Nerve Block for Jaw Pain

Overseen By Gayathri D Subramanian

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Rutgers, The State University of New Jersey

Disqualifiers: Heart disease, Diabetes, Psychiatric disorder, others

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

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 1 day

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a nerve block injection (Temporomasseteric Nerve Block) to assess its effects on jaw muscles and bite strength. Researchers aim to understand how this treatment alters muscle activity and bite force post-injection. Individuals without jaw disorders, experiencing no more than four headaches a month, and not using a nightguard may qualify for this study. Participants will also report their experience with the injection. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have any of the listed medical conditions or are undergoing certain treatments, you may not be eligible to participate.

What prior data suggests that the Temporomasseteric Nerve Block is safe?

Research has shown that the Temporomasseteric Nerve Block (TMNB) is generally safe. Studies have found that TMNB injections work well and are usually easy for people to tolerate. Participants in these studies did not report any major side effects, suggesting the treatment is safe for humans. However, further research is needed to fully confirm these results. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Unlike standard treatments for jaw pain, which often involve medications like NSAIDs or muscle relaxants, the temporomasseteric nerve block (TMNB) offers a targeted, non-systemic approach. This treatment is unique because it directly administers an anesthetic to the specific nerves responsible for pain, potentially providing faster and more localized relief. Researchers are excited about TMNB as it may reduce the need for systemic medications, lowering the risk of side effects and offering a more precise pain management option.

What evidence suggests that the Temporomasseteric Nerve Block is effective for jaw pain?

Research has shown that the Temporomasseteric Nerve Block (TMNB), which participants in this trial will receive, can help relieve jaw pain. In one study, patients who received TMNB experienced significantly less pain in their jaw, particularly around the temporomandibular joint (TMJ) and nearby muscles. Another study found that pain levels dropped by more than 70% within 10 to 15 minutes after administering the nerve block. These results suggest that TMNB might effectively reduce pain and improve jaw muscle function. ^{1 3 6 7 8}

Who Is on the Research Team?

Gayathri D Subramanian, DMD

Principal Investigator

Rutgers School of Dental Medicine

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 18-64 who speak English, can open their mouth and move their jaw without pain or stiffness, have not been diagnosed with TMD (jaw disorder), and do not have a significant history of facial pain. Excluded are those with kidney failure, seizures, recent facial trauma/surgery, heart disease, uncontrolled chronic conditions like hypertension/diabetes, substance abuse issues, psychiatric hospitalizations, cancer treatments or hyperthyroidism.

Inclusion Criteria

I am either male or female.

I have never been diagnosed with TMD.

All ethnicity

Exclusion Criteria

I am currently undergoing orthodontic treatment.

I have had a recent injury or surgery on my face or jaw within the last 6 months.

I have heart disease or heart failure.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants receive the TMNB injection and undergo assessments of bite-force distribution and surface electromyographic activity

1 day

1 visit (in-person)

Post-injection Assessment

Post-injection assessments are performed at 30 minutes, 2 hours, and 2 weeks after the injection to evaluate the impact of the TMNB

2 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Temporomasseteric Nerve Block

Trial Overview The study tests the Temporomasseteric Nerve Block (TMNB) on healthy volunteers to see how it affects bite-force distribution and muscle activity in the jaw. Participants will be evaluated at different times after receiving the TMNB injection to measure its effects on muscle function.

How Is the Trial Designed?

Group I: Temporo-masseteric Nerve Block Administration Experimental Treatment 1 Intervention

Non-randomized administration of the TMNB injection (unilateral) followed by bite force distribution and surface EMG assessment of the temporalis and masseter muscles on the side of the injection

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials

471

Recruited

81,700+

Published Research Related to This Trial

The twin block technique, introduced in 2014, is more effective than the earlier masseteric nerve block for managing myogenous orofacial pain, providing quick and lasting relief from pain in the masseter muscle.

In a 6-month prospective study, the twin block was found to be as effective as trigger point injections for chronic myofascial pain, highlighting its safety and efficacy in treating pain from both the masseter and temporalis muscles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Twin Block in Myogenous Orofacial Pain: Applied Anatomy, Technique Update, and Safety. Quek, SYP., Gomes-Zagury, J., Subramanian, G.[2020]

A continuous bilateral mandibular nerve block (MNB) using a suprazygomatic approach effectively managed refractory trismus and pain in a patient with tetraplegia, providing analgesia for up to 72 hours.

