Laser Acupuncture for Fatigue in Hemodialysis Patients

Официальное название

Laser Acupuncture Improves Fatigue and Quality of Life in Hemodialysis Patients: a Randomized Double-blind Clinical Trial Pilot Study

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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.
• Устройство 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.

Первичные конечные точки

• VAS for fatigue [Срок оценки: Baseline (Day 0), Week 4 (end of intervention), and Week 8 (follow-up).]
• Brief Fatigue Inventory (BFI) [Срок оценки: Baseline (Day 0), Week 4 (end of intervention), and Week 8 (follow-up).]

Вторичные конечные точки (7)

• Kidney Disease Quality of Life 36 (KDQOL-36) [Срок оценки: Baseline, Week 4, and Week 8.]
• Laser Doppler Flowmetry Analysis (LDFA) Score [Срок оценки: Baseline, Week 4, and Week 8.]
• Photoplethysmography Analysis (PPGA) Score [Срок оценки: Baseline, Week 4, and Week 8.]
• Brachial Pulse Wave Analysis (BPWA) score [Срок оценки: Baseline, Week 4, and Week 8.]
• Heart Rate Variability (HRV) [Срок оценки: Baseline, Week 4, and Week 8.]
• Constitution in Chinese Medicine Questionnaire (CCMQ) [Срок оценки: Baseline, Week 4, and Week 8.]
• Tongue Moisture Index (TMI) [Срок оценки: Baseline, Week 4, and Week 8.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Тайвань · 1 центр

• Taipei City Hospital, Renai Branch — Taipei

Публикации

• 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. PMID 36644273
• 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. PMID 32874405
• 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. PMID 37651553
• 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. PMID 35887386
• 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. PMID 38958682

Идентификаторы

NCT: NCT07538310 · TCHIRB-11405003

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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