Clinical trial NCT05507164: Characterization of the Temporo-masseteric Nerve Block (TMNB) in Healthy Subjects
Official title: Non-randomized Pilot Study to Characterize Temporo-masseteric Nerve Block (TMNB) in
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Occlusion
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2022-08-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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).

Detailed description: 1.1 Purpose/Specific Aims The Temporo-masseteric Nerve Block (TMNB) is a local anesthetic injection targeting the deep temporal and masseteric branches of the mandibular division of the Trigeminal Nerve, that supply the temporalis and masseter muscles. Emerging evidence supports the TMNB's therapeutic potential in alleviating both acute and chronic myogenous pain of temporalis or masseteric origin. The TMNB injection is safe and well tolerated by patients.

The nerves targeted by the TMNB are mixed nerves and supply both sensory and motor innervation to the muscles. In addition, pain relief from the TMNB injection is sustained beyond the duration of the local anesthetic's duration of action. It is important to characterize the TMNB block, particularly its effects on the target muscles to understand the mechanism for its sustained pain relief.

The temporalis and the masseter muscles mediate jaw closure and clenching actions. 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).

A. Objectives 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).

B. Hypotheses / Research Question(s) (Alternate hypotheses)

1. The TMNB injection alters bite force distribution
2. The TMNB injection alters the surface electromyographic activity of the temporalis and masseter muscles on the side of the injection

1.2 Research Significance The TMNB injection is a local anesthetic injection technique that targets the anterior deep temporal and masseteric branches of the mandibular division of the Trigeminal Nerve. It has been in clinical use for over seven years. It has value as a diagnostic tool in helping differentiate between a toothache and jaw muscle pain when it is difficult for the patient and the clinician to otherwise differentiate between the two. In addition, it also has the ability to ease chronic jaw muscle pain that impacts the masseter and temporalis muscles. However, the mechanism of its sustained pain relief is not known. Given that the local anesthetic action usually lasts for over an hour, it is important to decipher how the TMNB brings about sustained pain relief for longer periods of time. In fact, the pain relief achieved by the TMNB injection in chronic myogenous Temporomandibular disorder involving the masseter and temporalis muscles is comparable to trigger point injections, a standard management modality that requires specialty training and hence is not readily accessible to all patients. The investigators speculate that the nerves to the masseter and temporalis muscles being mixed nerves (i.e., carrying both sensory and motor nerve supply), administration of the TMNB injection could ease muscle tone and activity, relieving chronic pain. Interruption of the pain-contraction-pain cycle may help relieve chronic pain. In order to verify this speculation, the investigators propose the use of TMNB in healthy subjects followed by assessment of jaw muscle function, as measured by bite force distribution and surface electromyographic assessment of the masseter and temporalis muscles. Elucidating the mechanism of TMNB's action has important implications on understanding its therapeutic potential in mTMD as well as elucidating the mechanisms of chronic myogenous TMD itself.

1.3 Research Design and Methods This study is a non-randomized prospective pilot study with twenty study subjects. 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, to capture the impact of onset, known duration of action of the local anesthetic used for the study (standard dental local anesthetic, 2% lidocaine with 1:100,000 epinephrine) after a period of 2 weeks.5 Participants will be surveyed regarding their experience receiving the TMNB injection (secondary outcomes).

A. Research Procedures The study will be conducted at the Clinical Research Center at Rutgers School of Dental Medicine. Healthy subjects with no history of TMDs will be recruited (see Eligibility criteria, Figure 1a and b).6 10 male and 10 female subjects will be recruited as per criteria outlined elsewhere.

Subject eligibility and initial evaluation will be conducted by PI SA, a Board-certified Oro-facial Pain Specialist. Informed consent will be obtained from all study participants and all participants can withdraw study consent at any time during the study. The TMNB injection will be delivered using the published technique. The needle position will be verified using a Nerve conduction study (a standard technique for verification of motor nerve blocks). The subsequent assessments including occlusal analysis (OA) and surface electromyography (sEMG) will be administered by either PI GS, PI SA or Co-I SYPQ, using T-scan/BioEMG (Tekscan, Inc., Boston, MA and BioRESEARCH, Inc., Brown Deer, WI). The side of TMNB administration will randomly assigned as left or right side.

