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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05058547
Other study ID # Dnr 2019-01264
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 1, 2022
Est. completion date December 2024

Study information

Verified date March 2022
Source Linkoeping University
Contact Mathilda Björk, PhD
Phone +4611363531
Email mathilda.bjork@liu.se
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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 loss of productivity. After completing an Interdisciplinary Pain Rehabilitation Program (IPRP), patients with CMSP experience a gap in the return to work (RTW) process when the responsibility for RTW is taken over by the employer. To fill this gap, we aim to evaluate the clinical effectiveness of a digital support (SWEPPE) for promoting a sustainable RTW for persons with CMSP and to facilitate the employers' supportive role and responsibilities in the process. Our hypothesis is that using SWEPPE will decrease the need for sick-leave. SWEPPE is a smartphone application where the individual can create an action plan, perform daily registrations of health aspects, self-monitoring of health aspects and goals, have access to a library with evidence-based facts and a coach, and the possibility to share information with the employer.The employer access SWEPPE via a web application. In this trial, we will recruit patients with CMSP aged 18-65 years who have completed IPRP, and who need support during RTW or continued support at the work placement for creating a sustainable work situation. The participants will be randomly assigned to either receive SWEPPE or to the control group. The intervention group will use SWEPPE during twelve months and the control group will not receive any active intervention for RTW which is standard clinical practice. Participants will be recruited from specialist and primary care level units connected to the Swedish National Quality Registry for Pain Rehabilitation (SQRP) and providing IPRP for patients with CMSP. All participants will fill in questionnaires when they have completed the rehabilitation program and before the intervention starts. Study ending assessment will be performed after twelve months. The clinical effectiveness of SWEPPE will be assessed by number of days with sickness cash benefit. Several dimensions of sick-leave will be assessed according to the Swedish Social Insurance Agency's (SSIA) proposal of outcome measures of RTW. Other outcomes and explanatory variables including important domains affected by CMSP such as health-related quality of life, functioning and work ability will be collected. A sample size calculation indicates the need for recruiting 360 participants (n=180 for each group).


Recruitment information / eligibility

Status Recruiting
Enrollment 360
Est. completion date December 2024
Est. primary completion date December 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: Patients entering the trial must have completed IPRP. The principal inclusion criteria for IPRP in Sweden are: - persistent or intermittent pain lasting =3 months - pain affecting daily activities to a large extent, - completed systematic assessment and non-pharmacological optimization is completed, - screening for psychosocial risk factors and differential diagnosis completed In addition the following criteria will be applied: - Completed participation in an Interdisciplinary Pain Rehabilitation Program (IPRP) at any of the participating units. - Having an employment to return to after IPRP or having returned to work but need continued support for creating a sustainable work situation after IPRP. Exclusion criteria: - Completed IPRP but are unemployed or unable to return to work.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
SWEPPE
In the smartphone application SWEPPE the individual can create an action plan, perform daily registrations of health aspects, self-monitoring of health aspects and goals, have access to a library with evidence-based facts and a coach, and possibility to share information with the employer.

Locations

Country Name City State
Sweden Danderyd hospital Danderyd
Sweden Smärtcentrum Karlstad
Sweden County council of Ostergotland Linköping
Sweden Smärtcentrum Lund
Sweden Spine Center Stockholm

Sponsors (2)

Lead Sponsor Collaborator
Linkoeping University Swedish Council for Working Life and Social Research

Country where clinical trial is conducted

Sweden, 

References & Publications (32)

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Coe-O'Brien R, Joseph L, Kuisma R, Paungmali A, Sitilertpisan P, Pirunsan U. Outcome measures used in the smartphone applications for the management of low back pain: a systematic scoping review. Health Inf Sci Syst. 2020 Jan 2;8(1):5. doi: 10.1007/s13755-019-0097-x. eCollection 2020 Dec. Review. — View Citation

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Coutu MF, Légaré F, Durand MJ, Stacey D, Labrecque ME, Corbière M, Bainbridge L. Acceptability and Feasibility of a Shared Decision-Making Model in Work Rehabilitation: A Mixed-Methods Study of Stakeholders' Perspectives. J Occup Rehabil. 2019 Mar;29(1):128-139. doi: 10.1007/s10926-018-9770-1. — View Citation

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Devan H, Hale L, Hempel D, Saipe B, Perry MA. 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 May 1;98(5):381-397. doi: 10.1093/ptj/pzy029. — View Citation

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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 May 1;20(5):e10235. doi: 10.2196/10235. — View Citation

