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

Trial Summary

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.

What evidence supports the effectiveness of the drug 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, topical diclofenac has been found to be as effective as oral diclofenac for TMJ dysfunction symptoms, with fewer side effects. ^{1 2 3 4 5}

Is topical diclofenac safe for treating TMJ pain?

Topical diclofenac is generally safe for treating TMJ pain, with some patients experiencing mild irritation at the application site, which usually resolves on its own. It avoids the stomach-related side effects seen with oral diclofenac. ^{1 2 3 6 7}

How is the topical cream treatment for TMJ pain different from other treatments?

The topical cream treatment for TMJ pain is unique because it combines diclofenac, a non-steroidal anti-inflammatory drug (NSAID), and hydrocortisone, a corticosteroid, to reduce pain and inflammation directly at the site of application, potentially minimizing systemic side effects compared to oral medications. ^{1 2 3 5 8}

What is the purpose of 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 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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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 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]

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 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]

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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

Diclofenac sodium as an alternative treatment of temporomandibular joint pain. [2019]

2. Italy pubmed.ncbi.nlm.nih.gov

Topical versus systemic diclofenac in the treatment of temporo-mandibular joint dysfunction symptoms. [2015]

3. England pubmed.ncbi.nlm.nih.gov

Diclofenac sodium and occlusal splint therapy in TMJ osteoarthritis: a randomized controlled trial. [2016]

4. United States pubmed.ncbi.nlm.nih.gov

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

5. United States pubmed.ncbi.nlm.nih.gov

Topical nonsteroidal anti-inflammatory medications for treatment of temporomandibular joint degenerative pain: a systematic review. [2018]

6. Germany pubmed.ncbi.nlm.nih.gov

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

7. United States pubmed.ncbi.nlm.nih.gov

Diclofenac sodium, 0.1% (Voltaren Ophtha), versus sodium chloride, 5%, in the treatment of filamentary keratitis. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Use of Theraflex-TMJ topical cream for the treatment of temporomandibular joint and muscle pain. [2016]