Topical Treatment for TMJ Arthralgia

Phase

Condition

Muscle Pain

Arthritis And Arthritic Pain

Treatment

Diclofenac 1% topical

Hydrocortisone 2.5%

Clinical Study ID

NCT05816226

2023 Young A 1

Ages > 18
All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Arthralgia of at least 1 TMJ for at least 3 days

Exclusion

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 afterstudy is complete)

Study Design

Diclofenac 1% topical

June 01, 2023

April 30, 2026

Study Description

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

Connect with a study center

Arthur A. Dugoni School of Dentistry, University of the Pacific
San Francisco, California 94103
United States
Active - Recruiting

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