This technique allowed for significant pain relief and improved mouth opening, enabling the introduction of kinesitherapy while minimizing the need for opioid analgesics, demonstrating its safety and efficacy in challenging clinical situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suprazygomatic Access for Continuous Bilateral Mandibular Nerve Block for Pain and Trismus Relief in the Tetraplegic Patient. Dziadzko, MA., Heritier, F.[2017]

Myogenous temporomandibular disorder (TMD) is a common type of nonodontogenic pain, but diagnosing it can be challenging due to the lack of a straightforward diagnostic test.

The twin-block injection technique can help diagnose myogenous TMD by blocking the nerves to the temporalis and masseter muscles, which are often sources of referred pain, thus aiding in both diagnosis and management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new adjunctive tool to aid in the diagnosis of myogenous temporomandibular disorder pain originating from the masseter and temporalis muscles: Twin-block technique. Quek, SYP., Kalladka, M., Kanti, V., et al.[2020]

The twin block nerve block technique is effective for the long-term management of masticatory myofascial pain, showing similar pain reduction to trigger point injections over a 6-month period in a study of 40 patients.

Both treatment methods resulted in significant pain reduction from baseline (around 6.5) to follow-up (around 1.85), but there were no statistically significant differences in pain intensity between the two groups, indicating that the twin block is a viable alternative to trigger point injections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of the twin block compared with trigger point injections in patients with masticatory myofascial pain: a pilot study. Ananthan, S., Kanti, V., Zagury, JG., et al.[2022]

The twin block injection is effective in reducing pain from both the temporomandibular joint (TMJ) and associated muscle pain, as demonstrated in a case study of a 19-year-old man with acute anterior disc displacement and myalgia.

After receiving the twin block injection, the patient experienced significant pain relief in the TMJ and surrounding muscles, indicating its potential as a treatment for temporomandibular disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The twin block injection: an adjunctive clinical aid for the management of acute arthrogenous temporomandibular joint dysfunction. Ananthan, S., Subramanian, G., Patel, T., et al.[2021]

The twin block nerve block effectively targets both the masseteric and anterior deep temporal nerves, providing rapid and lasting relief for chronic masticatory myofascial pain, which is a common nonodontogenic pain condition.

This case series highlights the potential of the twin block as a promising alternative or complement to conventional treatments like physical therapy and medications for managing myofascial pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of the twin block, a peripheral nerve block for the management of chronic masticatory myofascial pain: A case series. Kanti, V., Ananthan, S., Subramanian, G., et al.[2021]

Citations

1. joma.amegroups.org joma.amegroups.org/article/view/5763/html

Nerve blocks and interventional procedures in the ... Nerve blocks and interventional procedures in the management of temporomandibular joint disorders: a scoping review.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11922512/

The Temporo-Masseteric Nerve Block (TMNB) for ... In terms of effectiveness, pain alleviation 10 to 15 minutes following TMNB(s) was noted with a mean reduction of pain scores by over 70 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11810664/

Safety, efficacy, and mechanism of action of the temporo- ... The objective of the study was to assess the utility and safety of Temporo-masseteric Nerve Block (TMNB), and to explore the mechanism for its apparent ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05507164

Characterization of the Temporo-masseteric Nerve Block ... The proposed pilot study is aimed at preliminary characterization of the TMNB injection in 20 healthy volunteers. Assessment of bite-force distribution and ...

5. withpower.com withpower.com/trial/phase-2-occlusion-7-2022-695d0

Nerve Block for Jaw Pain After receiving the twin block injection, the patient experienced significant pain relief in the TMJ and surrounding muscles, indicating its potential as a ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39801096/

Safety, efficacy, and mechanism of action of the temporo- ... The objective of the study was to assess the utility and safety of Temporo-masseteric Nerve Block (TMNB), and to explore the mechanism for its ...

7. jofph.com jofph.com/articles/10.22514/jofph.2024.014

Safety, efficacy, and mechanism of action of the temporo- ... The objective of the study was to assess the utility and safety of Temporo-masseteric Nerve Block (TMNB), and to explore the mechanism for its apparent ...

8. joma.amegroups.org joma.amegroups.org/article/view/5659/html

Nerve blocks in the management of acute temporomandibular ... The objective of the current narrative review is to familiarize healthcare professionals with clinical presentations and management of acute TMD emergencies ...