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Harmonic WaveNCT05434793

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

A study testing RJ-LASER, LASERPEN®; Reimers & Janssen, Germany in people with Harmonic Wave, run by China Medical University Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Harmonic Wave
What is being tested?
RJ-LASER, LASERPEN®; Reimers & Janssen, Germany
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
199 participants
Where
1 siteTaiwan
Study dates
25 Sep 2018to 24 Oct 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • OPD patients

Who cannot join

  • None

Trial locations and contacts

1 site in 1 country.

Taiwan1 site
  • Yu- Cheng Kuo

    Taipei

Other trials in Taiwan

About this study

Official title: 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.

Read the 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.

Conditions
Harmonic Wave
Being tested
RJ-LASER, LASERPEN®; Reimers & Janssen, Germany
Keywords
Sham Acupuncture, Arterial Pulse, Fourier Transformation, Harmonics

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RJ-LASER, LASERPEN®; Reimers & Janssen, GermanyDevice

    The device was frequently used in laser acupuncture on the superficial skin of the acupuncture point Tsu San Li (St-36).

Study groups in NCT05434793
Study groupRoleWhat they receive
The meridian effect of sham testing from mechanical stimulationExperimentalThe 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.
Receives: Device: RJ-LASER, LASERPEN®; Reimers & Janssen, Germany

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Magnitude Value of Harmonic Effects of Sham Acupuncture at Tsu San Li (St-36) in the Radial Pulse Wave

    Measured: two-year study

  2. The Phase Value of Harmonic Effects of Sham Acupuncture at Tsu San Li (St-36) in the Radial Pulse Wave

    Measured: two-year study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jun 2022
  2. Study start25 Sep 2018
  3. Primary completion24 Oct 2019
  4. Study completion24 Oct 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Model description
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.
Masking
None (open label)
Enrolment
199 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05434793
Sponsor's protocol ID
/CMUH107-REC2-145
Status last verified
Jun 2022
First submitted
21 Apr 2021
Last updated
28 Jun 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing RJ-LASER, LASERPEN®; Reimers & Janssen, Germany in people with Harmonic Wave, run by China Medical University Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Magnitude Value of Harmonic Effects of Sham Acupuncture at Tsu San Li (St-36) in the Radial Pulse Wave (time frame: two-year study). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2022.

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