Topical Creams for TMJ Pain

Overseen By Andrew Young, DDS, MSD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: University of the Pacific

Must not be taking: Steroids, Muscle relaxants

Disqualifiers: Systemic pain condition, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 3 weeks

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of two topical creams in relieving jaw joint pain (TMJ arthralgia). Participants will use either a 2.5% hydrocortisone cream (a corticosteroid) or a 1% diclofenac cream (a nonsteroidal anti-inflammatory drug) to determine which better reduces pain and improves jaw movement, while monitoring for side effects. The trial suits individuals who have experienced jaw pain for at least three days and are not currently using or have recently used steroids. As a Phase 3 trial, it represents the final step before FDA approval, allowing participants to contribute to the potential availability of a new treatment.

Will I have to stop taking my current medications?

The trial requires that you stop taking any steroids and muscle relaxants before participating. You can start muscle relaxants again after the study is complete.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study found that hydrocortisone 2.5% cream was generally well-tolerated when applied to the skin. It is commonly used for conditions like eczema and insect bites to relieve itching and swelling. Some individuals might notice minor side effects such as redness or irritation at the application site, but these are usually mild.

Research has shown that diclofenac 1% cream is also generally well-tolerated. It is often used to treat joint pain from arthritis. Some individuals might experience mild side effects like redness or dry skin at the application site.

Both treatments have been used safely for other conditions, so their safety is well-understood. However, it is important to remember that everyone's body reacts differently, and what works well for one person might not suit another. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for TMJ pain because they offer non-invasive, topical solutions compared to standard oral medications or injections. Diclofenac 1% cream targets inflammation directly at the site, potentially reducing side effects associated with oral NSAIDs. Hydrocortisone 2.5% cream provides a steroid-based approach, which can be effective in reducing inflammation and pain locally without systemic exposure. These creams provide a targeted, easy-to-apply option that could be more comfortable and accessible for patients seeking relief from TMJ pain.

What evidence suggests that this trial's treatments could be effective for TMJ pain?

This trial will compare two topical creams for TMJ pain. Research has shown that a 2.5% hydrocortisone cream, which participants in one arm of this trial may receive, can reduce pain and swelling in joints by calming the body's immune system, potentially easing jaw pain for those with TMJ arthralgia.

In another arm of this trial, participants may receive a 1% diclofenac cream. Studies have found that diclofenac, an NSAID, effectively reduces TMJ pain by lowering swelling and pain.

Both treatments have shown promise, with diclofenac often significantly reducing pain compared to placebos. This evidence suggests that both creams could be effective options for managing TMJ pain. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for individuals experiencing pain in at least one temporomandibular joint (TMJ) for a minimum of three days. It's not suitable for those with systemic pain conditions, past steroid reactions, current or recent steroid use, or those who've started using muscle relaxants or a new night guard around the study period.

Inclusion Criteria

I have had jaw joint pain for at least 3 days.

Exclusion Criteria

I have not started using a new night guard within the last month or during the study.

I have taken steroids in the past few months.

I am not currently taking muscle relaxants but can start after the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Treatment

Participants apply topical cream four times a day for 21 days

3 weeks

1 visit (in-person) on day 1, reminders on days 7, 14, and 21

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

Questionnaire follow-up

What Are the Treatments Tested in This Trial?

Interventions

• Diclofenac 1% topical
• Hydrocortisone 2.5%

Trial Overview The trial tests the effectiveness of two topical treatments: hydrocortisone (2.5%) and diclofenac (1%) on TMJ arthralgia. Participants will apply their assigned cream four times daily over three weeks to compare pain reduction, jaw function improvement, and side effects.

How Is the Trial Designed?

