Topical Treatment for TMJ Arthralgia

Study Overview
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Brief Summary
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The goal of this clinical trial is to evaluate the efficacy of topical 2.5% hydrocortisone in TMJ arthralgia. The main questions it aims to answer are: How does pain reduction compare? How does improvement in jaw function limitation compare? How do side effects compare? Participants will On day 1 be examined and report their pain level and jaw function limitation On days 1-21, apply their cream four times a day On day 21, report their pain level, jaw function limitation, compliance with instructions, and side effects. Researchers will compare topical 2.5% hydrocortisone and topical 1% diclofenac to see if efficacy and side effects differ.

Detailed Description
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Person 2 will label creams, patient packets (pre-stamped envelope, questionnaire, consent form), and give packets to Person 1 in the order in which they are to be dispensed. Person 1 will recruit all eligible patients in the order in which they are seen, enrolling all that consent. Packets and gel will be given to patient, and written and verbal instructions, including that email will be sent saying Keep it up! to remind them to continue applying get, as well as Please send us your questionnaire. Consent forms will be stored in locked drawer. Person 1 will remind patient on days 7 and 14 to continue with the study Person 1 will remind patient on day 21 to mail back the completed questionnaire Person 1 will reach out to all patients from whom the questionnaire is not returned within 1 week of day 21, and do so at weekly intervals a minimum of 3 times. Person 1 will enter data in Excel as it comes, reaching out to patients if there are questions. Excel file uses random number ID, not patient name, thereby anonymizing the data Persons 1, 2, 3, and 4 will decide which patient's data, if any, should be removed Person 1 will send complete anonymized Excel data file (containing all patients) to Person 3 Person 2 will determine, using random number generator, which group will be referred to as Group A during the statistical analysis, and which will be referred to as Group B Person 2 will tell Dr. Korczeniewska which data will be in Group A, and which will be in Group B Person 3 will perform statistical analysis Person 2 will reveal which group was Hydrocortisone, and which was Diclofenac

Official Title
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Comparison of Topical 1% Diclofenac and Topical 2.5% Hydrocortisone for TMJ Arthralgia

Conditions
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TMJ Pain

Intervention / Treatment
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* Drug: Hydrocortisone 2.5%
* Drug: Diclofenac 1% topical


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Arthralgia of at least 1 TMJ for at least 3 days Exclusion Criteria: Systemic pain condition Past adverse reaction to steroid Currently taking steroid Taken steroid in the past ___ months Muscle relaxants (may start after study is complete) New night guard during study, or within 1 month of start of study (may start after study is complete)

Ages Eligible for Study
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Minimum Age: 18 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hydrocortisone topical<br>2.5% hydrocortisone cream | Drug: Hydrocortisone 2.5%<br>* Applied four times daily to TMJ with arthralgia<br>|
| Active Comparator: Diclofenac topical<br>1% diclofenac cream | Drug: Diclofenac 1% topical<br>* Applied four times daily to TMJ with arthralgia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain intensity | Using Visual Analog Scale, Range 0 - 10 cm, with 0 cm = no pain, and 10 cm = extreme pain | Pain measured on days 1 and 21 | 
| Change in jaw function limitation | Using jaw function limitation scale, Range 0-10 for each of the 8 parameters, with 0 = no limitation, and 10 = severe limitation | Jaw function limitation measured on days 1 and 21 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with side effects | Write-in side effects, select intensity (mild, moderate, severe), write in length of each occurrence, and % of times it occurred with cream application | Reported on day 21 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diclofenac, hydrocortisone, TMJ, arthralgia