Topical Diclofenac, an Efficacious Treatment for Osteoarthritis: A Narrative Review.
Frédérique Bariguian Revel, Marina Fayet, Martina Hagen
https://pubmed.ncbi.nlm.nih.gov/32086778Actively Recruiting
Phase 3
Age: 18Years +
All Genders
ID05816226
Comparison of Topical 1% Diclofenac and Topical 2.5% Hydrocortisone for TMJ Arthralgia
Led by University of the Pacific · Updated on 2024-12-11
90
Participants Needed
1
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of topical 2.5% hydrocortisone compared to topical 1% diclofenac in treating temporomandibular joint (TMJ) arthralgia, which is pain in the jaw joint. The study aims to answer how these treatments compare in reducing pain, improving jaw function, and causing side effects. This is a randomized, phase 3 clinical trial sponsored by the University of the Pacific. Participants will apply either hydrocortisone 2.5% cream or diclofenac 1% cream to the affected TMJ area four times a day for 21 days. On the first day, participants will be examined, and their pain levels and jaw function limitations recorded. They will continue applying the cream for three weeks, with periodic reminders to maintain adherence. On day 21, participants will report their pain, jaw function, compliance, and any side effects experienced. During the study, researchers will collect data through questionnaires and monitor participant adherence with reminders by email and phone calls. Data will be anonymized and analyzed to compare the treatments' effects on pain intensity, jaw function limitation, and side effects. The main outcomes are pain and jaw function changes measured on days 1 and 21, with side effects reported on day 21. Participants are involved for a total of 21 days of treatment and follow-up.
CONDITIONS
Brief Title
Topical Treatment for TMJ Arthralgia
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Arthralgia of at least 1 temporomandibular joint for at least 3 days
- Age 18 years or older
You will not qualify if you...
- Systemic pain condition
- Past adverse reaction to steroids
- Currently taking steroids
- Taken steroids in the past months
- Currently using muscle relaxants
- New night guard during study or within 1 month before start
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 21 days
Participants apply either 2.5% hydrocortisone cream or 1% diclofenac cream four times daily to the affected temporomandibular joint for arthralgia.
1 baseline visit and 1 follow-up visit on day 21
Trial Site Locations
Total: 1 location
1
Arthur A. Dugoni School of Dentistry, University of the Pacific
San Francisco, California, United States, 94103
Actively Recruiting
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Research Team
A
Andrew Young, DDS, MSD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Fritz U Niethard, Morris S Gold, Gail S Solomon...
https://pubmed.ncbi.nlm.nih.gov/16331769