Laser Acupuncture for Fatigue in Hemodialysis Patients

Sponsor
Taipei City Hospital
Study ID
NCT07538310
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

First listed
Apr 20, 2026
Start date
Apr 8, 2026
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
Aug 31, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Laser Acupuncture Group
    Active low-level laser therapy at 7 specific acupoints.
  • Sham Comparator: Sham Control Group
    Inactive laser treatment using an identical-looking device without energy output.

Primary Outcome Measure

VAS for fatigue [ Time Frame: Baseline (Day 0), Week 4 (end of intervention), and Week 8 (follow-up). ]

Central Contacts

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