Near-Infrared Spectroscopy in Myofascial Pain Syndrome

August 25, 2021 updated by: Dr. Burcu Metin Ökmen, Bursa Yüksek İhtisas Education and Research Hospital

Investigation of the Diagnostic Effect of Muscle Tissue Oxygenation Values in Patients With Myofascial Pain Syndrome

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: myofascial pain syndrome
Patients diagnosed with myofascial pain syndrome Tissue oxygen saturation measured from 4 different regions defined on the trapezius muscle
Device: 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.
Active Comparator: Healthy volunteers
Healthy volunteers Tissue oxygen saturation measured from 4 different regions defined on the trapezius muscle
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
regional tissue saturation
Time Frame: 15 minute
tissue oxygen saturation measured from 4 different regions defined on the trapezius muscle. The NIRS probe will be used in these areas.
15 minute

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
peripheral oxygen saturation
Time Frame: 15 minute
A pulse oximeter will be used to measure peripheral oxygen saturation
15 minute
Visual Analogue Scale (VAS)
Time Frame: 6 month
for pain. 0: no pain at all, 10: worst pain imaginable
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bursa Yüksek İhtisas Education and Research Hospital

Investigators

  • Principal Investigator: Burcu M.D Metin ÖKMEN, Assoc. PhD., University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospital
  • Study Chair: Korgün MD Ökmen, Assoc. PhD., University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 23, 2021

Primary Completion (Anticipated)

November 23, 2021

Study Completion (Anticipated)

November 30, 2021

Study Registration Dates

First Submitted

August 21, 2021

First Submitted That Met QC Criteria

August 21, 2021

First Posted (Actual)

August 26, 2021

Study Record Updates

Last Update Posted (Actual)

August 30, 2021

Last Update Submitted That Met QC Criteria

August 25, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BYIERH3

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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