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Myo vs. Myofascial Injection for Myofascial Trigger Points

Primary Purpose

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

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
myo + fascial injection
traditional trigger point injection
Sponsored by
Bozyaka Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myofascial Pain focused on measuring usg-guided trigger point injections, myofascial pain, myofascial trigger point, fascial hydrodilatation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 -

Sites / Locations

  • Izmir Bozyaka Education and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Research arm

Control arm

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

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)
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)
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)
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)

Secondary Outcome Measures

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
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
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
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
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.
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.
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.

Full Information

First Posted
September 1, 2023
Last Updated
September 27, 2023
Sponsor
Bozyaka Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06029413
Brief Title
Myo vs. Myofascial Injection for Myofascial Trigger Points
Official Title
Myo Vs. Myofascial Injection for Myofascial Trigger Points. Is There Really a Difference? A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
September 26, 2023 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bozyaka Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myofascial Pain, Myofascial Trigger Point Pain, Trigger Point Pain, Myofascial
Keywords
usg-guided trigger point injections, myofascial pain, myofascial trigger point, fascial hydrodilatation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Research arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Control arm
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Procedure
Intervention Name(s)
myo + fascial injection
Intervention Description
10 cc 0.5 % lidocain solution injection for intermuscular hypersensitive nodule as well as for fascial layers as described.
Intervention Type
Procedure
Intervention Name(s)
traditional trigger point injection
Intervention Description
10 cc 0.5 % lidocain solution injection for intermuscular hypersensitive nodule as described.
Primary Outcome Measure Information:
Title
VAS(Visual Analog Scale)
Description
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)
Time Frame
Baseline
Title
VAS(Visual Analog Scale)
Description
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)
Time Frame
30 minutes after intervention
Title
VAS(Visual Analog Scale)
Description
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)
Time Frame
72 hours after intervention
Title
VAS(Visual Analog Scale)
Description
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)
Time Frame
1 week after intervention
Secondary Outcome Measure Information:
Title
Pressure Pain Threshold
Description
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
Time Frame
Baseline
Title
Pressure Pain Threshold
Description
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
Time Frame
30 minutes after intervention
Title
Pressure Pain Threshold
Description
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
Time Frame
72 hours after intervention
Title
Pressure Pain Threshold
Description
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
Time Frame
1 week after intervention
Title
Functional Status
Description
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.
Time Frame
Baseline
Title
Functional Status
Description
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.
Time Frame
72 hours after intervention
Title
Functional Status
Description
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.
Time Frame
1 week after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Buğra İnce
Organizational Affiliation
Izmir Bozyaka Education and Research Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Izmir Bozyaka Education and Research Hospital
City
İzmir
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35980166
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.
Results Reference
background
PubMed Identifier
35067549
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.
Results Reference
background
PubMed Identifier
36010234
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.
Results Reference
background
PubMed Identifier
30893405
Citation
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.
Results Reference
background
PubMed Identifier
22852442
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.
Results Reference
background

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Myo vs. Myofascial Injection for Myofascial Trigger Points

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