Efficacy of Steroid Supplementation After TMJ Rinsing for Pain Management

Phase 2

Completed

Conditions: Pain

Interventions: Drug: Triamcinolone hexacetonide
Drug: Lactated Ringers

Registration Number: NCT01770912

Lead Sponsor: University of Florida

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 24

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Triamcinolone acetonide	Triamcinolone hexacetonide	1 cc of triamcinolone acetonide (20 mg) injected once after the TMJ rinsing procedure.
Lactated Ringers	Lactated Ringers	1 cc of Lactated Ringers solution injected once after the TMJ rinsing procedure.

Primary Outcome Measures

Name	Time	Method
Change From Pre-Treatment in TMJ Loading Pain Rating at 12 Weeks	Baseline and 12 weeks post-treatment	TMJ loading pain is evaluated using ordinal scale ratings of 0-3 (none, mild, moderate, severe pain intensity).

Secondary Outcome Measures

Name	Time	Method
Change From Pre-Treatment in Mandibular Range of Pain-Free Motion at 12 Weeks	Baseline and 12 weeks post-treatment	Mandibular range of motion is measured in millimeters (mm) of vertical opening between the upper and lower central incisors plus vertical overlap of the incisors. These measures are made for jaw unassisted opening without pain, maximum unassisted opening and maximum assisted opening. Horizontal mandibular range of motion is measured in millimeters (mm) assessed for maximal right and left mandibular lateral movements and mandibular protrusion. A positive value represents an improvement (or larger range of motion) in mandibular opening/lateral movement.
Number of Participants With Change From Pre-Treatment Joint Sounds in 6 Weeks	Baseline and 6 weeks post-treatment	Opening and closing sounds (click, course crepitus, fine crepitus) detected by palpation on left, right or both sides of face.
Change From Pre-Treatment in TMJ Loading Pain Rating at 2 Weeks	Baseline and 2 weeks post-treatment	TMJ loading pain is evaluated using ordinal scale ratings of 0-3 (none, mild, moderate, severe pain intensity).
Change From Pre-Treatment Palpable Muscle Tenderness at 12 Weeks	Baseline and 12 weeks post-treatment	Palpable muscle tenderness of masticatory muscles using ordinal ratings of 0-3 (none, mild, moderate, severe pain to palpation) are summed. A standardized muscle palpation pressure is used at specific locations on each side of the face for a total of 20 locations. The range of possible scores is 0-60. The rating of each muscle palpation site is added for a composite muscle tenderness score.
Number of Participants With Change From Pre-Treatment Joint Sounds in 12 Weeks	Baseline and 12 weeks post-treatment	Opening and closing sounds (click, course crepitus, fine crepitus) detected by palpation on left, right or both sides of face.
Change From Pre-Treatment in TMJ Loading Pain Rating at 6 Weeks	Baseline and 6 weeks post-treatment	TMJ loading pain is evaluated using ordinal scale ratings of 0-3 (none, mild, moderate, severe pain intensity).
Change From Pre-Treatment in Mandibular Range of Motion at 6 Weeks	Baseline and 6 weeks post-treatment	Mandibular range of motion is measured in millimeters (mm) of vertical opening between the upper and lower central incisors plus vertical overlap of the incisors. These measures are made for jaw unassisted opening without pain, maximum unassisted opening and maximum assisted opening. Horizontal mandibular range of motion is measured in millimeters (mm) assessed for maximal right and left mandibular lateral movements and mandibular protrusion. A positive value represents an improvement (or larger range of motion) in mandibular opening/lateral movement.
Change From Pre-Treatment Palpable Muscle Tenderness at 2 Weeks	Baseline and 2 weeks post-treatment	Palpable muscle tenderness of masticatory muscles using ordinal ratings of 0-3 (none, mild, moderate, severe pain to palpation) are summed. A standardized muscle palpation pressure is used at specific locations on each side of the face for a total of 20 locations. The range of possible scores is 0-60. The rating of each muscle palpation site is added for a composite muscle tenderness score.
Number of Participants With Change From Pre-Treatment Joint Sounds in 2 Weeks	Baseline and 2 weeks post-treatment	Opening and closing sounds (click, course crepitus, fine crepitus) detected by palpation on left, right or both sides of face.
Change From Pre-Treatment Functional Pain (Chewing) at 2 Weeks	Baseline and 2 weeks post-treatment	Pain is assessed for average chewing pain intensity using a 100 mm visual analog scale with 0 representing "no pain" and 100 representing "the most intense chewing pain imaginable".
Change From Pre-Treatment in Mandibular Range of Motion Without Pain at 2 Weeks	Baseline and 2 weeks post-treatment	Mandibular range of motion is measured in millimeters (mm) of vertical opening between the upper and lower central incisors plus vertical overlap of the incisors. These measures are made for jaw unassisted opening without pain, maximum unassisted opening and maximum assisted opening. Horizontal mandibular range of motion is measured in millimeters (mm) assessed for maximal right and left mandibular lateral movements and mandibular protrusion. A positive value represents an improvement (or larger range of motion) in mandibular opening/lateral movement.
Change From Pre-Treatment Palpable Muscle Tenderness at 6 Weeks	Baseline and 6 weeks post-treatment	Palpable muscle tenderness of masticatory muscles using ordinal ratings of 0-3 (none, mild, moderate, severe pain to palpation) are summed. A standardized muscle palpation pressure is used at specific locations on each side of the face for a total of 20 locations. The range of possible scores is 0-60. The rating of each muscle palpation site is added for a composite muscle tenderness score.
Change From Pre-Treatment Functional Pain (Chewing) at 12 Weeks	Baseline and 12 weeks post-treatment	Pain is assessed for average chewing pain intensity using a 100 mm visual analog scale with 0 representing "no pain" and 100 representing "the most intense chewing pain imaginable".
Change From Pre-Treatment Functional Pain (Chewing) at 6 Weeks	Baseline and 6 weeks post-treatment	Pain is assessed for average chewing pain intensity using a 100 mm visual analog scale with 0 representing "no pain" and 100 representing "the most intense chewing pain imaginable".