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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2016-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Temporomandibular Joint Dysfunction Pain Arthrocentesis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Hyaluronic acid

Group Type EXPERIMENTAL

Hyaluronic acid

Intervention Type DRUG

1 cc hyalgan to be injected into superior joint space

Corticosteroid

Group Type ACTIVE_COMPARATOR

Corticosteroid

Intervention Type DRUG

1cc celestone (6 mg/cc) will be injected into the joint space

Saline

Group Type PLACEBO_COMPARATOR

Lactated Ringers

Intervention Type DRUG

1 cc lactated ringers solution will be injected into the joint space

Interventions

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Hyaluronic acid

1 cc hyalgan to be injected into superior joint space

Intervention Type DRUG

Corticosteroid

1cc celestone (6 mg/cc) will be injected into the joint space

Intervention Type DRUG

Lactated Ringers

1 cc lactated ringers solution will be injected into the joint space

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No