ESRD (End Stage Renal Disease)LA-HD-FatigueNCT07538310
Laser Acupuncture for Fatigue in Hemodialysis Patients
A study testing Low-Level Laser Acupuncture (LA) in people with ESRD (End Stage Renal Disease) and Dialysis, run by Taipei City Hospital at 1 site in Taiwan.
Trial summary
The goal of this clinical trial is to learn if laser acupuncture (low-level laser therapy) works to treat fatigue and improve quality of life in adults with end-stage renal disease (ESRD) undergoing hemodialysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ESRD (End Stage Renal Disease), Dialysis, Fatigue
- What is being tested?
- Low-Level Laser Acupuncture (LA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 8 Apr 2026to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with End-Stage Renal Disease (ESRD) who require regular maintenance hemodialysis.
- Must undergo hemodialysis treatment at least 3 times per week.
- Aged 18 years or older.
- Willing and able to provide informed consent to participate in the study.
Who cannot join
- Presence of acute infectious symptoms.
- Unstable vital signs.
- Diagnosis of malignant tumors.
- Pregnancy.
- Presence of open wounds at the sites designated for laser intervention.
- Patients with implanted cardiac pacemakers or other cardiac devices.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei City Hospital, Renai Branch
Taipei, 106
Ming Jen Wang, MD, +886-930-766-631, wanters0800@gmail.com
Ming Jen Wang, MD, 886-02-2709-3600 ext. 5213, dba77@tpech.gov.tw
About this study
Official title: Laser Acupuncture Improves Fatigue and Quality of Life in Hemodialysis Patients: a Randomized Double-blind Clinical Trial Pilot Study
The goal of this clinical trial is to learn if laser acupuncture (low-level laser therapy) works to treat fatigue and improve quality of life in adults with end-stage renal disease (ESRD) undergoing hemodialysis. It will also learn about how laser acupuncture affects blood circulation and autonomic nervous system balance.
The main questions it aims to answer are:
Read more
- Does laser acupuncture reduce the severity of fatigue and its interference with daily life?
- Can laser acupuncture improve related symptoms such as insomnia, poor appetite, and skin itching?
- How does laser acupuncture affect objective markers like microcirculation and heart rate variability? Researchers will compare laser acupuncture to a sham treatment (a look-alike procedure using a device that does not emit a laser) to see if laser acupuncture works to treat fatigue.
Participants will:
- Receive laser acupuncture or a sham treatment during their regular hemodialysis sessions 3 times a week for 4 weeks.
- Have their fatigue and life quality assessed through questionnaires on the first day, at 4 weeks, and at 8 weeks.
- Undergo non-invasive tests to measure microcirculation, heart rate variability, and pulse waves, and have photos of their tongue taken for Chinese medicine assessment.
Read the detailed description
Scientific Rationale Fatigue is a prevalent and debilitating symptom in patients with end-stage renal disease (ESRD) undergoing maintenance hemodialysis (HD). It is a multidimensional condition influenced by anemia, uremia, and the long-term psychosocial stress of dialysis. Conventional pharmacological treatments often yield limited efficacy for fatigue and sleep disturbances while posing risks of adverse effects. Non-pharmacological interventions, such as acupressure and exercise, have shown potential, but high-quality clinical evidence remains insufficient. Laser acupuncture (LA), or photobiomodulation (PBM), is a non-invasive, non-thermal therapy that applies low-level laser energy to traditional acupuncture points. It is proposed to modulate mitochondrial function, reduce oxidative stress, and inhibit inflammatory responses, offering a safe alternative for patients who may not be suitable for or are fearful of traditional needle acupuncture.
Study Protocol and Intervention This is a randomized, double-blind, sham-controlled pilot trial. A total of 50 participants will be recruited from the hemodialysis center and randomly assigned to either the experimental (LA) group or the sham control group in a 1:1 ratio.
- Experimental Group: Participants will receive low-level laser therapy at specific acupoints: KI1 (Yongquan), ST36 (Zusanli), SP10 (Xuehai), PC8 (Laogong), EX-UE9 (Bafeng), EX-UE9 (Baxie), and LU9 (Taiyuan). Each session lasts 15-30 minutes, administered 3 times per week during the dialysis process for a duration of 4 weeks.
