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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
Bursa Yüksek İhtisas Education and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Myofascial Pain Syndrome

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    April 27, 2022
    Last Updated
    April 30, 2022
    Sponsor
    Bursa Yüksek İhtisas Education and Research Hospital
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    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

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    Ultrasonographic Muscles and Fascia Measurement With Myofascial Pain Syndrome

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