Synvisc to Treat Osteoarthritis of the Temporomandibular Joint

NCT00078351 | Completed Phase 2

• 2 other identifiers: 04011104-D-0111
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study will examine the effectiveness of injected hylan (Synvisc) for treating pain associated with osteoarthritis of the temporomandibular joint (jaw joint) and improving function of the joint. Hylan is a synthetic product very similar to a component of normal healthy joint fluid (synovial fluid), which is present in much lower quantities and is abnormal in osteoarthritis. Hylan injections have been beneficial in treating osteoarthritis of the knee. Patients with temporomandibular (TMJ) joint pain of at least 3 months duration who have mouth opening limitation and moderate to severe joint pain made worse by joint movement may be eligible for this study. Patients must not have any TMJ growth disturbances and must not have had any TMJ surgery for 6 months before entering the study. Candidates are screened with questionnaires, a medical history, and a physical examination of the TMJs, including x-rays and magnetic resonance imaging. Participants are randomly assigned to receive three injections, each a week apart, of either Synvisc or placebo (a salt-water solution) into the affected joint. Before the first injection, a sample of synovial fluid is collected from the joint by needle aspiration for laboratory analysis. Patients return for follow-up visits 3, 6, and 12 months after the last treatment for a clinical examination of the jaw joint and review of jaw joint symptoms. A second aspiration is requested at the 3-month visit, but is not mandatory. All injections and aspirations are done after anesthetizing the overlying skin and joint capsule to minimize pain or discomfort. Participants record their daily use of pain relief medication throughout the study.

Conditions

Osteoarthritis

Keywords

Chronic Pain; Synvisc; Temporomandibular Joint; Osteoarthritis; TMD; Temporomandibular Joint Osteoarthritis; TMJ OA; Temporomandibular Joint Disease; TMJ

Interventions

High molecular weight hylan (Synvisc) injection PROCEDURE

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• Patients will be screened for any positive history of liver or kidney dysfunctions. Any patients with a medical history of diabetes, congestive heart failure, any chronic infections will also be excluded. Subjects that have primary psychiatric disease or score above average in comparison with normative scores on Symptom Checklist (SCL-90R) will not be able to participate. Pregnant women will not be included in the study, this will be determined by a pregnancy test, and subjects will be required to use 2 forms of contraception for the first 3 weeks of the study (to cover the synvisc injections). It is a standard practice in chronic pain study not to include patients who are involved in litigation. Patients with sepsis or with known hypersensitivity to hyaluronan and any of its components will be excluded to the study.

Sponsors & Collaborators

• National Institute of Dental and Craniofacial Research (NIDCR): lead

Study Sites (1)

National Institute of Dental And Craniofacial Research (NIDCR)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Huskisson EC, Donnelly S. Hyaluronic acid in the treatment of osteoarthritis of the knee. Rheumatology (Oxford). 1999 Jul;38(7):602-7. doi: 10.1093/rheumatology/38.7.602.

  PMID: 10461471 BACKGROUND

• Gabriel SE, Jaakkimainen L, Bombardier C. Risk for serious gastrointestinal complications related to use of nonsteroidal anti-inflammatory drugs. A meta-analysis. Ann Intern Med. 1991 Nov 15;115(10):787-96. doi: 10.7326/0003-4819-115-10-787.

  PMID: 1834002 BACKGROUND

• Allison MC, Howatson AG, Torrance CJ, Lee FD, Russell RI. Gastrointestinal damage associated with the use of nonsteroidal antiinflammatory drugs. N Engl J Med. 1992 Sep 10;327(11):749-54. doi: 10.1056/NEJM199209103271101.

  PMID: 1501650 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis; Chronic Pain; Temporomandibular Joint Disorders

Interventions

hylan; Injections

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Muscular Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: February 23, 2004
• First Posted: February 24, 2004
• Study Start: February 1, 2004
• Study Completion: October 1, 2005
• Last Updated: March 4, 2008

Record last verified: 2005-10

Locations

US (1)