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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Sygekassernes Helsefond
Apotekerfonden af 1991
Indenrigs- og sundhedsministeriet
Information provided by:
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)

Condition or disease Intervention/treatment Phase
Chronic Low Back Pain Procedure: Mod. functional restoration-Individ. dynamic back-muscle Phase 3

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Primary Outcome Measures :
  1. Pain VAS

Secondary Outcome Measures :
  1. Roland Morris Disability Questionnaire
  2. SF-36
  3. Low Back Pain Rating Scale
  4. Medicine use
  5. Work situation
  6. Pension
  7. Change in physical activity
  8. Global assessment

Information from the National Library of Medicine

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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:

  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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00256373

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Glostrup University Hospital
Glostrup, Denmark, 2600
Sponsors and Collaborators
University Hospital, Gentofte, Copenhagen
Sygekassernes Helsefond
Apotekerfonden af 1991
Indenrigs- og sundhedsministeriet
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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 automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information 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
Keywords provided by University Hospital, Gentofte, Copenhagen:
Low Back Pain
Dynamic Back-Muscle exercise Treatment
Interdisciplinary Treatment
Roland Morris Disability Questionnaire
Low Back Pain Rating Scale
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Neurologic Manifestations