Ultrasonographic Muscles and Fascia Measurement With Myofascial Pain Syndrome

January 5, 2025 updated by: Dr. Burcu Metin Ökmen, Bursa Yüksek İhtisas Education and Research Hospital

Investigation of the Diagnostic Effect of Ultrasonographic Measurement Values of Upper Back Muscles and Fascia in Patients With Myofascial Pain Syndrome

Pathologies in the trapezius muscle and rhomboid muscle are important in the course and treatment of the disease in patients with myofascial pain syndrome.

Study Overview

Detailed Description

In this study, the role of the thickness of these muscles and the shift during movement in the activity and diagnosis of the disease in myofascial pain syndrome will be investigated.

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

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 18-65 years old
  • myofascial pain syndrome

Exclusion Criteria:

  • Cervical radiculopathy
  • Fibromyalgia
  • Shoulder joint disease,
  • Peripheral and central nervous system disease
  • Polyneuropathy,
  • Inflammatory rheumatic disease,
  • Malignancy

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: Patients diagnosed with myofascial pain syndrome
Ultrasound measurements will be made while the upper back is at rest and during arm movements.
B mode measurements Trapezius and rhomboid muscle thickness and fascial thickness measurement M mode measurements Abduction at 90 and 180 degrees Forward flexion at 90 and 180 degrees
Under ultrasound guidance, a local anesthetic and steroid mixture will be injected into the fascia between the trapezius muscle and the rhomboid muscle.
Active Comparator: Healthy volunteers
Ultrasound measurements will be made while the upper back is at rest and during arm movements.
B mode measurements Trapezius and rhomboid muscle thickness and fascial thickness measurement M mode measurements Abduction at 90 and 180 degrees Forward flexion at 90 and 180 degrees

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Trapezius muscle and rhomboid muscle thickness
Time Frame: 20 minute
Trapezius and rhomboid muscle thickness and fascial thickness measurement will be made by ultrasonography at rest.
20 minute
fascial sliding
Time Frame: 20 minute

Measurements of the amount of slip measured during the movement of the fascial structures during shoulder and arm movements.

ultrasonography M-mode measurements Arm from the shoulder joint, cervical lateral flexion, cervical anterior flexion, shoulder elevation

20 minute

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VAS
Time Frame: 6 th month
visual analog scale (VAS) :for pain. 0: no pain at all, 10: worst pain imaginable
6 th month
NPDS
Time Frame: 6th month

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.

6th month
SF-12
Time Frame: 6th month

Short Form 12 (SF-12): 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.

Interpretation of Scores:

Utilize the norm-based scoring system to interpret PCS and MCS scores, with a mean of 50 and a standard deviation of 10 in the general population.

Scores above 50 indicate a better-than-average health-related quality of life, while scores below 50 suggest below-average health.

6th month

Collaborators and Investigators

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

Investigators

  • Study Chair: Korgün Ökmen, Assoc. PhD., Bursa Yuksek Ihtisas Training and Research Hospital

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)

May 1, 2021

Primary Completion (Actual)

May 1, 2024

Study Completion (Actual)

August 1, 2024

Study Registration Dates

First Submitted

April 27, 2022

First Submitted That Met QC Criteria

April 30, 2022

First Posted (Actual)

May 4, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 5, 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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