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

NCT00488735 | Completed

• 1 other identifier: KarolinskaI
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Back Pain; Neck Pain

Keywords

Randomized controlled trial; Back pain; Neck pain; Rehabilitation; Cognitive-behavioral; Primary care; Sick-listing; Health-care utilization.

Outcome Measures

Primary Outcomes (1)

• 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.

  18 months.

Secondary Outcomes (1)

• 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.

  Work ability: 18 months. Total sick-listing: 36 months (18 months preceding and after inclusion). Visits: 18 months.

Interventions

Cognitive-behavioral rehabilitation BEHAVIORAL

Traditional primary care BEHAVIORAL

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Centre for Family Medicine

Stockholm, Huddinge, SE-141 83, Sweden

Location

Related Publications (9)

• 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. doi: 10.1080/14034950410021808. No abstract available.

  PMID: 15513650 BACKGROUND

• 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.

  BACKGROUND

• Lindstrom 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. doi: 10.1093/ptj/72.4.279.

  PMID: 1533941 BACKGROUND

• 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.

  BACKGROUND

• Waddell G. Low back pain: a twentieth century health care enigma. Spine (Phila Pa 1976). 1996 Dec 15;21(24):2820-5. doi: 10.1097/00007632-199612150-00002.

  PMID: 9112705 BACKGROUND

• Brown H, Prescott R: Applied mixed models in medicine. Edinburgh: John Wiley & Sons LTD; 199-259, 2001.

  BACKGROUND

• 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. doi: 10.1186/1471-2474-8-31.

  PMID: 17407580 RESULT

• Lindell O, Johansson SE, Strender LE. Predictors of stable return-to-work in non-acute, non-specific spinal pain: low total prior sick-listing, high self prediction and young age. A two-year prospective cohort study. BMC Fam Pract. 2010 Jul 20;11:53. doi: 10.1186/1471-2296-11-53.

  PMID: 20646286 DERIVED

• Lindell O, Johansson SE, Strender LE. Subacute and chronic, non-specific back and neck pain: cognitive-behavioural rehabilitation versus primary care. A randomized controlled trial. BMC Musculoskelet Disord. 2008 Dec 30;9:172. doi: 10.1186/1471-2474-9-172.

  PMID: 19116007 DERIVED

MeSH Terms

Conditions

Back Pain; Neck Pain; Patient Acceptance of Health Care

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Lars-Erik Strender, Professor

  Centre for Family Medicine, Karolinska Institutet

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 19, 2007
• First Posted: June 20, 2007
• Study Start: August 1, 2000
• Study Completion: July 1, 2005
• Last Updated: May 7, 2010

Record last verified: 2007-06

Locations

SE (1)