Clinical trial NCT04339673: 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
Overall status: COMPLETED
Phase: NA
Conditions: Myofascial Pain - Dysfunction Syndrome of TMJ
Myofascial Trigger Point Pain
Local Anesthesia
Keywords: pain
injections
anesthetics
Lead sponsor: Erzincan University
Sponsor class: OTHER
First posted: 2020-04-09
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized parallel controlled
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The Rate of Pain on Function (PoF) assessed by Numerical pain Scale (NRS)
timeFrame: before the injections (T0, Baseline)
measure: The Rate of Pain on Function (PoF) assessed by Numerical pain Scale (NRS)
timeFrame: At 1st week (t1)
measure: The Rate of Pain on Function (PoF) assessed by Numerical pain Scale (NRS)
timeFrame: At 4th week (t2)
measure: The Rate of Pain on Function (PoF) assessed by Numerical pain Scale (NRS)
timeFrame: At 12th week (t3)
Secondary outcomes:
measure: The Rate of Pain Intensity on Palpation (PoP)
timeFrame: before the injections (T0, Baseline)
measure: The Rate of Pain Intensity on Palpation (PoP)
timeFrame: At 1st week (t1)
measure: The Rate of Pain Intensity on Palpation (PoP)
timeFrame: At 4th week (t2)
measure: The Rate of Pain Intensity on Palpation (PoP)
timeFrame: At 12th week (t3)
measure: The measurement of pain-free maximum mouth opening (MMO) in millimeters
timeFrame: before the injections (T0, Baseline)
measure: The measurement of pain-free maximum mouth opening (MMO) in millimeters
timeFrame: At 1st week (t1)
measure: The measurement of pain-free maximum mouth opening (MMO) in millimeters
timeFrame: At 4th week (t2)
measure: The measurement of pain-free maximum mouth opening (MMO) in millimeters
timeFrame: At 12th week (t3)
Other outcomes:
Locations:
city: Erzincan
country: Turkey
facility: Erzincan Ağiz Ve Diş Sağlığı Egt Araş Hastanesi
Study officials:
References:
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.
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.