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Laser AcupunctureNCT05458713

The Effect of Laser Acupuncture in Different Meridians on the Autonomic Nervous System and Its Brain Mechanisms

A study testing Laser acupuncture in people with Laser Acupuncture and Meridian, run by China Medical University, Taiwan 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

Traditional Chinese acupuncture has a history of several thousand years. The World Health Organization has published guidelines describing the efficacy of acupuncture in the cure or relief of 64 different symptoms and conditions as one of the most representative intangible cultural heritage of humanity. Read more about this study

Who is it for?
Ages 20 to 55 yearsHealthy volunteers can take part
What is being tested?
Laser acupuncture
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
103 participants
Where
1 siteTaiwan
Study dates
13 Nov 2022to 31 Dec 2024
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 20 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy adults between the ages of 20 and 55.
  • Body Mass Index (BMI) should fall between 18.5 and 24 kg/m2.
  • Voluntarily sign the subject's consent form reviewed and approved by the human trial committee, indicating voluntary participation in the research.

Who cannot join

  • Those diagnosed with chronic diseases such as coronary artery disease, diabetes, hypertension, hyperlipidemia, cancer, etc.
  • With the brain diseases, such as epilepsy, stroke, Parkinson's disease, dementia, brain tumor, traumatic brain injury, head trauma or brain surgery, etc.
  • The positive result for wrist Tinel sign, or who have experienced neurological symptoms such as median nerve compression recently and during the experiment.
  • Patients with mental disorders, such as major depression, bipolar disorder, generalized anxiety disorder, claustrophobia, schizophrenia, etc.
  • Cannot follow the instructions to perform the experiment due to hyperactivity and agitation.
  • Taken neuropsychiatric drugs (such as sleeping pills, anti-anxiety drugs) or pain relievers and other drugs that affect nerve activity in the past three months.
Show all 9Show fewer
  • Pregnant, plan to pregnant, or menopausal women.
  • Having metal implants in the body, or equipping with a pacemaker.
  • With scars or open wounds at the acupoints selection site, or the skin condition at the site may affect the selection of acupoints or laser acupuncture.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site
  • China Medical University

    Taichung, 404

Other trials in Taiwan

About this study

Traditional Chinese acupuncture has a history of several thousand years. The World Health Organization has published guidelines describing the efficacy of acupuncture in the cure or relief of 64 different symptoms and conditions as one of the most representative intangible cultural heritage of humanity. In recent years, the applications of laser acupuncture, or so-called low-level laser therapy which are belong to the domain of photobiomodulation therapy, become widespread. Laser acupuncture is not only applicate to stimuli specific areas in need, but also one of non-invasive intervention technic with hurtles intervention, no hematoma, bleeding or swelling unpleasant feeling after intervention, which could be more accepted by children, weakness people, and patients who afraid of acupuncture. However, the underlined mechanisms and the neural pathway of laser acupuncture are still obscure.

The inconsistent results from previous studies have been reported that laser acupuncture stimulation on the Neiguan (PC 6), the acupoint of Pericardium meridian, could affect the autonomic nerve system in terms of heart rate, blood pressure, activities of sympathetic and/or parasympathetic nerves. The results of previous studies on the changes of autonomic nervous system (ANS) caused by laser acupuncture on Neiguan (PC6), an acupoint of the pericardium meridian, have been inconsistent. Our preliminary results show that laser acupuncture on PC6 seems to have a biphasic dosage effect on the ANS changes. However, little is known about the possible central mechanisms underpinned these ANS changes. In addition, whether laser acupuncture on different meridians will also induce a biphasic dosage effect on the ANS is still unknown. Therefore, the main purposes of this project are: 1) to explore the changes of ANS and associated brain networks by applying laser acupuncture with on PC6 different intensities; and 2) to explore whether applying laser acupuncture on different meridians will have different ANS and related brain network responses. In this two-year, single-blind, parallel experiment design project, the recruited healthy subjects will randomly assign to the group with high energy density, low energy density, or no energy of laser acupuncture on PC6 (in first year) or on Shugu (in second year), which is an acupoint of the bladder meridian (BL65). Via a non-invasive wearable photoplethysmography, the peripheral pulse rate variability will be calculated as the index of ANS changes. In addition, the resting-state functional MRI scans will be performed before and after laser acupuncture to explore the immediate changes in the brain networks that may regulates the activity of ANS. The investigators hope that through the application of modern scientific methods to probe the meridian phenomenon in Chinese medicine, The investigators can further understand the neurological mechanisms of the meridian and provide a new insight for the traditional meridian theory of Chinese medicine.

Read the detailed description

Acupuncture therapy is an important branch of traditional Chinese medicine for the treatment of clinical diseases. However, due to its more invasive treatment, some patients (such as children or patients with trauma to acupoints) are not suitable for this treatment. In recent years, laser acupuncture (irradiating acupoints with low-power lasers) has gradually become popular in the clinical application of traditional Chinese medicine because of its non-invasiveness, no pain, and few side effects. There are many domestic and foreign case reports showing that it may have curative effects . For example, in patients with severe peripheral facial nerve palsy who have not been significantly improved for 12 years, after four months of laser acupuncture intervention, the affected side of the eye can be completely closed, and the sagging facial muscles on the affected side can be significantly raised. For severe sciatica patients with an average Visual Analogue Scale (VAS) score of 9.6, the pain was relieved by more than half after the first laser acupuncture, and their symptoms disappeared completely after the 56th intervention. For children with low acceptance of traditional acupuncture, some studies have also pointed out that laser acupuncture treatment for about 12 times a month can effectively improve children with tension-type cerebral palsy due to central regulation problems. of muscle spasm, especially in the biceps brachii, iliopsoas, thigh adductor muscle group, etc., the effect is more significant. For carpal tunnel syndrome, studies have also confirmed that after about 20 laser acupuncture interventions a month, the symptoms of peripheral carpal tunnel syndrome have been significantly improved.

Although the above-mentioned clinical cases and studies have shown that laser acupuncture may have clinical efficacy in some diseases, its mechanism is not yet clear. At present, most of its clinical efficacy is explained by the mechanism of photomodulation therapy, that is, after laser stimulation, it will change the redox reaction of local mitochondria, promote the synthesis of ATP and increase the body\'s energy source, and can activate endocrine regulation, regulate the concentration of neurotransmitters, anti-inflammatory, and restore blood circulation, thereby resulting in a series of clinical effects such as repair and functional recovery. However, laser acupuncture has not accumulated as many research results as traditional acupuncture, and the mechanism through which the central nervous system achieves clinical efficacy has not been extensively explored, let alone its relationship with the meridians. Several pilot studies have previously performed laser acupuncture at different acupoints and observed changes in heart rate variability (HRV) to explore whether laser acupuncture could alter the autonomic nervous system. However, due to the differences in operating parameters such as wavelength, time, output power, probe size, and even energy density of laser acupuncture, the research results on whether laser acupuncture affects HRV and even the autonomic nervous system are inconsistent. Some reports show that laser acupuncture at Neiguan can increase the overall power of HRV, but other studies show no significant change. If the effect of laser acupuncture on sympathetic or parasympathetic nerve activity is further analyzed, it has been reported that in subjects on night shifts, laser acupuncture at Neiguan acupoint can significantly increase parasympathetic nerve activity and reduce sympathetic nerve activity . However, in patients with chronic insomnia, laser acupuncture at Neiguan acupoint significantly increased sympathetic nerve activity and decreased parasympathetic nerve activity. Therefore, there is still a lot of room to be clarified and explored in the way of laser acupuncture at Neiguan, the influence on the autonomic nervous system, and its possible central nervous system.

Research Objectives Past research on light modulation therapy has pointed out that its dose effect often presents a biphasic dosage effect, that is, the Arndt-Schulz law: after the dose exceeds the minimum threshold, the effect of the low dose area increases with the dose increase, but The effect in high-dose regions decreases with increasing dose. Therefore, the inconsistent results of laser acupuncture at Neiguan acupoint on HRV and even the autonomic nervous system may also be related to the biphasic dose effect. The purpose of this study is to 1) explore the changes in the autonomic nervous system and brain activities caused by laser acupuncture of different intensities on Neiguan point; 2) to explore whether laser acupuncture is accompanied by different autonomic nerve responses and brain activities on acupoints of different meridians. In this study, the investigators expected to recruit healthy subjects, and in a parallel experimental design, the three-intensity laser was applied to the Neiguan point on the pericardium meridian or the Shugu point (BL65) of the bladder meridian with high, low and no intensities Acupuncture, through PRV changes (such as heartbeat, systolic blood pressure, diastolic blood pressure, heartbeat interval, low frequency power, high frequency power, low/high frequency power ratio, etc.), observe the effect on the autonomic nervous system. In addition, resting-state fMRI was also used to understand the corresponding changes in the regulation of autonomic nervous system-related brain network activity before and after laser acupuncture. Through these designs, the investigators hope to explore the relationship between laser acupuncture dose, autonomic changes, and changes in related brain network activity to clarify their possible neural mechanisms. And by extension, compare it with the bladder meridian of Foot Taiyang, analyze the meridian phenomenon contained in the pericardium meridian of handicapped Jueyin, and conduct a pilot study on its possible clinical treatment of neural mechanism.

Being tested
Laser acupuncture
Keywords
pericardium meridian, laser acupuncture, pulse rate variability, Resting-state functional magnetic resonance imaging, bladder meridian

What participants receive

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

  • Laser acupunctureDevice

    Irradiate acupoints with low power laser

Study groups in NCT05458713
Study groupRoleWhat they receive
PC6 High Energy groupExperimentalThe participants of this group will be irradiated with a 4mm probe for 60 seconds with an output power of 100mW on PC6 (acupoint Neiguan).
Receives: Device: Laser acupuncture
PC6 Low Energy groupExperimentalThe participants of this group will be irradiated with a 4mm probe for 20 seconds with an output power of 100mW on PC6 (acupoint Neiguan).
Receives: Device: Laser acupuncture
PC6 Placebo groupPlacebo comparatorThe participants of this group will be irradiated with a 4mm probe for 0 seconds with an output power of 100mW on PC6 (acupoint Neiguan).
Receives: Device: Laser acupuncture
BL65 High Energy groupActive comparatorThe participants of this group will be irradiated with a 4mm probe for 60 seconds with an output power of 100mW on BL65 (acupoint Shugu).
Receives: Device: Laser acupuncture
BL65 Low Energy groupActive comparatorThe participants of this group will be irradiated with a 4mm probe for 20 seconds with an output power of 100mW on BL65 (acupoint Shugu).
Receives: Device: Laser acupuncture
BL65 Sham groupSham comparatorThe participants of this group will be irradiated with a 4mm probe for 0 seconds with an output power of 100mW on BL65 (acupoint Shugu).
Receives: Device: Laser acupuncture

What is being measured

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

  1. Functional connectivity in brain

    The changes of functional connectivity with laser acupuncture intervention

    Measured: 500 seconds before and 30 seconds after laser acupuncture intervention

Secondary outcomes (1)
  1. Heart rate variability (HRV)

    The changes of heart rate variability (HRV) with laser acupuncture intervention

    Measured: 500 seconds before and 30 seconds after laser acupuncture intervention

Timeline

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

  1. First posted14 Jul 2022
  2. Study start13 Nov 2022
  3. Primary completion31 Jul 2024
  4. Study completion31 Dec 2024

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
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
103 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05458713
Sponsor's protocol ID
MOST 111-2320-B-039-031-MY2
Status last verified
Mar 2026
First submitted
10 Jul 2022
Last updated
12 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Laser acupuncture in people with Laser Acupuncture and Meridian, run by China Medical University, Taiwan 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 3 inclusion and 9 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 12 Mar 2026. 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. Some participants in this study may receive a placebo. 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?

Functional connectivity in brain (time frame: 500 seconds before and 30 seconds after laser acupuncture intervention). 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 12 Mar 2026.

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