Comparison of the Therapeutic Effects of Press Needle and Sham Press Needle on 5-D Pruritus Scale in Hemodialysis Patients With Chronic Kidney Disease-Associated Pruritus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- 5-D Pruritus Scale
研究概览
简要总结
The goal of this clinical trial is to assess whether press needle acupuncture (PN) is more effective than sham press needle (sham PN) in reducing pruritus in patients with chronic kidney disease-associated pruritus (CKDaP) undergoing hemodialysis. The main questions it aims to answer are:
- Does PN, compared to sham PN, reduce pruritus severity as measured by 5-D Pruritus Scale after the 2nd, 4th, 6th, and 8th therapy sessions?
- Does PN, compared to sham PN, maintain a superior reduction in pruritus severity four weeks after the final session?
- Are there any side effects associated with PN or sham PN in CKDaP patients on hemodialysis?
Participants will:
- Be patients undergoing hemodialysis with confirmed CKDaP
- Undergo cognitive screening with MMSE to ensure accurate self-reporting
- Be randomly assigned to receive either PN (needle inserted) or sham PN (tape only)
- Have PN or sham PN applied unilaterally to acupoints LI11, SP10, ST36, and SP6, replaced every 3-4 days over a 4-week period
- Complete the 5-D Pruritus Scale questionnaire before intervention, after every 2 sessions (2nd, 4th, 6th, 8th), and 4 weeks post-treatment
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The participant and outcomes assessor will be blinded to group allocation.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with CKD-associated pruritus (CKDaP) undergoing regular hemodialysis twice a week for at least 6 months and in a hemodynamically stable condition, who meet the criteria for moderate to severe pruritus based on the 5-D Pruritus Scale
- •Subjects aged between 18 and 65 years.
- •Subjects have not received acupuncture therapy for at least one month prior to the study.
- •Subjects have good cognitive function as assessed by the MMSE.
- •Subjects are willing to participate in the study according to the scheduled timeline and have signed the informed consent form.
排除标准
- •Subjects have malignancies or infectious lesions at the acupuncture points to be treated.
- •Subjects have primary skin diseases such as allergic dermatitis, irritant contact dermatitis, neurodermatitis, or psoriasis.
- •Subjects have a history of hypersensitivity reactions to previous acupuncture therapy (such as metal allergy, atopy, keloids, or other hypersensitivities).
结局指标
主要结局
5-D Pruritus Scale
时间窗: Baseline, after 2nd, 4th, 6th, and 8th treatment sessions, and 4 weeks post-treatment
Pruritus severity will be assessed using the validated 5-D Pruritus Scale, which evaluates five dimensions: duration, degree, direction, disability, and distribution. Scores range from 5 to 25, with higher scores indicating more severe pruritus.
Adverse events
时间窗: After 2nd, 4th, 6th, and 8th treatment sessions, and 4 weeks post-treatment
Any adverse events related to the intervention, including pain, bleeding, skin irritation, or infection at the site of application, will be recorded and monitored.
次要结局
未报告次要终点
研究者
Visto Pangestu
Principal Investigator
Indonesia University