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

March 27, 2017 updated by: Gary F Bouloux MD, DDS, MDSc, FRACDS, FRACDS, Emory University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

102

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90024
        • University California Los Angeles
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University
    • Ohio
      • Cinncinati, Ohio, United States, 45219
        • University of Cinncinati
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health Sciences University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Saline
Drug: Lactated Ringers
1 cc lactated ringers solution will be injected into the joint space
Active Comparator: Corticosteroid
Drug: Corticosteroid
1cc celestone (6 mg/cc) will be injected into the joint space
Experimental: Hyaluronic acid
Drug: Hyaluronic acid
1 cc hyalgan to be injected into superior joint space

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pain Between Baseline and Month 1 Scores
Time Frame: Baseline (preoperation), Month 1
The change in pain level was assessed using a single-item visual analogue pain scale at Baseline (preoperatively) and at Month 1. Participants indicate their level on pain on a scale of 0 (no pain) to 10 (worst pain imaginable). The right and left side of each participant's jaw was evaluated separately. The change in pain score was obtained by subtracting the Month 1 score from the Baseline score and a negative value indicates a reduction in pain level.
Baseline (preoperation), Month 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Maximum Incisal Opening (MIO) Between Baseline, Month 1, and Month 3
Time Frame: Baseline (preoperation), Month 1, Month 3
Range of motion was assessed at Baseline (preoperatively) and again at Months 1 and 3 using a millimeter ruler for maximum incisal opening. MIO was measurements were taken for maximum opening without and with pain.
Baseline (preoperation), Month 1, Month 3
Jaw Function Limitation Scale (JFLS) Score
Time Frame: Month 1
The Jaw Function Limitation Scale (JFLS) is an 8 item survey where respondents indicate the presence or absence of problems with chewing, drinking, eating hard food, eating soft food, smiling or laughing, yawning, swallowing, and talking. Responses of "no" are scored as "0" and responses of "yes" are scored as "1". The total score categorizes jaw limitation as: none (0), mild (1-3), moderate (4-6), and severe (7-8).
Month 1
Jaw Function Limitation Scale (JFLS) Score
Time Frame: Month 3
The Jaw Function Limitation Scale (JFLS) is an 8 item survey where respondents indicate the presence or absence of problems with chewing, drinking, eating hard food, eating soft food, smiling or laughing, yawning, swallowing, and talking. Responses of "no" are scored as "0" and responses of "yes" are scored as "1". The total score categorizes jaw limitation as: none (0), mild (1-3), moderate (4-6), and severe (7-8).
Month 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emory University

Collaborators

University of Pennsylvania
University of California, Los Angeles
Oregon Health and Science University
University of Minnesota
University of Cincinnati

Investigators

  • Principal Investigator: Gary F Bouloux, MD, DDS, Emory University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

January 29, 2012

First Submitted That Met QC Criteria

January 31, 2012

First Posted (Estimate)

February 2, 2012

Study Record Updates

Last Update Posted (Actual)

May 5, 2017

Last Update Submitted That Met QC Criteria

March 27, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00018682
  • Arthrocentesis (Other Identifier: Other)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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