Topical Treatment for TMJ Arthralgia

Sponsor

University of the Pacific (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05816226

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
TMJ Pain	Drug: Hydrocortisone 2.5% Drug: Diclofenac 1% topical	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

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

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Apr 1, 2025

Anticipated Study Completion Date :

Apr 1, 2025

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Pain reduction [Pain measured on days 1 and 21]
Using Visual analog scale
Improvement in jaw function limitation [Jaw function limitation measured on days 1 and 21]
Using jaw function limitation scale

Secondary Outcome Measures

Side effects [Reported on day 21]
Side effects

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of the Pacific

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Andrew Young, Assistant Professor, Department of Diagnostic Sciences, University of the Pacific

ClinicalTrials.gov Identifier:

NCT05816226

Other Study ID Numbers:

2023 Young A 1

First Posted:

Apr 18, 2023

Last Update Posted:

Apr 18, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Andrew Young, Assistant Professor, Department of Diagnostic Sciences, University of the Pacific

diclofenac, hydrocortisone, TMJ, arthralgia

Additional relevant MeSH terms:

Arthralgia

Hydrocortisone

Diclofenac

Study Results

No Results Posted as of Apr 18, 2023