This trial is active, not recruiting.

Condition chronic low back pain
Treatment mod. functional restoration-individ. dynamic back-muscle
Phase phase 3
Sponsor University Hospital, Gentofte, Copenhagen
Collaborator Sygekassernes Helsefond
Start date January 2001
End date November 2005
Trial identifier NCT00256373, KA 01011


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)

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind
Primary purpose treatment

Primary Outcomes

Pain VAS
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Secondary Outcomes

Roland Morris Disability Questionnaire
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Low Back Pain Rating Scale
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Medicine use
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Work situation
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Change in physical activity
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Global assessment
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Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

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

Additional Information

Principal investigator Ninna Dufour, MD
Trial information was received from ClinicalTrials.gov and was last updated in April 2006.
Information provided to ClinicalTrials.gov by University Hospital, Gentofte, Copenhagen.