Topical Treatment for TMJ Arthralgia

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

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.

Study Overview

• Status: Recruiting
• Conditions: TMJ Pain
• Intervention / Treatment: Drug: Hydrocortisone 2.5%; Drug: Diclofenac 1% topical

Detailed 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

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Andrew Young, DDS, MSD; Phone Number: 4153517126; Email: ayoung@pacific.edu

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94103
      • Recruiting
      • Arthur A. Dugoni School of Dentistry, University of the Pacific
      • Contact: Andrew Young, DDS, MSD; Phone Number: 415-929-6611; Email: ayoung@pacific.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of the Pacific

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: April 3, 2023
• First Submitted That Met QC Criteria: April 3, 2023
• First Posted (Actual): April 18, 2023

Study Record Updates

• Last Update Posted (Actual): October 13, 2023
• Last Update Submitted That Met QC Criteria: October 11, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: TMJ; hydrocortisone; diclofenac; arthralgia
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Diclofenac; Hydrocortisone
• Other Study ID Numbers: 2023 Young A 1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No