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.
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.
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 group | Role | What they receive |
|---|---|---|
| The meridian effect of sham testing from mechanical stimulation | Experimental | 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. 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.
The Magnitude Value of Harmonic Effects of Sham Acupuncture at Tsu San Li (St-36) in the Radial Pulse Wave
Measured: two-year study
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.
- First posted28 Jun 2022
- Study start25 Sep 2018
- Primary completion24 Oct 2019
- Study completion24 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Harmonic WaveStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- China Medical University, Taichung, Taiwan,
- ClinicalTrials.gov ID
- NCT05434793
- Acronym / sponsor ID
- /CMUH107-REC2-145
- Conditions
- Harmonic Wave
- Keywords
- Sham Acupuncture, Arterial Pulse, Fourier Transformation, Harmonics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 25 Sep 2018 (actual)
- Primary completion
- 24 Oct 2019 (actual)
- Study completion
- 24 Oct 2019 (actual)
- First posted
- 28 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| The meridian effect of sham testing from mechanical stimulation | Experimental | Device: RJ-LASER, LASERPEN®; Reimers & Janssen, GermanyThe 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- OPD patients
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RJ-LASER, LASERPEN®; Reimers & Janssen, GermanyThe device was frequently used in laser acupuncture on the superficial skin of the acupuncture point Tsu San Li (St-36). | Device | The meridian effect of sham testing from mechanical stimulation |
Primary outcome
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 Phase Value of Harmonic Effects of Sham Acupuncture at Tsu San Li (St-36) in the Radial Pulse Wave
Time frame: two-year study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2022.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.