- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00256373
Treatment of Chronic Low Back Pain: A Trial Comparing Traditional Back School and Individual Therapist-Assisted Exercise
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)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Phase
- Phase 3
Contacts and Locations
Study Locations
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Glostrup, Denmark, 2600
- Glostrup University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Pain VAS
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Secondary Outcome Measures
Outcome Measure |
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SF-36
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Global assessment
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Roland Morris Disability Questionnaire
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Low Back Pain Rating Scale
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Medicine use
|
Work situation
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Pension
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Change in physical activity
|
Collaborators and Investigators
Investigators
- 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
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KA 01011
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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