Efficacy of Steroid Supplementation After TMJ Rinsing for Pain Management

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized, Double-Blind Study of the Efficacy of Steroid Supplementation After Temporomandibular Joint Arthrocentesis

Conditions
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Pain

Intervention / Treatment
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* Drug: Lactated Ringers
* Drug: Triamcinolone hexacetonide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Lactated Ringers<br>1 cc of Lactated Ringers solution injected once after the TMJ rinsing procedure. | Drug: Lactated Ringers<br>* Solution used for TMJ arthrocentesis procedure. 1 cc of Lactated Ringers solution injected once after the TMJ rinsing procedure.<br>|
| Active Comparator: Triamcinolone acetonide<br>1 cc of triamcinolone acetonide (20 mg) injected once after the TMJ rinsing procedure. | Drug: Triamcinolone hexacetonide<br>* 1 cc of triamcinolone hexacetonide (5 mg) injected once after the TMJ rinsing procedure.<br>* Other names: steroid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Pre-Treatment in TMJ Loading Pain Rating at 2 Weeks | TMJ loading pain is evaluated using ordinal scale ratings of 0-3 (none, mild, moderate, severe pain intensity). | Baseline and 2 weeks post-treatment | 
| Change From Pre-Treatment in TMJ Loading Pain Rating at 6 Weeks | TMJ loading pain is evaluated using ordinal scale ratings of 0-3 (none, mild, moderate, severe pain intensity). | Baseline and 6 weeks post-treatment | 
| Change From Pre-Treatment in Mandibular Range of Motion Without Pain at 2 Weeks | 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. | Baseline and 2 weeks post-treatment | 
| Change From Pre-Treatment in Mandibular Range of Motion at 6 Weeks | 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. | Baseline and 6 weeks post-treatment | 
| Change From Pre-Treatment in Mandibular Range of Pain-Free Motion at 12 Weeks | 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. | Baseline and 12 weeks post-treatment | 
| Change From Pre-Treatment Palpable Muscle Tenderness at 2 Weeks | 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. | Baseline and 2 weeks post-treatment | 
| Change From Pre-Treatment Palpable Muscle Tenderness at 6 Weeks | 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. | Baseline and 6 weeks post-treatment | 
| Change From Pre-Treatment Palpable Muscle Tenderness at 12 Weeks | 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. | Baseline and 12 weeks post-treatment | 
| Number of Participants With Change From Pre-Treatment Joint Sounds in 2 Weeks | Opening and closing sounds (click, course crepitus, fine crepitus) detected by palpation on left, right or both sides of face. | Baseline and 2 weeks post-treatment | 
| Number of Participants With Change From Pre-Treatment Joint Sounds in 6 Weeks | Opening and closing sounds (click, course crepitus, fine crepitus) detected by palpation on left, right or both sides of face. | Baseline and 6 weeks post-treatment | 
| Number of Participants With Change From Pre-Treatment Joint Sounds in 12 Weeks | Opening and closing sounds (click, course crepitus, fine crepitus) detected by palpation on left, right or both sides of face. | Baseline and 12 weeks post-treatment | 
| Change From Pre-Treatment Functional Pain (Chewing) at 2 Weeks | 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. | Baseline and 2 weeks post-treatment | 
| Change From Pre-Treatment Functional Pain (Chewing) at 6 Weeks | 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. | Baseline and 6 weeks post-treatment | 
| Change From Pre-Treatment Functional Pain (Chewing) at 12 Weeks | 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. | Baseline and 12 weeks post-treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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facial pain, temporomandibular joint, arthrocentesis, steroid