Returning to Work. Efficacy of Tailored Physical Activity or Chronic Pain Self-management Program in Sicklisted Citizens With Chronic Musculoskeletal Pain

Study Overview
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Brief Summary
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TEst the effect of Tailored Physical Activity or Chronic Pain Self-management Program on Returning to Work in Sicklisted Citizens With Chronic Pain Related to the Spine or Upper Body

Detailed Description
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Pain affects quality of life and it's important for the individual who experience chronic pain to find strategies to prevent or reduce pain. In some situations pain can't be reduced and the individual has to master pain by learning to live with it. Pain can lead to a loss of functions which may change one's roles both in relation to the family as to colleagues, for example sick leave from work. Limited evidence is available on the effects of interventions to sick-listed citizens with chronic musculoskeletal pain. This study test the effect of either tailored physical activity or Chronic Pain Self-management Program on returning to work and the parameters pain, function and quality of life respectively on the body function and participation level of sick-listed people with chronic musculoskeletal pain related to columna and the upper body. Citizens in DK-Sønderborg Municipality sick-listed for a maximum of 9 weeks will be invited. Participants will be randomized for either tailored physical activity, Chronic Pain Self-Management Program or reference group. Primary endpoint is 3 months and 12 months follow-up.

Official Title
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Efficacy of Tailored Physical Activity or Chronic Pain Self-management Program on Returning to Work: a Randomized Controlled Trial in Sicklisted Citizens With Chronic Pain Related to the Spine or Upper Body

Conditions
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Musculoskeletal Pain

Intervention / Treatment
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* Other: Tailored Physical Activity
* Behavioral: Chronic Pain Self-management Programme
* Behavioral: Health counselling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sick-listed with musculoskeletal pain related to columna or the upper body for a maximum period of 9 weeks in DK-Sønderborg Municipality

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 66 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tailored Physical Activity<br> | Other: Tailored Physical Activity<br>* Health counselling (1,5h) and graded physical activity (3×50 min/week in 10 weeks)<br>|
| Active Comparator: Chronic Pain Self-management Programme<br> | Behavioral: Chronic Pain Self-management Programme<br>* Health counselling (1,5h) and 'Chronic Pain Self-management Program' (2,5h in 6 weeks)<br>|
| Other: Health Counselling<br> | Behavioral: Health counselling<br>* Health guidance (1,5h)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sick-listed or not | Registration of the participants status as sick-listed or not and co-primary the number of days on sick-leave in the period. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aerobic capacity |  | 3 months | 
| hand-grip strength |  | 3 months | 
| Body weight, waist circumference, hip circumference |  | 3 months | 
| Questionnaire |  | 3 months | 
| Sick-listed or not | Registration of the participants status as sick-listed or not and co-primary the number of days on sick-leave in the period. | 12-months follow-up | 
| Aerobic capacity |  | 12-months follow-up | 
| Hand-grip strength |  | 12-months follow-up | 
| Questionnaire |  | 12-months follow-up | 
| Body weight, waist circumference, hip circumference |  | 12 months follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sick-listed, Tailored physical activity, Patient education, Returning to work, DK-Sønderborg Municipality, columna, upper body