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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01356784
First Posted: May 19, 2011
Last Update Posted: April 24, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
DK-Sønderborg Municipality
Information provided by (Responsible Party):
Lotte Nygaard Andersen, University of Southern Denmark
  Purpose
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

Condition Intervention Phase
Musculoskeletal Pain Other: Tailored Physical Activity Behavioral: "Chronic Pain Self-management Programme" Behavioral: Health counselling Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Lotte Nygaard Andersen, University of Southern Denmark:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Aerobic capacity [ Time Frame: 3 months ]
  • hand-grip strength [ Time Frame: 3 months ]
  • Body weight, waist circumference, hip circumference [ Time Frame: 3 months ]
  • Questionnaire [ Time Frame: 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.

  • Aerobic capacity [ Time Frame: 12-months follow-up ]
  • Hand-grip strength [ Time Frame: 12-months follow-up ]
  • Questionnaire [ Time Frame: 12-months follow-up ]
  • Body weight, waist circumference, hip circumference [ Time Frame: 12 months follow-up ]

Enrollment: 141
Study Start Date: May 2011
Study Completion Date: April 2014
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
Health Counselling Behavioral: Health counselling
Health guidance (1,5h)

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 66 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01356784


Locations
Denmark
Health Care Centre
Sønderborg, Denmark, 6400
Sponsors and Collaborators
University of Southern Denmark
DK-Sønderborg Municipality
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lotte Nygaard Andersen, Ph.d. fellow, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT01356784     History of Changes
Other Study ID Numbers: 95-154-32028
First Submitted: May 13, 2011
First Posted: May 19, 2011
Last Update Posted: April 24, 2014
Last Verified: April 2014

Keywords provided by Lotte Nygaard Andersen, University of Southern Denmark:
Sick-listed
Tailored physical activity
Patient education
Returning to work
DK-Sønderborg Municipality
columna
upper body

Additional relevant MeSH terms:
Chronic Pain
Musculoskeletal Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases