Myo vs. Myofascial Injection for Myofascial Trigger Points

Trigger Point Pain, Myofascial Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06029413
• Other study ID #: SOY23
• Status: Enrolling by invitation
• Phase: N/A
• Start date: September 26, 2023
• Est. completion date: June 2024

Study information

• Verified date: September 2023
• Source: Bozyaka Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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:

1. Taut band

2. Hypersensitive point

3. 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

-

Related Conditions & MeSH terms

• Myofascial Pain
• Myofascial Pain Syndromes
• Myofascial Trigger Point Pain
• Trigger Point Pain, Myofascial

Intervention

Procedure:
• myo + fascial injection
10 cc 0.5 % lidocain solution injection for intermuscular hypersensitive nodule as well as for fascial layers as described.
• traditional trigger point injection
10 cc 0.5 % lidocain solution injection for intermuscular hypersensitive nodule as described.

Locations

Country	Name	City	State
Turkey	Izmir Bozyaka Education and Research Hospital	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Bozyaka Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

Nouged E, Dajani J, Ku B, Al-Eryani K, Padilla M, Enciso R. Local Anesthetic Injections for the Short-Term Treatment of Head and Neck Myofascial Pain Syndrome: A Systematic Review with Meta-Analysis. J Oral Facial Pain Headache. 2019 Spring;33(2):183-198. doi: 10.11607/ofph.2277. Epub 2019 Mar 20. — View Citation

Pirri C, Pirri N, Guidolin D, Macchi V, De Caro R, Stecco C. Ultrasound Imaging of the Superficial Fascia in the Upper Limb: Arm and Forearm. Diagnostics (Basel). 2022 Aug 4;12(8):1884. doi: 10.3390/diagnostics12081884. — View Citation

Ricci V, Ricci C, Gervasoni F, Cocco G, Andreoli A, Ozcakar L. From Histoanatomy to Sonography in Myofascial Pain Syndrome: A EURO-MUSCULUS/USPRM Approach. Am J Phys Med Rehabil. 2023 Jan 1;102(1):92-97. doi: 10.1097/PHM.0000000000001975. Epub 2022 Jan 21. — View Citation

Ricci V, Ricci C, Mezian K, Nanka O, Ozcakar L. Trapezius Muscle and the Cutaneous Branches of Spinal Nerves: Sonographic/Anatomic Discussion of Myofascial Pain and Superficial Injections. Pain Med. 2023 Mar 1;24(3):221-225. doi: 10.1093/pm/pnac125. No abstract available. — View Citation

Stecco C, Macchi V, Porzionato A, Duparc F, De Caro R. The fascia: the forgotten structure. Ital J Anat Embryol. 2011;116(3):127-38. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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