Osteoarthritis
Conditions
Keywords
Chronic Pain, Synvisc, Temporomandibular Joint, Osteoarthritis, TMD, Temporomandibular Joint Osteoarthritis, TMJ OA, Temporomandibular Joint Disease, TMJ
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.
Detailed description
The proposed clinical trial will evaluate the effects of high molecular weight hylan (Synvisc) injection in comparison with control treatment (saline injection) for osteoarthritis (OA) affecting the temporomandibular joint (TMJ). Patients with TMJ OA of at least three-month duration and who have not responded to conservative treatments will be included. Patients will be randomly assigned to either high molecular hylan injection or control. At baseline and follow up visits, clinical outcome measures will be assessed such as pain and range of motion. Positive findings in clinical outcome measures will provide evidence for the clinical utility of Synvisc in patients with painful TMJ OA. In addition to clinical outcome measures, a sample of synovial fluid from the affected joint will be obtained at the baseline visit and at 12 week follow up, and levels of tumor necrosis factor alpha (TNF alpha), Matrix metalloproteinase (MMP) and Tissue inhibitor of metalloproteinase (TIMP) will be analyzed. By studying the synovial fluid levels of TNF alpha, MMP and TIMP, we will assess the effects of viscosupplementation with Synvisc on the local inflammatory process and proteolytic activity in TMJ OA in comparison with control treatment. Positive findings in clinical symptoms and synovial fluid analysis will also provide implications of clinical utility of Synvisc in patients with painful TMJ OA. Furthermore, this analysis of synovial fluid may identify biomarkers associated with OA affecting the TMJ.
Interventions
PROCEDUREHigh molecular weight hylan (Synvisc) injection
Sponsors
National Institute of Dental and Craniofacial Research (NIDCR)
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
INCLUSION AND
Exclusion criteria
We will recruit patients with TMJ OA defined by the Research Diagnostic Criteria. Patients are required to have chronic preauricular pain for more than 3 months, even though they have received some palliative treatment (NSAIDs and/or stabilization splint therapy). Radiological imaging is indicated in addition to clinical evaluation to confirm the diagnosis of TMJ OA. Radiographic evidence of OA includes flattening of condyle, increased opacity of cortical bone of condyle, or osteophyte formation. Prior to being admitted to the study, patients will be screened with standard temporomandibular joint radiological imaging, including panoramic, tomographic and magnetic resonance imaging (MRI) studies. Radiological imaging will not be repeated at the end of the study unless medically indicated. The patients are required to have mouth opening limitation (less than normal) and moderate to severe joint pain aggravated by jaw movement. Patients who have undergone any TMJ surgery within the preceding 6 months will be excluded, as well as those who have taken analgesic, anti-inflammatory, steroids or narcotic medications during the last 15 days. Further
Countries
United States
Outcome results
None listed