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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:
Researchers will compare topical 2.5% hydrocortisone and topical 1% diclofenac to see if efficacy and side effects differ.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hydrocortisone topical | Experimental | 2.5% hydrocortisone cream |
|
| Diclofenac topical | Active Comparator | 1% diclofenac cream |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydrocortisone 2.5% | Drug | Applied four times daily to TMJ with arthralgia |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrew Young, DDS, MSD | Contact | 4153517126 | ayoung@pacific.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arthur A. Dugoni School of Dentistry, University of the Pacific | Recruiting | San Francisco | California | 94103 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32086778 | Result | Bariguian Revel F, Fayet M, Hagen M. Topical Diclofenac, an Efficacious Treatment for Osteoarthritis: A Narrative Review. Rheumatol Ther. 2020 Jun;7(2):217-236. doi: 10.1007/s40744-020-00196-6. Epub 2020 Feb 21. | |
| 31353997 | Result | Wade AG, Crawford GM, Young D, Corson S, Brown C. Comparison of diclofenac gel, ibuprofen gel, and ibuprofen gel with levomenthol for the topical treatment of pain associated with musculoskeletal injuries. J Int Med Res. 2019 Sep;47(9):4454-4468. doi: 10.1177/0300060519859146. Epub 2019 Jul 29. |
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| ID | Term |
|---|---|
| D018771 | Arthralgia |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D004008 | Diclofenac |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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Cream containers labeled by randomly-generated numbers, by person not involved in analysis or patient interaction.
Statistical analysis done by person not aware of the treatment received by each group
| Diclofenac 1% topical |
| Drug |
Applied four times daily to TMJ with arthralgia |
|
| 16331769 | Result | Niethard FU, Gold MS, Solomon GS, Liu JM, Unkauf M, Albrecht HH, Elkik F. Efficacy of topical diclofenac diethylamine gel in osteoarthritis of the knee. J Rheumatol. 2005 Dec;32(12):2384-92. |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |