clin Rheumatol 2016;30:1098–109. 10.1016/j.berh.2017.04.002
    1. Coe-O'Brien R, Joseph L, Kuisma R, et al. . Outcome measures used in the smartphone applications for the management of low back pain: a systematic scoping review. Health Inf Sci Syst 2020;8:5. 10.1007/s13755-019-0097-x
    1. Chan A-W, Tetzlaff JM, Altman DG, et al. . SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med 2013;158:200–7. 10.7326/0003-4819-158-3-201302050-00583
    1. Schulz KF, Altman DG, Moher D, et al. . CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. Int J Surg 2011;9:672–7. 10.1016/j.ijsu.2011.09.004
    1. Campbell MK, Piaggio G, Elbourne DR, et al. . Consort 2010 statement: extension to cluster randomised trials. BMJ 2012;345:e5661. 10.1136/bmj.e5661
    1. WHO . WHO trial registration data set (version 1.3.1): World Health organization, 2021. Available:
    1. LoMartire R, Dahlström Örjan, Björk M, et al. . Predictors of sickness absence in a clinical population with chronic pain. J Pain 2021;22:1180–94. 10.1016/j.jpain.2021.03.145
    1. Altman DG, Bland JM. How to randomise. BMJ 1999;319:703–4. 10.1136/bmj.319.7211.703
    1. Kim J, Shin W. How to do random allocation (randomization). Clin Orthop Surg 2014;6:103–9. 10.4055/cios.2014.6.1.103
    1. Sedgwick P. Treatment allocation in trials: block randomisation. BMJ 2014;348:g2409. 10.1136/bmj.g2409
    1. Sennehed CP, Stigmar K, Grahn B, et al. . Evaluation of a multimodal pain rehabilitation programme in primary care based on clinical register data: a feasibility study. Prim Health Care Res Dev 2020;21:e2. 10.1017/S1463423619000884
    1. Rivano Fischer M, Persson EB, Stålnacke B-M, et al. . Return to work after interdisciplinary pain rehabilitation: one- and two-year follow-up based on the Swedish quality Registry for pain rehabilitation. J Rehabil Med 2019;51:281–9. 10.2340/16501977-2544
    1. IASP . IASP terminology. Available:
    1. Ballantyne JC, Sullivan MD. Intensity of chronic pain-the wrong metric? N Engl J Med 2015;373:2098–9. 10.1056/NEJMp1507136
    1. Turk DC, Dworkin RH, Revicki D, et al. . Identifying important outcome domains for chronic pain clinical trials: an IMMPACT survey of people with pain. Pain 2008;137:276–85. 10.1016/j.pain.2007.09.002
    1. Patel KV, Amtmann D, Jensen MP, et al. . Clinical outcome assessment in clinical trials of chronic pain treatments. Pain Rep 2021;6:e784. 10.1097/PR9.0000000000000784
    1. Försäkringskassan . Förslag på utfallsmått för att mäta återgång i arbete efter sjukskrivning. Försäkringskassan Analys och prognos, 2016.
    1. Williamson A, Hoggart B. Pain: a review of three commonly used pain rating scales. J Clin Nurs 2005;14:798–804. 10.1111/j.1365-2702.2005.01121.x
    1. Bergström G, Jensen IB, Bodin L, et al. . Reliability and factor structure of the Multidimensional Pain Inventory--Swedish Language Version (MPI-S). Pain 1998;75:101–10. 10.1016/S0304-3959(97)00210-8
    1. Kerns RD, Turk DC, Rudy TE. The West Haven-Yale multidimensional pain inventory (WHYMPI). Pain 1985;23:345–56. 10.1016/0304-3959(85)90004-1
    1. Bjelland I, Dahl AA, Haug TT, et al. . The validity of the hospital anxiety and depression scale. An updated literature review. J Psychosom Res 2002;52:69–77. 10.1016/s0022-3999(01)00296-3
    1. LoMartire R, Äng BO, Gerdle B, et al. . Psychometric properties of short Form-36 health survey, EuroQol 5-dimensions, and hospital anxiety and depression scale in patients with chronic pain. Pain 2020;161:83–95. 10.1097/j.pain.0000000000001700
    1. Snaith RP. The hospital anxiety and depression scale. Health Qual Life Outcomes 2003;1:29. 10.1186/1477-7525-1-29
    1. Vetter TR. A primer on health-related quality of life in chronic pain medicine. Anesth Analg 2007;104:703–18. 10.1213/01.ane.0000255290.64837.61
