- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04339673
Is Masseteric Nerve Block Effective in Myofascial Pain
Comparison of the Efficacy of Different Treatment Modalities in Masseteric Myofascial Pain: Masseteric Nerve Block, Local Anesthetic Injection and Dry-needling
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Erzincan, Turkey
- Erzincan Ağiz Ve Diş Sağlığı Egt Araş Hastanesi
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: MNB- masseteric nerve block
masseteric nerve block with local anesthesia lidocaine single app.
|
regional bloc of masseter
|
ACTIVE_COMPARATOR: LA -trigger point injection with local anesthetic
local anesthetic injections on trigger points in masseter
|
trigger point injection with local anesthetic
|
PLACEBO_COMPARATOR: DN-dry needling
dren needling to masseter
|
needling with acupuncture needles of trigger points in masseter
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
before the injections (T0, Baseline)
|
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)
|
At 1st week (t1)
|
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)
|
At 4th week (t2)
|
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)
|
At 12th week (t3)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
before the injections (T0, Baseline)
|
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.
|
At 1st week (t1)
|
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.
|
At 4th week (t2)
|
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.
|
At 12th week (t3)
|
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.
|
before the injections (T0, Baseline)
|
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.
|
At 1st week (t1)
|
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.
|
At 4th week (t2)
|
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.
|
At 12th week (t3)
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 135162
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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