Health TrialsbyHealthPanel

Laser Acupuncture for Fatigue in Hemodialysis Patients

ConditionsESRD (End Stage Renal Disease)DialysisFatigue
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTaipei City Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Presence of acute infectious symptoms.

Unstable vital signs.

Diagnosis of malignant tumors.

Pregnancy.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 Acupuncture

    Device

    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.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Laser Acupuncture GroupExperimental treatment 1 intervention
Group B: Sham Control GroupSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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).
2

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).

Secondary outcomes

1

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.
2

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.
3

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.
4

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.

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Taipei City Hospital, Renai Branch Status unavailable 106, Taipei, TaipeiTaiwanTaiwan

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Taipei City Hospital

Lead sponsor

National Yang Ming Chiao Tung University

Collaborator

National Taiwan University of Science and Technology

Collaborator

Source ClinicalTrials.gov

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