- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05359523
Ultrasonographic Muscles and Fascia Measurement With Myofascial Pain Syndrome
Investigation of the Diagnostic Effect of Ultrasonographic Measurement Values of Upper Back Muscles and Fascia in Patients With Myofascial Pain Syndrome
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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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
Accepts Healthy Volunteers
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
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: Patients diagnosed with myofascial pain syndrome
Ultrasound measurements will be made while the upper back is at rest and during arm movements.
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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.
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Active Comparator: Healthy volunteers
Ultrasound measurements will be made while the upper back is at rest and during arm movements.
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Trapezius muscle and rhomboid muscle thickness
Time Frame: 20 minute
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Trapezius and rhomboid muscle thickness and fascial thickness measurement will be made by ultrasonography at rest.
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20 minute
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fascial sliding
Time Frame: 20 minute
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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VAS
Time Frame: 6 th month
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visual analog scale (VAS) :for pain.
0: no pain at all, 10: worst pain imaginable
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6 th month
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NPDS
Time Frame: 6th month
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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. |
6th month
|
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SF-12
Time Frame: 6th month
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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
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Collaborators and Investigators
Investigators
- Study Chair: Korgün Ökmen, Assoc. PhD., Bursa Yuksek Ihtisas Training and Research Hospital
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021/10-16
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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