Myo vs. Myofascial Injection for Myofascial Trigger Points

Study Overview
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Brief Summary
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In this study, the effectiveness of two different application methods that can be used in myofascial trigger point injection treatment will be compared.

Detailed Description
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This study aims to compare the intramuscular trigger point injection, which is traditionally used in the treatment of myofascial trigger points with the method in which facial layers are also included in the application.

Official Title
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Myo Vs. Myofascial Injection for Myofascial Trigger Points. Is There Really a Difference? A Randomized Controlled Trial

Conditions
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Myofascial Pain, Myofascial Trigger Point Pain, Trigger Point Pain, Myofascial

Intervention / Treatment
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* Procedure: myo + fascial injection
* Procedure: traditional trigger point injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pain in the upper back area Detection of active trigger point in upper back muscles (trapezius, levator scapula, rhomboids, supraspinatus and infraspinatus) Presence of at least two of the three criteria recommended for the diagnosis of trigger point: Taut band Hypersensitive point Referred pain Pain VAS score ≥ 4 Between the ages of 18-65 - Exclusion Criteria: Using analgesics or anti-inflammatory medicines. Having received physical therapy for the same symptoms in the past 3 months Serious psychiatric illness Presence of malignancy or infection Coagulation disorder Pregnancy History of operation in the relevant region Presence of fibromyalgia syndrome History of allergy to local anesthetics -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: This study is planned to compare the effects of USG guided intramuscular trigger point injection with the effects of USG guided intramuscular plus fascial trigger point injection. This is a single-center randomized trial with 2 parallel arms.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Research arm<br>After the myofascial trigger points are determined by ultrasonography (HI VISION Preirus; Hitachi Aloka Medical, Ltd., Tokyo, Japan), injections will be given to the myofascial layers from the deep to the superficial. First, the local anesthetic solution will be injected to create a separation in the intermuscle (epimysial) fascia. The injectable will then be infiltrated into the intermuscular hypoechoic nodule. Then, the deep fascia will be infiltrated layer by layer. Finally, the procedure will be completed by infiltrating the superficial fascia. | Procedure: myo + fascial injection<br>* 10 cc 0.5 % lidocain solution injection for intermuscular hypersensitive nodule as well as for fascial layers as described.<br>|
| Active Comparator: Control arm<br>Patients in the control group will be injected with the same amount of local anesthetic solution under ultrasound guidance to intramuscular hypoechoic nodules detected by ultrasonography (HI VISION Preirus; Hitachi Aloka Medical, Ltd., Tokyo, Japan). | Procedure: traditional trigger point injection<br>* 10 cc 0.5 % lidocain solution injection for intermuscular hypersensitive nodule as described.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS(Visual Analog Scale) | Pain intensity will be evaluated with the visual analog scale (VAS). VAS is a scale used to digitize subjective values such as behavior or characteristics that cannot be measured directly. Two end definitions of the parameter to be evaluated are written on both ends of a 10 cm line and the patient is asked to indicate where his/her condition is appropriate on this line by drawing a line (0. : no pain, 10: very severe pain) | Baseline | 
| VAS(Visual Analog Scale) | Pain intensity will be evaluated with the visual analog scale (VAS). VAS is a scale used to digitize subjective values such as behavior or characteristics that cannot be measured directly. Two end definitions of the parameter to be evaluated are written on both ends of a 10 cm line and the patient is asked to indicate where his/her condition is appropriate on this line by drawing a line (0. : no pain, 10: very severe pain) | 30 minutes after intervention | 
| VAS(Visual Analog Scale) | Pain intensity will be evaluated with the visual analog scale (VAS). VAS is a scale used to digitize subjective values such as behavior or characteristics that cannot be measured directly. Two end definitions of the parameter to be evaluated are written on both ends of a 10 cm line and the patient is asked to indicate where his/her condition is appropriate on this line by drawing a line (0. : no pain, 10: very severe pain) | 72 hours after intervention | 
| VAS(Visual Analog Scale) | Pain intensity will be evaluated with the visual analog scale (VAS). VAS is a scale used to digitize subjective values such as behavior or characteristics that cannot be measured directly. Two end definitions of the parameter to be evaluated are written on both ends of a 10 cm line and the patient is asked to indicate where his/her condition is appropriate on this line by drawing a line (0. : no pain, 10: very severe pain) | 1 week after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pressure Pain Threshold | The Baseline 1200-303 (Push-Pull Force Gauge®, Fabrication Enterprises, Inc.) algometer will be used to measure pressure pain threshold. The Baseline 1200-3031 cm2 is a dynamometer applied with a flat tip. The device is brought into contact with the skin at an angle of 90º and a force is applied to provide an increase of 1 kg per second. The first value at which the patient feels the sensation of pain is recorded. The average of 3 measurements taken at 30-second intervals is recorded as the patient's pressure pain threshold | Baseline | 
| Pressure Pain Threshold | The Baseline 1200-303 (Push-Pull Force Gauge®, Fabrication Enterprises, Inc.) algometer will be used to measure pressure pain threshold. The Baseline 1200-3031 cm2 is a dynamometer applied with a flat tip. The device is brought into contact with the skin at an angle of 90º and a force is applied to provide an increase of 1 kg per second. The first value at which the patient feels the sensation of pain is recorded. The average of 3 measurements taken at 30-second intervals is recorded as the patient's pressure pain threshold | 30 minutes after intervention | 
| Pressure Pain Threshold | The Baseline 1200-303 (Push-Pull Force Gauge®, Fabrication Enterprises, Inc.) algometer will be used to measure pressure pain threshold. The Baseline 1200-3031 cm2 is a dynamometer applied with a flat tip. The device is brought into contact with the skin at an angle of 90º and a force is applied to provide an increase of 1 kg per second. The first value at which the patient feels the sensation of pain is recorded. The average of 3 measurements taken at 30-second intervals is recorded as the patient's pressure pain threshold | 72 hours after intervention | 
| Pressure Pain Threshold | The Baseline 1200-303 (Push-Pull Force Gauge®, Fabrication Enterprises, Inc.) algometer will be used to measure pressure pain threshold. The Baseline 1200-3031 cm2 is a dynamometer applied with a flat tip. The device is brought into contact with the skin at an angle of 90º and a force is applied to provide an increase of 1 kg per second. The first value at which the patient feels the sensation of pain is recorded. The average of 3 measurements taken at 30-second intervals is recorded as the patient's pressure pain threshold | 1 week after intervention | 
| Functional Status | The change in the functional status of the patients will be evaluated with the neck disability index (NDI). NDI is a 10-question questionnaire most commonly used to evaluate nonspecific mechanical neck pain. A total score between 0 and 50 is obtained by scoring each question between 0 (no disability) and 5 (complete disability). The validity and reliability study of the Turkish version of the scale was shown. | Baseline | 
| Functional Status | The change in the functional status of the patients will be evaluated with the neck disability index (NDI). NDI is a 10-question questionnaire most commonly used to evaluate nonspecific mechanical neck pain. A total score between 0 and 50 is obtained by scoring each question between 0 (no disability) and 5 (complete disability). The validity and reliability study of the Turkish version of the scale was shown. | 72 hours after intervention | 
| Functional Status | The change in the functional status of the patients will be evaluated with the neck disability index (NDI). NDI is a 10-question questionnaire most commonly used to evaluate nonspecific mechanical neck pain. A total score between 0 and 50 is obtained by scoring each question between 0 (no disability) and 5 (complete disability). The validity and reliability study of the Turkish version of the scale was shown. | 1 week after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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usg-guided trigger point injections, myofascial pain, myofascial trigger point, fascial hydrodilatation