Activity and Life-role Targeted Pain Rehabilitation in Primary Health Care
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Musculoskeletal Neck Pain Musculoskeletal Shoulder Pain |
Other: Activity targeted pain rehabilitation Other: Treatment as usual |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Activity and Life-role Targeted Pain Rehabilitation in Primary Health Care: a Randomized Controlled Trial |
- Number of days of sickness absence from work [ Time Frame: 6 months ] [ Designated as safety issue: No ]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 [ Time Frame: 1 year ] [ Designated as safety issue: No ]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 [ Time Frame: 2 years ] [ Designated as safety issue: No ]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 [ Time Frame: 5 years ] [ Designated as safety issue: No ]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.
- Return-to-work after sickness absence [ Time Frame: Before treatment (at baseline), with follow-ups at 6 months, 1 , 2 and 5 years after treatment (after baseline assessment) ] [ Designated as safety issue: No ]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 [ Time Frame: Before treatment (at baseline), with follow-ups at 6 months, 1 , 2 and 5 years after treatment (after baseline assessment) ] [ Designated as safety issue: No ]Pain-related disability according to Pain Disability Index (PDI).
| Estimated Enrollment: | 233 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | June 2017 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Activity targeted pain rehabilitation
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.
|
Other: Activity targeted pain rehabilitation
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.
|
|
Active Comparator: Treatment as usual
Usual treatment consisting of multimodal rehabilitation provided by multi-professional teams in primary health care in the County of Dalarna, Sweden.
|
Other: Treatment as usual
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.
|
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, will be 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, two and five years post-treatment.
The treatment manual has been developed and education of the staff delivering the experimental treatment has started.
The results of this pragmatic study will be directly applicable in the management of pain in primary care and will thus contribute to improved rehabilitation for persons with disabling pain.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Catharina Gustavsson, RPT PhD | +46 23 18348 | catharina.gustavsson@ltdalarna.se |
| Contact: Anne Söderlund, RPT Prof | +46 21 151708 | anne.soderlund@mdh.se |
| Sweden | |
| The County Council of Dalarna; Primary Health Care units | Recruiting |
| Falun, Sweden, 79182 | |
| Contact: Catharina Gustavsson, RPT PhD +46 23 18348 catharina.gustavsson@ltdalarna.se | |
| Contact: Anne Söderlund, RPT Prof +46 21 151708 anne.soderlund@mdh.se | |
| Principal Investigator: Catharina Gustavsson, RPT PhD | |
More Information
No publications provided
| Responsible Party: | Catharina Gustavsson, RPT PhD, Principal Investigator Registered Physical Therapist PhD, Uppsala University |
| ClinicalTrials.gov Identifier: | NCT01447953 History of Changes |
| Other Study ID Numbers: | ALAR-2009RS |
| Study First Received: | September 9, 2011 |
| Last Updated: | April 3, 2013 |
| Health Authority: | Sweden: The National Board of Health and Welfare |
Keywords provided by Uppsala University:
|
Activity disability life-role multimodal rehabilitation |
primary health care persistent pain randomized controlled trial Musculoskeletal back pain |
Additional relevant MeSH terms:
|
Neck Pain Shoulder Pain Pain Neurologic Manifestations Nervous System Diseases |
Signs and Symptoms Arthralgia Joint Diseases Musculoskeletal Diseases |
ClinicalTrials.gov processed this record on May 21, 2013