Clinical Trials Directory

Trials / Terminated

TerminatedNCT01447953

Activity and Life-role Targeted Pain Rehabilitation in Primary Health Care

Activity and Life-role Targeted Pain Rehabilitation in Primary Health Care: a Randomized Controlled Trial

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
65 (actual)
Sponsor
Uppsala University · Academic / Other
Sex
All
Age
18 Years – 60 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERActivity targeted pain rehabilitationAn 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.
OTHERTreatment as usualUsual 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.

Timeline

Start date
2011-10-01
Primary completion
2013-06-01
Completion
2015-06-01
First posted
2011-10-06
Last updated
2015-12-15

Locations

1 site across 1 country: Sweden

Source: ClinicalTrials.gov record NCT01447953. Inclusion in this directory is not an endorsement.