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

Phase 3

• Conditions: Chronic Low Back Pain

• Registration Number: NCT00256373
• Lead Sponsor: University Hospital, Gentofte, Copenhagen

Brief 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)

Detailed Description

Not available

Study Timeline

• Study Start: 2001-01
• Status Verified: 2005-09
• Study Completion: 2005-11
• Study First Submitted: 2005-11-16
• Study First Submitted QC: 2005-11-16
• Study First Posted: 2005-11-21
• Last Update Submitted: 2006-04-18
• Last Update Posted: 2006-04-19

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain VAS

Secondary Outcome Measures

Name	Time	Method
SF-36
Pension
Low Back Pain Rating Scale
Work situation
Global assessment
Roland Morris Disability Questionnaire
Medicine use
Change in physical activity

Trial Locations

Locations (1)

Glostrup University Hospital; 🇩🇰 Glostrup, Denmark