- Sham Control Group: Participants will undergo an identical procedure using a sham device that mimics the operation and appearance of the laser equipment but does not emit actual laser energy, ensuring the maintenance of blinding.
Technical Assessment and Data Analysis
To objectively evaluate the systemic effects of LA on the circulatory and autonomic nervous systems, this study integrates several biomedical engineering technologies:
- Microcirculation Analysis: Skin microvascular blood flow and blood volume changes are monitored using Laser Doppler Flowmetry (LDF) and Photoplethysmography (PPG).
- Vascular and Autonomic Assessment: Brachial Pulse Wave (BPW) analysis will be used to evaluate arterial stiffness, while Heart Rate Variability (HRV) will assess the balance of the sympathetic and parasympathetic nervous systems.
- Traditional Chinese Medicine (TCM) Evaluation: Standardized tongue diagnosis photography and the Constitution in Chinese Medicine Questionnaire (CCMQ) will be used to track changes in the participants' TCM constitutional types and internal "Qi" and blood status.
Statistical analysis will utilize t-tests or Mann-Whitney U tests to compare symptom improvement between groups. Mixed-effects models or Generalized Estimating Equations (GEE) will be employed to evaluate the long-term impact of treatment on blood pressure and microcirculation while controlling for potential confounding factors such as age and dialysis vintage.
- Conditions
- ESRD (End Stage Renal Disease), Dialysis, Fatigue
- Being tested
- Low-Level Laser Acupuncture (LA), Sham Laser Acupuncture
- Keywords
- Hemodialysis, End-Stage Renal Disease, Laser Acupuncture, Photobiomodulation, Fatigue, Quality of Life, Microcirculation, Low-Level Laser Therapy, Traditional Chinese Medicine, Heart Rate Variability
- Medical subject headings
- Renal Insufficiency, Chronic, Fatigue, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-Level Laser Acupuncture (LA)Device
Device: Low-level laser therapy (LLLT) device. Acupoints: KI1 (Yongquan), ST36 (Zusanli), SP10 (Xuehai), PC8 (Laogong), EX-UE9 (Bafeng), EX-UE9 (Baxie), and LU9 (Taiyuan).
Dosage/Frequency: Administered 3 times per week during the hemodialysis process for 4 weeks.
Duration: Each treatment session lasts approximately 15 to 30 minutes.
Sham Laser AcupunctureDevice
Description:Device: An inactive sham laser device that is identical in appearance and operational procedure to the active device.
Procedure: The device will be applied to the same 7 acupoints (KI1, ST36, SP10, PC8, Bafeng, Baxie, LU9) for 15-30 minutes.
Blinding: The device will not emit actual laser energy but will mimic the treatment process to maintain participant blinding.
Frequency: 3 times per week for 4 weeks during hemodialysis.
| Study group | Role | What they receive |
|---|---|---|
| Laser Acupuncture Group | Experimental | Active low-level laser therapy at 7 specific acupoints. Receives: Device: Low-Level Laser Acupuncture (LA) |
| Sham Control Group | Sham comparator | Inactive laser treatment using an identical-looking device without energy output. Receives: Device: Sham Laser Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS for fatigue
The VAS is a subjectively reported scale used to evaluate fatigue intensity. Participants mark their fatigue level on a 100-mm line ranging from "no symptoms" (0) to "most severe symptoms" (100). Higher scores indicate more severe fatigue.
Measured: Baseline (Day 0), Week 4 (end of intervention), and Week 8 (follow-up).
Brief Fatigue Inventory (BFI)
The BFI consists of 9 items assessing the severity of fatigue and its impact on daily functional activities over the past week. Each item is scored from 0 to 10, with higher total scores representing more severe fatigue and greater interference with daily life.
Measured: Baseline (Day 0), Week 4 (end of intervention), and Week 8 (follow-up).
Secondary outcomes (7)
Kidney Disease Quality of Life 36 (KDQOL-36)
Kidney Disease Quality of Life (KDQOL). A specific instrument to assess the quality of life in patients with kidney disease. The scores range from 0 to 100, where higher scores represent a better quality of life (better health status).
