Evaluation of the Efficacy of Laser Acupuncture on Uremic Pruritus-Randomized Controlled Trial Double Blind
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Title: Evaluation of the Efficacy of Laser Acupuncture on Ureimc Pruritus
研究概览
简要总结
Sixty patients were randomly assigned to either the experimental group (n=30) receiving laser acupuncture or the control group (n=30) receiving sham laser acupuncture. Treatment sessions were conducted during dialysis sessions. The experimental group received laser acupuncture at Xuehai, Quchi, and Bai Chongwo acupoints three times per week for four weeks. The control group received sham laser acupuncture at the same acupoints. The 5-D Pruritus Scale and DLQI were used to assess pruritus severity before and after the intervention.
详细描述
The subjects were divided into two groups to investigate whether laser acupuncture can improve uremic pruritus.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 20 years.
- •Intact parathyroid hormone (iPTH) levels < 68 pg/mL (patients with -thyroidectomy excluded).
- •Urea nitrogen (BUN) clearance rate (Kt/V) ≥ 1.2 at each dialysis session.
- •Serum phosphate levels < 5.5 mg/dL.
- •Receiving hemodialysis three times weekly for at least three consecutive months.
- •No history of acute illnesses like infections or cardiovascular disease.
- •Avoiding a high-phosphorus diet.
- •Adjusting dialysate calcium concentration to 8.6-10 mg/dL.
- •Replacing the artificial kidney or increasing dialysis blood flow
排除标准
- •Pregnant or nursing.
- •History of photosensitivity.
- •Recent use of systemic or local medications for pruritus (e.g., immunosuppressants, opioid agonists/antagonists, glucocorticoids, antihistamines, ultraviolet B therapy).
- •Hepatobiliary dysfunction based on medical history and liver function tests.
- •Malignancies.
- •Other itchy skin conditions diagnosed by a dermatologist.
- •Wounds near acupuncture points, contraindicating laser acupuncture
研究组 & 干预措施
laser acupuncture on acupoint
The experimental group is a powered, functional laser device,
干预措施: laser acupuncture (Device)
shame laser on acupoints
the control group is a non-functional laser device that does not emit light and has no therapeutic effect.
干预措施: laser acupuncture (Device)
结局指标
主要结局
Title: Evaluation of the Efficacy of Laser Acupuncture on Ureimc Pruritus
时间窗: A 4-week timeframe from enrollment to treatment completion.
The severity of uremic pruritus was assessed using the 5-D Itch Scale, a validated instrument that measures itch duration, degree, direction, disability, and distribution. The total score ranges from 5 to 25, with higher scores indicating worse pruritus. Measurements were taken at baseline and at week 4 after completion of the laser acupuncture or sham intervention.
次要结局
未报告次要终点