Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
90 participants
INTERVENTIONAL
2023-06-01
2026-04-30
Brief Summary
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* 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 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
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Statistical analysis done by person not aware of the treatment received by each group
Study Groups
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Hydrocortisone topical
2.5% hydrocortisone cream
Hydrocortisone 2.5%
Applied four times daily to TMJ with arthralgia
Diclofenac topical
1% diclofenac cream
Diclofenac 1% topical
Applied four times daily to TMJ with arthralgia
Interventions
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Hydrocortisone 2.5%
Applied four times daily to TMJ with arthralgia
Diclofenac 1% topical
Applied four times daily to TMJ with arthralgia
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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)
18 Years
ALL
No
Sponsors
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University of the Pacific
OTHER
Responsible Party
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Andrew Young
Assistant Professor, Department of Diagnostic Sciences
Locations
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Arthur A. Dugoni School of Dentistry, University of the Pacific
San Francisco, California, United States
Countries
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Central Contacts
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Facility Contacts
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Andrew Young, DDS, MSD
Role: primary
References
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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.
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.
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.
Other Identifiers
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2023 Young A 1
Identifier Type: -
Identifier Source: org_study_id