Subacute and Chronic, Non-specific Back and Neck Pain: Cognitive-behavioral Rehabilitation vs. Traditional Primary Care

This study has been completed.
Sponsor:
Information provided by:
Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT00488735
First received: June 19, 2007
Last updated: May 6, 2010
Last verified: June 2007
  Purpose

BACKGROUND

Non-specific back and neck pain (BNP) dominates sick-listing. A program of cognitive-behavioral rehabilitation for subacute and chronic BNP was compared, with 18-month follow-up, with traditional primary care concerning sick-listing and health-care visits.

METHODS

After stratification to age (44 (years) and younger/45 and older) and subacute/chronic BNP (= full-time sick-listed 43-84/85-730 days respectively), 125 primary-care patients were randomized to a rehabilitation center or continued health-center care. Outcome measures were Return-to-work (=the proportion who regained work ability for at least 30 consecutive days), the proportion with Work ability at different time points, Total sick-listing (expressed in whole days) and the total number of Visits (to physicians, physiotherapists etc.) 1-18 months and corresponding six-month periods. For the analyses were used t-test, z-test, generalized estimating equations and a mixed, linear model.


Condition Intervention
Back Pain
Neck Pain
Behavioral: Cognitive-behavioral rehabilitation
Behavioral: Traditional primary care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Subacute and Chronic, Non-specific Back and Neck Pain: Cognitive-behavioral Rehabilitation Compared With Traditional Primary Care Concerning Sick-listing and Health-care Visits. A Randomized Controlled Trial, 18-month Follow-up

Resource links provided by NLM:


Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • Return-to-work=the proportion of patients who during 1-18 months regained a degree of work ability>0 for at least 30 days in succession. [ Time Frame: 18 months. ]

Secondary Outcome Measures:
  • Work ability (=the proportion with work ability>0). Total sick-listing=the sum of sick-listing of any degree, expressed in whole days. Visits=the total number of consultations to different health-care staff, for example, physicians or physiotherapists. [ Time Frame: Work ability: 18 months. Total sick-listing: 36 months (18 months preceding and after inclusion). Visits: 18 months. ]

Enrollment: 125
Study Start Date: August 2000
Study Completion Date: July 2005
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  Eligibility

Ages Eligible for Study:   18 Years to 59 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Working age up to and including 59 years.
  2. Sick-listed full-time for BNP for at least 42 days and at most 730 days.
  3. Able to manage tolerably well to fill in forms.

Exclusion Criteria:

  1. Temporary disability pension or disability pension being paid or in preparation.
  2. A primary need of action by a hospital specialist.
  3. Pregnancy and diseases which would probably make rehabilitation impracticable (for example, advanced pulmonary disease).
  4. Whiplash-associated disorders as a primary obstacle to working.
  5. Previous rehabilitation at the rehabilitation centre.
  6. Other multidisciplinary rehabilitation going on or planned.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00488735

Locations
Sweden
Centre for Family Medicine
Stockholm, Huddinge, Sweden, SE-141 83
Sponsors and Collaborators
Karolinska Institutet
Investigators
Study Chair: Lars-Erik Strender, Professor Centre for Family Medicine, Karolinska Institutet
  More Information

Additional Information:
Publications:
Söderström M, Englund L: Treatment of neck and low back pain in primary care. In Neck and back pain. The scientific evidence of causes, diagnosis, and treatment. Edited by Nachemson A, Jonson E. Philadelphia: Lippincott, Williams & Williams; 2000:383-398.
Linton SJ: Utility of cognitive-behavioral psychological treatments. In Neck and back pain. The scientific evidence of causes, diagnosis, and treatment. Edited by Nachemson A, Jonson E. Philadelphia: Lippincott, Williams & Williams; 2000:361-381.
Brown H, Prescott R: Applied mixed models in medicine. Edinburgh: John Wiley & Sons LTD; 199-259, 2001.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00488735     History of Changes
Other Study ID Numbers: KarolinskaI
Study First Received: June 19, 2007
Last Updated: May 6, 2010
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Karolinska Institutet:
Randomized controlled trial
Back pain
Neck pain
Rehabilitation
Cognitive-behavioral
Primary care
Sick-listing
Health-care utilization.

Additional relevant MeSH terms:
Neck Pain
Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 16, 2014