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

This study has been completed.
Sponsor:
Collaborators:
University of California, Los Angeles
Oregon Health and Science University
University of Minnesota - Clinical and Translational Science Institute
University of Cincinnati
University of Pennsylvania
Information provided by (Responsible Party):
Gary F Bouloux MD, DDS, MDSc, FRACDS, FRACDS, Emory University
ClinicalTrials.gov Identifier:
NCT01524913
First received: January 29, 2012
Last updated: March 27, 2017
Last verified: March 2017
  Purpose

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 Intervention Phase
Temporomandibular Joint Dysfunction Pain Arthrocentesis Drug: Hyaluronic acid Drug: Corticosteroid Drug: Lactated Ringers Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Gary F Bouloux MD, DDS, MDSc, FRACDS, FRACDS, Emory University:

Primary Outcome Measures:
  • 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:
  • 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.

  • 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).

  • 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).


Enrollment: 102
Study Start Date: January 2012
Study Completion Date: April 2016
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01524913

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 - Clinical and Translational Science Institute
University of Cincinnati
University of Pennsylvania
Investigators
Principal Investigator: Gary F Bouloux, MD, DDS Emory University
  More Information

Publications:
Responsible Party: Gary F Bouloux MD, DDS, MDSc, FRACDS, FRACDS, National PI, Emory University
ClinicalTrials.gov Identifier: NCT01524913     History of Changes
Other Study ID Numbers: IRB00018682
Arthrocentesis ( Other Identifier: Other )
Study First Received: January 29, 2012
Results First Received: January 12, 2017
Last Updated: March 27, 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

ClinicalTrials.gov processed this record on June 28, 2017