Myo vs. Myofascial Injection for Myofascial Trigger Points

NCT06029413 | Completed

• 1 other identifier: SOY23
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

usg-guided trigger point injections; myofascial pain; myofascial trigger point; fascial hydrodilatation

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (7)

• Pressure Pain Threshold

  Baseline

• Pressure Pain Threshold

  30 minutes after intervention

• Pressure Pain Threshold

  72 hours after intervention

• Pressure Pain Threshold

  1 week after intervention

• Functional Status

  Baseline

Study Arms (2)

Research arm

EXPERIMENTAL

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

Control arm

ACTIVE COMPARATOR

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

Interventions

myo + fascial injection PROCEDURE

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

Research arm

traditional trigger point injection PROCEDURE

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

Control arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 -

You may not qualify if:

• 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

Sponsors & Collaborators

• Bozyaka Training and Research Hospital: lead

Study Sites (1)

Izmir Bozyaka Education and Research Hospital

Izmir, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  PMID: 35980166 BACKGROUND

• 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.

  PMID: 35067549 BACKGROUND

• 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.

  PMID: 36010234 BACKGROUND

• 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.

  PMID: 30893405 BACKGROUND

• 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.

  PMID: 22852442 BACKGROUND

MeSH Terms

Conditions

Myofascial Pain Syndromes

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases

Study Officials

• Buğra İnce

  Izmir Bozyaka Education and Research Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Professor, MD

Model Details: 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.

Study Record Dates

• First Submitted: September 1, 2023
• First Posted: September 8, 2023
• Study Start: September 26, 2023
• Primary Completion: July 25, 2024
• Study Completion: July 25, 2024
• Last Updated: August 28, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)