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

This study has been completed.
Sponsor:
Collaborator:
Stiftelsen Helse og Rehabilitering
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00404079
First received: November 23, 2006
Last updated: April 4, 2011
Last verified: February 2011

November 23, 2006
April 4, 2011
December 2006
August 2009   (final data collection date for primary outcome measure)
Roland Morris Disability Questionnaire [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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 ClinicalTrials.gov Archive Site
  • Visual Analogue Scale [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • EuroQol-5D [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Visual Analogue Scale
  • EuroQol-5D
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
250
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
Both
25 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT00404079
28130805
Yes
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