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NCT Number: NCT05816226

Topical Treatment 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.

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Key information

Conditions

TMJ Pain Arthralgia Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

San Francisco, California, 94103, United States

Location status: Recruiting

Location contact

Andrew Young, DDS, MSD

CONTACT

[email protected]

4159296611

About this study

  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Hydrocortisone 2.5%

Drug

Applied four times daily to TMJ with arthralgia

Diclofenac 1% topical

Drug

Applied four times daily to TMJ with arthralgia

Primary outcomes

  1. Change in pain intensity

    Time frame: Pain measured on days 1 and 21

    Using Visual Analog Scale, Range 0 - 10 cm, with 0 cm = no pain, and 10 cm = extreme pain

  2. Change in jaw function limitation

    Time frame: Jaw function limitation measured on days 1 and 21

    Using jaw function limitation scale, Range 0-10 for each of the 8 parameters, with 0 = no limitation, and 10 = severe limitation

Secondary outcomes

  1. Number of participants with side effects

    Time frame: Reported on day 21

    Write-in side effects, select intensity (mild, moderate, severe), write in length of each occurrence, and % of times it occurred with cream application

Study contacts

Contact information is provided by the study sponsor or research team.

Andrew Young, DDS, MSD

CONTACT

[email protected]

4153517126

Sponsors and collaborators

Lead sponsor

University of the Pacific

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Apr 18, 2023
Registry last updated
Dec 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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