Measured: Baseline, Week 4, and Week 8.
Laser Doppler Flowmetry Analysis (LDFA) Score
Integrate multiple features from the Laser Doppler Flowmetry (LDF) thermal hyperemia process, including the amplitudes of various peaks and the total area under the curve, into a single continuous variable score via a specific computational model. This score is utilized to evaluate the overall physiological status of the microcirculation. Since the score is a continuous variable, it does not have a predefined minimum or maximum limit. Higher numerical values indicate higher peripheral blood flow velocity and better microvascular function.
Measured: Baseline, Week 4, and Week 8.
Photoplethysmography Analysis (PPGA) Score
A composite score derived from PPG signals. The PPG waveform is captured through photoelectric conversion and processed using Fast Fourier Transform (FFT) to obtain the frequency domain spectrum. Specific spectral features are extracted and integrated based on the Harmonic Series Principle to calculate the final PPGA score.
Since the score is a continuous variable based on spectral energy distribution, it does not have a predefined maximum limit. Higher numerical values indicate a pulse pattern more consistent with healthy physiological status.
Measured: Baseline, Week 4, and Week 8.
Brachial Pulse Wave Analysis (BPWA) score
A composite score derived from the Brachial Pulse Wave (BPW) to assess the hemodynamic characteristics and arterial stiffness of the upper limb. The brachial pressure waveform is captured and processed using Fast Fourier Transform (FFT) to obtain the frequency domain spectrum. Specific spectral features are extracted and integrated based on the Harmonic Series Principle to calculate the final BPWA score.
Since the score is a continuous variable based on spectral energy distribution, it does not have a predefined minimum or maximum limit. Higher numerical values indicate a pulse pattern more consistent with healthy arterial elasticity and physiological status.
Measured: Baseline, Week 4, and Week 8.
Heart Rate Variability (HRV)
Analysis of time variations between heartbeats to assess the balance between sympathetic and parasympathetic nervous systems and overall stress status.
Measured: Baseline, Week 4, and Week 8.
Constitution in Chinese Medicine Questionnaire (CCMQ)
Constitution in Chinese Medicine Questionnaire (CCMQ). This scale assesses the individual's TCM constitution. Each subscale score ranges from 0 to 100. For the "Gentle" (Neutral) constitution, higher scores indicate a healthier state. For the other eight "Biased" constitutions (e.g., Yang-deficiency, Qi-stasis), higher scores indicate a more severe imbalance or worse condition.
Measured: Baseline, Week 4, and Week 8.
Tongue Moisture Index (TMI)
An assessment of tongue moisture using an Artificial Intelligence (AI) image recognition system. The AI model analyzes digital tongue images to extract hydration-related features and classifies or scores the degree of moisture. The score ranges from 0 to 100, where a higher score indicates a higher level of tongue hydration (more moisture).
Measured: Baseline, Week 4, and Week 8.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start8 Apr 2026
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ESRD (End Stage Renal Disease)Studies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized, double-blind, sham-controlled, parallel-group pilot trial. Eligible participants with End-Stage Renal Disease (ESRD) undergoing regular hemodialysis will be randomly assigned to either the Laser Acupuncture (LA) group or the Sham Control group in a 1:1 ratio. Each group will follow their assigned intervention protocol simultaneously for a duration of 4 weeks, with clinical outcomes and physiological markers assessed at baseline, 4 weeks, and 8 weeks to evaluate both immediate and follow-up effects.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei City Hospital
- Sponsor type
- Other government
- Collaborators
- National Yang Ming Chiao Tung University, National Taiwan University of Science and Technology
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07538310
- Sponsor's protocol ID
- TCHIRB-11405003
- Acronym
- LA-HD-Fatigue
- Status last verified
- Oct 2026
- First submitted
- 5 Apr 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data that underlie the results reported in future publications (including text, tables, figures, and appendices) will be made available to qualified researchers for academic purposes.
Publications
Saito M, Jingu H, Osawa H, Oyama Y, Tanaka T, Shiono A, Machida M. Pulse Amplitude Measured with a Portable Laser Doppler Flowmeter Is Useful for Screening of Dialysis Patients for Peripheral Arterial Disease: An Observational Study. Ann Vasc Dis. 2022 Dec 25;15(4):301-307. doi: 10.3400/avd.oa.21-00126.
