Chronic PainSWEPPENCT05058547
A Digital Support to Facilitate Sustainable Return to Work for Persons With Chronic Pain and Their Employers
A study testing SWEPPE in people with Chronic Pain, run by Linkoeping University at 5 sites in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- SWEPPE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 5 sitesSweden
- Study dates
- 1 Mar 2022to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Completed IPRP but are unemployed or unable to return to work.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Sweden5 sites, 5 recruiting
- Recruiting
Danderyd hospital
Danderyd, 182 57
- Not yet recruiting
Smärtcentrum
Karlstad
- Recruiting
County council of Ostergotland
Linköping, 581 83
- Not yet recruiting
Smärtcentrum
Lund
- Not yet recruiting
Spine Center
Stockholm
About this study
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.
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.
Read more
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).
- Conditions
- Chronic Pain
- Being tested
- SWEPPE
- Keywords
- collaboration support, eHealth, employer support, smartphone application, return to work, self-management
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SWEPPEDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| SWEPPE | Experimental | Participants will receive the smartphone application SWEPPE. Receives: Device: SWEPPE |
| Control | No intervention | Participants randomized to the control group will not receive any active intervention for return to work after completing an Interdisciplinary Pain Rehabilitation Program . |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sick leave
Number of gross and net days with sickness cash benefit
Measured: 12 months follow up after IPRP
Secondary outcomes (13)
Return to work
Return to work (partially or full time) every month
Measured: 12 months follow up after IPRP
Sick-leave spells per months
Number of sick-leave spells (per month)
Measured: 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)
Measured: 12 months follow up after IPRP
Working days before new sick leave
Number of days in work before new sick leave during study period
Measured: 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
Measured: 12 months follow up after IPRP
Total sick-leave spells
Number of sick-leave spells during study period
Measured: 12 months follow up after IPRP
Length of total sick leave
Length of total sick leave during study period
Measured: 12 months follow up after IPRP
Pain intensity last 7 days
Numeric rating scale
Measured: Baseline and 12 months
Consequences of pain on daily life
Multidimensional Pain Inventory Swedish version
Measured: Baseline and 12 months
Overall emotional distress
Hospital Anxiety and Depression Scale Swedish version
Measured: Baseline and 12 months
Physical and mental health
RAND-36 Swedish version
Measured: Baseline and 12 months
Goal fulfilment and satisfaction during the study period
Self-reported data
Measured: Baseline and 12 months
Self-reported physical work environment
Questionnaire based on the Swedish Work Environment Authority ergonomics checklist
Measured: Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2021
- Study start1 Mar 2022
- Primary completionDec 2023 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (33)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Linkoeping UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Collaborators
- Swedish Council for Working Life and Social Research
- Responsible party
- Principal investigator, Mathilda Björk, Linkoeping University
- Investigators
- Mathilda Björk, PhD, Principal investigator, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05058547
- Sponsor's protocol ID
- Dnr 2019-01264
- Acronym
- SWEPPE
- Status last verified
- Mar 2022
- First submitted
- 24 Sep 2021
- Last updated
- 25 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22693667Reid 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.
PubMed 21194394Perez C, Margarit C, Sanchez-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.
PubMed 27782366Gerdle B, Bjork 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.
PubMed 15229963Caceres-Matos R, Gil-Garcia E, Barrientos-Trigo S, Porcel-Galvez AM, Cabrera-Leon 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.
PubMed 32321056Asmundson 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.
PubMed 19691031Shupler 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.
PubMed 30503860Svanholm F, Liedberg GM, Lofgren M, Bjork 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.
PubMed 32580604Toye 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. doi: 10.3109/09638288.2015.1049377.
PubMed 26017361Liedberg GM, Bjork 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):1247. doi: 10.3390/jcm10061247.
PubMed 33802906Saunders 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.
PubMed 23519737Grant 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.
PubMed 31227529Magalhães 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
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.
PubMed 22729796Scott 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. Online ahead of print.
PubMed 29704880
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05058547
- Acronym / sponsor ID
- SWEPPE / Dnr 2019-01264
- Conditions
- Chronic Pain
- Keywords
- collaboration support, eHealth, employer support, smartphone application, return to work, self-management
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Linkoeping UniversityOther government
- Collaborators
- Swedish Council for Working Life and Social Research
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 27 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SWEPPE | Experimental | Device: SWEPPEParticipants will receive the smartphone application SWEPPE. |
| Control | No intervention | –Participants randomized to the control group will not receive any active intervention for return to work after completing an Interdisciplinary Pain Rehabilitation Program . |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (1 listed)
- Completed IPRP but are unemployed or unable to return to work.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SWEPPEIn 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. | Device | SWEPPE |
Primary outcome
Sick leave
Time frame: 12 months follow up after IPRP
Number of gross and net days with sickness cash benefit
13 secondary outcomes
Return to work
Time frame: 12 months follow up after IPRP
Sick-leave spells per months
Time frame: 12 months follow up after IPRP
Return to work group level
Time frame: 12 months follow up after IPRP
Working days before new sick leave
Time frame: 12 months follow up after IPRP
Proportion back to work
Time frame: 12 months follow up after IPRP
Total sick-leave spells
Time frame: 12 months follow up after IPRP
Length of total sick leave
Time frame: 12 months follow up after IPRP
Pain intensity last 7 days
Time frame: Baseline and 12 months
Consequences of pain on daily life
Time frame: Baseline and 12 months
Overall emotional distress
Time frame: Baseline and 12 months
Physical and mental health
Time frame: Baseline and 12 months
Goal fulfilment and satisfaction during the study period
Time frame: Baseline and 12 months
Self-reported physical work environment
Time frame: Baseline and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2022.
- Background: PubMed 22693667Harker 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.
- Background: PubMed 21194394Reid 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.
- Background: PubMed 27782366Perez C, Margarit C, Sanchez-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.
- Background: PubMed 15229963Gerdle B, Bjork 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.
- Background: PubMed 32321056Caceres-Matos R, Gil-Garcia E, Barrientos-Trigo S, Porcel-Galvez AM, Cabrera-Leon 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.
- Background: PubMed 19691031Asmundson 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.
- Background: PubMed 30503860Shupler 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.
- Background: PubMed 32580604Svanholm F, Liedberg GM, Lofgren M, Bjork 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.
- Background: PubMed 26017361Toye 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. doi: 10.3109/09638288.2015.1049377.
- Background: PubMed 33802906Liedberg GM, Bjork 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):1247. doi: 10.3390/jcm10061247.
- Background: PubMed 23519737Saunders 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.
- Background: PubMed 31227529Grant 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mathilda Björk, PhD principal investigator
Linkoeping University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SWEPPE in people with Chronic Pain, run by Linkoeping University at 5 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mathilda Björk, PhD (+4611363531, mathilda.bjork@liu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sick leave (time frame: 12 months follow up after IPRP). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05058547, which also lists 33 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2022.