A Digital Support to Facilitate Sustainable Return to Work for Persons With Chronic Pain and Their Employers

Chronic Pain Clinical Trial

— SWEPPE  

Official title:

An Evidence-based Digital Support for One Year to Facilitate a Sustainable Return to Work for Persons With Chronic Musculoskeletal Pain and Their Employers: Study Protocol for a Registry-based Multicentre Randomized Controlled Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05058547
• Other study ID #: Dnr 2019-01264
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Chronic Pain

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)

Asmundson GJ, Katz J. Understanding the co-occurrence of anxiety disorders and chronic pain: state-of-the-art. Depress Anxiety. 2009;26(10):888-901. doi: 10.1002/da.20600. Review. — View Citation

Braillard O, Cedraschi C, Jesaimani A, Piguet V. [Chronic noncancer pain and patient education: a place for e-learning?]. Rev Med Suisse. 2015 Jun 24;11(480):1400, 1402-5. French. — View Citation

Cáceres-Matos R, Gil-García E, Barrientos-Trigo S, Porcel-Gálvez AM, Cabrera-León A. Consequences of Chronic Non-Cancer Pain in adulthood. Scoping Review. Rev Saude Publica. 2020 Apr 17;54:39. doi: 10.11606/s1518-8787.2020054001675. eCollection 2020. Review. English, Spanish. — View Citation

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

Cohen D, Allen J, Rhydderch M, Aylward M. 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 Jul;44(8):677-83. doi: 10.2340/16501977-0996. — View Citation

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

Devan H, Farmery D, Peebles L, Grainger R. Evaluation of Self-Management Support Functions in Apps for People With Persistent Pain: Systematic Review. JMIR Mhealth Uhealth. 2019 Feb 12;7(2):e13080. doi: 10.2196/13080. — View Citation

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

Garg S, Garg D, Turin TC, Chowdhury MF. Web-Based Interventions for Chronic Back Pain: A Systematic Review. J Med Internet Res. 2016 Jul 26;18(7):e139. doi: 10.2196/jmir.4932. Review. — View Citation

Gerdle B, Björk J, Henriksson C, Bengtsson A. Prevalence of current and chronic pain and their influences upon work and healthcare-seeking: a population study. J Rheumatol. 2004 Jul;31(7):1399-406. — View Citation

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 all — Click 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