PubMed 36644273Yang J, Mallory MJ, Wu Q, Bublitz SE, Do A, Xiong D, Chen CYY, Dorsher PT, Chon TY, Bauer BA. The Safety of Laser Acupuncture: A Systematic Review. Med Acupunct. 2020 Aug 1;32(4):209-217. doi: 10.1089/acu.2020.1419. Epub 2020 Aug 13.
PubMed 32874405Natale P, Ju A, Strippoli GF, Craig JC, Saglimbene VM, Unruh ML, Stallone G, Jaure A. Interventions for fatigue in people with kidney failure requiring dialysis. Cochrane Database Syst Rev. 2023 Aug 31;8(8):CD013074. doi: 10.1002/14651858.CD013074.pub2.
PubMed 37651553Bian J, Liebert A, Bicknell B, Chen XM, Huang C, Pollock CA. Therapeutic Potential of Photobiomodulation for Chronic Kidney Disease. Int J Mol Sci. 2022 Jul 21;23(14):8043. doi: 10.3390/ijms23148043.
PubMed 35887386Chang YP, Lin CC, Wu JH, Hsieh YH, Chou KH, Su CT. The impact of photobiomodulation on sleep and life quality in hemodialysis patients: A randomized controlled trial. Lasers Med Sci. 2024 Jul 3;39(1):169. doi: 10.1007/s10103-024-04114-y.
PubMed 38958682
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laser Acupuncture Improves Fatigue and Quality of Life in Hemodialysis Patients: a Randomized Double-blind Clinical Trial Pilot Study
- ClinicalTrials.gov ID
- NCT07538310
- Acronym / sponsor ID
- LA-HD-Fatigue / TCHIRB-11405003
- Conditions
- ESRD (End Stage Renal Disease), Dialysis, Fatigue
- Keywords
- Hemodialysis, End-Stage Renal Disease, Laser Acupuncture, Photobiomodulation, Fatigue, Quality of Life, Microcirculation, Low-Level Laser Therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Taipei City HospitalOther government
- Collaborators
- National Yang Ming Chiao Tung University, National Taiwan University of Science and Technology
- Study start
- 8 Apr 2026 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 20 Apr 2026 (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.
The goal of this clinical trial is to learn if laser acupuncture (low-level laser therapy) works to treat fatigue and improve quality of life in adults with end-stage renal disease (ESRD) undergoing hemodialysis. It will also learn about how laser acupuncture affects blood circulation and autonomic nervous system balance.
The main questions it aims to answer are:
- Does laser acupuncture reduce the severity of fatigue and its interference with daily life?
- Can laser acupuncture improve related symptoms such as insomnia, poor appetite, and skin itching?
- How does laser acupuncture affect objective markers like microcirculation and heart rate variability? Researchers will compare laser acupuncture to a sham treatment (a look-alike procedure using a device that does not emit a laser) to see if laser acupuncture works to treat fatigue.
Participants will:
- Receive laser acupuncture or a sham treatment during their regular hemodialysis sessions 3 times a week for 4 weeks.
- Have their fatigue and life quality assessed through questionnaires on the first day, at 4 weeks, and at 8 weeks.
- Undergo non-invasive tests to measure microcirculation, heart rate variability, and pulse waves, and have photos of their tongue taken for Chinese medicine assessment.
Detailed description
Scientific Rationale Fatigue is a prevalent and debilitating symptom in patients with end-stage renal disease (ESRD) undergoing maintenance hemodialysis (HD). It is a multidimensional condition influenced by anemia, uremia, and the long-term psychosocial stress of dialysis. Conventional pharmacological treatments often yield limited efficacy for fatigue and sleep disturbances while posing risks of adverse effects. Non-pharmacological interventions, such as acupressure and exercise, have shown potential, but high-quality clinical evidence remains insufficient. Laser acupuncture (LA), or photobiomodulation (PBM), is a non-invasive, non-thermal therapy that applies low-level laser energy to traditional acupuncture points. It is proposed to modulate mitochondrial function, reduce oxidative stress, and inhibit inflammatory responses, offering a safe alternative for patients who may not be suitable for or are fearful of traditional needle acupuncture.
