Rapid Extremity Pain Relief by Battlefield Acupuncture After Orthopedic Surgery: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 279
- 试验地点
- 4
- 主要终点
- Pain score
研究概览
简要总结
The purpose of this study is to determine if the addition of Battlefield Auricular Acupuncture (BFA) to standard therapy causes reduction in pain, medication use, time to ambulation without assistance, hours missed from work and increases quality of life after lower extremity surgery at two Air Force Medical Centers.
详细描述
We will recruit 429subjects into this research study, for an expected 309 completing the study. We estimate 120 subjects will either withdraw consent or become ineligible for the study. Subjects will be ≥18 years or older and scheduled for lower extremity surgery. To randomize subjects, we will employ a random number generator, which will minimize difference between study groups. Additionally, we will collect data about patients' length of hospital stay, which will allow for statistical control of the variable, complexity of surgical procedure. The Research Assistants/Coordinators will be responsible for obtaining Informed Consent and HIPAA Authorization from subjects, collecting data, and de-identifying data prior to review and analysis by the Investigators. The Investigators will be responsible for ongoing protocol monitoring, insertion of needles, verifying inclusion/exclusion criteria, and analyzing data.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •THIS STUDY IS BEING CONDUCTED AT A MILITARY INSTALLATION. YOU MUST HAVE MILITARY INSURANCE IN ORDER TO PARTICIPATE IN THIS STUDY.
- •Inclusion Criteria:
- •Male and female subjects (DoD beneficiaries), 18 years or older who are scheduled for lower extremity surgery below the hip.
排除标准
- •Pregnant or breastfeeding Absence of their ear Active cellulitis of their ear Ear anatomy precluding identification of acupuncture landmarks Non-English speaking Use of Hearing Aids that preclude the insertion of ASP needles Inability to comply with study protocol
研究组 & 干预措施
Placebo acupuncture
Placebo acupuncture up to 5 acupuncture needles* in each ear (up to 10 needles total) at points identified by point-finder to have no electrical conductance) plus usual operative and post-operative care (narcotic and non-narcotic pain medication).
干预措施: Placebo acupuncture (Other)
Battlefield Acupuncture
Usual operative and post-operative care (narcotic and non-narcotic pain medication) plus Battlefield Acupuncture (up to 5 acupuncture needles* in each ear (up to 10 needles total), identified by a point-finder.
干预措施: Battlefield Acupuncture (Other)
standard therapy
standard therapy
结局指标
主要结局
Pain score
时间窗: 1 month
次要结局
未报告次要终点
