Ultrasonographic Muscles and Fascia Measurement With Myofascial Pain Syndrome
Primary Purpose
Myofascial Pain Syndrome
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ultrasonographic measurements of the trapezius and rhomboid muscle and fascia
Sponsored by
About this trial
This is an interventional diagnostic trial for Myofascial Pain Syndrome
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Patients diagnosed with myofascial pain syndrome
Healthy volunteers
Arm Description
Ultrasound measurements will be made while the upper back is at rest and during arm movements.
Ultrasound measurements will be made while the upper back is at rest and during arm movements.
Outcomes
Primary Outcome Measures
Trapezius muscle and rhomboid muscle thickness
Trapezius and rhomboid muscle thickness and fascial thickness measurement will be made by ultrasonography at rest.
fascial slip
Measurements of the amount of slip measured during the movement of the fascial structures during shoulder and arm movements.
ultrasonography M-mode measurements shoulder abduction at 90 and 180 degrees Shoulder forward flexion at 90 and 180 degrees
Secondary Outcome Measures
VAS
visual analog scale (VAS) :for pain. 0: no pain at all, 10: worst pain imaginable
Full Information
NCT ID
NCT05359523
First Posted
April 27, 2022
Last Updated
April 30, 2022
Sponsor
Bursa Yüksek İhtisas Education and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05359523
Brief Title
Ultrasonographic Muscles and Fascia Measurement With Myofascial Pain Syndrome
Official Title
Investigation of the Diagnostic Effect of Ultrasonographic Measurement Values of Upper Back Muscles and Fascia in Patients With Myofascial Pain Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 1, 2022 (Anticipated)
Primary Completion Date
July 1, 2022 (Anticipated)
Study Completion Date
August 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bursa Yüksek İhtisas Education and Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Pathologies in the trapezius muscle and rhomboid muscle are important in the course and treatment of the disease in patients with myofascial pain syndrome.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myofascial Pain Syndrome
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients diagnosed with myofascial pain syndrome
Arm Type
Active Comparator
Arm Description
Ultrasound measurements will be made while the upper back is at rest and during arm movements.
Arm Title
Healthy volunteers
Arm Type
Active Comparator
Arm Description
Ultrasound measurements will be made while the upper back is at rest and during arm movements.
Intervention Type
Device
Intervention Name(s)
Ultrasonographic measurements of the trapezius and rhomboid muscle and fascia
Intervention Description
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
Primary Outcome Measure Information:
Title
Trapezius muscle and rhomboid muscle thickness
Description
Trapezius and rhomboid muscle thickness and fascial thickness measurement will be made by ultrasonography at rest.
Time Frame
20 minute
Title
fascial slip
Description
Measurements of the amount of slip measured during the movement of the fascial structures during shoulder and arm movements.
ultrasonography M-mode measurements shoulder abduction at 90 and 180 degrees Shoulder forward flexion at 90 and 180 degrees
Time Frame
20 minute
Secondary Outcome Measure Information:
Title
VAS
Description
visual analog scale (VAS) :for pain. 0: no pain at all, 10: worst pain imaginable
Time Frame
20 minute
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Burcu Metin Ökmen, Assoc. PhD.
Phone
+902242955000
Email
burcumetinokmen@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Korgün Ökmen, Assoc. PhD.
Organizational Affiliation
Bursa Yuksek Ihtisas Training and Research Hospital
Official's Role
Study Chair
12. IPD Sharing Statement
Learn more about this trial
Ultrasonographic Muscles and Fascia Measurement With Myofascial Pain Syndrome
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