Study Protocol and Intervention This is a randomized, double-blind, sham-controlled pilot trial. A total of 50 participants will be recruited from the hemodialysis center and randomly assigned to either the experimental (LA) group or the sham control group in a 1:1 ratio.
- Experimental Group: Participants will receive low-level laser therapy at specific acupoints: KI1 (Yongquan), ST36 (Zusanli), SP10 (Xuehai), PC8 (Laogong), EX-UE9 (Bafeng), EX-UE9 (Baxie), and LU9 (Taiyuan). Each session lasts 15-30 minutes, administered 3 times per week during the dialysis process for a duration of 4 weeks.
- Sham Control Group: Participants will undergo an identical procedure using a sham device that mimics the operation and appearance of the laser equipment but does not emit actual laser energy, ensuring the maintenance of blinding.
Technical Assessment and Data Analysis
To objectively evaluate the systemic effects of LA on the circulatory and autonomic nervous systems, this study integrates several biomedical engineering technologies:
- Microcirculation Analysis: Skin microvascular blood flow and blood volume changes are monitored using Laser Doppler Flowmetry (LDF) and Photoplethysmography (PPG).
- Vascular and Autonomic Assessment: Brachial Pulse Wave (BPW) analysis will be used to evaluate arterial stiffness, while Heart Rate Variability (HRV) will assess the balance of the sympathetic and parasympathetic nervous systems.
- Traditional Chinese Medicine (TCM) Evaluation: Standardized tongue diagnosis photography and the Constitution in Chinese Medicine Questionnaire (CCMQ) will be used to track changes in the participants' TCM constitutional types and internal "Qi" and blood status.
Statistical analysis will utilize t-tests or Mann-Whitney U tests to compare symptom improvement between groups. Mixed-effects models or Generalized Estimating Equations (GEE) will be employed to evaluate the long-term impact of treatment on blood pressure and microcirculation while controlling for potential confounding factors such as age and dialysis vintage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized, double-blind, sham-controlled, parallel-group pilot trial. Eligible participants with End-Stage Renal Disease (ESRD) undergoing regular hemodialysis will be randomly assigned to either the Laser Acupuncture (LA) group or the Sham Control group in a 1:1 ratio. Each group will follow their assigned intervention protocol simultaneously for a duration of 4 weeks, with clinical outcomes and physiological markers assessed at baseline, 4 weeks, and 8 weeks to evaluate both immediate and follow-up effects.
| Arm | Type | Receives |
|---|---|---|
| Laser Acupuncture Group | Experimental | Device: Low-Level Laser Acupuncture (LA)Active low-level laser therapy at 7 specific acupoints. |
| Sham Control Group | Sham comparator | Device: Sham Laser AcupunctureInactive laser treatment using an identical-looking device without energy output. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with End-Stage Renal Disease (ESRD) who require regular maintenance hemodialysis.
- Must undergo hemodialysis treatment at least 3 times per week.
- Aged 18 years or older.
- Willing and able to provide informed consent to participate in the study.
Key exclusion criteria (6 listed)
- Presence of acute infectious symptoms.
- Unstable vital signs.
- Diagnosis of malignant tumors.
- Pregnancy.
- Presence of open wounds at the sites designated for laser intervention.
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 |
|---|---|---|
| Low-Level Laser Acupuncture (LA)Device: Low-level laser therapy (LLLT) device. Acupoints: KI1 (Yongquan), ST36 (Zusanli), SP10 (Xuehai), PC8 (Laogong), EX-UE9 (Bafeng), EX-UE9 (Baxie), and LU9 (Taiyuan). Dosage/Frequency: Administered 3 times per week during the hemodialysis process for 4 weeks. Duration: Each treatment session lasts approximately 15 to 30 minutes. | Device | Laser Acupuncture Group |
| Sham Laser AcupunctureDescription:Device: An inactive sham laser device that is identical in appearance and operational procedure to the active device. Procedure: The device will be applied to the same 7 acupoints (KI1, ST36, SP10, PC8, Bafeng, Baxie, LU9) for 15-30 minutes. Blinding: The device will not emit actual laser energy but will mimic the treatment process to maintain participant blinding. Frequency: 3 times per week for 4 weeks during hemodialysis. | Device | Sham Control Group |
Primary outcome
VAS for fatigue
Time frame: Baseline (Day 0), Week 4 (end of intervention), and Week 8 (follow-up).
