NCT05816226

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2023

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 3, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 18, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

December 11, 2024

Status Verified

December 1, 2024

Enrollment Period

2.6 years

First QC Date

April 3, 2023

Last Update Submit

December 5, 2024

Conditions

TMJ Pain

Keywords

diclofenachydrocortisoneTMJarthralgia

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Number of participants with side effects

    Reported on day 21

Study Arms (2)

Hydrocortisone topical

EXPERIMENTAL

2.5% hydrocortisone cream

Drug: Hydrocortisone 2.5%

Diclofenac topical

ACTIVE COMPARATOR

1% diclofenac cream

Drug: Diclofenac 1% topical

Interventions

Hydrocortisone 2.5%DRUG

Applied four times daily to TMJ with arthralgia

Hydrocortisone topical
Diclofenac 1% topicalDRUG

Applied four times daily to TMJ with arthralgia

Diclofenac topical

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Arthralgia of at least 1 TMJ for at least 3 days

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arthur A. Dugoni School of Dentistry, University of the Pacific

San Francisco, California, 94103, United States

RECRUITING

Related 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.

    PMID: 32086778BACKGROUND

  • 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.

    PMID: 31353997BACKGROUND

  • 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.

    PMID: 16331769BACKGROUND

MeSH Terms

Conditions

Arthralgia

Interventions

Diclofenac

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Central Study Contacts

Andrew Young, DDS, MSD

CONTACT

4153517126ayoung@pacific.edu

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Department of Diagnostic Sciences

Study Record Dates

First Submitted

April 3, 2023

First Posted

April 18, 2023

Study Start

June 1, 2023

Primary Completion

January 1, 2026

Study Completion

April 1, 2026

Last Updated

December 11, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)