Laser Acupuncture for Fatigue in Hemodialysis Patients

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. 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.

Conditions

• ESRD (End Stage Renal Disease)
• Dialysis
• Fatigue

Interventions

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.

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.

Sponsors & Collaborators

• National Yang Ming Chiao Tung University

  collaborator OTHER

• National Taiwan University of Science and Technology

  collaborator OTHER

• Taipei City Hospital

  lead OTHER_GOV

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-04-08

Primary Completion

2026-12-31

Completion

2027-08-31

Countries

• Taiwan