Participants will be surveyed regarding their experience receiving the TMNB injection (secondary outcomes). The questionnaire will be offered to the subjects on the day of their injection and again at the two-week post-TMNB injection.

Eligibility criteria: Inclusion Criteria:

* 18-64 years of age
* All ethnicity
* Male and female sex
* Fluent in written/spoken English
* Never been diagnosed with TMD
* No significant history of orofacial pain
* \<5 headaches/month in the 3 months before enrollment
* No reported use of a nightguard or occlusal splint 'No' to all questions on self-administered questionnaire for TMD screening:
* Pain in jaw or temple on either side of the face in the last 30 days
* Stiffness or pain in jaw upon awakening in the last 30 days
* Any pain increase/reduction in the jaw/temple region during the last 30 days with

  * Chewing hard or tough food
  * Opening mouth or moving jaw forward or to the side
  * Hold teeth together/clenching/grinding/chewing gum
  * Using the jaw during activities such as talking, kissing or yawning

Exclusion Criteria:

* Traumatic injury/ surgery on face or jaw \< 6 months
* current orthodontic treatment
* pregnant or nursing,
* kidney failure or renal dialysis,
* heart disease or heart failure,
* uncontrolled chronic respiratory disease/ hypertension/ diabetes
* history of
* seizures
* hyperthyroidism
* drug or alcohol abuse
* psychiatric disorder/conditions requiring hospitalization
* chemotherapy/radiation

Primary outcomes:
measure: Change in Bite force distribution
timeFrame: Baseline, 30 min, 2 hours and 2 weeks
measure: Change in Surface EMG
timeFrame: Baseline, 30 min, 2 hours and 2 weeks
measure: Survey
timeFrame: At 2 weeks post injection
Secondary outcomes:
Other outcomes:
Locations:
city: Newark
country: United States
facility: Rutgers School of Dental Medicine
state: New Jersey
Study officials:
affiliation: Rutgers School of Dental Medicine
name: Gayathri D Subramanian, DMD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Quek S, Young A, Subramanian G. The twin block: a simple technique to block both the masseteric and the anterior deep temporal nerves with one anesthetic injection. Oral Surg Oral Med Oral Pathol Oral Radiol. 2014 Sep;118(3):e65-7. doi: 10.1016/j.oooo.2014.01.227. Epub 2014 Feb 6.
citation: Ananthan S, Kanti V, Zagury JG, Quek SYP, Benoliel R. The effect of the twin block compared with trigger point injections in patients with masticatory myofascial pain: a pilot study. Oral Surg Oral Med Oral Pathol Oral Radiol. 2020 Mar;129(3):222-228. doi: 10.1016/j.oooo.2019.09.014. Epub 2019 Oct 13.
citation: Quek SYP, Kalladka M, Kanti V, Subramanian G. A new adjunctive tool to aid in the diagnosis of myogenous temporomandibular disorder pain originating from the masseter and temporalis muscles: Twin-block technique. J Indian Prosthodont Soc. 2018 Apr-Jun;18(2):181-185. doi: 10.4103/jips.jips_293_17.
citation: Kanti V, Ananthan S, Subramanian G, Quek SYP. Efficacy of the twin block, a peripheral nerve block for the management of chronic masticatory myofascial pain: A case series. Quintessence Int. 2017 Oct 6:725-729. doi: 10.3290/j.qi.a39094. Online ahead of print.
citation: Schiffman E, Ohrbach R. Executive summary of the Diagnostic Criteria for Temporomandibular Disorders for clinical and research applications. J Am Dent Assoc. 2016 Jun;147(6):438-45. doi: 10.1016/j.adaj.2016.01.007. Epub 2016 Feb 26.
citation: Quek SYP, Gomes-Zagury J, Subramanian G. Twin Block in Myogenous Orofacial Pain: Applied Anatomy, Technique Update, and Safety. Anesth Prog. 2020 Jun 1;67(2):103-106. doi: 10.2344/anpr-67-01-03.