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NCT Number: NCT04339673

Is Masseteric Nerve Block Effective in Myofascial Pain

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).

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Key information

Conditions

Myofascial Pain - Dysfunction Syndrome of TMJ Craniomandibular Disorders Jaw Diseases Joint Diseases Local Anesthesia Mandibular Diseases Muscular Diseases Musculoskeletal Diseases Myofascial Pain Syndromes Myofascial Trigger Point Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomatognathic Diseases Temporomandibular Joint Disorders

Age range

18 year–54 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erzincan Ağiz Ve Diş Sağlığı Egt Araş Hastanesi

Erzincan, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

masseteric nerve block

Procedure

regional bloc of masseter

trigger point injection

Procedure

trigger point injection with local anesthetic

dry needling

Procedure

needling with acupuncture needles of trigger points in masseter

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

Erzincan University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 9, 2020
Registry last updated
Apr 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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