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

Trial Summary

What is the purpose of this trial?

The proposed pilot study is aimed at preliminary characterization of the TMNB injection in 20 healthy volunteers. Assessment of bite-force distribution and surface electromyographic activity of the temporalis and the masseter muscles, at rest and clench, before and after unilateral TMNB injection, will be the primary outcome measures. Post-injection assessments will be performed at 30 minutes, 2 hours, and 2 weeks after the injection. Participants will be surveyed regarding their experience receiving the TMNB injection (secondary outcomes).

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 data supports the effectiveness of the treatment Temporomasseteric Nerve Block, Twin Block, Temporo-masseteric Nerve Block, TMNB for jaw pain?

Research shows that the twin block, a type of nerve block, is effective in providing short-term relief for jaw pain related to masticatory myofascial pain, which involves pain in the muscles used for chewing. It has also been found to be comparable to trigger point injections for managing chronic myofascial pain and offers advantages over other nerve blocks by targeting multiple nerves responsible for jaw pain. ^{1 2 3 4 5}

Is the nerve block for jaw pain safe for humans?

The twin block, a type of nerve block for jaw pain, has been used in studies for managing pain without specific safety concerns reported, suggesting it is generally safe for humans. ^{1 2 3 5 6}

How does the twin block treatment for jaw pain differ from other treatments?

The twin block is a unique nerve block treatment that targets both the masseteric and deep temporal nerves, providing relief for jaw pain by addressing the two main sources of pain in the masseter and temporalis muscles. Unlike other treatments, it offers a more comprehensive approach by blocking multiple nerve branches, which can lead to faster and more sustained pain relief. ^{1 2 3 4 5}

Research Team

Gayathri D Subramanian, DMD

Principal Investigator

Rutgers School of Dental Medicine

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. United States 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. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

The twin block injection: an adjunctive clinical aid for the management of acute arthrogenous temporomandibular joint dysfunction. [2021]

3. Germany 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. [2021]

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

Twin Block in Myogenous Orofacial Pain: Applied Anatomy, Technique Update, and Safety. [2020]

5. India 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. [2020]

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

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