Clinical trial NCT06029413: 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
Overall status: COMPLETED
Phase: NA
Conditions: Myofascial Pain
Myofascial Trigger Point Pain
Trigger Point Pain, Myofascial
Keywords: usg-guided trigger point injections
myofascial pain
myofascial trigger point
fascial hydrodilatation
Lead sponsor: Bozyaka Training and Research Hospital
Sponsor class: OTHER
First posted: 2023-09-08
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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:

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

-

Primary outcomes:
measure: VAS(Visual Analog Scale)
timeFrame: Baseline
measure: VAS(Visual Analog Scale)
timeFrame: 30 minutes after intervention
measure: VAS(Visual Analog Scale)
timeFrame: 72 hours after intervention
measure: VAS(Visual Analog Scale)
timeFrame: 1 week after intervention
Secondary outcomes:
measure: Pressure Pain Threshold
timeFrame: Baseline
measure: Pressure Pain Threshold
timeFrame: 30 minutes after intervention
measure: Pressure Pain Threshold
timeFrame: 72 hours after intervention
measure: Pressure Pain Threshold
timeFrame: 1 week after intervention
measure: Functional Status
timeFrame: Baseline
measure: Functional Status
timeFrame: 72 hours after intervention
measure: Functional Status
timeFrame: 1 week after intervention
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Izmir Bozyaka Education and Research Hospital
Study officials:
affiliation: Izmir Bozyaka Education and Research Hospital
name: Buğra İnce
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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.