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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05022888
Other study ID # BYIERH3
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date August 23, 2021
Est. completion date November 30, 2021

Study information

Verified date August 2021
Source Bursa Yüksek Ihtisas Education and Research Hospital
Contact Burcu M.D Metin ÖKMEN, Assoc. PhD.
Phone +902242955000
Email burcumetinokmen@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date November 30, 2021
Est. primary completion date November 23, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Bursa Yüksek Ihtisas Education and Research Hospital

Outcome

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