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.|
|ClinicalTrials.gov Identifier: NCT00404079|
Recruitment Status : Completed
First Posted : November 27, 2006
Results First Posted : April 29, 2011
Last Update Posted : April 29, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Low Back Pain||Drug: Glucosamine sulphate Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||250 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Phase 4 Study of Glucosamine Sulphate in the Treatment for Chronic Low Back Pain Patients With Degenerative Lumbar MRI Findings|
|Study Start Date :||December 2006|
|Actual Primary Completion Date :||August 2009|
|Actual Study Completion Date :||November 2010|
|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
- 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.
- Visual Analogue Scale [ Time Frame: 1 year ]
- EuroQol-5D [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00404079
|Ulleval Universtiy Hospital|
|Oslo, Norway, 0450|
|Principal Investigator:||Oliver Grundnes, MD||Ullevaal University Hospital|