The Glucosamine-study: The Effect of Glucosamine in Treatment of Chronic Low Back Pain
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Phase 4 Study of Glucosamine Sulphate in the Treatment for Chronic Low Back Pain Patients With Degenerative Lumbar MRI Findings|
- 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.
- Visual Analogue Scale [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- EuroQol-5D [ Time Frame: 1 year ] [ Designated as safety issue: No ]
|Study Start Date:||December 2006|
|Study Completion Date:||November 2010|
|Primary Completion Date:||August 2009 (Final data collection date for primary outcome measure)|
|Experimental: Glucosamine Sulphate||
Drug: Glucosamine sulphate
Oral intake of 1500 mg glucosamine sulfate(from Pharma Nord) daily for 6 months
Other Name: Glucosamine sulfata Pharma Nord
|Placebo Comparator: Placebo||
Oral intake of 3 placebo capsules (similiar looking to the glucosamine sulfate capsules)daily for 6 months
|Ulleval Universtiy Hospital|
|Oslo, Norway, 0450|
|Principal Investigator:||Oliver Grundnes, MD||Ullevaal University Hospital|