Group I: Hydrocortisone topical Experimental Treatment 1 Intervention

2.5% hydrocortisone cream

Group II: Diclofenac topical Active Control 1 Intervention

1% diclofenac cream

Diclofenac 1% topical is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Voltaren for:

• Pain relief
• Inflammation
• Arthritis
• Musculoskeletal disorders

Approved in United States as Diclofenac for:

• Pain relief
• Osteoarthritis
• Rheumatoid arthritis
• Ankylosing spondylitis

Approved in Canada as Voltaren for:

• Pain relief
• Inflammation
• Arthritis
• Musculoskeletal disorders

Approved in Japan as Diclofenac for:

• Pain relief
• Inflammation
• Arthritis

Who Is Running the Clinical Trial?

University of the Pacific

Lead Sponsor

Trials

16

Recruited

1,000+

Published Research Related to This Trial

In a six-month double-blind study involving 138 patients, diclofenac sodium (Voltaren) was found to effectively reduce pain, swelling, and trismus after the removal of impacted lower third molars.

The study supports the use of diclofenac sodium as a preventive medication to manage postoperative swelling and pain associated with dental procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Antiphlogistic and analgesic effect of diclofenac sodium after maxillofacial interventions in a double-blind trial]. Mayer, M., Weiss, P.[2013]

Topically applied diclofenac and oral diclofenac were found to be equally effective in relieving symptoms of temporomandibular joint dysfunction in a study of 36 adult patients over 14 days.

Topical diclofenac has the added benefit of fewer systemic side effects compared to oral diclofenac, which caused gastric discomfort in some patients, making it a safer option for treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topical versus systemic diclofenac in the treatment of temporo-mandibular joint dysfunction symptoms. Di Rienzo Businco, L., Di Rienzo Businco, A., D'Emilia, M., et al.[2015]

In a study involving 32 patients with filamentary keratitis due to secondary Sjögren's syndrome, diclofenac sodium, 0.1%, demonstrated a significantly faster improvement in clinical symptoms compared to sodium chloride, 5%.

Both treatments were effective in eliminating filaments, and no significant adverse effects were reported, indicating that diclofenac sodium is a safe option for treating this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diclofenac sodium, 0.1% (Voltaren Ophtha), versus sodium chloride, 5%, in the treatment of filamentary keratitis. Avisar, R., Robinson, A., Appel, I., et al.[2019]

In a study of 29 patients with temporomandibular joint osteoarthritis, diclofenac sodium provided faster relief from pain and discomfort within one week compared to occlusal splint therapy, which showed significant symptom reduction after one month.

Both diclofenac and splint therapy were effective in reducing symptoms of TMJ osteoarthritis over three months, with sustained improvements noted at a one-year follow-up, and both treatments had minimal adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diclofenac sodium and occlusal splint therapy in TMJ osteoarthritis: a randomized controlled trial. Mejersjö, C., Wenneberg, B.[2016]

In a double-blind study of 32 patients with temporomandibular joint (TMJ) pain, diclofenac sodium (50 mg two or three times a day) significantly reduced pain and tenderness compared to placebo, indicating its efficacy in managing TMJ pain.

Patients with a shorter duration of pain responded best to diclofenac, suggesting it may be more effective for acute TMJ pain, although it should not be considered a primary treatment but rather a complementary option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diclofenac sodium as an alternative treatment of temporomandibular joint pain. Ekberg, EC., Kopp, S., Akerman, S.[2019]

In a randomized, double-blind study involving 52 participants, the topical cream Theraflex-TMJ significantly reduced pain levels in patients with masseter muscle and TMJ pain over a two-week treatment period, with improvements noted at multiple time points (p < 0.01 to p < 0.001).

The study indicated that Theraflex-TMJ is safe, with only minor side effects like skin irritation reported in a few subjects, while the placebo group showed no significant changes in pain levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Theraflex-TMJ topical cream for the treatment of temporomandibular joint and muscle pain. Lobo, SL., Mehta, N., Forgione, AG., et al.[2016]

A clinical trial involving 20 patients over 12 weeks found that topical NSAIDs reduced pain intensity in temporomandibular joint degenerative joint disease (TMJ DJD), but there was no significant difference compared to placebo.

