Efficacy of Steroid Supplementation After TMJ Rinsing for Pain Management

NCT ID: NCT01770912

Last Updated: 2020-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2019-01-24

Brief Summary

The hypothesis to be tested is temporomandibular joint (TMJ) rinsing followed by steroid injection is more efficacious than a placebo injection based on standard pain and physical measures that are recorded before and after treatment.

All procedures will be the same as if following normal TMJ arthrocentesis (rinsing) clinical care except that the patient will be randomly assigned to one of two groups: (1) TMJ rinsing followed by the injection of 1 cc (about ¼ of a teaspoon) of the same rinsing solution (this is the placebo) into the jaw joint; or (2) TMJ rinsing followed by the injection of 1 cc (about ¼ teaspoon) of a steroid (5 mg of triamcinolone hexacetonide) into the jaw joint. A pregnancy test (urine test) will be conducted on all women of child-bearing age to verify that the patient is not pregnant before the rinsing procedure. The patient will fill out a short questionnaire and have a short exam of the TMJ and jaw muscles at each appointment.

Detailed Description

Temporomandibular joint disorders are common and poorly understood in terms of etiology and pathogenesis. These disorders are multifactorial in origin including physical and psychosocial aspects; however, there is little understanding as to how much each of these components are associated with a particular diagnosis and subsequent treatment outcome of temporomandibular joint disorders. There is also a paucity of information regarding the relative effectiveness of different therapies for the treatment of patients with temporomandibular joint disorders. The identification of the least invasive and most efficacious therapy is vital to proper management of these patients with temporomandibular joint pain.

Patients enrolled into the study will be examined and treated at the Department of Oral and Maxillofacial Surgery. At the first appointment, they will be examined following standard procedures to determine if they would potentially benefit from the TMJ arthrocentesis procedure. If the patient meets the inclusion criteria for the study and with their informed consent, they will be required to complete a questionnaire about their physical and pain symptoms and undergo a standardized clinical exam. At the next appointment, the patients will undergo the standard clinical protocol for TMJ arthrocentesis with either only normal saline or normal saline with adjunctive steroids (triamcinolone hexacetonide). Follow-up appointments will be at 2 weeks, 6 weeks and 12 weeks where the pain VAS and clinical exams will be completed.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Lactated Ringers

1 cc of Lactated Ringers solution injected once after the TMJ rinsing procedure.

Group Type: PLACEBO_COMPARATOR

Lactated Ringers

Intervention Type: DRUG

Solution used for TMJ arthrocentesis procedure. 1 cc of Lactated Ringers solution injected once after the TMJ rinsing procedure.

Triamcinolone acetonide

1 cc of triamcinolone acetonide (20 mg) injected once after the TMJ rinsing procedure.

Group Type: ACTIVE_COMPARATOR

Triamcinolone hexacetonide

Intervention Type: DRUG

1 cc of triamcinolone hexacetonide (5 mg) injected once after the TMJ rinsing procedure.

Interventions

Lactated Ringers

Solution used for TMJ arthrocentesis procedure. 1 cc of Lactated Ringers solution injected once after the TMJ rinsing procedure.

Intervention Type: DRUG

Triamcinolone hexacetonide

1 cc of triamcinolone hexacetonide (5 mg) injected once after the TMJ rinsing procedure.

Intervention Type: DRUG

Other Intervention Names

Aristospan; steroid

Eligibility Criteria

Inclusion Criteria

• Female
• 18-80 years of age
• TMJ arthralgia
• Masticatory myalgia
• TMJ sounds
• History of at least 6 weeks use of occlusal appliance therapy

Exclusion Criteria

• Contraindication to sedation including pregnancy or medical history
• History of previous TMJ procedure including arthrocentesis, arthroscopy or arthrotomy
• History of steroidal injection into TMJ
• History of trauma to TMJ
• TMJ pain longer than 3 years
• History of narcotic drug use on a scheduled basis
• Current active infection

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Charles G. Widmer, DDS, MS

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

University of Florida College of Dentistry

Gainesville, Florida, United States

Countries

United States

References

Dworkin SF, LeResche L. Research diagnostic criteria for temporomandibular disorders: review, criteria, examinations and specifications, critique. J Craniomandib Disord. 1992 Fall;6(4):301-55. No abstract available.

Reference Type: BACKGROUND

PMID: 1298767 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IRB201600060

Identifier Type: -

Identifier Source: org_study_id