Myo vs. Myofascial Injection for Myofascial Trigger Points

NCT ID: NCT06029413

Last Updated: 2024-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-26

Study Completion Date

2024-07-25

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.

Conditions

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Myofascial Pain Myofascial Trigger Point Pain Trigger Point Pain, Myofascial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Research arm

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.

Group Type EXPERIMENTAL

myo + fascial injection

Intervention Type PROCEDURE

10 cc 0.5 % lidocain solution injection for intermuscular hypersensitive nodule as well as for fascial layers as described.

Control arm

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).

Group Type ACTIVE_COMPARATOR

traditional trigger point injection

Intervention Type PROCEDURE

10 cc 0.5 % lidocain solution injection for intermuscular hypersensitive nodule as described.

Interventions

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myo + fascial injection

10 cc 0.5 % lidocain solution injection for intermuscular hypersensitive nodule as well as for fascial layers as described.

Intervention Type PROCEDURE

traditional trigger point injection

10 cc 0.5 % lidocain solution injection for intermuscular hypersensitive nodule as described.

Intervention Type PROCEDURE

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:

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

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bozyaka Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Buğra İnce

Assoc. Professor, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Buğra İnce

Role: STUDY_DIRECTOR

Izmir Bozyaka Education and Research Hospital

Locations

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Izmir Bozyaka Education and Research Hospital

Izmir, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 35980166 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35067549 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36010234 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30893405 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22852442 (View on PubMed)

Other Identifiers

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SOY23

Identifier Type: -

Identifier Source: org_study_id

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