An interventional study of SWEPPE in Chronic Pain, sponsored by Linkoeping University. Status unknown at 5 sites in Sweden. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-03-25.
Sponsored by Linkoeping University · Not applicable, Interventional, and Treatment
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).
2,998 studies on the registry are indexed under Chronic Pain; 706 are open to participants now.
This study's planned enrollment of 360 is above the median of 60 across 2,209 interventional studies indexed under Chronic Pain.
Browse Chronic Pain studies →Linkoeping University is the lead sponsor of 193 studies on the registry; 41 are open to participants now.
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Patients entering the trial must have completed IPRP. The principal inclusion criteria for IPRP in Sweden are:
In addition the following criteria will be applied:
Exclusion criteria:
Participants will receive the smartphone application SWEPPE.
Device: SWEPPE
Participants randomized to the control group will not receive any active intervention for return to work after completing an Interdisciplinary Pain Rehabilitation Program .
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.
Sick leave
Number of gross and net days with sickness cash benefit
Time frame: 12 months follow up after IPRP
Return to work
Return to work (partially or full time) every month
Time frame: 12 months follow up after IPRP
Sick-leave spells per months
Number of sick-leave spells (per month)
Time frame: 12 months follow up after IPRP
Return to work group level
Proportions of a group who returns to full- or part-time work (per month)
Time frame: 12 months follow up after IPRP
Working days before new sick leave
Number of days in work before new sick leave during study period
Time frame: 12 months follow up after IPRP
Proportion back to work
Proportion of a group back to work \>28 days (full- or part time) before a new sick-leave spell occurs
Time frame: 12 months follow up after IPRP
Total sick-leave spells
Number of sick-leave spells during study period
Time frame: 12 months follow up after IPRP
Length of total sick leave
Length of total sick leave during study period
Time frame: 12 months follow up after IPRP
Pain intensity last 7 days
Numeric rating scale
Time frame: Baseline and 12 months
Consequences of pain on daily life
Multidimensional Pain Inventory Swedish version
Time frame: Baseline and 12 months
Overall emotional distress
Hospital Anxiety and Depression Scale Swedish version
Time frame: Baseline and 12 months
Physical and mental health
RAND-36 Swedish version
Time frame: Baseline and 12 months
Goal fulfilment and satisfaction during the study period
Self-reported data
Time frame: Baseline and 12 months
Self-reported physical work environment
Questionnaire based on the Swedish Work Environment Authority ergonomics checklist
Time frame: Baseline and 12 months
Self-reported fatigue the last 7 days
Numeric rating scale
Time frame: Baseline and 12 months
Self-reported level of sleepiness
Karolinska Sleepiness Scale Swedish version
Time frame: Baseline and 12 months
Self-reported level of sleep disturbance
Insomnia Severity Index Swedish version
Time frame: Baseline and 12 months
Self-reported fear of movement
Tampa Scale for Kinesiophobia Swedish version
Time frame: Baseline and 12 months
Self-reported physical activity
the National Board of Health and Welfare's three questions on physical activity, exercise, and sedentary behavior.
Time frame: Baseline and 12 months
Pain catastrophizing
Pain Catastrophizing scale Swedish version
Time frame: Baseline and 12 months
Perceived work ability
Work Ability Index Swedish version
Time frame: Baseline and 12 months
Self-reported demands, control, and support at the workplace
Demand Control Support Questionnaire Swedish version
Time frame: Baseline and 12 months
Perceived life Satisfaction
Life satisfaction Scale Swedish version
Time frame: Baseline and 12 months
Self-reported work situation during the study period
Barriers for return to work, strategies to handle barriers and need of support from the employer
Time frame: Baseline and 12 months
Self-reported workload an average day
Number of hours per day for paid work and unpaid household work
Time frame: Baseline and 12 months
Plan to share: No
Started Mar 2022 (actual). Primary completion is estimated for Dec 2023, 21 months after the start.
Of 1,209 non-industry interventional studies with no phase under Chronic Pain, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 39. This study's planned 21 months is close to that.
Counting every sponsor, half of 1,296 studies reached it within 21 months; a quarter within 9 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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