    1. Orwelius L, Nilsson M, Nilsson E, et al. . The Swedish RAND-36 Health Survey - reliability and responsiveness assessed in patient populations using Svensson's method for paired ordinal data. J Patient Rep Outcomes 2017;2:4. 10.1186/s41687-018-0030-0
    1. Wressle E, Lindstrand J, Neher M, et al. . The Canadian occupational performance measure as an outcome measure and team tool in a day treatment programme. Disabil Rehabil 2003;25:497–506. 10.1080/0963828031000090560
    1. Aaronson LS, Teel CS, Cassmeyer V, et al. . Defining and measuring fatigue. Image J Nurs Sch 1999;31:45–50. 10.1111/j.1547-5069.1999.tb00420.x
    1. Chuang L-L, Lin K-C, Hsu A-L, et al. . Reliability and validity of a vertical numerical rating scale supplemented with a faces rating scale in measuring fatigue after stroke. Health Qual Life Outcomes 2015;13:91. 10.1186/s12955-015-0290-9
    1. Dailey DL, Frey Law LA, Vance CGT, et al. . Perceived function and physical performance are associated with pain and fatigue in women with fibromyalgia. Arthritis Res Ther 2016;18:68. 10.1186/s13075-016-0954-9
    1. Akerstedt T, Anund A, Axelsson J, et al. . Subjective sleepiness is a sensitive indicator of insufficient sleep and impaired waking function. J Sleep Res 2014;23:240–52. 10.1111/jsr.12158
    1. Morin CM. Measuring outcomes in randomized clinical trials of insomnia treatments. Sleep Med Rev 2003;7:263–79. 10.1053/smrv.2002.0274
    1. Boersma K, Linton S, Overmeer T, et al. . Lowering fear-avoidance and enhancing function through exposure in vivo. A multiple baseline study across six patients with back pain. Pain 2004;108:8–16. 10.1016/j.pain.2003.03.001
    1. Agerberg M. Ställ rätt fråga om fysisk aktivitet. Läkartidningen 2014;48:C9AY.
    1. Sullivan MJL, Bishop SR, Pivik J, Scott R. The pain Catastrophizing scale: development and validation. Psychol Assess 1995;7:524–32. 10.1037/1040-3590.7.4.524
    1. Lundin A, Leijon O, Vaez M, et al. . Predictive validity of the work ability index and its individual items in the general population. Scand J Public Health 2017;45:350–6. 10.1177/1403494817702759
    1. Sanne B, Torp S, Mykletun A, et al. . The Swedish Demand-Control-Support questionnaire (DCSQ): factor structure, item analyses, and internal consistency in a large population. Scand J Public Health 2005;33:166–74. 10.1080/14034940410019217
    1. Arbetsmiljöverket . Belastningsergonomi. Arbetsmiljöverkets föreskrifter och allmänna råd om belastningsergonomi. 2. AFS, 2012.
    1. Arbetsmiljöverket . Checklista för bedömning - utifrån föreskrifterna om belastningsergonomi, AFS 2012:2. Stockholm: Arbetsmiljöverket, 2013.
    1. Stålnacke B-M. Life satisfaction in patients with chronic pain - relation to pain intensity, disability, and psychological factors. Neuropsychiatr Dis Treat 2011;7:683. 10.2147/NDT.S25321
    1. Fugl-Meyer A, Bränholm I, Fugl-Meyer K. Happiness and domain-specific life satisfaction in adult Northern Swedes. Clin Rehabil 1991;5:25–33.
    1. Krantz G, Berntsson L, Lundberg U. Total workload, work stress and perceived symptoms in Swedish male and female white-collar employees. Eur J Public Health 2005;15:209–14. 10.1093/eurpub/cki079
    1. Kahn R. The forms of women’s work. In: Frankenhaeuser M, Lundberg U, Chesney M, eds. Women, work and health. stress and opportunities. New York Plenum Press, 1991: 65–83.
    1. Mårdberg B, Lundberg ULF, Frankenhaeuser M. The total workload of parents employed in white-collar jobs: construction of a questionnaire and a scoring system. Scand J Psychol 1991;32:233–9. 10.1111/j.1467-9450.1991.tb00873.x
    1. Palermo TM, Slack K, Loren D, et al. . Measuring and reporting adverse events in clinical trials of psychological treatments for chronic pain. Pain 2020;161:713–7. 10.1097/j.pain.0000000000001772
    1. Chan A-W, Tetzlaff JM, Gøtzsche PC, et al. . Spirit 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ 2013;346:e7586. 10.1136/bmj.e7586

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