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

Not Applicable

Completed

• Conditions: Myofascial Pain Syndromes

• Registration Number: NCT06764212
• Lead Sponsor: Bursa Yüksek İhtisas Education and Research Hospital

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.

Detailed Description

The rhomboid and trapezius muscles are commonly involved in MPS, which often affects the upper extremity.

This study hypothesized that muscle sliding decreases in patients with MPS. To this end, the investigators measured the amount of fascial sliding of the trapezius muscle in healthy volunteers and patients with MPS using M-mode ultrasound and a software-assisted program to investigate the differences and diagnostic value.

Study Timeline

• Study Start: 2020-02-01
• Primary Completion: 2022-02-01
• Study Completion: 2023-09-01
• Status Verified: 2025-01
• Study First Submitted: 2025-01-02
• Study First Submitted QC: 2025-01-02
• Study First Posted: 2025-01-08
• Last Update Submitted: 2025-01-08
• Last Update Posted: 2025-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
m-mode	30 minutes	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.

Secondary Outcome Measures

Name	Time	Method
vas	baseline	Visual Analog Scale was used for pain. Pain intensity was measured using 0-10 cm visual analogue scale (VAS). The findings suggested that 100-mm VAS ratings of 0 to 4 mm can be considered no pain; 5 to 44 mm, mild pain; 45 to 74 mm, moderate pain; and 75 to 100 mm, severe pain.
Trapezius and rhomboid muscle	30 minutes	Trapezius and rhomboid muscle thickness measurements will be made via ultrasound
NPDS	baseline	Neck and Disability Scale (NPDS): The 20-item Neck and Disability Scale is scored on a 10 cm visual analog scale and ranges from 0 to 5 points. The test aims to measure the impact of neck pain on quality of life, functionality, and disability
sf-12	baseline	The SF-12 form, which includes scales to assess physical (SF-12-PCS) and mental (SF-12-MCS) status, was created by taking 12 different items from 8 other titles of the SF-36, which is the extended version

Trial Locations

Locations (2)

Burcu Metin Ökmen; 🇹🇷 Nilüfer, Bursa, Turkey

Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi; 🇹🇷 Bursa, Turkey