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临床试验/NCT02093637
NCT02093637已完成不适用

Rapid Extremity Pain Relief by Battlefield Acupuncture After Orthopedic Surgery: A Randomized Clinical Trial

Mike O'Callaghan Military Hospital4 个研究点 分布在 1 个国家目标入组 279 人开始时间: 2013年8月1日最近更新:
适应症
干预措施

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

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 Comparator

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

Experimental

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

No Intervention

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

研究者

发起方
Mike O'Callaghan Military Hospital
申办方类型
Fed
责任方
Sponsor

研究点 (4)

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