Effects of Glucosamine on Joint Fluid in Osteoarthritis Patients
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Investigation of Oral Glucosamine Effects on Synovial Fluid Viscosity and Viscoelasticity in Osteoarthritis Patients|
- Changes in synovial fluid viscosity and viscoelasticity compared to baseline [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score [ Time Frame: 3 months ] [ Designated as safety issue: No ]
|Study Start Date:||June 2015|
|Estimated Study Completion Date:||June 2017|
|Estimated Primary Completion Date:||June 2017 (Final data collection date for primary outcome measure)|
Glucosamine sulphate tablets
Dietary Supplement: Glucosamine sulphate
750mg glucosamine sulphate (oral tablets), twice per day for 3 months
Placebo Comparator: 2
Placebo tablets, twice per day for 3 months
The effectiveness of glucosamine sulphate as a treatment for OA is still under debate. Most clinical trials evaluate the effectiveness of OA treatments by self-administered questionnaires about joint pain, stiffness and function (Lequesne Algofunctional Index, Western Ontario and McMaster Universities Osteoarthritis Index - WOMAC).
Although OA has been shown to reduce the viscosity and viscoelasticity of synovial fluid, few studies have used these properties as objective outcome measures in the assessment of glucosamine therapy.
The purpose of this study is to investigate whether glucosamine sulphate oral supplements improve the viscous and viscoelastic properties of synovial fluid in osteoarthritis patients and to explore potential correlations between these properties and subjective assessments of joint pain and function.
Patients will be invited to participate in the study if they have been recommended for synovial fluid aspiration to relieve joint discomfort caused by effusion. Subjects will be randomly assigned to receive either 1500mg of glucosamine sulphate or a placebo daily for 3 months. To relieve pain, subjects will be allowed to take up to 4000 mg of acetaminophen per day. If this is insufficient, NSAIDS will be permitted up to a maximum period of 5 consecutive days. Subjects will be asked to keep a log of their analgesics consumption.
At the baseline visit, patient demographics will be recorded and subjects will be asked to complete the WOMAC index questionnaire, which includes 24 questions to evaluate joint pain, stiffness and physical function. After noting the degree of joint effusion (minor, moderate, severe), an experienced physician will aspirate synovial fluid from the study knee to relieve joint pressure. A sample will be collected for analysis of viscosity and viscoelasticity.
Followup visits will be scheduled after every 4 weeks over the 3-month study period. Each visit will include the completion of a WOMAC questionnaire, clinical assessment of the degree of joint effusion and aspiration of synovial fluid (as necessary) for characterization. Any adverse events (such as headaches, abdominal pain, allergic episodes) will also be reported to the physician.
Changes in synovial fluid viscosity and viscoelasticity will be determined after 3 months of glucosamine supplementation and compared to the placebo group. Correlations between synovial fluid properties and WOMAC scores will also be described.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01074476
|Canada, British Columbia|
|OASIS Vancouver Clinic, Gordon & Leslie Diamond Health Care Centre|
|Vancouver, British Columbia, Canada, V5Z 1M9|
|University of British Columbia Health Clinic|
|Vancouver, British Columbia, Canada, V6T 1Z3|
|Principal Investigator:||Ezra Kwok, Dr||University of British Columbia|
|Study Director:||Dana Grecov, Dr.||University of British Columbia|
|Study Director:||Christie Newton, Dr.||University of British Columbia|