Clinical trial NCT06540781: The Efficacy of Wet Cupping Therapy on Cerebral Oxygenation
Official title: Investigation of Wet Cupping Therapy Effect on Cerebral Oxygenation Levels by NIRS
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cerebral Hypoxia
Keywords: Cerebral oxygenation
Wet cupping therapy
NIRS
Lead sponsor: Karabuk University
Sponsor class: OTHER
First posted: 2024-08-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single arm pretest-posttest interventional study
Primary purpose: PREVENTION

Brief summary: The aim of this clinical trial is to investigate the efficacy of wet cupping therapy (WCT) on cerebral oxygenation using the NIRS device. With the demonstration of the positive effect of the WCT on cerebral oxygenation, it was aimed to use it effectively in stroke rehabilitation.

In the outpatient clinic setting, firstly the sensor pads of the NIRS device will be attached to the arcus superciliaris (GB14) under the tuber frontalis on both sides. After the measurement is initiated, WCT will be applied to the planum occipitale (DU 20) and to the pars squamosa (GB6-8) of the temporal bone on the sides. Measurement will continue for 10 minutes during and after the WCT application. NIRS and oxygenation measurement data will be compared before, during, and after the WCT application.

Detailed description: The importance of NIRS is that it can detect differences in tissue oxygen uptake that cannot be routinely identified by existing methods (24). The ability of near-infrared (NIR; near infrared; wavelength 650 - 1100nm) light to penetrate tissues and to be absorbed by some chromophores (such as haemoglobin, cytochrome oxidase, bilirubin, urobilin) has formed the basis of regional cerebral oxygen saturation (rScO2) measurement (15). NIRS is a technique in which the amount of absorption of NIR light by chromophore molecules \[such as oxyhaemoglobin (O2Hb) and deoxyhaemoglobin (HHb), cytochrome-c oxidase (CCO), myoglobin\] is measured while passing through tissues (16). rScO2 values less than 40% or changes greater than 25% from baseline values may be a harbinger of cerebral ischaemia (17). Cerebral oximetry has attracted attention because it is easy to use and uncomplicated. NIRS should be used as a trend monitor.

In the current study, it is aimed to investigate the efficacy of wet cupping therapy (WCT) on cerebral oxygenation using the NIRS device. Following the enrollment of the healthy individuals, they will all receive one session of WCT. During the WCT application, the cerebral oxygenation levels will be measured with an NIRS device.

In the outpatient clinic setting, the NIRS device's sensor pads will be attached to the arcus superciliaris (GB14) under the tuber frontalis on both sides. After the measurement is initiated, WCT will be applied to the planum occipitale (DU 20) and the pars squamosa (GB6-8) of the temporal bone on the sides. Measurement will continue for 10 minutes during and after the WCT application. The data obtained by NIRS will be compared before, during, and after the WCT application so that we will be able to find out any possible effects of WCT on cerebral oxygenation.

Eligibility criteria: Inclusion Criteria:

* Healthy individual
* Age 18-65 years
* Consent to participate

Exclusion Criteria:

* Having received cupping therapy in the past 3 months
* Contraindications for WCT (such as hemoglobin level below 9.5 g/dL, bleeding disorders, receiving antithrombotic or antiplatelet therapy, INR value above 1.5),
* Coexisting chronic conditions and using any medication

Primary outcomes:
measure: Oxygen levels
timeFrame: Just before WCT application and 10 minutes after the application
Secondary outcomes:
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Kayseri City Hospital
Study officials:
affiliation: Kayseri research hospital
name: Ali R Benli
role: STUDY_CHAIR
References: