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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00488735
First Posted: June 20, 2007
Last Update Posted: May 7, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Karolinska Institutet
  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
Intervention Model: Parallel Assignment
Masking: None (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
Lindell O, Eriksson L, Strender LE. The reliability of a 10-test package for patients with prolonged back and neck pain: could an examiner without formal medical education be used without loss of quality? A methodological study. BMC Musculoskelet Disord. 2007 Apr 3;8:31.
Alexanderson K, Norlund A. Swedish Council on Technology Assessment in Health Care (SBU). Chapter 1. Aim, background, key concepts, regulations, and current statistics. Scand J Public Health Suppl. 2004;63:12-30. Review.
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.
Lindström I, Ohlund C, Eek C, Wallin L, Peterson LE, Fordyce WE, Nachemson AL. The effect of graded activity on patients with subacute low back pain: a randomized prospective clinical study with an operant-conditioning behavioral approach. Phys Ther. 1992 Apr;72(4):279-90; discussion 291-3.
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.
Waddell G. Low back pain: a twentieth century health care enigma. Spine (Phila Pa 1976). 1996 Dec 15;21(24):2820-5.
Brown H, Prescott R: Applied mixed models in medicine. Edinburgh: John Wiley & Sons LTD; 199-259, 2001.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00488735     History of Changes
Other Study ID Numbers: KarolinskaI
First Submitted: June 19, 2007
First Posted: June 20, 2007
Last Update Posted: May 7, 2010
Last Verified: June 2007

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


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