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

• ClinicalTrials.gov Identifier: NCT01524913
• Recruitment Status: Completed
• First Posted: February 2, 2012
• Results First Posted: May 5, 2017
• Last Update Posted: May 5, 2017
• Sponsor: Emory University
• Collaborators: University of California, Los Angeles; Oregon Health and Science University; University of Minnesota; University of Cincinnati; University of Pennsylvania
• Information provided by (Responsible Party): Gary F Bouloux MD, DDS, MDSc, FRACDS, FRACDS, Emory University

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Temporomandibular Joint Dysfunction; Pain; Arthrocentesis	Drug: Hyaluronic acid; Drug: Corticosteroid; Drug: Lactated Ringers	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 102 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Double Blind Randomised Study Comparing Hyaluronic Acid, Corticosteroid and Placebo During Arthrocentesis for Temporomandibular Joint Dysfunction
• Study Start Date: January 2012
• Actual Primary Completion Date: December 2015
• Actual Study Completion Date: April 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.
2. 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).
3. 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).

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 90 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, California

University California Los Angeles

Los Angeles, California, United States, 90024

United States, Georgia

Emory University

Atlanta, Georgia, United States, 30322

United States, Ohio

University of Cinncinati

Cinncinati, Ohio, United States, 45219

United States, Oregon

Oregon Health Sciences University

Portland, Oregon, United States, 97239

United States, Pennsylvania

University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

Sponsors and Collaborators

Emory University

University of California, Los Angeles

Oregon Health and Science University

University of Minnesota

University of Cincinnati

University of Pennsylvania

Investigators

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

More Information

Publications of Results:

Bouloux GF, Chou J, Krishnan D, Aghaloo T, Kahenasa N, Smith JA, Giannakopoulos H. Is Hyaluronic Acid or Corticosteroid Superior to Lactated Ringer Solution in the Short-Term Reduction of Temporomandibular Joint Pain After Arthrocentesis? Part 1. J Oral Maxillofac Surg. 2017 Jan;75(1):52-62. doi: 10.1016/j.joms.2016.08.006. Epub 2016 Aug 20.

Bouloux GF, Chou J, Krishnan D, Aghaloo T, Kahenasa N, Smith JA, Giannakopoulos H. Is Hyaluronic Acid or Corticosteroid Superior to Lactated Ringer Solution in the Short Term for Improving Function and Quality of Life After Arthrocentesis? Part 2. J Oral Maxillofac Surg. 2017 Jan;75(1):63-72. doi: 10.1016/j.joms.2016.08.008. Epub 2016 Aug 20.

• Responsible Party: Gary F Bouloux MD, DDS, MDSc, FRACDS, FRACDS, National PI, Emory University
• ClinicalTrials.gov Identifier: NCT01524913
• Other Study ID Numbers: IRB00018682; Arthrocentesis ( Other Identifier: Other )
• First Posted: February 2, 2012
• Results First Posted: May 5, 2017
• Last Update Posted: May 5, 2017
• Last Verified: March 2017

Additional relevant MeSH terms:

Joint Diseases; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome; Musculoskeletal Diseases; Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Muscular Diseases; Stomatognathic Diseases; Myofascial Pain Syndromes; Hyaluronic Acid; Adjuvants, Immunologic; Immunologic Factors; Physiological Effects of Drugs; Viscosupplements; Protective Agents