Non-randomized Pilot Study to Characterize Temporo-masseteric Nerve Block (TMNB) in
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Change in Bite force distribution
Study Overview
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)
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 64 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- •hyperthyroidism
- •drug or alcohol abuse
- •psychiatric disorder/conditions requiring hospitalization
- •chemotherapy/radiation
Arms & Interventions
Temporo-masseteric Nerve Block Administration
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
Intervention: Temporomasseteric Nerve Block (Drug)
Outcomes
Primary Outcomes
Change in Bite force distribution
Time Frame: Baseline, 30 min, 2 hours and 2 weeks
Left vs Right distribution of bite force upon clenching will be assessed as an average of 3 consequent measurements.
Change in Surface EMG
Time Frame: Baseline, 30 min, 2 hours and 2 weeks
Surface EMG will be utilized to measure surface electrical activity over the temporalis and masseter muscles at rest and clenching
Survey
Time Frame: At 2 weeks post injection
All subjects will be surveyed for their experience as part of their participation in the study
Secondary Outcomes
No secondary outcomes reported
Investigators
Gayathri Subramanian
Associate Professor
Rutgers, The State University of New Jersey