Clinical trial NCT06872216: Effect of Cupping Therapy on Microcirculation in Healthy Volunteers
Official title: Evaluation the Impact of Dry Cupping Therapy on Microvascular Reactivity by Near-infrared Spectroscopy with Vascular Occlusion Test in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Microcirculation
Keywords: Cupping therapy
microcirculation
near-infrared spectroscopy
Lead sponsor: Tokat Gaziosmanpasa University
Sponsor class: OTHER
First posted: 2025-03-12
Enrollment: 20
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
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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 \[(minimum rSO2 - rSO2 at 10 seconds) / 10 seconds\].

Eligibility criteria: 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%

Primary outcomes:
measure: the rSO2 values
timeFrame: Periprocedural
Secondary outcomes:
measure: the time to reach the lowest rSO2
timeFrame: Periprocedural
measure: the time to reach the highest values
timeFrame: Periprocedural
measure: the occlusion slope
timeFrame: Periprocedural
measure: Recovery slope
timeFrame: Periprocedural
measure: The 10th second recovery slope
timeFrame: Periprocedural
Other outcomes:
Locations:
city: Tokat
country: Turkey
facility: Tokat Gaziosmanpaşa üniversity
Study officials:
References:
citation: 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.
citation: 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.