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

January 8, 2025 updated by: Dr. Burcu Metin Ökmen, Bursa Yüksek İhtisas Education and Research Hospital

Investigation of the Diagnostic Efficacy of the Amount of Fascial Sliding Measured by M-Mode Ultrasonography in the Diagnosis of Myofascial Pain Syndrome

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.

Study Overview

Status

Completed

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Bursa, Turkey, 16320
        • Bursa Yüksek İhtisas Eğitim Ve Araştırma Hastanesi
    • Bursa
      • Nilüfer, Bursa, Turkey, 16110
        • Burcu Metin Ökmen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: mps
M-mode ultrasonography images of the fascia under the trapezius muscle will be recorded during 3 different movements.
M-mode ultrasonography images of the fascia under the trapezius muscle will be recorded during 3 different movements.
Other Names:
  • M-Mode musculoskeletal ultrasound
Active Comparator: healthy volunteers
M-mode ultrasonography images of the fascia under the trapezius muscle will be recorded during 3 different movements.
M-mode ultrasonography images of the fascia under the trapezius muscle will be recorded during 3 different movements.
Other Names:
  • M-Mode musculoskeletal ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
m-mode
Time Frame: 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.
30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Trapezius and rhomboid muscle
Time Frame: 30 minutes
Trapezius and rhomboid muscle thickness measurements will be made via ultrasound
30 minutes
vas
Time Frame: 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.
baseline
NPDS
Time Frame: 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

baseline
sf-12
Time Frame: 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
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2020

Primary Completion (Actual)

February 1, 2022

Study Completion (Actual)

September 1, 2023

Study Registration Dates

First Submitted

January 2, 2025

First Submitted That Met QC Criteria

January 2, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 8, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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