Subacute and Chronic, Non-specific Back and Neck Pain: Cognitive-behavioral Rehabilitation vs. Traditional Primary Care
This study has been completed.
Sponsor:
Karolinska Institutet
Information provided by:
Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT00488735
First received: June 19, 2007
Last updated: May 6, 2010
Last verified: June 2007
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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 |
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 59 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Working age up to and including 59 years.
- Sick-listed full-time for BNP for at least 42 days and at most 730 days.
- Able to manage tolerably well to fill in forms.
Exclusion Criteria:
- Temporary disability pension or disability pension being paid or in preparation.
- A primary need of action by a hospital specialist.
- Pregnancy and diseases which would probably make rehabilitation impracticable (for example, advanced pulmonary disease).
- Whiplash-associated disorders as a primary obstacle to working.
- Previous rehabilitation at the rehabilitation centre.
- Other multidisciplinary rehabilitation going on or planned.
Contacts and Locations
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:
|
Back Pain Neck Pain Pain |
Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on May 23, 2013