The Glucosamine-study: The Effect of Glucosamine in Treatment of Chronic Low Back Pain

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: NCT00404079
Recruitment Status : Completed
First Posted : November 27, 2006
Results First Posted : April 29, 2011
Last Update Posted : April 29, 2011
Stiftelsen Helse og Rehabilitering
Information provided by:
Oslo University Hospital

November 23, 2006
November 27, 2006
February 21, 2011
April 29, 2011
April 29, 2011
December 2006
August 2009   (Final data collection date for primary outcome measure)
Roland Morris Disability Questionnaire [ Time Frame: 1 year ]
The primary outcome was scores on the Norwegian version of Roland Morris Disability Questionnaire (RMDQ). RMDQ is a widely used back-specific, self-administered measure of pain-related disability. Greater levels of disability give higher numbers on a 24-point scale. RMDQ has content and construct validity and internal consistency. It is also reproducible and sensitive to change over time for LBP patients. A 3-point reduction in the total RMDQ was a priori classified as a response to treatment.
Roland Morris Disability Questionnaire
Complete list of historical versions of study NCT00404079 on Archive Site
  • Visual Analogue Scale [ Time Frame: 1 year ]
  • EuroQol-5D [ Time Frame: 1 year ]
  • Visual Analogue Scale
  • EuroQol-5D
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The Glucosamine-study: The Effect of Glucosamine in Treatment of Chronic Low Back Pain
Phase 4 Study of Glucosamine Sulphate in the Treatment for Chronic Low Back Pain Patients With Degenerative Lumbar MRI Findings

Low back pain (LBP) is the most frequent cause of sick leave and disability pension, and degenerative and osteoarthritic (OA) changes is a significant cause of pain and disability. Some indications exist for symptomatic and possible cartilage-structurmodifying effect on knee- and hip-osteoarthritis with glucosamine sulphate (GS). The OA process in the lumbar spine is most likely to OA processes in knees and hips, hence GS could have comparable symptomatic and structural effect on lumbar OA.

Study hypothesis: No difference in treatment effect exists between oral intake of GS- or placebo-capsules for patients` with chronic low back pain measured with Roland Morris Disability Questionnaire.

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Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Low Back Pain
  • Drug: Glucosamine sulphate
    Oral intake of 1500 mg glucosamine sulfate(from Pharma Nord) daily for 6 months
    Other Name: Glucosamine sulfata Pharma Nord
  • Drug: Placebo
    Oral intake of 3 placebo capsules (similiar looking to the glucosamine sulfate capsules)daily for 6 months
  • Experimental: Glucosamine Sulphate
    Intervention: Drug: Glucosamine sulphate
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Not Provided
November 2010
August 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Low back pain for more than 6 months
  • Patient older than 25 years old
  • MRI findings comparable with lumbar degenerative/osteoarthritic changes.

Exclusion Criteria:

  • Spinal stenosis with neurological deficits
  • Spinal prolapse with neurological deficits
  • Rheumatoid arthritis, psoriatic arthritis,
  • Old lumbar fractures
  • Chronic pain syndromes (e.g. fibromyalgia)
  • Psychosocial status not suitable for participation
  • Pregnancy
  • Breastfeeding
  • Allergic to shellfish
Sexes Eligible for Study: All
25 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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Dr. Oliver Grundnes, Ullevaal University Hospital
Ullevaal University Hospital
Stiftelsen Helse og Rehabilitering
Principal Investigator: Oliver Grundnes, MD Ullevaal University Hospital
Oslo University Hospital
February 2011

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