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Acupuncture for Pain Management After Hip or Knee Arthroplasty - NCT00455182-55125(Clinical Trial 167235)



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City:  Woodbury
State:  
MN
Zip Code: 55125
Conditions: Pain - Postoperative Complications
Purpose: 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.
Study summary: 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.
Criteria: Inclusion Criteria: - 18-80 years old - Undergoing total hip or total knee arthroplasty - Spinal anesthesia during surgery Exclusion Criteria: - 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.
Study is available at: HealthEast Woodwinds Hospital
Woodbury, MN 55125
United States

Primary Contact:
Daniel Hoeffel, M.D.
Email: dhoeffel@summitortho.com
Phone: 651-842-5200

Secondary Contact:
Daniel Hoeffel, M.D.
Email: dhoeffel@summitortho.com
Phone: 651-842-5200
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 22, 2011
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