Laser Acupuncture for Fatigue in Hemodialysis Patients (LA-HD-Fatigue)

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:

1. Does laser acupuncture reduce the severity of fatigue and its interference with daily life?
2. Can laser acupuncture improve related symptoms such as insomnia, poor appetite, and skin itching?
3. 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:

1. Receive laser acupuncture or a sham treatment during their regular hemodialysis sessions 3 times a week for 4 weeks.
2. Have their fatigue and life quality assessed through questionnaires on the first day, at 4 weeks, and at 8 weeks.
3. Undergo non-invasive tests to measure microcirculation, heart rate variability, and pulse waves, and have photos of their tongue taken for Chinese medicine assessment.

Study Overview

• Status: Not yet recruiting
• Conditions: Fatigue; Dialysis; ESRD (End Stage Renal Disease)
• Intervention / Treatment: Device: Low-Level Laser Acupuncture (LA); Device: Sham Laser Acupuncture

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.

1. 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.
2. 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:

1. Microcirculation Analysis: Skin microvascular blood flow and blood volume changes are monitored using Laser Doppler Flowmetry (LDF) and Photoplethysmography (PPG).
2. 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.
3. 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 Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ming Jen Wang, MD; Phone Number: +886-930-766-631; Email: wanters0800@gmail.com
• Study Contact Backup: Name: Chao-Tsung Chen, Ph.D.; Phone Number: +886-979-306-080; Email: dai44@tpech.gov.tw

Study Locations

• Taiwan
  • Taipei
    • Taipei, Taipei, Taiwan, 106
      • Taipei City Hospital, Renai Branch
      • Contact: Ming Jen Wang, MD; Phone Number: +886-930-766-631; Email: wanters0800@gmail.com
      • Contact: Ming Jen Wang, MD; Phone Number: 5213 886-02-2709-3600; Email: dba77@tpech.gov.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Laser Acupuncture Group; Active low-level laser therapy at 7 specific acupoints.	Device: 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.
Sham Comparator: Sham Control Group; Inactive laser treatment using an identical-looking device without energy output.	Device: Sham Laser Acupuncture; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Baseline (Day 0), Week 4 (end of intervention), and Week 8 (follow-up).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	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.	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.	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.	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.	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).	Baseline, Week 4, and Week 8.

Collaborators and Investigators

• Sponsor: Taipei City Hospital
• Collaborators: National Yang Ming Chiao Tung University; National Taiwan University of Science and Technology

Publications and helpful links

General 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.
• Yang 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.
• Natale 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.
• Bian 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.
• Chang 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.

Study record dates

Study Major Dates

• Study Start (Estimated): April 8, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): August 31, 2027

Study Registration Dates

• First Submitted: April 5, 2026
• First Submitted That Met QC Criteria: April 12, 2026
• First Posted (Actual): April 20, 2026

Study Record Updates

• Last Update Posted (Actual): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 12, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Quality of Life; Fatigue; Heart Rate Variability; Traditional Chinese Medicine; Hemodialysis; Photobiomodulation; Microcirculation; Low-Level Laser Therapy; End-Stage Renal Disease; Laser Acupuncture
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Fatigue; Kidney Failure, Chronic; Renal Insufficiency, Chronic
• Other Study ID Numbers: TCHIRB-11405003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data will be available beginning 6 months and ending 36 months following article publication.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No