Treatment of Chronic Low Back Pain: A Trial Comparing Traditional Back School and Individual Therapist-Assisted Exercise
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ClinicalTrials.gov Identifier: NCT00256373 |
Recruitment Status : Unknown
Verified September 2005 by University Hospital, Gentofte, Copenhagen.
Recruitment status was: Active, not recruiting
First Posted : November 21, 2005
Last Update Posted : April 19, 2006
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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)
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Low Back Pain | Procedure: Mod. functional restoration-Individ. dynamic back-muscle | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single |
Primary Purpose: | Treatment |
Study Start Date : | January 2001 |
Study Completion Date : | November 2005 |
- Pain VAS
- Roland Morris Disability Questionnaire
- SF-36
- Low Back Pain Rating Scale
- Medicine use
- Work situation
- Pension
- Change in physical activity
- Global assessment

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Low Back Pain lasting more than 12 weeks with or with out pain radiating into the leg(s)
- Age 18 - 60 years
Exclusion Criteria:
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Serious spinal pathology
- Malignancy
- Osteoporosis,
- Fresh vertebral fracture
- Newly operation on the back
- Stenosis of the lumbar spine
- Unstable spondylolistesis
- Infections in the back
- Neurological dysfunction of the thoracic or abdominal muscles
- Pregnancy/breastfeeding
- Mental illness
- Health conditions which prohibit intensive training.
- Languish problems/ dyslexia

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): NCT00256373
Denmark | |
Glostrup University Hospital | |
Glostrup, Denmark, 2600 |
Study Chair: | Charlotte Lundsgaard, MD | ||
Study Director: | Claus Hellesen, MD | ||
Study Director: | Alex Oefeldt, Therapist | ||
Study Director: | Gorm Thamsborg, Dr.Med.Sci. | ||
Study Director: | Arne Astrup, Dr.Med.Sci. | ||
Study Chair: | Steen Stender, Dr.Med.Sci. | ||
Principal Investigator: | Ninna Dufour, MD | Unfilliated |
ClinicalTrials.gov Identifier: | NCT00256373 |
Other Study ID Numbers: |
KA 01011 |
First Posted: | November 21, 2005 Key Record Dates |
Last Update Posted: | April 19, 2006 |
Last Verified: | September 2005 |
Low Back Pain Dynamic Back-Muscle exercise Treatment Interdisciplinary Treatment |
Roland Morris Disability Questionnaire SF-36 Low Back Pain Rating Scale |
Back Pain Low Back Pain Pain Neurologic Manifestations |