Health TrialsbyHealthPanel

Topical Treatment for TMJ Arthralgia

ConditionTMJ Pain
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of the Pacific

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Arthralgia of at least 1 TMJ for at least 3 days

Disqualifiers

Systemic pain condition

Past adverse reaction to steroid

Currently taking steroid

Taken steroid in the past ___ months

Trial design

Design model

Parallel

Treatments tested in this trial

  • Hydrocortisone 2.5%

    Drug

    Applied four times daily to TMJ with arthralgia

  • Diclofenac 1% topical

    Drug

    Applied four times daily to TMJ with arthralgia

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: Hydrocortisone topicalExperimental treatment 1 intervention
Group B: Diclofenac topicalActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in pain intensity

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

Time frame
Pain measured on days 1 and 21
2

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

Time frame
Jaw function limitation measured on days 1 and 21

Secondary outcomes

1

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

Time frame
Reported on day 21

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of the Pacific

Lead sponsor

Source ClinicalTrials.gov
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