The Effect of Laser Acupuncture Stimuli at ZUSANLI(ST36) on Pulse Spectrum Variations

China Medical University, Taichung, Taiwan,

Background: Acupuncture has been criticized as a theatrical placebo for the sham effect. Unfortunately, sham tests used in control groups in acupuncture studies have always ignored the underlying biophysical factors, including resonance involved in acupuncture points and meridians.

Methods: In this study, the effects of sham acupuncture at Tsu San Li (St-36) were examined by analyzing noninvasive 30-sec. recordings of the radial arterial pulses for 3 groups of patients treated with different probes (blunt, sharp, and patch) on the superficial skin of the acupuncture point. The 3 groups were then treated with the sharp probe for 3 different periods (16, 30, and 50 seconds). Then the investigators compared the harmonics of the radial arterial pulse after Fourier transformation before and after the treatment.

Study Overview

• Status: Completed
• Conditions: Harmonic Wave
• Intervention / Treatment: Device: RJ-LASER, LASERPEN®; Reimers & Janssen, Germany

Detailed Description

Acupuncture has been criticized as a theatrical placebo for its sham effect. It is unfortunate that sham tests designed as the control group in acupuncture studies have always ignored the biophysical factors, resonance, in acupuncture points, and thus have led to confusing results. The investigators' previous studies revealed that specific frequency effects are found at the acupuncture points on the Fourier components of the radial arterial pulse. The nearby non-acupuncture point also has similar but insignificant effects as the acupuncture point.

Meridians are the groups of acupuncture points, and can be measured from the harmonics of the arterial pulse, and thus physicians who practice traditional Chinese Medicine use the pulse to diagnose disease, to evaluate patients' physical conditions, and even to predict death. The importance of the information within arterial pulse waves has long been recognized in clinical medicine. Arterial pulse wave analysis has been widely used in clinical practice, for example, in cases of hypertension, cardiac failure, and aging. The investigators' previous studies revealed that the pulse spectrum of the radial arterial pulse could be highly correlated among patients with abnormal liver function. The specific Fourier components in the pulse provide more physiologic information than do systolic and diastolic blood pressure measurements during the process of dying. In addition, pulse spectrum analysis can be used to differentiate atopic dermatitis with the third harmonic of the radial pulse, and the fourth harmonic of the radial pulse wave has been shown to predict adverse cardiac events in asymptomatic patients with type 2 diabetes. Recently, pulse spectrum analysis has facilitated the diagnosis of coronary artery disease. The investigators can qualitatively and quantitatively gain physiologic or pathologic information by measuring the harmonics of blood pressure because the resonance in the cardiovascular system is highly efficient for hemodynamic evolution design. Each organ and its related meridian are in resonance with a specific Fourier component of pressure waves.

Meridians present in harmonics are the biophysical design for resonance, showing that the heart drives the cardiovascular system with less than 2 watts. This tiny factor, including acupuncture, moxibustion, massage, bian stone, and acupressure, which change resonance, will redistribute the hemodynamics of the cardiovascular system and then appear in the harmonics of the arterial pulse. If the investigators do not consider resonance, meridian, and acupuncture, the investigators will miss the effect when designing a sham test.

This study was derived from the sham test for laser acupuncture, and the results showed that the sham effect cannot be ignored. Thus, the investigators examined the effect of sham acupuncture at Tsu San Li (St-36) by noninvasively recording the radial arterial pulses for patients treated with different types of probes (blunt, sharp, and patch) on the superficial skin of the acupuncture point for 30 sec. A second group of patients was tested with a sharp probe for differing amounts of time (16, 30, and 50 sec.). The investigators then compared the harmonics of the radial arterial pulse after the Fourier transformation before and after the treatment. The investigators hypothesized that harmonics could be physiologic indicators corresponding with the resonance on the tiny change of acupuncture point, and could explain the sham effect found in clinical studies.

• Study Type: Interventional
• Enrollment (Actual): 199
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Yu- Cheng Kuo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• OPD patients

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: The meridian effect of sham testing from mechanical stimulation; The effects of sham acupuncture at Tsu San Li (St-36) were examined by analyzing noninvasive 30-sec. recordings of the radial arterial pulses for 3 groups of patients treated with different probes (blunt, sharp, and patch) on the superficial skin of the acupuncture point. The 3 groups were then treated with the sharp probe for 3 different periods (16, 30, and 50 seconds). Then we compared the harmonics of the radial arterial pulse after Fourier transformation before and after the treatment.

Device: RJ-LASER, LASERPEN®; Reimers & Janssen, Germany; The device was frequently used in laser acupuncture on the superficial skin of the acupuncture point Tsu San Li (St-36).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The Magnitude Value of Harmonic Effects of Sham Acupuncture at Tsu San Li (St-36) in the Radial Pulse Wave	two-year study
The Phase Value of Harmonic Effects of Sham Acupuncture at Tsu San Li (St-36) in the Radial Pulse Wave	two-year study

Collaborators and Investigators

• Sponsor: China Medical University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2018
• Primary Completion (Actual): October 24, 2019
• Study Completion (Actual): October 24, 2019

Study Registration Dates

• First Submitted: April 21, 2021
• First Submitted That Met QC Criteria: June 27, 2022
• First Posted (Actual): June 28, 2022

Study Record Updates

• Last Update Posted (Actual): June 28, 2022
• Last Update Submitted That Met QC Criteria: June 27, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Sham Acupuncture; Arterial Pulse; Fourier Transformation; Harmonics
• Other Study ID Numbers: /CMUH107-REC2-145

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No