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

Musculoskeletal Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01356784
• Other study ID #: 95-154-32028
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: May 13, 2011
• Last updated: April 22, 2014
• Start date: May 2011
• Est. completion date: April 2014

Study information

• Verified date: April 2014
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 141
• Est. completion date: April 2014
• Est. primary completion date: July 2013
• Gender: Both
• Age group: 18 Years to 66 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chronic Pain
• Musculoskeletal Pain

Intervention

Other:
• Tailored Physical Activity
Health counselling (1,5h) and graded physical activity (3×50 min/week in 10 weeks)

Behavioral:
• "Chronic Pain Self-management Programme"
Health counselling (1,5h) and 'Chronic Pain Self-management Program' (2,5h in 6 weeks)
• Health counselling
Health guidance (1,5h)

Locations

Country	Name	City	State
Denmark	Health Care Centre	Sønderborg

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern Denmark	DK-Sønderborg Municipality

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Aerobic capacity		3 months	No
Secondary	hand-grip strength		3 months	No
Secondary	Body weight, waist circumference, hip circumference		3 months	No
Secondary	Questionnaire		3 months	No
Secondary	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	No
Secondary	Aerobic capacity		12-months follow-up	No
Secondary	Hand-grip strength		12-months follow-up	No
Secondary	Questionnaire		12-months follow-up	No
Secondary	Body weight, waist circumference, hip circumference		12 months follow-up	No

External Links

•   University of Southern Denmark