Laser Acupuncture for Fatigue in Hemodialysis Patients

Condition(s) studied

Investigational drug(s) / intervention(s)

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 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.

Study 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.

Eligibility

Primary outcome measure(s)

• VAS for fatigue — 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) — 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.

Trial sites (1)

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