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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
DK-Sønderborg Municipality
Information provided by (Responsible Party):
Lotte Nygaard Andersen, University of Southern Denmark
ClinicalTrials.gov Identifier:
NCT01356784
First received: May 13, 2011
Last updated: February 3, 2014
Last verified: February 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 University of Southern Denmark:

Primary Outcome Measures:
  • Sick-listed or not [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • hand-grip strength [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Body weight, waist circumference, hip circumference [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Questionnaire [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Sick-listed or not [ Time Frame: 12-months follow-up ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Hand-grip strength [ Time Frame: 12-months follow-up ] [ Designated as safety issue: No ]
  • Questionnaire [ Time Frame: 12-months follow-up ] [ Designated as safety issue: No ]
  • Body weight, waist circumference, hip circumference [ Time Frame: 12 months follow-up ] [ Designated as safety issue: No ]

Enrollment: 141
Study Start Date: May 2011
Estimated Study Completion Date: March 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

Ages Eligible for Study:   18 Years to 66 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01356784

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

Additional Information:
No publications provided by University of Southern Denmark

Additional 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
Study First Received: May 13, 2011
Last Updated: February 3, 2014
Health Authority: Denmark: Danish Dataprotection Agency

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

ClinicalTrials.gov processed this record on April 17, 2014