Laser Acupuncture Improves Fatigue and Quality of Life in Hemodialysis Patients: a Randomized Double-blind Clinical Trial Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- VAS for fatigue
研究概览
简要总结
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:
- Does laser acupuncture reduce the severity of fatigue and its interference with daily life?
- Can laser acupuncture improve related symptoms such as insomnia, poor appetite, and skin itching?
- 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:
- Receive laser acupuncture or a sham treatment during their regular hemodialysis sessions 3 times a week for 4 weeks.
- Have their fatigue and life quality assessed through questionnaires on the first day, at 4 weeks, and at 8 weeks.
- Undergo non-invasive tests to measure microcirculation, heart rate variability, and pulse waves, and have photos of their tongue taken for Chinese medicine assessment.
详细描述
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.
- 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.
- 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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Laser Acupuncture Group
Active low-level laser therapy at 7 specific acupoints.
干预措施: Low-Level Laser Acupuncture (LA) (Device)
Sham Control Group
Inactive laser treatment using an identical-looking device without energy output.
干预措施: Sham Laser Acupuncture (Device)
结局指标
主要结局
VAS for fatigue
时间窗: 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)
时间窗: 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.
次要结局
- Kidney Disease Quality of Life 36 (KDQOL-36)(Baseline, Week 4, and Week 8.)
- Laser Doppler Flowmetry Analysis (LDFA) Score(Baseline, Week 4, and Week 8.)
- Photoplethysmography Analysis (PPGA) Score(Baseline, Week 4, and Week 8.)
- Brachial Pulse Wave Analysis (BPWA) score(Baseline, Week 4, and Week 8.)
- Heart Rate Variability (HRV)(Baseline, Week 4, and Week 8.)
- Constitution in Chinese Medicine Questionnaire (CCMQ)(Baseline, Week 4, and Week 8.)
- Tongue Moisture Index (TMI)(Baseline, Week 4, and Week 8.)