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
  Purpose

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 Intervention Phase
Chronic Low Back Pain
Procedure: Mod. functional restoration-Individ. dynamic back-muscle
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by University Hospital, Gentofte, Copenhagen:

Primary Outcome Measures:
  • Pain VAS

Secondary Outcome Measures:
  • Roland Morris Disability Questionnaire
  • SF-36
  • Low Back Pain Rating Scale
  • Medicine use
  • Work situation
  • Pension
  • Change in physical activity
  • Global assessment

Study Start Date: January 2001
Estimated Study Completion Date: November 2005
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00256373

Locations
Denmark
Glostrup University Hospital
Glostrup, Denmark, 2600
Sponsors and Collaborators
University Hospital, Gentofte, Copenhagen
Sygekassernes Helsefond
Apotekerfonden af 1991
Indenrigs- og sundhedsministeriet
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
  More Information

No publications provided by University Hospital, Gentofte, Copenhagen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00256373     History of Changes
Other Study ID Numbers: KA 01011
Study First Received: November 16, 2005
Last Updated: April 18, 2006
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by University Hospital, Gentofte, Copenhagen:
Low Back Pain
Dynamic Back-Muscle exercise Treatment
Interdisciplinary Treatment
Roland Morris Disability Questionnaire
SF-36
Low Back Pain Rating Scale

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on October 20, 2014