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

Not Applicable

Recruiting

• Conditions: Chronic Pain
• Interventions: Device: SWEPPE

• Registration Number: NCT05058547
• Lead Sponsor: Linkoeping University

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-24
• Study First Submitted QC: 2021-09-24
• Study First Posted: 2021-09-27
• Status Verified: 2022-03
• Study Start: 2022-03-01
• Last Update Submitted: 2022-03-09
• Last Update Posted: 2022-03-25
• Primary Completion: 2023-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 360

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SWEPPE	SWEPPE	Participants will receive the smartphone application SWEPPE.

Primary Outcome Measures

Name	Time	Method
Sick leave	12 months follow up after IPRP	Number of gross and net days with sickness cash benefit

Secondary Outcome Measures

Name	Time	Method
Pain intensity last 7 days	Baseline and 12 months	Numeric rating scale
Proportion back to work	12 months follow up after IPRP	Proportion of a group back to work \>28 days (full- or part time) before a new sick-leave spell occurs
Total sick-leave spells	12 months follow up after IPRP	Number of sick-leave spells during study period
Return to work	12 months follow up after IPRP	Return to work (partially or full time) every month
Length of total sick leave	12 months follow up after IPRP	Length of total sick leave during study period
Consequences of pain on daily life	Baseline and 12 months	Multidimensional Pain Inventory Swedish version
Sick-leave spells per months	12 months follow up after IPRP	Number of sick-leave spells (per month)
Return to work group level	12 months follow up after IPRP	Proportions of a group who returns to full- or part-time work (per month)
Working days before new sick leave	12 months follow up after IPRP	Number of days in work before new sick leave during study period
Overall emotional distress	Baseline and 12 months	Hospital Anxiety and Depression Scale Swedish version
Physical and mental health	Baseline and 12 months	RAND-36 Swedish version
Goal fulfilment and satisfaction during the study period	Baseline and 12 months	Self-reported data
Self-reported physical work environment	Baseline and 12 months	Questionnaire based on the Swedish Work Environment Authority ergonomics checklist

Trial Locations

Locations (4)

Danderyd hospital; 🇸🇪 Danderyd, Sweden

Smärtcentrum; 🇸🇪 Lund, Sweden

County council of Ostergotland; 🇸🇪 Linköping, Sweden

Spine Center; 🇸🇪 Stockholm, Sweden