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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Double Blind Randomised Study Comparing Hyaluronic Acid, Corticosteroid and Placebo During Arthrocentesis for Temporomandibular Joint Dysfunction

Conditions
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Temporomandibular Joint Dysfunction, Pain, Arthrocentesis

Intervention / Treatment
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* Drug: Hyaluronic acid
* Drug: Corticosteroid
* Drug: Lactated Ringers


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

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 |
| --- | --- |
| Experimental: Hyaluronic acid<br> | Drug: Hyaluronic acid<br>* 1 cc hyalgan to be injected into superior joint space<br>|
| Active Comparator: Corticosteroid<br> | Drug: Corticosteroid<br>* 1cc celestone (6 mg/cc) will be injected into the joint space<br>|
| Placebo Comparator: Saline<br> | Drug: Lactated Ringers<br>* 1 cc lactated ringers solution will be injected into the joint space<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain Between Baseline and Month 1 Scores | The change in pain level was assessed using a single-item visual analogue pain scale at Baseline (preoperatively) and at Month 1. Participants indicate their level on pain on a scale of 0 (no pain) to 10 (worst pain imaginable). The right and left side of each participant's jaw was evaluated separately. The change in pain score was obtained by subtracting the Month 1 score from the Baseline score and a negative value indicates a reduction in pain level. | Baseline (preoperation), Month 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Maximum Incisal Opening (MIO) Between Baseline, Month 1, and Month 3 | Range of motion was assessed at Baseline (preoperatively) and again at Months 1 and 3 using a millimeter ruler for maximum incisal opening. MIO was measurements were taken for maximum opening without and with pain. | Baseline (preoperation), Month 1, Month 3 | 
| Jaw Function Limitation Scale (JFLS) Score | The Jaw Function Limitation Scale (JFLS) is an 8 item survey where respondents indicate the presence or absence of problems with chewing, drinking, eating hard food, eating soft food, smiling or laughing, yawning, swallowing, and talking. Responses of no are scored as 0 and responses of yes are scored as 1. The total score categorizes jaw limitation as: none (0), mild (1-3), moderate (4-6), and severe (7-8). | Month 1 | 
| Jaw Function Limitation Scale (JFLS) Score | The Jaw Function Limitation Scale (JFLS) is an 8 item survey where respondents indicate the presence or absence of problems with chewing, drinking, eating hard food, eating soft food, smiling or laughing, yawning, swallowing, and talking. Responses of no are scored as 0 and responses of yes are scored as 1. The total score categorizes jaw limitation as: none (0), mild (1-3), moderate (4-6), and severe (7-8). | Month 3 |