Effects of Glucosamine on Joint Fluid in Osteoarthritis Patients

• ClinicalTrials.gov Identifier: NCT01074476
• Recruitment Status: Unknown
• First Posted: February 24, 2010
• Last Update Posted: June 29, 2016
• Sponsor: University of British Columbia
• Information provided by (Responsible Party): University of British Columbia

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Knee Osteoarthritis	Dietary Supplement: Glucosamine sulphate; Other: Placebo	Not Applicable

Detailed 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Investigation of Oral Glucosamine Effects on Synovial Fluid Viscosity and Viscoelasticity in Osteoarthritis Patients
• Study Start Date: June 2015
• Estimated Primary Completion Date: June 2017
• Estimated Study Completion Date: June 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: 1; Glucosamine sulphate tablets	Dietary Supplement: Glucosamine sulphate; 750mg glucosamine sulphate (oral tablets), twice per day for 3 months
Placebo Comparator: 2; Placebo tablets	Other: Placebo; Placebo tablets, twice per day for 3 months

Outcome Measures

Primary Outcome Measures :

1. Changes in synovial fluid viscosity and viscoelasticity compared to baseline [ Time Frame: 3 months ]

Secondary Outcome Measures :

1. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score [ Time Frame: 3 months ]

Eligibility Criteria

• Ages Eligible for Study: 30 Years to 85 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

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

Sponsors and Collaborators

University of British Columbia

Investigators

• 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

More Information

Publications:

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

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

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

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.

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.

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.

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.

• Responsible Party: University of British Columbia
• ClinicalTrials.gov Identifier: NCT01074476
• Other Study ID Numbers: H10-00146
• First Posted: February 24, 2010
• Last Update Posted: June 29, 2016
• Last Verified: June 2016

Keywords provided by University of British Columbia:

Knee osteoarthritis; glucosamine; synovial fluid; viscosity; viscoelasticity; WOMAC

Additional relevant MeSH terms:

Osteoarthritis; Osteoarthritis, Knee; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases