Effects of Glucosamine on Joint Fluid in Osteoarthritis Patients

Knee Osteoarthritis Clinical Trial

Official title:

Investigation of Oral Glucosamine Effects on Synovial Fluid Viscosity and Viscoelasticity in Osteoarthritis Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01074476
• Other study ID #: H10-00146
• Status: Active, not recruiting
• Phase: N/A
• First received: February 22, 2010
• Last updated: June 28, 2016
• Start date: June 2015
• Est. completion date: June 2017

Study information

• Verified date: June 2016
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

Osteoarthritis (OA) is the most common joint disease associated with aging. Although many patients take glucosamine supplements as a non-traditional treatment for osteoarthritis, the effectiveness of these supplements is questionable. This study will evaluate glucosamine therapy by directly analyzing two functions of joint fluid that are impaired by osteoarthritis - namely, the abilities to lubricate the joint and absorb shocks during activity. Joint fluid samples will be collected from subjects with knee osteoarthritis and analyzed on a device that simulates typical joint movements. After 3 months of glucosamine supplementation, samples will be collected again to detect potential improvements in joint fluid function.

Description:

Background:

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.

Research Method:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 85 Years

Eligibility

Inclusion Criteria:

• are between 30 and 85 years of age

• are clinically diagnosed with moderate to severe knee OA

• are recommended for synovial fluid aspiration

Exclusion Criteria:

• are clinically diagnosed with inflammatory arthritis

• had previous joint surgery in the study knee

• had injection in the study knee within the past 12 months

• have taken glucosamine and/or chondroitin supplements within the past 3 months

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Dietary Supplement:
• Glucosamine sulphate
750mg glucosamine sulphate (oral tablets), twice per day for 3 months

Other:
• Placebo
Placebo tablets, twice per day for 3 months

Locations

Country	Name	City	State
Canada	OASIS Vancouver Clinic, Gordon & Leslie Diamond Health Care Centre	Vancouver	British Columbia
Canada	University of British Columbia Health Clinic	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

References & Publications (7)

Anadere I, Chmiel H, Laschner W. Viscoelasticity of "normal" and pathological synovial fluid. Biorheology. 1979;16(3):179-84. — View Citation

Black C, Clar C, Henderson R, MacEachern C, McNamee P, Quayyum Z, Royle P, Thomas S. The clinical effectiveness of glucosamine and chondroitin supplements in slowing or arresting progression of osteoarthritis of the knee: a systematic review and economic evaluation. Health Technol Assess. 2009 Nov;13(52):1-148. doi: 10.3310/hta13520. Review. — View Citation

Clegg DO, Reda DJ, Harris CL, Klein MA, O'Dell JR, Hooper MM, Bradley JD, Bingham CO 3rd, Weisman MH, Jackson CG, Lane NE, Cush JJ, Moreland LW, Schumacher HR Jr, Oddis CV, Wolfe F, Molitor JA, Yocum DE, Schnitzer TJ, Furst DE, Sawitzke AD, Shi H, Brandt KD, Moskowitz RW, Williams HJ. Glucosamine, chondroitin sulfate, and the two in combination for painful knee osteoarthritis. N Engl J Med. 2006 Feb 23;354(8):795-808. — View Citation

Fam H, Bryant JT, Kontopoulou M. Rheological properties of synovial fluids. Biorheology. 2007;44(2):59-74. Review. — View Citation

Matsuno H, Nakamura H, Katayama K, Hayashi S, Kano S, Yudoh K, Kiso Y. Effects of an oral administration of glucosamine-chondroitin-quercetin glucoside on the synovial fluid properties in patients with osteoarthritis and rheumatoid arthritis. Biosci Biotechnol Biochem. 2009 Feb;73(2):288-92. Epub 2009 Feb 7. — View Citation

Schurz J, Ribitsch V. Rheology of synovial fluid. Biorheology. 1987;24(4):385-99. — View Citation

Vangsness CT Jr, Spiker W, Erickson J. A review of evidence-based medicine for glucosamine and chondroitin sulfate use in knee osteoarthritis. Arthroscopy. 2009 Jan;25(1):86-94. doi: 10.1016/j.arthro.2008.07.020. Epub 2008 Sep 30. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in synovial fluid viscosity and viscoelasticity compared to baseline		3 months	No
Secondary	Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score		3 months	No