Clinical trial NCT01447953: 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
Overall status: TERMINATED
Phase: NA
Conditions: Musculoskeletal Neck Pain
Musculoskeletal Shoulder Pain
Keywords: Activity
disability
life-role
multimodal rehabilitation
primary health care
persistent pain
randomized controlled trial
Musculoskeletal back pain
Lead sponsor: Uppsala University
Sponsor class: OTHER
Collaborators: name: Center for Clinical Research Dalarna, Sweden
name: Dalarna County Council, Sweden
name: REHSAM, Sweden
First posted: 2011-10-06
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of days of sickness absence from work
timeFrame: 6 months
measure: Number of days of sickness absence from work
timeFrame: 1 year
measure: Number of days of sickness absence from work
timeFrame: 2 years
Secondary outcomes:
measure: Return-to-work after sickness absence
timeFrame: Before treatment (at baseline), with follow-ups at 6 months, 1 , 2 and 5 years after treatment (after baseline assessment)
measure: Disability
timeFrame: Before treatment (at baseline), with follow-ups at 6 months, 1 , 2 and 5 years after treatment (after baseline assessment)
Other outcomes:
Locations:
city: Falun
country: Sweden
facility: The County Council of Dalarna; Primary Health Care units
Study officials:
References: