NCT00233831已完成2 期
Millimeter Wave Therapy (MWT) Versus Placebo for Analgesia and Wound Healing After Elective Total Knee Arthroplasty - a Randomized Controlled Trial
University Medicine Greifswald2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2004年3月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Total amount of weak opioid drug piritramide delivered via Patient-Controlled-Analgesia pump, registered daily until the 3rd postoperative day
研究概览
简要总结
The aim of the study was to test whether the exposure to electromagnetic millimeter waves - Millimeter Wave Therapy (MWT) is effective for relief of acute postoperative pain in patients after elective unilateral total knee arthroplasty (TKA)
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
入排标准
- 年龄范围
- 35 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with an American Society of Anesthesiologists physical status of II or III scheduled for elective TKA
- •without previous opioid medication
- •patients 35-80 years old able to use PCA pumps and Visual Analogue Scale for pain intensity measurement
- •patients who have signed consent form
排除标准
- •pregnant or nursing females
- •recidivist alcoholics
- •extremely obese patients (body mass index > 35)
- •inability to operate PCA-pump.
- •females with the history of unstable angina pectoris (s. Risks for participants)
- •patients who are unable to understand the consent form
- •systemic infection
- •history of psychiatric disease
- •necessity to change postoperative analgesic scheme for particular patient
- •severe intercurrent disease during the course of MWT
结局指标
主要结局
Total amount of weak opioid drug piritramide delivered via Patient-Controlled-Analgesia pump, registered daily until the 3rd postoperative day
次要结局
- Total amount of ibuprofen; pain intensity measured on VAS-100 twice a day; Insall knee function score; incidence of analgesia side-effects ; inflammation and wound healing parameters; credibility of patients' and research stuff blinding
研究者
研究点 (2)
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