NCT07380581已完成1 期
The Herbal Acupoint Patch for Improving Pain, Depression, and Quality of Life in Dialysis Patient With Fistula-related Pain: Holistic Study for A Double-blind Randomized Controlled Trial
Chang Gung Memorial Hospital1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2024年2月15日最近更新:
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Brief Pain Inventory (BPI)
研究概览
简要总结
To evaluate the effect of a traditional Chinese medicine (TCM) intervention on pain relief, mood and quality of life (QOL) in hemodialytic patients at a dialysis center in Southern Taiwan.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •maintenance HD > 6 months ,
- •reporting fistula pain during HD sessions that was associated with a hypersensitive palpable nodule in a taut band, at least 6 times in the past month,
- •a NRS pain score >4,
- •no changes in pain relievers such as NSAIDs, opioids, topical ointments, or muscle relaxants over the past week,
- •voluntarily agreed to participate in the trial and presented written informed consent.
排除标准
- •severe comorbid organ dysfunction,
- •existence of cervical radiculopathy or thoracic outlet syndrome
- •inflammation of the skin or soft tissue at the fistula site,
- •dementia,
- •psychiatric diseases,
- •allergy to herbal patch
- •currently participating in other clinical studies
研究组 & 干预措施
Sham (No Treatment)
Sham Comparator
干预措施: Sham (No Treatment) (Other)
Artemisias-ginger patch (AGP)
Experimental
干预措施: Artemisias-ginger patch (AGP) (Other)
结局指标
主要结局
Brief Pain Inventory (BPI)
时间窗: Weeks 0 (baseline), 2, 4, and 6 (2 weeks of follow-up)
Pain severity and interference are rated on a numerical rating scale (NRS) from 0 ("no pain"/"does not interfere") to 10 ("worst imaginable pain"/"completely interferes").
次要结局
- Health Questionnaire Depression Rating Scale (PHQ-9)(Week 0 (baseline) and 4)
- EuroQol-5-dimension questionnaire (EQ-5D)(Week 0(baseline) and 4)
研究者
Ming-Yen Tsai
Chief of Department of Chinese Medicine
Chang Gung Memorial Hospital
研究点 (1)
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