The current evidence is insufficient to recommend topical NSAIDs as an effective treatment for TMJ DJD pain, indicating a need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topical nonsteroidal anti-inflammatory medications for treatment of temporomandibular joint degenerative pain: a systematic review. Senye, M., Mir, CF., Morton, S., et al.[2018]

In a study involving 2177 patients with various chronic pain conditions, two compounded topical creams (Cream I and Cream II) significantly reduced pain intensity scores by 37% and 35%, respectively, compared to a 19% reduction with Voltaren gel.

Both Cream I and Cream II were found to be more effective than Voltaren gel, suggesting that compounded topical formulations may offer better pain relief options for patients with chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retrospective Evaluation on the Analgesic Activities of 2 Compounded Topical Creams and Voltaren Gel in Chronic Noncancer Pain. Somberg, JC., Molnar, J.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/8811136/

Diclofenac sodium as an alternative treatment of ... The frequency of TMJ pain showed a greater reduction in the diclofenac group than in the placebo group, and there was a significant reduction of daily TMJ pain ...

2. longdom.org longdom.org/open-access/topical-diclofenac-gel-application-as-first-line-medication-for-acute-temporomandibular-joint-pain-92586.html

Topical Diclofenac Gel Application as First Line Medication ... Results: The performed two tailed t-test showed that the pain reduction was statistically significant. No side effects were reported. Conclusion: The topical ...

3. bmcoralhealth.biomedcentral.com bmcoralhealth.biomedcentral.com/articles/10.1186/s12903-025-06729-1

Comparative evaluation of the effects of diclofenac sodium ... The aim of this study is to comparatively evaluate the effectiveness of diclofenac sodium treatment as a nonsteroidal anti-inflammatory drug ( ...

4. withpower.com withpower.com/trial/phase-3-arthralgia-3-2023-d5525

Topical Creams for TMJ Pain Research shows that diclofenac sodium, a key ingredient in the treatment, significantly reduces TMJ pain and tenderness compared to a placebo. Additionally, ...

5. jofph.com jofph.com/articles/10.11607/jofph.2626

Topical Nonsteroidal Anti-inflammatory Medications for ... Outcomes evaluated were pain reduction/pain control and/or incidence of side effects. ... This study revealed a pain intensity decrease within treatment groups ...

6. webmd.com webmd.com/drugs/2/drug-22221-1065/diclofenac-sodium-topical/diclofenac-1-topical/details

Diclofenac topical (Voltaren) - Uses, Side Effects, and More Overview: Topical diclofenac (Voltaren) is used for arthritis pain. Common side effects include redness, itching, rash, dry skin, scaling, or ...

7. mayoclinic.org mayoclinic.org/drugs-supplements/diclofenac-topical-application-route/description/drg-20063434

Diclofenac (topical application route) - Side effects & dosage Diclofenac is used to treat pain and other symptoms of arthritis of the joints (eg, osteoarthritis), such as inflammation, swelling, stiffness, and joint pain.

8. drugs.com drugs.com/mtm/diclofenac-topical.html

Diclofenac topical Uses, Side Effects & Warnings Diclofenac topical (for the skin) is used in adults to treat joint pain caused by osteoarthritis. diclofenac topical is for use on the hands, wrists, elbows, ...

9. voltaren.ca voltaren.ca/en/products/topical-gels/

How Voltaren gel works and how to use it for pain relief Voltaren Emulgel Active with a No Mess Applicator is clinically proven to relieve pain from minor sports injuries & sore muscles to help you stay active.

10. medlineplus.gov medlineplus.gov/druginfo/meds/a611002.html

Diclofenac Topical (arthritis pain) The risk may be higher for people who use NSAIDs for a long time, are 60 years of age or older, have poor health, smoke, or drink alcohol while ...