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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Uppsala University
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: April 3, 2013
Last verified: April 2013

September 9, 2011
April 3, 2013
October 2011
June 2013   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01447953 on ClinicalTrials.gov Archive Site
  • 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).
Same as current
Not Provided
Not Provided
 
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

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Musculoskeletal Neck Pain
  • Musculoskeletal Shoulder Pain
  • 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.
  • 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.
  • 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.
    Intervention: Other: Activity targeted pain rehabilitation
  • 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.
    Intervention: Other: Treatment as usual
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
233
June 2017
June 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
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
 
NCT01447953
ALAR-2009RS
No
Catharina Gustavsson, RPT PhD, Uppsala University
Uppsala University
  • Center for Clinical Research Dalarna, Sweden
  • County Council of Dalarna, Sweden
  • REHSAM, Sweden
Not Provided
Uppsala University
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP