Is Masseteric Nerve Block Effective in Myofascial Pain

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Procedure: masseteric nerve block
* Procedure: trigger point injection
* Procedure: dry needling


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 54 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized parallel controlled
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: MNB- masseteric nerve block<br>masseteric nerve block with local anesthesia lidocaine single app. | Procedure: masseteric nerve block<br>* regional bloc of masseter<br>|
| Active Comparator: LA -trigger point injection with local anesthetic<br>local anesthetic injections on trigger points in masseter | Procedure: trigger point injection<br>* trigger point injection with local anesthetic<br>|
| Placebo Comparator: DN-dry needling<br>dren needling to masseter | Procedure: dry needling<br>* needling with acupuncture needles of trigger points in masseter<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | before the injections (T0, Baseline) | 
| 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. | At 1st week (t1) | 
| 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. | At 4th week (t2) | 
| 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. | At 12th week (t3) | 
| 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. | before the injections (T0, Baseline) | 
| 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. | At 1st week (t1) | 
| 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. | At 4th week (t2) | 
| 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. | At 12th week (t3) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain, injections, anesthetics