A Double Blind Study Comparing Hyaluronic Acid, Corticosteroid and Placebo During Arthrocentesis for Temporomandibular Joint (TMJ) Dysfunction

• Status: Completed
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether the administration of hyaluronic acid or corticosteroid during arthrocentesis of the temporomandibular joint provides additional pain relief and improved function.

The overall hypothesis for the study is that hyalgan will result in a 30% reduction in the mean visual analogue scale (VAS) at one month when compared to celestone and placebo.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Emory University
• Collaborators: Oregon Health and Science University; University of California, Los Angeles; University of Cincinnati; University of Minnesota; University of Minnesota - Clinical and Translational Science Institute; University of Pennsylvania
• Treatments: Hyaluronic Acid

Criteria

Inclusion Criteria:

• age greater than 18 years

• arthralgia of one or both temporomandibular joints

• Wilkes II to IV internal derangement of the symptomatic joint OR

• limited opening of <35 mm

Exclusion Criteria:

• myofascial pain as the primary source of pain

• cervical pain as the primary source of pain

• systemic arthropathy

• fibromyalgia

• use of NSAIDS within 48 hours

• allergy to study medications

• edentulous subjects

• pregnancy or breast feeding

• current physical therapy, muscle relaxants or antiseizure medications

• current use of a splint issued within last 12 weeks