A Double Blind Study Comparing Hyaluronic Acid, Corticosteroid and Placebo During Arthrocentesis for TMJ

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01524913
• Other study ID #: IRB00018682
• Secondary ID: Arthrocentesis
• Status: Completed
• Phase: Phase 4
• First received: January 29, 2012
• Last updated: May 25, 2016
• Start date: January 2012
• Est. completion date: April 2016

Study information

• Verified date: May 2016
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

This study will enroll patients with temporomandibular joint dysfunction who are deemed appropriate candidates for irrigation of their jaw joints secondary to pain or limited opening. At the completion of the joint irrigation subjects will be injected by one of three different products to determine if the additional injection results in a further decrease in jaw joint pain and improved opening. Subjects will be followed for 3 months. Those who do not show improvement may be candidates for additional treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: April 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Arthrocentesis
• Joint Diseases
• Pain
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction
• Temporomandibular Joint Dysfunction Syndrome

Intervention

Drug:
• Hyaluronic acid
1 cc hyalgan to be injected into superior joint space
• Corticosteroid
1cc celestone (6 mg/cc) will be injected into the joint space
• Lactated Ringers
1 cc lactated ringers solution will be injected into the joint space

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	University of Cinncinati	Cinncinati	Ohio
United States	University California Los Angeles	Los Angeles	California
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Oregon Health Sciences University	Portland	Oregon

Sponsors (6)

Lead Sponsor	Collaborator
Emory University	Oregon Health and Science University, University of California, Los Angeles, University of Cincinnati, University of Minnesota - Clinical and Translational Science Institute, University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain	Pain will be assessed preoperatively and again at 1 and 3 months using a visual analogue scale	3 months	No
Secondary	Function	Range of motion will be assessed preoperatively and again at 1 and 3 months using a millimeter ruler for maximum incisal opening and a jaw function limitation scale for other functional activities	3 months	No