search
Back to results

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

Primary Purpose

Musculoskeletal Pain

Status
Completed
Phase
Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
Tailored Physical Activity
"Chronic Pain Self-management Programme"
Health counselling
Sponsored by
University of Southern Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Musculoskeletal Pain focused on measuring Sick-listed, Tailored physical activity, Patient education, Returning to work, DK-Sønderborg Municipality, columna, upper body

Eligibility Criteria

18 Years - 66 Years (Adult, Older Adult)All Sexes

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

Sites / Locations

  • Health Care Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Other

Arm Label

Tailored Physical Activity

"Chronic Pain Self-management Programme"

Health Counselling

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Aerobic capacity
hand-grip strength
Body weight, waist circumference, hip circumference
Questionnaire
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.
Aerobic capacity
Hand-grip strength
Questionnaire
Body weight, waist circumference, hip circumference

Full Information

First Posted
May 13, 2011
Last Updated
April 22, 2014
Sponsor
University of Southern Denmark
Collaborators
DK-Sønderborg Municipality
search

1. Study Identification

Unique Protocol Identification Number
NCT01356784
Brief Title
Returning to Work. Efficacy of "Tailored Physical Activity or" "Chronic Pain Self-management Program" in Sicklisted Citizens With Chronic Musculoskeletal Pain
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern Denmark
Collaborators
DK-Sønderborg Municipality

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Musculoskeletal Pain
Keywords
Sick-listed, Tailored physical activity, Patient education, Returning to work, DK-Sønderborg Municipality, columna, upper body

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
141 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tailored Physical Activity
Arm Type
Experimental
Arm Title
"Chronic Pain Self-management Programme"
Arm Type
Active Comparator
Arm Title
Health Counselling
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Tailored Physical Activity
Intervention Description
Health counselling (1,5h) and graded physical activity (3×50 min/week in 10 weeks)
Intervention Type
Behavioral
Intervention Name(s)
"Chronic Pain Self-management Programme"
Intervention Description
Health counselling (1,5h) and 'Chronic Pain Self-management Program' (2,5h in 6 weeks)
Intervention Type
Behavioral
Intervention Name(s)
Health counselling
Intervention Description
Health guidance (1,5h)
Primary Outcome Measure Information:
Title
Sick-listed or not
Description
Registration of the participants status as sick-listed or not and co-primary the number of days on sick-leave in the period.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Aerobic capacity
Time Frame
3 months
Title
hand-grip strength
Time Frame
3 months
Title
Body weight, waist circumference, hip circumference
Time Frame
3 months
Title
Questionnaire
Time Frame
3 months
Title
Sick-listed or not
Description
Registration of the participants status as sick-listed or not and co-primary the number of days on sick-leave in the period.
Time Frame
12-months follow-up
Title
Aerobic capacity
Time Frame
12-months follow-up
Title
Hand-grip strength
Time Frame
12-months follow-up
Title
Questionnaire
Time Frame
12-months follow-up
Title
Body weight, waist circumference, hip circumference
Time Frame
12 months follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
66 Years
Eligibility 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
Facility Information:
Facility Name
Health Care Centre
City
Sønderborg
ZIP/Postal Code
6400
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
23343386
Citation
Andersen LN, Juul-Kristensen B, Roessler KK, Herborg LG, Sorensen TL, Sogaard K. Efficacy of 'Tailored Physical Activity' or 'Chronic Pain Self-Management Program' on return to work for sick-listed citizens: design of a randomised controlled trial. BMC Public Health. 2013 Jan 23;13:66. doi: 10.1186/1471-2458-13-66.
Results Reference
derived
Links:
URL
http://www.sdu.dk
Description
University of Southern Denmark

Learn more about this trial

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

We'll reach out to this number within 24 hrs