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

This study has been terminated.
(Organizational changes in health care made further recruitment to the treatment options unpossible.)
Sponsor:
Collaborators:
Center for Clinical Research Dalarna, Sweden
County Council of Dalarna, Sweden
REHSAM, Sweden
Information provided by (Responsible Party):
Catharina Gustavsson, RPT PhD, Uppsala University
ClinicalTrials.gov Identifier:
NCT01447953
First received: September 9, 2011
Last updated: December 2, 2014
Last verified: December 2014
  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

Resource links provided by NLM:


Further study details as provided by Uppsala University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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).


Enrollment: 65
Study Start Date: October 2011
Estimated Study Completion Date: June 2015
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, 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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01447953

Locations
Sweden
The County Council of Dalarna; Primary Health Care units
Falun, Sweden, 79182
Sponsors and Collaborators
Uppsala University
Center for Clinical Research Dalarna, Sweden
County Council of Dalarna, Sweden
REHSAM, Sweden
  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: December 2, 2014
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:
Shoulder Pain
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on June 30, 2015