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

Primary Purpose

Temporomandibular Joint Dysfunction, Pain, Arthrocentesis

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Hyaluronic acid
Corticosteroid
Lactated Ringers
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Temporomandibular Joint Dysfunction

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University California Los Angeles
  • Emory University
  • University of Cinncinati
  • Oregon Health Sciences University
  • University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Hyaluronic acid

Corticosteroid

Saline

Arm Description

Outcomes

Primary Outcome Measures

Change in Pain Between Baseline and Month 1 Scores
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
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
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
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).

Full Information

First Posted
January 29, 2012
Last Updated
March 27, 2017
Sponsor
Emory University
Collaborators
University of California, Los Angeles, Oregon Health and Science University, University of Minnesota, University of Cincinnati, University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT01524913
Brief Title
A Double Blind Study Comparing Hyaluronic Acid, Corticosteroid and Placebo During Arthrocentesis for Temporomandibular Joint (TMJ) Dysfunction
Official Title
A Double Blind Randomised Study Comparing Hyaluronic Acid, Corticosteroid and Placebo During Arthrocentesis for Temporomandibular Joint Dysfunction
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
University of California, Los Angeles, Oregon Health and Science University, University of Minnesota, University of Cincinnati, University of Pennsylvania

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Joint Dysfunction, Pain, Arthrocentesis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hyaluronic acid
Arm Type
Experimental
Arm Title
Corticosteroid
Arm Type
Active Comparator
Arm Title
Saline
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Hyaluronic acid
Intervention Description
1 cc hyalgan to be injected into superior joint space
Intervention Type
Drug
Intervention Name(s)
Corticosteroid
Intervention Description
1cc celestone (6 mg/cc) will be injected into the joint space
Intervention Type
Drug
Intervention Name(s)
Lactated Ringers
Intervention Description
1 cc lactated ringers solution will be injected into the joint space
Primary Outcome Measure Information:
Title
Change in Pain Between Baseline and Month 1 Scores
Description
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.
Time Frame
Baseline (preoperation), Month 1
Secondary Outcome Measure Information:
Title
Change in Maximum Incisal Opening (MIO) Between Baseline, Month 1, and Month 3
Description
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.
Time Frame
Baseline (preoperation), Month 1, Month 3
Title
Jaw Function Limitation Scale (JFLS) Score
Description
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).
Time Frame
Month 1
Title
Jaw Function Limitation Scale (JFLS) Score
Description
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).
Time Frame
Month 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary F Bouloux, MD, DDS
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University California Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
University of Cinncinati
City
Cinncinati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Oregon Health Sciences University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27632069
Citation
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.
Results Reference
result
PubMed Identifier
27632067
Citation
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.
Results Reference
result

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

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