TMJ PainPhase 3NCT05816226
Topical Treatment for TMJ Arthralgia
A Phase 3 study testing Hydrocortisone 2.5% and Diclofenac 1% topical in people with TMJ Pain, run by University of the Pacific at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- TMJ Pain
- What is being tested?
- Hydrocortisone 2.5% and Diclofenac 1% topical
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2023to Apr 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Arthralgia of at least 1 TMJ for at least 3 days
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Arthur A. Dugoni School of Dentistry, University of the Pacific
San Francisco, California, 94103
Andrew Young, DDS, MSD, 4159296611, ayoung@pacific.edu
About this study
Official title: Comparison of Topical 1% Diclofenac and Topical 2.5% Hydrocortisone 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.
Read the 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
- Conditions
- TMJ Pain
- Being tested
- Hydrocortisone 2.5%, Diclofenac 1% topical
- Keywords
- diclofenac, hydrocortisone, TMJ, arthralgia
- Medical subject headings
- Arthralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrocortisone 2.5%Drug
Applied four times daily to TMJ with arthralgia
Diclofenac 1% topicalDrug
Applied four times daily to TMJ with arthralgia
| Study group | Role | What they receive |
|---|---|---|
| Hydrocortisone topical | Experimental | 2.5% hydrocortisone cream Receives: Drug: Hydrocortisone 2.5% |
| Diclofenac topical | Active comparator | 1% diclofenac cream Receives: Drug: Diclofenac 1% topical |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain intensity
Using Visual Analog Scale, Range 0 - 10 cm, with 0 cm = no pain, and 10 cm = extreme pain
Measured: 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
Measured: 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
Measured: Reported on day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start1 Jun 2023
- Primary completionJan 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for TMJ PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of the Pacific
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Young, University of the Pacific
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05816226
- Sponsor's protocol ID
- 2023 Young A 1
- Status last verified
- Dec 2024
- First submitted
- 3 Apr 2023
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32086778Wade 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.
PubMed 31353997Niethard 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.
PubMed 16331769
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Topical 1% Diclofenac and Topical 2.5% Hydrocortisone for TMJ Arthralgia
- ClinicalTrials.gov ID
- NCT05816226
- Acronym / sponsor ID
- 2023 Young A 1
- Conditions
- TMJ Pain
- Keywords
- diclofenac, hydrocortisone, TMJ, arthralgia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of the PacificUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 18 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydrocortisone topical | Experimental | Drug: Hydrocortisone 2.5%2.5% hydrocortisone cream |
| Diclofenac topical | Active comparator | Drug: Diclofenac 1% topical1% diclofenac cream |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Arthralgia of at least 1 TMJ for at least 3 days
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydrocortisone 2.5%Applied four times daily to TMJ with arthralgia | Drug | Hydrocortisone topical |
| Diclofenac 1% topicalApplied four times daily to TMJ with arthralgia | Drug | Diclofenac topical |
Primary outcome
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
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
1 secondary outcome
Number of participants with side effects
Time frame: Reported on day 21
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
- Results publication: PubMed 32086778Bariguian 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 publication: PubMed 31353997Wade 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 publication: PubMed 16331769Niethard 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hydrocortisone 2.5% and Diclofenac 1% topical in people with TMJ Pain, run by University of the Pacific at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrew Young, DDS, MSD (4153517126, ayoung@pacific.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain intensity (time frame: Pain measured on days 1 and 21). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05816226, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2024.