Investigation of the Diagnostic Efficacy of the M-Mode Ultrasonography in the Diagnosis of Myofascial Pain Syndrome

NCT06764212 | Completed DMC

• 1 other identifier: BursaYIEAH-2019-6-24
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

Myofascial pain syndrome, or MPS, is a prevalent musculoskeletal disorder, which is characterised by the presence of muscle pain and tenderness. The inflammation and microtrauma that are the consequence result in adhesions between the fascial layers. It has been reported that these adhesions prevent the fasciae from sliding over each other and contribute to pain.

Conditions

Myofascial Pain Syndromes

Keywords

pain; ultrasound

Outcome Measures

Primary Outcomes (1)

• m-mode

  The amount of displacement of the fascia under the Trapezius muscle during arm lift, neck lateral and anterior flexion, and shoulder lift in a sitting position and the M-mode ultrasonography image will be recorded. The measurements obtained from the recordings will be recorded.

  30 minutes

Secondary Outcomes (4)

• Trapezius and rhomboid muscle

  30 minutes

• vas

  baseline

• NPDS

  baseline

• sf-12

  baseline

Study Arms (2)

mps

ACTIVE COMPARATOR

M-mode ultrasonography images of the fascia under the trapezius muscle will be recorded during 3 different movements.

Diagnostic Test: Ultrasound

healthy volunteers

ACTIVE COMPARATOR

M-mode ultrasonography images of the fascia under the trapezius muscle will be recorded during 3 different movements.

Diagnostic Test: Ultrasound

Interventions

Ultrasound DIAGNOSTIC_TEST

M-mode ultrasonography images of the fascia under the trapezius muscle will be recorded during 3 different movements.

Also known as: M-Mode musculoskeletal ultrasound

healthy volunteers; mps

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• At least one active trigger point
• Moderate back pain lasting more than 3 months
• Diagnosis of MPS according to Travell and Simons diagnostic criteria
• Healthy volunteers

You may not qualify if:

• cervical disc disease
• Fibromyalgia
• Central or peripheral nerve disease
• Shoulder joint disease
• Malignancy
• Rheumatic disease
• those who had been treated for MPS within 6 months

Sponsors & Collaborators

• Bursa Yuksek Ihtisas Training and Research Hospital: lead

Study Sites (2)

Burcu Metin Ökmen

Nilufer, Bursa, 16110, Turkey (Türkiye)

Location

Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi

Bursa, 16320, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Myofascial Pain Syndromes; Pain

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 2, 2025
• First Posted: January 8, 2025
• Study Start: February 1, 2020
• Primary Completion: February 1, 2022
• Study Completion: September 1, 2023
• Last Updated: January 9, 2025

Record last verified: 2025-01

Locations

TU (2)