Phase 4
Completed N=102
A Double Blind Study Comparing Hyaluronic Acid, Corticosteroid and Placebo During Arthrocentesis for Temporomandibular Joint (TMJ) Dysfunction
Temporomandibular Joint Dysfunction · Postoperative Pain · Arthrocentesis
Source: ClinicalTrials.gov NCT01524913 ↗
Enrolled (actual)
102
Serious AEs
0.0%
Results posted
May 2017
Primary outcomePrimary: Change in Pain Between Baseline and Month 1 Scores — -1.1; -1.7; -2.6; -2.0 units on a scale
◆ Published Evidence
Established
71citations · ~8 / year
Is Hyaluronic Acid or Corticosteroid Superior to Lactated Ringer Solution in the Short-Term Reduction of Temporomandibular Joint Pain After Arthrocentesis? Part 1.
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.
Linked Publications (2)
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Is Hyaluronic Acid or Corticosteroid Superior to Lactated Ringer Solution in the Short-Term Reduction of Temporomandibular Joint Pain After Arthrocentesis? Part 1.
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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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Pain Between Baseline and Month 1 Scores |
-1.1; -1.7; -2.6; -2.0; -2.1; -2.3 | — |
| SECONDARY Change in Maximum Incisal Opening (MIO) Between Baseline, Month 1, and Month 3 |
28.3; 27.9; 25.7; 37.0; 33.9; 34.1 | — |
| SECONDARY Jaw Function Limitation Scale (JFLS) Score |
5; 5; 6; 8; 7; 5 | — |
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
Data sourced from ClinicalTrials.gov (NCT01524913) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.