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Is Masseteric Nerve Block Effective in Myofascial Pain

Primary Purpose

Myofascial Pain - Dysfunction Syndrome of TMJ, Myofascial Trigger Point Pain, Local Anesthesia

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
masseteric nerve block
trigger point injection
dry needling
Sponsored by
Erzincan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myofascial Pain - Dysfunction Syndrome of TMJ focused on measuring pain, injections, anesthetics

Eligibility Criteria

18 Years - 54 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Erzincan Ağiz Ve Diş Sağlığı Egt Araş Hastanesi

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

MNB- masseteric nerve block

LA -trigger point injection with local anesthetic

DN-dry needling

Arm Description

masseteric nerve block with local anesthesia lidocaine single app.

local anesthetic injections on trigger points in masseter

dren needling to masseter

Outcomes

Primary Outcome Measures

The Rate of Pain on Function (PoF) assessed by Numerical pain Scale (NRS)
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)
The Rate of Pain on Function (PoF) assessed by Numerical pain Scale (NRS)
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)
The Rate of Pain on Function (PoF) assessed by Numerical pain Scale (NRS)
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)
The Rate of Pain on Function (PoF) assessed by Numerical pain Scale (NRS)
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)

Secondary Outcome Measures

The Rate of Pain Intensity on Palpation (PoP)
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.
The Rate of Pain Intensity on Palpation (PoP)
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.
The Rate of Pain Intensity on Palpation (PoP)
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.
The Rate of Pain Intensity on Palpation (PoP)
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.
The measurement of pain-free maximum mouth opening (MMO) in millimeters
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.
The measurement of pain-free maximum mouth opening (MMO) in millimeters
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.
The measurement of pain-free maximum mouth opening (MMO) in millimeters
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.
The measurement of pain-free maximum mouth opening (MMO) in millimeters
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.

Full Information

First Posted
April 2, 2020
Last Updated
April 6, 2020
Sponsor
Erzincan University
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1. Study Identification

Unique Protocol Identification Number
NCT04339673
Brief Title
Is Masseteric Nerve Block Effective in Myofascial Pain
Official Title
Comparison of the Efficacy of Different Treatment Modalities in Masseteric Myofascial Pain: Masseteric Nerve Block, Local Anesthetic Injection and Dry-needling
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
November 30, 2019 (Actual)
Study Completion Date
November 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Erzincan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myofascial Pain - Dysfunction Syndrome of TMJ, Myofascial Trigger Point Pain, Local Anesthesia
Keywords
pain, injections, anesthetics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized parallel controlled
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MNB- masseteric nerve block
Arm Type
Active Comparator
Arm Description
masseteric nerve block with local anesthesia lidocaine single app.
Arm Title
LA -trigger point injection with local anesthetic
Arm Type
Active Comparator
Arm Description
local anesthetic injections on trigger points in masseter
Arm Title
DN-dry needling
Arm Type
Placebo Comparator
Arm Description
dren needling to masseter
Intervention Type
Procedure
Intervention Name(s)
masseteric nerve block
Intervention Description
regional bloc of masseter
Intervention Type
Procedure
Intervention Name(s)
trigger point injection
Intervention Description
trigger point injection with local anesthetic
Intervention Type
Procedure
Intervention Name(s)
dry needling
Intervention Description
needling with acupuncture needles of trigger points in masseter
Primary Outcome Measure Information:
Title
The Rate of Pain on Function (PoF) assessed by Numerical pain Scale (NRS)
Description
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)
Time Frame
before the injections (T0, Baseline)
Title
The Rate of Pain on Function (PoF) assessed by Numerical pain Scale (NRS)
Description
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)
Time Frame
At 1st week (t1)
Title
The Rate of Pain on Function (PoF) assessed by Numerical pain Scale (NRS)
Description
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)
Time Frame
At 4th week (t2)
Title
The Rate of Pain on Function (PoF) assessed by Numerical pain Scale (NRS)
Description
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)
Time Frame
At 12th week (t3)
Secondary Outcome Measure Information:
Title
The Rate of Pain Intensity on Palpation (PoP)
Description
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.
Time Frame
before the injections (T0, Baseline)
Title
The Rate of Pain Intensity on Palpation (PoP)
Description
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.
Time Frame
At 1st week (t1)
Title
The Rate of Pain Intensity on Palpation (PoP)
Description
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.
Time Frame
At 4th week (t2)
Title
The Rate of Pain Intensity on Palpation (PoP)
Description
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.
Time Frame
At 12th week (t3)
Title
The measurement of pain-free maximum mouth opening (MMO) in millimeters
Description
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.
Time Frame
before the injections (T0, Baseline)
Title
The measurement of pain-free maximum mouth opening (MMO) in millimeters
Description
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.
Time Frame
At 1st week (t1)
Title
The measurement of pain-free maximum mouth opening (MMO) in millimeters
Description
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.
Time Frame
At 4th week (t2)
Title
The measurement of pain-free maximum mouth opening (MMO) in millimeters
Description
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.
Time Frame
At 12th week (t3)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
54 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Erzincan Ağiz Ve Diş Sağlığı Egt Araş Hastanesi
City
Erzincan
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19241799
Citation
Venancio Rde A, Alencar FG Jr, Zamperini C. Botulinum toxin, lidocaine, and dry-needling injections in patients with myofascial pain and headaches. Cranio. 2009 Jan;27(1):46-53. doi: 10.1179/crn.2009.008.
Results Reference
background
PubMed Identifier
26715419
Citation
Quek SY, Subramanian G, Patel J, Ananthan S, Zagury JG, Khan J. Efficacy of regional nerve block in management of myofascial pain of masseteric origin. Cranio. 2015 Oct;33(4):285-90. doi: 10.1080/08869634.2015.1097300. Epub 2015 Dec 29.
Results Reference
result

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Is Masseteric Nerve Block Effective in Myofascial Pain

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