The VAS is a subjectively reported scale used to evaluate fatigue intensity. Participants mark their fatigue level on a 100-mm line ranging from "no symptoms" (0) to "most severe symptoms" (100). Higher scores indicate more severe fatigue.
Brief Fatigue Inventory (BFI)
Time frame: Baseline (Day 0), Week 4 (end of intervention), and Week 8 (follow-up).
The BFI consists of 9 items assessing the severity of fatigue and its impact on daily functional activities over the past week. Each item is scored from 0 to 10, with higher total scores representing more severe fatigue and greater interference with daily life.
7 secondary outcomes
Kidney Disease Quality of Life 36 (KDQOL-36)
Time frame: Baseline, Week 4, and Week 8.
Laser Doppler Flowmetry Analysis (LDFA) Score
Time frame: Baseline, Week 4, and Week 8.
Photoplethysmography Analysis (PPGA) Score
Time frame: Baseline, Week 4, and Week 8.
Brachial Pulse Wave Analysis (BPWA) score
Time frame: Baseline, Week 4, and Week 8.
Heart Rate Variability (HRV)
Time frame: Baseline, Week 4, and Week 8.
Constitution in Chinese Medicine Questionnaire (CCMQ)
Time frame: Baseline, Week 4, and Week 8.
Tongue Moisture Index (TMI)
Time frame: Baseline, Week 4, and Week 8.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Background: PubMed 36644273Saito M, Jingu H, Osawa H, Oyama Y, Tanaka T, Shiono A, Machida M. Pulse Amplitude Measured with a Portable Laser Doppler Flowmeter Is Useful for Screening of Dialysis Patients for Peripheral Arterial Disease: An Observational Study. Ann Vasc Dis. 2022 Dec 25;15(4):301-307. doi: 10.3400/avd.oa.21-00126.
- Background: PubMed 32874405Yang J, Mallory MJ, Wu Q, Bublitz SE, Do A, Xiong D, Chen CYY, Dorsher PT, Chon TY, Bauer BA. The Safety of Laser Acupuncture: A Systematic Review. Med Acupunct. 2020 Aug 1;32(4):209-217. doi: 10.1089/acu.2020.1419. Epub 2020 Aug 13.
- Background: PubMed 37651553Natale P, Ju A, Strippoli GF, Craig JC, Saglimbene VM, Unruh ML, Stallone G, Jaure A. Interventions for fatigue in people with kidney failure requiring dialysis. Cochrane Database Syst Rev. 2023 Aug 31;8(8):CD013074. doi: 10.1002/14651858.CD013074.pub2.
- Background: PubMed 35887386Bian J, Liebert A, Bicknell B, Chen XM, Huang C, Pollock CA. Therapeutic Potential of Photobiomodulation for Chronic Kidney Disease. Int J Mol Sci. 2022 Jul 21;23(14):8043. doi: 10.3390/ijms23148043.
- Background: PubMed 38958682Chang YP, Lin CC, Wu JH, Hsieh YH, Chou KH, Su CT. The impact of photobiomodulation on sleep and life quality in hemodialysis patients: A randomized controlled trial. Lasers Med Sci. 2024 Jul 3;39(1):169. doi: 10.1007/s10103-024-04114-y.
- Individual participant dataSharing planned: Yes. De-identified individual participant data that underlie the results reported in future publications (including text, tables, figures, and appendices) will be made available to qualified researchers for academic purposes.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-Level Laser Acupuncture (LA) in people with ESRD (End Stage Renal Disease) and Dialysis, run by Taipei City 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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 26 Oct 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ming Jen Wang, MD (+886-930-766-631, wanters0800@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS for fatigue (time frame: Baseline (Day 0), Week 4 (end of intervention), and Week 8 (follow-up).). 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?
On the ClinicalTrials.gov record for NCT07538310, which also lists 5 linked publications.
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 26 Oct 2026.