Acupuncture for Pain Management of Hemodialysis Patients: a Randomized, Controlled Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 4
- 主要终点
- Pain measured on 0-6 scale of symptom 1 subscale score in the Measure Your Medical Outcome Profile2 (MYMOP2) questionnaire.
研究概览
简要总结
The purpose of this study is to determine the feasibility, effectiveness and safety of acupuncture for pain management in hemodialysis patients.
详细描述
Pain is one of the most common symptoms experienced by end-stage renal disease (ESRD) patients, which subsequently debilitates patient's quality of life. Although reducing pain is crucial to successful patient care in hemodialysis population, symptoms are often undertreated.Conventional pharmacological approaches are limited in dialysis population , given their altered pharmacokinetics and pharmacodynamic profiles and increased potential for adverse reactions. Acupuncture has been known to be beneficial in various chronic pain condition. As a non-pharmacologic intervention, it might be valuable for pain management in hemodialysis patients whose analgesic use are limited due to altered pharmacokinetics. However, little is known for the benefits of acupuncture for pain management in dialysis population. This study aims to determine whether acupuncture is a feasible, effective and safe therapeutic intervention for pain management in hemodialysis patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •started hemodialysis at least 3 months ago
- •receiving hemodialysis 3 times a week regularly
- •equilibrated Kt/V ≥ 1.2
- •pain occurred at least 3 months ago
- •MYMOP2 symptom 1 score ≥ 3
- •willingness to participate in this study
排除标准
- •acute/chronic liver disease
- •events of life-threatening cardiovascular disease within 6 months
- •events of life-threatening neurological disorder within 6 months
- •current/past history of neoplasm (in past 5 years)
- •hemorrhagic disorder
- •drug abuse/alcoholism
- •other infectious disease
- •history of the use of acupuncture, moxibustion or herbs within 1 month
结局指标
主要结局
Pain measured on 0-6 scale of symptom 1 subscale score in the Measure Your Medical Outcome Profile2 (MYMOP2) questionnaire.
时间窗: 6 weeks
Patients will be asked to measure their pain on 0-6 scales (higher scores reflect worse pain) in the MYMOP2 questionnaire. Other subscales and summed profiles of MYMOP2 questionnaire will be regarded as secondary outcomes.
次要结局
- Depressive moods measured by Beck Depression Inventory (BDI)(6 weeks)
- Quality of life of patients measured by Kidney Disease Quality of Life Version 1.3 (KDQOL-V 1.3)(6 weeks)
- Other patient-perceived changes on health and daily life measured by the MYMOP2(6 weeks)