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Near-Infrared Spectroscopy in Myofascial Pain Syndrome

Primary Purpose

Myofascial Pain Syndrome, Regional Tissue Oxygen Saturation

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
regional tissue saturation
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 - 65 Years (Adult, Older 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

    myofascial pain syndrome

    Healthy volunteers

    Arm Description

    Patients diagnosed with myofascial pain syndrome Tissue oxygen saturation measured from 4 different regions defined on the trapezius muscle

    Healthy volunteers Tissue oxygen saturation measured from 4 different regions defined on the trapezius muscle

    Outcomes

    Primary Outcome Measures

    regional tissue saturation
    tissue oxygen saturation measured from 4 different regions defined on the trapezius muscle. The NIRS probe will be used in these areas.

    Secondary Outcome Measures

    peripheral oxygen saturation
    A pulse oximeter will be used to measure peripheral oxygen saturation
    Visual Analogue Scale (VAS)
    for pain. 0: no pain at all, 10: worst pain imaginable

    Full Information

    First Posted
    August 21, 2021
    Last Updated
    August 25, 2021
    Sponsor
    Bursa Yüksek İhtisas Education and Research Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05022888
    Brief Title
    Near-Infrared Spectroscopy in Myofascial Pain Syndrome
    Official Title
    Investigation of the Diagnostic Effect of Muscle Tissue Oxygenation Values in Patients With Myofascial Pain Syndrome
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 23, 2021 (Anticipated)
    Primary Completion Date
    November 23, 2021 (Anticipated)
    Study Completion Date
    November 30, 2021 (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
    Yes

    5. Study Description

    Brief Summary
    Myofascial pain syndrome is a regional pain syndrome accompanied by sensorial, motor and autonomic symptoms . myofascial trigger points are most frequently detected in the upper trapezius, levator scapula, and axial postural muscles such as rhomboid major. Myofascial pain syndrome is characterized by active myofascial trigger points in the form of focal hyperirritable nodules palpated in the tight band of the muscle . Alteration of tissue vascularization could limit or prevent th may cause adhesions, contractures and pain. As a result of decreased blood flow, tissue oxygenation may decrease.
    Detailed Description
    In this study, it will be tried to determine the role of muscle tissue oxygenation in the activity and diagnosis of the disease in myofascial pain syndrome.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Myofascial Pain Syndrome, Regional Tissue Oxygen Saturation

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    prospective
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    myofascial pain syndrome
    Arm Type
    Active Comparator
    Arm Description
    Patients diagnosed with myofascial pain syndrome Tissue oxygen saturation measured from 4 different regions defined on the trapezius muscle
    Arm Title
    Healthy volunteers
    Arm Type
    Active Comparator
    Arm Description
    Healthy volunteers Tissue oxygen saturation measured from 4 different regions defined on the trapezius muscle
    Intervention Type
    Device
    Intervention Name(s)
    regional tissue saturation
    Intervention Description
    tissue oxygen saturation measured from 4 different regions defined on the trapezius muscle. The NIRS probe will be used in these areas.
    Primary Outcome Measure Information:
    Title
    regional tissue saturation
    Description
    tissue oxygen saturation measured from 4 different regions defined on the trapezius muscle. The NIRS probe will be used in these areas.
    Time Frame
    15 minute
    Secondary Outcome Measure Information:
    Title
    peripheral oxygen saturation
    Description
    A pulse oximeter will be used to measure peripheral oxygen saturation
    Time Frame
    15 minute
    Title
    Visual Analogue Scale (VAS)
    Description
    for pain. 0: no pain at all, 10: worst pain imaginable
    Time Frame
    6 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 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 M.D Metin ÖKMEN, Assoc. PhD.
    Phone
    +902242955000
    Email
    burcumetinokmen@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Burcu M.D Metin ÖKMEN, Assoc. PhD.
    Organizational Affiliation
    University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospital
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Korgün MD Ökmen, Assoc. PhD.
    Organizational Affiliation
    University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospital
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    Near-Infrared Spectroscopy in Myofascial Pain Syndrome

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