Topical Treatment for TMJ Arthralgia

TMJ Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05816226
• Other study ID #: 2023 Young A 1
• Status: Recruiting
• Phase: Phase 3
• Start date: June 1, 2023
• Est. completion date: April 2025

Study information

• Verified date: October 2023
• Source: University of the Pacific
• Contact: Andrew Young, DDS, MSD
• Phone: 4153517126
• Email: ayoung[@]pacific.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Arthralgia
• TMJ Pain

Intervention

Drug:
• Hydrocortisone 2.5%
Applied four times daily to TMJ with arthralgia
• Diclofenac 1% topical
Applied four times daily to TMJ with arthralgia

Locations

Country	Name	City	State
United States	Arthur A. Dugoni School of Dentistry, University of the Pacific	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of the Pacific

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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