Efficacy of Steroid Supplementation After TMJ Rinsing for Pain Management

NCT01770912 | Completed Phase 2 Results

• 1 other identifier: IRB201600060
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

facial pain; temporomandibular joint; arthrocentesis; steroid

Outcome Measures

Primary Outcomes (1)

• Change From Pre-Treatment in TMJ Loading Pain Rating at 12 Weeks

  TMJ loading pain is evaluated using ordinal scale ratings of 0-3 (none, mild, moderate, severe pain intensity).

  Baseline and 12 weeks post-treatment

Secondary Outcomes (14)

• Change From Pre-Treatment in TMJ Loading Pain Rating at 2 Weeks

  Baseline and 2 weeks post-treatment

• Change From Pre-Treatment in TMJ Loading Pain Rating at 6 Weeks

  Baseline and 6 weeks post-treatment

• Change From Pre-Treatment in Mandibular Range of Motion Without Pain at 2 Weeks

  Baseline and 2 weeks post-treatment

• Change From Pre-Treatment in Mandibular Range of Motion at 6 Weeks

  Baseline and 6 weeks post-treatment

• Change From Pre-Treatment in Mandibular Range of Pain-Free Motion at 12 Weeks

  Baseline and 12 weeks post-treatment

Study Arms (2)

Lactated Ringers

PLACEBO COMPARATOR

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

Drug: Lactated Ringers

Triamcinolone acetonide

ACTIVE COMPARATOR

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

Drug: Triamcinolone hexacetonide

Interventions

Lactated Ringers DRUG

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

Lactated Ringers

Triamcinolone hexacetonide DRUG

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

Also known as: Aristospan, steroid

Triamcinolone acetonide

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida College of Dentistry

Gainesville, Florida, 32610, United States

Location

Related Publications (1)

• 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.

  PMID: 1298767 BACKGROUND

MeSH Terms

Conditions

Pain; Facial Pain

Interventions

Ringer's Lactate; triamcinolone hexacetonide; Steroids

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Charles G. Widmer, Associate Professor
• Organization: University of Florida

widmer@dental.ufl.edu

352-273-5696

Study Officials

• Charles G. Widmer, DDS, MS

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2013
• First Posted: January 18, 2013
• Study Start: March 1, 2013
• Primary Completion: January 24, 2019
• Study Completion: January 24, 2019
• Last Updated: October 8, 2020
• Results First Posted: October 8, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)