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

Emory University

Status and phase: Completed; Phase 4

Conditions: Temporomandibular Joint Dysfunction; Arthrocentesis; Pain

Treatments: Drug: Hyaluronic acid; Drug: Lactated Ringers; Drug: Corticosteroid

Study type: Interventional

Funder types: Other

Identifiers

NCT01524913

IRB00018682

Arthrocentesis (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 102 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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102 participants in 3 patient groups, including a placebo group

Hyaluronic acid

Experimental group

Treatment:

Drug: Hyaluronic acid

Corticosteroid

Active Comparator group

Treatment:

Drug: Corticosteroid

Saline

Placebo Comparator group

Treatment:

Drug: Lactated Ringers