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Completed

NCT Number: NCT06764212

Investigation of the Diagnostic Efficacy of the 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.

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Key information

Conditions

Myofascial Pain Syndromes Muscular Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Burcu Metin Ökmen, Nilufer, Bursa, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasound

Diagnostic Test

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

Other names: M-Mode musculoskeletal ultrasound

Primary outcomes

  1. 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.

Secondary outcomes

  1. Trapezius and rhomboid muscle

    Time frame: 30 minutes

    Trapezius and rhomboid muscle thickness measurements will be made via ultrasound

  2. 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.

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Bursa Yuksek Ihtisas Training and Research Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Jan 8, 2025
Registry last updated
Jan 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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