Grant M, O-Beirne-Elliman J, Froud R, Underwood M, Seers K. The work of return to work. Challenges of returning to work when you have chronic pain: a meta-ethnography. BMJ Open. 2019 Jun 20;9(6):e025743. doi: 10.1136/bmjopen-2018-025743. Review. — View Citation

Harker J, Reid KJ, Bekkering GE, Kellen E, Bala MM, Riemsma R, Worthy G, Misso K, Kleijnen J. Epidemiology of chronic pain in denmark and sweden. Pain Res Treat. 2012;2012:371248. doi: 10.1155/2012/371248. Epub 2012 May 23. — View Citation

Kristjánsdóttir ÓB, Fors EA, Eide E, Finset A, Stensrud TL, van Dulmen S, Wigers SH, Eide H. 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 Mar 28;15(3):e72. doi: 10.2196/jmir.2442. — View Citation

Ledel Solem IK, Varsi C, Eide H, Kristjansdottir OB, Børøsund E, Schreurs KMG, Waxenberg LB, Weiss KE, Morrison EJ, Haaland-Øverby M, Bevan K, Zangi HA, Stubhaug A, Solberg Nes L. A User-Centered Approach to an Evidence-Based Electronic Health Pain Management Intervention for People With Chronic Pain: Design and Development of EPIO. J Med Internet Res. 2020 Jan 21;22(1):e15889. doi: 10.2196/15889. — View Citation

Ledel Solem IK, Varsi C, Eide H, Kristjansdottir OB, Mirkovic J, Børøsund E, Haaland-Øverby M, Heldal K, Schreurs KM, Waxenberg LB, Weiss KE, Morrison EJ, Solberg Nes L. Patients' Needs and Requirements for eHealth Pain Management Interventions: Qualitative Study. J Med Internet Res. 2019 Apr 1;21(4):e13205. doi: 10.2196/13205. — View Citation

Liedberg GM, Björk M, Dragioti E, Turesson C. 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 Mar 17;10(6). pii: 1247. doi: 10.3390/jcm10061247. Review. — View Citation

Machado GC, Pinheiro MB, Lee H, Ahmed OH, Hendrick P, Williams C, Kamper SJ. Smartphone apps for the self-management of low back pain: A systematic review. Best Pract Res Clin Rheumatol. 2016 Dec;30(6):1098-1109. doi: 10.1016/j.berh.2017.04.002. Epub 2017 May 25. Review. — View Citation

Magalhães L, Chan C, Chapman A, Majed L, Samigullina R, Trninic D, et al. Successful return to work of individuals with chronic pain according to health care providers: a meta-synthesis. Cadernos Brasileiros de Terapia Ocupacional/Brazilian Journal of Occupational Therapy 2017;25(4):825-37

Mamykina L, Smaldone AM, Bakken SR. Adopting the sensemaking perspective for chronic disease self-management. J Biomed Inform. 2015 Aug;56:406-17. doi: 10.1016/j.jbi.2015.06.006. Epub 2015 Jun 10. — View Citation

Morton K, Dennison L, May C, Murray E, Little P, McManus RJ, Yardley L. Using digital interventions for self-management of chronic physical health conditions: A meta-ethnography review of published studies. Patient Educ Couns. 2017 Apr;100(4):616-635. doi: 10.1016/j.pec.2016.10.019. Epub 2016 Oct 20. Review. — View Citation

Pérez C, Margarit C, Sánchez-Magro I, de Antonio A, Villoria J. Chronic Pain Features Relate to Quality of Life More than Physiopathology: A Cross-Sectional Evaluation in Pain Clinics. Pain Pract. 2017 Sep;17(7):866-878. doi: 10.1111/papr.12533. Epub 2017 Feb 25. — View Citation

Reid KJ, Harker J, Bala MM, Truyers C, Kellen E, Bekkering GE, Kleijnen J. Epidemiology of chronic non-cancer pain in Europe: narrative review of prevalence, pain treatments and pain impact. Curr Med Res Opin. 2011 Feb;27(2):449-62. doi: 10.1185/03007995.2010.545813. Epub 2011 Jan 3. Review. — View Citation

Ruckenstein M. Visualized and interacted life: personal analytics and engagement with data doubles. Societies. 2014;4:68-84. doi: 10.3390/soc4010068.

