Activity and Life-role Targeted Pain Rehabilitation in Primary Health Care
Primary Purpose
Musculoskeletal Neck Pain, Musculoskeletal Shoulder Pain
Status
Terminated
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Activity targeted pain rehabilitation
Treatment as usual
Sponsored by
About this trial
This is an interventional treatment trial for Musculoskeletal Neck Pain focused on measuring Activity, disability, life-role, multimodal rehabilitation, primary health care, persistent pain, randomized controlled trial, Musculoskeletal back pain
Eligibility Criteria
Inclusion Criteria:
- Persons seeking primary health care due to back, neck or shoulder pain
- Aged 18 to 60 years
- Being on sick leave or disability compensation
- Able to understand, read and write Swedish
Sites / Locations
- The County Council of Dalarna; Primary Health Care units
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Activity targeted pain rehabilitation
Treatment as usual
Arm Description
A new activity and life-role targeting pain rehabilitation program (ALAR) has been developed to reduce psychosocial barriers to rehabilitation progress, promote re-integration into life-role activities and facilitate return-to-work.
Usual treatment consisting of multimodal rehabilitation provided by multi-professional teams in primary health care in the County of Dalarna, Sweden.
Outcomes
Primary Outcome Measures
Number of days of sickness absence from work
Number of days of sickness absence from work during a 3-month period preceding the baseline measurement and preceding each follow-up, and specified in percent of full-time work.
Number of days of sickness absence from work
Number of days of sickness absence from work during a 3-month period preceding the baseline measurement and preceding each follow-up, and specified in percent of full-time work.
Number of days of sickness absence from work
Number of days of sickness absence from work during a 3-month period preceding the baseline measurement and preceding each follow-up, and specified in percent of full-time work.
Secondary Outcome Measures
Return-to-work after sickness absence
Number of participants that return to work after sickness absence, i.e. that were on sick leave before the study and that has returned to work after the study.
Disability
Pain-related disability according to Pain Disability Index (PDI).
Full Information
NCT ID
NCT01447953
First Posted
September 9, 2011
Last Updated
December 14, 2015
Sponsor
Uppsala University
Collaborators
Center for Clinical Research Dalarna, Sweden, Dalarna County Council, Sweden, REHSAM, Sweden
1. Study Identification
Unique Protocol Identification Number
NCT01447953
Brief Title
Activity and Life-role Targeted Pain Rehabilitation in Primary Health Care
Official Title
Activity and Life-role Targeted Pain Rehabilitation in Primary Health Care: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Terminated
Why Stopped
Organizational changes in health care made further recruitment to the treatment options unpossible.
Study Start Date
October 2011 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Uppsala University
Collaborators
Center for Clinical Research Dalarna, Sweden, Dalarna County Council, Sweden, REHSAM, Sweden
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary goal of the Swedish national rehabilitation plan on pain is to reduce disability and facilitate return-to-work. However, there is a lack of treatment strategies that effectively target and affect return-to-work and reduce sickness absence, and that in addition are sufficiently easy and feasible to administer in primary care. A new activity and life-role targeting rehabilitation program (ALAR) has been developed to reduce psychosocial barriers to rehabilitation progress, promote re-integration into life-role activities and facilitate return-to-work. The program will be implemented and provided as one of the pain treatment modalities available through multi-professional teams in primary care in one Swedish county. This study aims to evaluate the effect of an activity and life-role targeting pain rehabilitation program on the outcome variables return-to-work and sickness absence.
Detailed Description
The primary goal of the Swedish national rehabilitation plan on pain is to reduce disability and facilitate return-to-work. However, there is a lack of treatment strategies that effectively target and affect return-to-work and reduce sickness absence, and that in addition are sufficiently easy and feasible to administer in primary care. A new activity and life-role targeting rehabilitation program (ALAR) has been developed to reduce psychosocial barriers to rehabilitation progress, promote re-integration into life-role activities and facilitate return-to-work. The program will be implemented and provided as one of the pain treatment modalities available through multi-professional teams in primary care in one Swedish county. This study aims to evaluate the effect of an activity and life-role targeting pain rehabilitation program on the outcome variables return-to-work and sickness absence.
