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Completed

NCT Number: NCT06872216

Effect of Cupping Therapy on Microcirculation 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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tokat Gaziosmanpaşa üniversity

Tokat Province, 60100, Turkey (Türkiye)

About this study

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].

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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%

Treatment and study plan

Cupping therapy

Procedure

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.

Vascular occlusion test

Diagnostic 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.

Primary outcomes

  1. the rSO2 values

    Time frame: Periprocedural

    monitored at tenar region on the dominant hand with near infrared spectrometry

Secondary outcomes

  1. the time to reach the lowest rSO2

    Time frame: Periprocedural

    the interval of the basal and minimal rSO2 is measured

  2. the time to reach the highest values

    Time frame: Periprocedural

    the interval of the minimal to maximal rSO2 is measured

  3. the occlusion slope

    Time frame: Periprocedural

    The occlusion slope was calculated based on time to reach to the lowest rSO2 as [(baseline rSO2 -minimum rSO2)/ time to lowest rSO2], %/minute.

  4. Recovery slope

    Time frame: Periprocedural

    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.

  5. The 10th second recovery slope

    Time frame: Periprocedural

    The 10th second recovery slope was calculated as [(minimum rSO2 - at first 10th second rSO2)/ 10 second].

Sponsors and collaborators

Lead sponsor

Tokat Gaziosmanpasa University

Other

Registry information

Official study title

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

Acronym: CTWN

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 12, 2025
Registry last updated
Mar 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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