Clinical trial NCT01524913: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Temporomandibular Joint Dysfunction
Pain
Arthrocentesis
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: University of California, Los Angeles
name: Oregon Health and Science University
name: University of Minnesota
name: University of Cincinnati
name: University of Pennsylvania
First posted: 2012-02-02
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Pain Between Baseline and Month 1 Scores
timeFrame: Baseline (preoperation), Month 1
Secondary outcomes:
measure: Change in Maximum Incisal Opening (MIO) Between Baseline, Month 1, and Month 3
timeFrame: Baseline (preoperation), Month 1, Month 3
measure: Jaw Function Limitation Scale (JFLS) Score
timeFrame: Month 1
measure: Jaw Function Limitation Scale (JFLS) Score
timeFrame: Month 3
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University California Los Angeles
state: California
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Cinncinati
country: United States
facility: University of Cinncinati
state: Ohio
city: Portland
country: United States
facility: Oregon Health Sciences University
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Emory University
name: Gary F Bouloux, MD, DDS
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.