Patients seeking care due to disabling back, neck or shoulder pain at seven primary health care units in the County of Dalarna, Sweden, was randomly allocated to ALAR or usual multimodal rehabilitation. Between and within-group differences on return-to-work, sickness absence and disability will be evaluated at 10 weeks, six months, one and two years post-treatment.
The enrollment of patients was ended on preterm in june 2013. Due to changes in the organization in primary health care it was no longer possible to ensure that treatment arms could be delivered as intended. Data collection up to 1-year follow-up is completed. Data from longterm follow-up at 2 years will be completed in june 2015. Data analyses and reporting of results is presently undertaken. The number of enrolled participants is not enough to reach statistical power. Thus, results will need to be interpreted with caution.
Still the results of this pragmatic study will be of importance for the planning of a full scale study to accurately evaluate the effects of ALAR, to be conducted in primary care.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Musculoskeletal Neck Pain, Musculoskeletal Shoulder Pain
Keywords
Activity, disability, life-role, multimodal rehabilitation, primary health care, persistent pain, randomized controlled trial, Musculoskeletal back pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Activity targeted pain rehabilitation
Arm Type
Experimental
Arm Description
A new activity and life-role targeting pain rehabilitation program (ALAR) has been developed to reduce psychosocial barriers to rehabilitation progress, promote re-integration into life-role activities and facilitate return-to-work.
Arm Title
Treatment as usual
Arm Type
Active Comparator
Arm Description
Usual treatment consisting of multimodal rehabilitation provided by multi-professional teams in primary health care in the County of Dalarna, Sweden.
Intervention Type
Other
Intervention Name(s)
Activity targeted pain rehabilitation
Intervention Description
An activity and life-role targeting rehabilitation programme (ALAR) provided by one of the care givers in the multi-professional rehabilitation teams at each of the eight participating primary health care centres, by ten weekly 1-hour treatment sessions.
Intervention Type
Other
Intervention Name(s)
Treatment as usual
Intervention Description
Usual treatment with type of treatment modalities, number, frequency and duration of visits according to the judgement of the muli-professional teams at each primary health care centre.
Primary Outcome Measure Information:
Title
Number of days of sickness absence from work
Description
Number of days of sickness absence from work during a 3-month period preceding the baseline measurement and preceding each follow-up, and specified in percent of full-time work.
Time Frame
6 months
Title
Number of days of sickness absence from work
Description
Number of days of sickness absence from work during a 3-month period preceding the baseline measurement and preceding each follow-up, and specified in percent of full-time work.
Time Frame
1 year
Title
Number of days of sickness absence from work
Description
Number of days of sickness absence from work during a 3-month period preceding the baseline measurement and preceding each follow-up, and specified in percent of full-time work.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Return-to-work after sickness absence
Description
Number of participants that return to work after sickness absence, i.e. that were on sick leave before the study and that has returned to work after the study.
Time Frame
Before treatment (at baseline), with follow-ups at 6 months, 1 , 2 and 5 years after treatment (after baseline assessment)
Title
Disability
Description
Pain-related disability according to Pain Disability Index (PDI).
Time Frame
Before treatment (at baseline), with follow-ups at 6 months, 1 , 2 and 5 years after treatment (after baseline assessment)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Persons seeking primary health care due to back, neck or shoulder pain
Aged 18 to 60 years
Being on sick leave or disability compensation
Able to understand, read and write Swedish
Facility Information:
Facility Name
The County Council of Dalarna; Primary Health Care units
City
Falun
ZIP/Postal Code
79182
Country
Sweden
12. IPD Sharing Statement
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Activity and Life-role Targeted Pain Rehabilitation in Primary Health Care
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