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

April 22, 2014 updated by: Lotte Nygaard Andersen, University of Southern Denmark

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

141

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Sønderborg, Denmark, 6400
        • Health Care Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sick-listed or not
Time Frame: 3 months
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
Time Frame: 3 months
3 months
hand-grip strength
Time Frame: 3 months
3 months
Body weight, waist circumference, hip circumference
Time Frame: 3 months
3 months
Questionnaire
Time Frame: 3 months
3 months
Sick-listed or not
Time Frame: 12-months follow-up
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
Time Frame: 12-months follow-up
12-months follow-up
Hand-grip strength
Time Frame: 12-months follow-up
12-months follow-up
Questionnaire
Time Frame: 12-months follow-up
12-months follow-up
Body weight, waist circumference, hip circumference
Time Frame: 12 months follow-up
12 months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern Denmark

Collaborators

DK-Sønderborg Municipality

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

May 13, 2011

First Submitted That Met QC Criteria

May 18, 2011

First Posted (Estimate)

May 19, 2011

Study Record Updates

Last Update Posted (Estimate)

April 24, 2014

Last Update Submitted That Met QC Criteria

April 22, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 95-154-32028

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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