Is Masseteric Nerve Block Effective in Myofascial Pain

April 6, 2020 updated by: Fatih TASKESEN, Erzincan University

Comparison of the Efficacy of Different Treatment Modalities in Masseteric Myofascial Pain: Masseteric Nerve Block, Local Anesthetic Injection and Dry-needling

The aim of the present study was to compare the efficacy of three different treatment methods in the management of myofascial pain: masseteric nerve block (MN), trigger point injection(TrP) with local anesthetic (LA) and dry needling (DN).Study Design: 45 subjects aged 18-54 years were randomly assigned to the MN group (n= 15), LA group (n=15) and DN group (n=15).

Study Overview

Detailed Description

The study sample consisted 45 patients with masseter muscle originated myofascial pain, were selected in accordance with the following criteria:

Patients were grouped according to the treatment they received: dry-needling (DN), TrP injections with local anesthetic (LA) and masseteric nerve block (MNB). Localization of the masseteric trigger points (MTPs) was based on clinician's sense and patients' expressions of pain. Local twitch response was not observable in all case. This procedure was completed by using digital palpation (1.5 Kg), and the clinical examiner's palpation was calibrated using a pressure algometer.

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Erzincan, Turkey
        • Erzincan Ağiz Ve Diş Sağlığı Egt Araş Hastanesi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 54 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of myofascial pain.
  • Presence of at least one trigger point in masseter muscle.

Exclusion Criteria:

  • Generalized muscle disorders.
  • Hypersensitivity to local anesthetics.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: MNB- masseteric nerve block
masseteric nerve block with local anesthesia lidocaine single app.
regional bloc of masseter
ACTIVE_COMPARATOR: LA -trigger point injection with local anesthetic
local anesthetic injections on trigger points in masseter
trigger point injection with local anesthetic
PLACEBO_COMPARATOR: DN-dry needling
dren needling to masseter
needling with acupuncture needles of trigger points in masseter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Rate of Pain on Function (PoF) assessed by Numerical pain Scale (NRS)
Time Frame: before the injections (T0, Baseline)
Patients rated their pain on function (pain during chewing or speaking etc.) on a Numeric Rating Scale (NRS) (0-10 where 0 is no pain and 10 is the worst pain imaginable)
before the injections (T0, Baseline)
The Rate of Pain on Function (PoF) assessed by Numerical pain Scale (NRS)
Time Frame: At 1st week (t1)
Patients rated their pain on function (pain during chewing or speaking etc.) on a Numeric Rating Scale (NRS) (0-10 where 0 is no pain and 10 is the worst pain imaginable)
At 1st week (t1)
The Rate of Pain on Function (PoF) assessed by Numerical pain Scale (NRS)
Time Frame: At 4th week (t2)
Patients rated their pain on function (pain during chewing or speaking etc.) on a Numeric Rating Scale (NRS) (0-10 where 0 is no pain and 10 is the worst pain imaginable)
At 4th week (t2)
The Rate of Pain on Function (PoF) assessed by Numerical pain Scale (NRS)
Time Frame: At 12th week (t3)
Patients rated their pain on function (pain during chewing or speaking etc.) on a Numeric Rating Scale (NRS) (0-10 where 0 is no pain and 10 is the worst pain imaginable)
At 12th week (t3)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Rate of Pain Intensity on Palpation (PoP)
Time Frame: before the injections (T0, Baseline)
Patients rated their pain intensity on masseter muscle by a 4-point Likert-type scale (0 = no pain, 3 = as worst pain imaginable) while a calibrated examiner palpating their masseter muscle.
before the injections (T0, Baseline)
The Rate of Pain Intensity on Palpation (PoP)
Time Frame: At 1st week (t1)
Patients rated their pain intensity on masseter muscle by a 4-point Likert-type scale (0 = no pain, 3 = as worst pain imaginable) while a calibrated examiner palpating their masseter muscle.
At 1st week (t1)
The Rate of Pain Intensity on Palpation (PoP)
Time Frame: At 4th week (t2)
Patients rated their pain intensity on masseter muscle by a 4-point Likert-type scale (0 = no pain, 3 = as worst pain imaginable) while a calibrated examiner palpating their masseter muscle.
At 4th week (t2)
The Rate of Pain Intensity on Palpation (PoP)
Time Frame: At 12th week (t3)
Patients rated their pain intensity on masseter muscle by a 4-point Likert-type scale (0 = no pain, 3 = as worst pain imaginable) while a calibrated examiner palpating their masseter muscle.
At 12th week (t3)
The measurement of pain-free maximum mouth opening (MMO) in millimeters
Time Frame: before the injections (T0, Baseline)
Pain-free MMO was measured as the distance between the incisal edges of the upper and lower incisors while patient's mouth is open as possible without any assistance and without pain in masseter muscle. Three measurements were performed, and their average is recorded.
before the injections (T0, Baseline)
The measurement of pain-free maximum mouth opening (MMO) in millimeters
Time Frame: At 1st week (t1)
Pain-free MMO was measured as the distance between the incisal edges of the upper and lower incisors while patient's mouth is open as possible without any assistance and without pain in masseter muscle. Three measurements were performed, and their average is recorded.
At 1st week (t1)
The measurement of pain-free maximum mouth opening (MMO) in millimeters
Time Frame: At 4th week (t2)
Pain-free MMO was measured as the distance between the incisal edges of the upper and lower incisors while patient's mouth is open as possible without any assistance and without pain in masseter muscle. Three measurements were performed, and their average is recorded.
At 4th week (t2)
The measurement of pain-free maximum mouth opening (MMO) in millimeters
Time Frame: At 12th week (t3)
Pain-free MMO was measured as the distance between the incisal edges of the upper and lower incisors while patient's mouth is open as possible without any assistance and without pain in masseter muscle. Three measurements were performed, and their average is recorded.
At 12th week (t3)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2019

Primary Completion (ACTUAL)

November 30, 2019

Study Completion (ACTUAL)

November 30, 2019

Study Registration Dates

First Submitted

April 2, 2020

First Submitted That Met QC Criteria

April 6, 2020

First Posted (ACTUAL)

April 9, 2020

Study Record Updates

Last Update Posted (ACTUAL)

April 9, 2020

Last Update Submitted That Met QC Criteria

April 6, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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