- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06764212
Investigation of the Diagnostic Efficacy of the M-Mode Ultrasonography in the Diagnosis of Myofascial Pain Syndrome
Investigation of the Diagnostic Efficacy of the Amount of Fascial Sliding Measured by M-Mode Ultrasonography in the Diagnosis of Myofascial Pain Syndrome
Study Overview
Status
Conditions
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Bursa, Turkey, 16320
- Bursa Yüksek İhtisas Eğitim Ve Araştırma Hastanesi
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Bursa
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Nilüfer, Bursa, Turkey, 16110
- Burcu Metin Ökmen
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
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
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 |
|---|---|
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Active Comparator: mps
M-mode ultrasonography images of the fascia under the trapezius muscle will be recorded during 3 different movements.
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M-mode ultrasonography images of the fascia under the trapezius muscle will be recorded during 3 different movements.
Other Names:
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Active Comparator: healthy volunteers
M-mode ultrasonography images of the fascia under the trapezius muscle will be recorded during 3 different movements.
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M-mode ultrasonography images of the fascia under the trapezius muscle will be recorded during 3 different movements.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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m-mode
Time Frame: 30 minutes
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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.
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30 minutes
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Trapezius and rhomboid muscle
Time Frame: 30 minutes
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Trapezius and rhomboid muscle thickness measurements will be made via ultrasound
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30 minutes
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vas
Time Frame: baseline
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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.
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baseline
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NPDS
Time Frame: baseline
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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
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sf-12
Time Frame: baseline
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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
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baseline
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BursaYIEAH-2019-6-24
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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