Saunders SL, Nedelec B. What work means to people with work disability: a scoping review. J Occup Rehabil. 2014 Mar;24(1):100-10. doi: 10.1007/s10926-013-9436-y. Review. — View Citation

Scott W, Chilcot J, Guildford B, Daly-Eichenhardt A, McCracken LM. Feasibility randomized-controlled trial of online Acceptance and Commitment Therapy for patients with complex chronic pain in the United Kingdom. Eur J Pain. 2018 Apr 28. doi: 10.1002/ejp.1236. [Epub ahead of print] — View Citation

Shupler MS, Kramer JK, Cragg JJ, Jutzeler CR, Whitehurst DGT. Pan-Canadian Estimates of Chronic Pain Prevalence From 2000 to 2014: A Repeated Cross-Sectional Survey Analysis. J Pain. 2019 May;20(5):557-565. doi: 10.1016/j.jpain.2018.10.010. Epub 2018 Nov 29. — View Citation

Slattery BW, Haugh S, O'Connor L, Francis K, Dwyer CP, O'Higgins S, Egan J, McGuire BE. 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 Jul 17;21(7):e11086. doi: 10.2196/11086. — View Citation

Svanholm F, Liedberg GM, Löfgren M, Björk M. 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 Mar;44(5):736-744. doi: 10.1080/09638288.2020.1780479. Epub 2020 Jun 25. — View Citation

Thurnheer SE, Gravestock I, Pichierri G, Steurer J, Burgstaller JM. Benefits of Mobile Apps in Pain Management: Systematic Review. JMIR Mhealth Uhealth. 2018 Oct 22;6(10):e11231. doi: 10.2196/11231. Review. — View Citation

Timmers T, Janssen L, Kool RB, Kremer JA. Educating Patients by Providing Timely Information Using Smartphone and Tablet Apps: Systematic Review. J Med Internet Res. 2020 Apr 13;22(4):e17342. doi: 10.2196/17342. — View Citation

Toye F, Seers K, Allcock N, Briggs M, Carr E, Barker K. A synthesis of qualitative research exploring the barriers to staying in work with chronic musculoskeletal pain. Disabil Rehabil. 2016;38(6):566-72. Review. — View Citation

* Note: There are 32 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Other Self-reported fatigue the last 7 days Numeric rating scale Baseline and 12 months
Other Self-reported level of sleepiness Karolinska Sleepiness Scale Swedish version Baseline and 12 months
Other Self-reported level of sleep disturbance Insomnia Severity Index Swedish version Baseline and 12 months
Other Self-reported fear of movement Tampa Scale for Kinesiophobia Swedish version Baseline and 12 months
Other Self-reported physical activity the National Board of Health and Welfare's three questions on physical activity, exercise, and sedentary behavior. Baseline and 12 months
Other Pain catastrophizing Pain Catastrophizing scale Swedish version Baseline and 12 months
Other Perceived work ability Work Ability Index Swedish version Baseline and 12 months
Other Self-reported demands, control, and support at the workplace Demand Control Support Questionnaire Swedish version Baseline and 12 months
Other Perceived life Satisfaction Life satisfaction Scale Swedish version Baseline and 12 months
Other Self-reported work situation during the study period Barriers for return to work, strategies to handle barriers and need of support from the employer Baseline and 12 months
Other Self-reported workload an average day Number of hours per day for paid work and unpaid household work Baseline and 12 months
Primary Sick leave Number of gross and net days with sickness cash benefit 12 months follow up after IPRP
Secondary Return to work Return to work (partially or full time) every month 12 months follow up after IPRP
Secondary Sick-leave spells per months Number of sick-leave spells (per month) 12 months follow up after IPRP
Secondary Return to work group level Proportions of a group who returns to full- or part-time work (per month) 12 months follow up after IPRP
Secondary Working days before new sick leave Number of days in work before new sick leave during study period 12 months follow up after IPRP
Secondary Proportion back to work Proportion of a group back to work >28 days (full- or part time) before a new sick-leave spell occurs 12 months follow up after IPRP
Secondary Total sick-leave spells Number of sick-leave spells during study period 12 months follow up after IPRP
Secondary Length of total sick leave Length of total sick leave during study period 12 months follow up after IPRP
Secondary Pain intensity last 7 days Numeric rating scale Baseline and 12 months
Secondary Consequences of pain on daily life Multidimensional Pain Inventory Swedish version Baseline and 12 months
Secondary Overall emotional distress Hospital Anxiety and Depression Scale Swedish version Baseline and 12 months
Secondary Physical and mental health RAND-36 Swedish version Baseline and 12 months
Secondary Goal fulfilment and satisfaction during the study period Self-reported data Baseline and 12 months
Secondary Self-reported physical work environment Questionnaire based on the Swedish Work Environment Authority ergonomics checklist Baseline and 12 months
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