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
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
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
NCT ID
NCT05022888
First Posted
August 21, 2021
Last Updated
August 25, 2021
Sponsor
Bursa Yüksek İhtisas Education and Research Hospital
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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