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临床试验/NCT00455182
NCT00455182撤回不适用

Acupuncture for Pain Management After Hip or Knee Arthroplasty

HealthEast Care System2 个研究点 分布在 1 个国家开始时间: 2007年3月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Pain intensity as measured by the Visual Analog Scale

研究概览

简要总结

The purpose of this study is to determine whether patients treated with acupuncture post-operatively following knee or hip arthroplasty achieve better pain control as measured by the Visual Analog Scale and pain medication use.

详细描述

The postoperative acute pain of hip or knee arthroplasty can decrease early postoperative rehabilitation if uncontrolled. This pain is commonly managed with medications, which can be associated with a variety of side effects, including sedation, confusion, and falls. These side effects are particularly common among the elderly, who undergo the majority of these procedures. Adding non-pharmacologic therapies for pain management that can decrease the use of medication during the early post-operative period following hip or knee arthroplasty would be beneficial to patient recovery.

According to the National Institutes of Health (NIH) Consensus Statement, acupuncture has shown promising results in some medical situations, such as the management of post-operative and chemotherapy induced nausea and vomiting, as well as in post-operative dental pain. While a recent study funded by the NIH National Center for Complementary and Alternative Medicine showed that acupuncture provides pain relief and improves function for people with osteoarthritis of the knee, studies involving acupuncture and arthroplasty are few.

Two recent studies in which acupuncture was used in patients who underwent arthroplasty showed mixed results. In a study of ear acupuncture for pain relief in hip arthroplasty, there was decreased use of pain medication in those receiving acupuncture; however, the pain intensity rating was the same in both the acupuncture and sham acupuncture control groups (Usichenko TI, Pain, 2005). In a study that involved a longer duration of acupuncture therapy following total knee arthroplasty, patients who were treated with acupuncture in addition to standard physiotherapy showed no difference in pain, stiffness, or function at the end of six weeks when compared to patients who received standard physiotherapy(van Arendonk N, Physiotherapy, 2004-Abstract only). Further studies are needed to assess the efficacy of acupuncture in the post-operative pain management of patients who have undergone hip or knee arthroplasty.

The purpose of this pilot study is to test the feasibility of conducting such a study in order to competitively apply for funding for a full clinical trial.

This study is a randomized, single-blind, controlled trial with acupuncture in the immediate post-operative period versus sham acupuncture or standard medical care at HealthEast Woodwinds Hospital in Woodbury, Minnesota. Ninety (90) patients scheduled for elective hip or knee arthroplasty will be recruited from Woodwinds Hospital and randomized to one of the three treatment groups in a 1:1:1 ratio (30 patients in each group). Patients in the acupuncture or sham acupuncture group will receive one treatment on postoperative day 1. Pain medication use will be recorded and pain intensity will be assessed using the Visual Analog Scale.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18-80 years old
  • Undergoing total hip or total knee arthroplasty
  • Spinal anesthesia during surgery

排除标准

  • Arthroplasty of contralateral limb within the past three months
  • Medical condition, in judgement of examiner, that may preclude safe participation in protocol or prevents completion of the study
  • General anesthesia
  • Use of any investigational drug in the past 30 days
  • Has received acupuncture in the past
  • Currently participating in another interventional study
  • Unwilling to be randomized
  • Patients who request Healing Touch, another form of alternative treatment that is offered at Woodwinds Hospital.

结局指标

主要结局

Pain intensity as measured by the Visual Analog Scale

时间窗: Before and immediately following treatment

Pain medication use

时间窗: before and after treatment

次要结局

  • Cost of pain treatment(Annually)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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