Treatment of Chronic Low Back Pain: A Trial Comparing Traditional Back School and Individual Therapist-Assisted Exercise

Chronic Low Back Pain Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00256373
• Other study ID #: KA 01011
• Status: Active, not recruiting
• Phase: Phase 3
• First received: November 16, 2005
• Last updated: April 18, 2006
• Start date: January 2001
• Est. completion date: November 2005

Study information

• Verified date: September 2005
• Source: University Hospital, Gentofte, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial Summary

Rheumatologists are discussing, whether rehabilitation of patients with low back pain (LBP) can be improved. At present patients with LBP start treatment as soon as possible, this also applies for patients with chronic low back pain (CLBP) - pain lasting over 12 weeks. At Glostrup University Hospital department of Physical Medicine/rheumatology we use a method (method A) where an interdisciplinary team gives the patients a treatment composed of various topics. This includes among other things education, physical team training, exercises in swimming pool, stretching exercises, and occupational therapy. A different method (method B) originates from the Rehabilitation centre in Karlslunde led by Teddy Oefeldt. Here they focus strictly on dynamic training of muscles in the back and the buttocks. A therapist, who in the beginning partly carries the patient through the exercises, assists this training.

In both methods, individually considerations are taken, but to a greater extend in method B. The treatment will extend over a three months period.

A few earlier investigations have compared these two methods, but they have not been systematized to such a degree, that they gave any final conclusions. Therefore, we initialized an investigation including a larger number of patients, where the two methods are compared from the results the patients achieve after 3, 6, 12 and 24 months.

286 consecutive patients were included and randomized to one of the two methods. Those, who did not wish to participate in the investigation, were treated according to the department’s normal procedure (Method A)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 0
• Est. completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Low Back Pain lasting more than 12 weeks with or with out pain radiating into the leg(s)

2. Age 18 - 60 years

Exclusion Criteria:

1. Serious spinal pathology

1. Malignancy

2. Osteoporosis,

3. Fresh vertebral fracture

4. Newly operation on the back

5. Stenosis of the lumbar spine

6. Unstable spondylolistesis

7. Infections in the back

2. Neurological dysfunction of the thoracic or abdominal muscles

3. Pregnancy/breastfeeding

4. Mental illness

5. Health conditions which prohibit intensive training.

6. Languish problems/ dyslexia

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

Intervention

Procedure:
• Mod. functional restoration-Individ. dynamic back-muscle

Locations

Country	Name	City	State
Denmark	Glostrup University Hospital	Glostrup

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital, Gentofte, Copenhagen	Apotekerfonden af 1991, Indenrigs- og sundhedsministeriet, Sygekassernes Helsefond

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain VAS
Secondary	Roland Morris Disability Questionnaire
Secondary	SF-36
Secondary	Low Back Pain Rating Scale
Secondary	Medicine use
Secondary	Work situation
Secondary	Pension
Secondary	Change in physical activity
Secondary	Global assessment