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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by University Hospital, Gentofte, Copenhagen.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Sygekassernes Helsefond
Apotekerfonden af 1991
Indenrigs- og sundhedsministeriet
Information provided by:
University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier:
NCT00256373
First received: November 16, 2005
Last updated: April 18, 2006
Last verified: September 2005

November 16, 2005
April 18, 2006
January 2001
Not Provided
Pain VAS
Same as current
Complete list of historical versions of study NCT00256373 on ClinicalTrials.gov Archive Site
  • Roland Morris Disability Questionnaire
  • SF-36
  • Low Back Pain Rating Scale
  • Medicine use
  • Work situation
  • Pension
  • Change in physical activity
  • Global assessment
Same as current
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Not Provided
 
Treatment of Chronic Low Back Pain: A Trial Comparing Traditional Back School and Individual Therapist-Assisted Exercise
Not Provided

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)

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Chronic Low Back Pain
Procedure: Mod. functional restoration-Individ. dynamic back-muscle
Not Provided
Dufour N, Thamsborg G, Oefeldt A, Lundsgaard C, Stender S. Treatment of chronic low back pain: a randomized, clinical trial comparing group-based multidisciplinary biopsychosocial rehabilitation and intensive individual therapist-assisted back muscle strengthening exercises. Spine (Phila Pa 1976). 2010 Mar 1;35(5):469-76.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
Not Provided
November 2005
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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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00256373
KA 01011
Not Provided
Not Provided
University Hospital, Gentofte, Copenhagen
  • Sygekassernes Helsefond
  • Apotekerfonden af 1991
  • Indenrigs- og sundhedsministeriet
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
University Hospital, Gentofte, Copenhagen
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP