Effect of Cupping Therapy on Microcirculation in Healthy Volunteers (CTWN)

Evaluation the Impact of Dry Cupping Therapy on Microvascular Reactivity by Near-infrared Spectroscopy with Vascular Occlusion Test in Healthy Volunteers

Twenty healthy volunteers were included in the study. The NIRS was placed on the thenar region of the hand. The vascular occlusion protocol had been done before and after cupping therapy (CT). Regional oxygen saturation (rSO2), the times to the lowest and highest values were recorded. The occlusion slope, the recovery slope and the first 10 second recovery slope were calculated.

Study Overview

• Status: Completed
• Conditions: Microcirculation
• Intervention / Treatment: Procedure: cupping therapy; Diagnostic test: Vascular occlusion test

Detailed Description

Participants rested in a seated position at standard temperature for at least 10 minutes. A blood pressure cuff was applied to the upper arm, and the NIRS device (Covidien INVOS™ 5100C Cerebral/Somatic Oximeter, Dublin) was used to monitor regional oxygen levels in the thenar region of the hand throughout the protocol. After a 3-minute stabilization period, the vascular occlusion protocol commenced: the blood pressure cuff was inflated rapidly within 3-4 seconds to 50 mmHg above the baseline systolic blood pressure and maintained for 3 minutes, then deflated within 1 second. The participant rested for another 10 minutes before a certified cupping therapist placed a plastic therapy cup on the forearm, 5 cm from the medial and lateral epicondyles. The size of the cup was based on the participant's forearm, covering 50% of the area. The cup was vacuumed twice using a manual hand pump and left in place for 5 minutes before the air was released through the valve. Following a 3-minute stabilization period, the vascular occlusion protocol was repeated. During the test, rSO2 values and the time to reach the lowest and highest values were recorded. Using this data, the occlusion slope, recovery slope, and 10-second recovery slope were calculated. The occlusion slope was determined by the formula [(baseline rSO2 - minimum rSO2) / time to lowest rSO2], in %/minute. The recovery slope was calculated as [(minimum rSO2 - maximum rSO2) / time to reach the highest rSO2], in %/second. The 10-second recovery slope was calculated as [(minimum rSO2 - rSO2 at 10 seconds) / 10 seconds].

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Tokat, Turkey, 60100
    • Tokat Gaziosmanpasa University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 18-65 years old
• Healthy

Exclusion Criteria:

• Smoking or using tobacco products
• Taking alcohol or other substances, or any medication
• Have conditions affecting microcirculation
• Have acute or chronic pain
• Anemia
• Obesity
• Reynaud's phenomenon
• Baseline blood pressure being 140-90mmHg or above
• sPO2 value being below 96%

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: cupping therapy; nırs monitored during vot test pre-post cupping therapy

Procedure: cupping therapy; After the initial vascular occlusion test and a subsequent 10-minute rest period, the plastic therapy cup was placed on the forearm, 5 cm away from the medial and lateral epicondyles by a certified cupping therapist. The size of used cup was determined according to the size of the volunteer's forearm which cover 50% of the area. The cup was vacuumed two times full pumping with a manual hand pump and remained in place for 5 minutes. And then the air was removed by releasing the cups through the release valve.; Diagnostic test: Vascular occlusion test; A blood pressure cuff was placed on the upper arm. The adult probe of the NIRS device (Covidien INVOS™ 5100C Cerebral/Somatic Oximeter, Dublin) was placed on the thenar region of the ipsilateral hand and the regional oxygen value was recorded during all study term. Baseline arterial pressure and oxygen saturation were monitored (GE Healthcare Oy, Helsinki, Finland) from the side of dominant hand and recorded. After a 3-minute stabilization period, the vascular occlusion protocol was started. The blood pressure cuff was rapidly inflated within 3-4 seconds to 50 mmHg above baseline systolic blood pressure and kept at this pressure during 3 minutes. Following this, the cuff was deflated within 1 second. Five minutes after cupping therapy this protocol had done again.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the rSO2 values	monitored at tenar region on the dominant hand with near infrared spectrometry	Periprocedural

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the time to reach the lowest rSO2	the interval of the basal and minimal rSO2 is measured	Periprocedural
the time to reach the highest values	the interval of the minimal to maximal rSO2 is measured	Periprocedural
the occlusion slope	The occlusion slope was calculated based on time to reach to the lowest rSO2 as [(baseline rSO2 -minimum rSO2)/ time to lowest rSO2], %/minute.	Periprocedural
Recovery slope	Recovery slope was calculated based on the time to reach the highest rSO2 value as [(minimum rSO2 - maximum rSO2)/ time to reach the highest rSO2], %/second.	Periprocedural
The 10th second recovery slope	The 10th second recovery slope was calculated as [(minimum rSO2 - at first 10th second rSO2)/ 10 second].	Periprocedural

Collaborators and Investigators

• Sponsor: Tokat Gaziosmanpasa University

Publications and helpful links

General Publications

• Gomez H, Torres A, Polanco P, Kim HK, Zenker S, Puyana JC, Pinsky MR. Use of non-invasive NIRS during a vascular occlusion test to assess dynamic tissue O(2) saturation response. Intensive Care Med. 2008 Sep;34(9):1600-7. doi: 10.1007/s00134-008-1145-1. Epub 2008 Jun 4.
• Liu W, Piao S, Meng Xi, Wei L. Effects of cupping on blood flow under skin of back in healthy human. World Journal of Acupuncture - Moxibustion. 2013; 23 (3): 50-52. doi.org/10.1016/S1003-5257(13)60061-6.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Actual): January 1, 2023
• Study Completion (Actual): May 1, 2023

Study Registration Dates

• First Submitted: February 18, 2025
• First Submitted That Met QC Criteria: March 6, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 6, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: microcirculation; near-infrared spectroscopy; Cupping therapy
• Other Study ID Numbers: NIRS-CUPPİNG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No