An interventional study of Low-Level Laser Acupuncture (LA) and Sham Laser Acupuncture in ESRD (End Stage Renal Disease), Dialysis and Fatigue, sponsored by Taipei City Hospital. Recruiting at 1 site in Taiwan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by Taipei City Hospital · Not applicable, Interventional, and Treatment
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:
Participants will:
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.
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:
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.
2,108 studies on the registry are indexed under Kidney Failure, Chronic; 273 are open to participants now.
This study's planned enrollment of 50 is below the median of 57 across 1,569 interventional studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →Taipei City Hospital is the lead sponsor of 57 studies on the registry; 9 are open to participants now.
Compared within Kidney Failure, Chronic, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Renal Insufficiency, Chronic. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Active low-level laser therapy at 7 specific acupoints.
Device: Low-Level Laser Acupuncture (LA)
Inactive laser treatment using an identical-looking device without energy output.
Device: Sham Laser Acupuncture
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.
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.
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.
Time frame: 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.
Time frame: Baseline (Day 0), Week 4 (end of intervention), and Week 8 (follow-up).
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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: Baseline, Week 4, and Week 8.
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Data will be available beginning 6 months and ending 36 months following article publication.
Access criteria: Data requests should be directed to the Principal Investigator. Proposers will need to sign a data access agreement and provide a scientifically sound research proposal.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Taipei City Hospital