Topical Treatment for TMJ Arthralgia
Primary Purpose
TMJ Pain
Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Hydrocortisone 2.5%
Diclofenac 1% topical
Sponsored by
About this trial
This is an interventional treatment trial for TMJ Pain focused on measuring diclofenac, hydrocortisone, TMJ, arthralgia
Eligibility Criteria
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)
Sites / Locations
- Arthur A. Dugoni School of Dentistry, University of the PacificRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Hydrocortisone topical
Diclofenac topical
Arm Description
2.5% hydrocortisone cream
1% diclofenac cream
Outcomes
Primary Outcome Measures
Change in pain intensity
Using Visual Analog Scale, Range 0 - 10 cm, with 0 cm = no pain, and 10 cm = extreme pain
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
Secondary Outcome Measures
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
Full Information
NCT ID
NCT05816226
First Posted
April 3, 2023
Last Updated
October 11, 2023
Sponsor
University of the Pacific
1. Study Identification
Unique Protocol Identification Number
NCT05816226
Brief Title
Topical Treatment for TMJ Arthralgia
Official Title
Comparison of Topical 1% Diclofenac and Topical 2.5% Hydrocortisone for TMJ Arthralgia
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
April 2025 (Anticipated)
Study Completion Date
April 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of the Pacific
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
TMJ Pain
Keywords
diclofenac, hydrocortisone, TMJ, arthralgia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes 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
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hydrocortisone topical
Arm Type
Experimental
Arm Description
2.5% hydrocortisone cream
Arm Title
Diclofenac topical
Arm Type
Active Comparator
Arm Description
1% diclofenac cream
Intervention Type
Drug
Intervention Name(s)
Hydrocortisone 2.5%
Intervention Description
Applied four times daily to TMJ with arthralgia
Intervention Type
Drug
Intervention Name(s)
Diclofenac 1% topical
Intervention Description
Applied four times daily to TMJ with arthralgia
Primary Outcome Measure Information:
Title
Change in pain intensity
Description
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
Title
Change in jaw function limitation
Description
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 Outcome Measure Information:
Title
Number of participants with side effects
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrew Young, DDS, MSD
Phone
4153517126
Email
ayoung@pacific.edu
Facility Information:
Facility Name
Arthur A. Dugoni School of Dentistry, University of the Pacific
City
San Francisco
State/Province
California
ZIP/Postal Code
94103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew Young, DDS, MSD
Phone
415-929-6611
Email
ayoung@pacific.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32086778
Citation
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.
Results Reference
result
PubMed Identifier
31353997
Citation
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.
Results Reference
result
PubMed Identifier
16331769
Citation
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.
Results Reference
result
Learn more about this trial
Topical Treatment for TMJ Arthralgia
We'll reach out to this number within 24 hrs