Is Masseteric Nerve Block Effective in Myofascial Pain

NCT04339673 | Completed DMC

• 1 other identifier: 135162
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Keywords

pain; injections; anesthetics

Outcome Measures

Primary Outcomes (4)

• 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)

  before the injections (T0, Baseline)

• 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)

  At 1st week (t1)

• 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)

  At 4th week (t2)

• 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)

  At 12th week (t3)

Secondary Outcomes (8)

• The Rate of Pain Intensity on Palpation (PoP)

  before the injections (T0, Baseline)

• The Rate of Pain Intensity on Palpation (PoP)

  At 1st week (t1)

• The Rate of Pain Intensity on Palpation (PoP)

  At 4th week (t2)

• The Rate of Pain Intensity on Palpation (PoP)

  At 12th week (t3)

• The measurement of pain-free maximum mouth opening (MMO) in millimeters

  before the injections (T0, Baseline)

Study Arms (3)

MNB- masseteric nerve block

ACTIVE COMPARATOR

masseteric nerve block with local anesthesia lidocaine single app.

Procedure: masseteric nerve block

LA -trigger point injection with local anesthetic

ACTIVE COMPARATOR

local anesthetic injections on trigger points in masseter

Procedure: trigger point injection

DN-dry needling

PLACEBO COMPARATOR

dren needling to masseter

Procedure: dry needling

Interventions

masseteric nerve block PROCEDURE

regional bloc of masseter

MNB- masseteric nerve block

trigger point injection PROCEDURE

trigger point injection with local anesthetic

LA -trigger point injection with local anesthetic

dry needling PROCEDURE

needling with acupuncture needles of trigger points in masseter

DN-dry needling

Eligibility Criteria

• Age: 18 Years - 54 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Generalized muscle disorders.
• Hypersensitivity to local anesthetics.

Sponsors & Collaborators

• Erzincan University: lead

Study Sites (1)

Erzincan Ağiz Ve Diş Sağlığı Egt Araş Hastanesi

Erzincan, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 19241799 BACKGROUND

• 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.

  PMID: 26715419 RESULT

MeSH Terms

Conditions

Temporomandibular Joint Disorders; Myofascial Pain Syndromes; Pain

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Dept. Oral and Maxillofacial Surgery

Model Details: randomized parallel controlled

Study Record Dates

• First Submitted: April 2, 2020
• First Posted: April 9, 2020
• Study Start: July 1, 2019
• Primary Completion: November 30, 2019
• Study Completion: November 30, 2019
• Last Updated: April 9, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)