Acupuncture for Pain Management After Hip or Knee Arthroplasty
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|ClinicalTrials.gov Identifier: NCT00455182|
Recruitment Status : Withdrawn (Inability to enroll subjects who were willing to be randomized to control group)
First Posted : April 3, 2007
Last Update Posted : March 19, 2015
|Condition or disease||Intervention/treatment||Phase|
|Pain Postoperative Complications||Procedure: Acupuncture Procedure: Sham Acupuncture Procedure: Standard medical care||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Acupuncture for Pain Management After Hip or Knee Arthroplasty|
|Study Start Date :||March 2007|
|Actual Primary Completion Date :||June 2011|
|Actual Study Completion Date :||June 2011|
Placebo Comparator: 1
Standard medical care
Procedure: Standard medical care
Standard medical care at Woodwinds Hospital includes guided imagery, essential oils and massage.
Standard medical care plus a single true acupuncture treatment.The needles are strategically inserted into the scalp, trunk, arms or legs (not near the surgical site) and manipulated. The needles are withdrawn between 5 minutes and 30 minutes after insertion.
Sham Comparator: 3
Procedure: Sham Acupuncture
Standard medical care plus sham acupuncture. A single treatment, using a maximum of 9 sham needles, which adhere to the skin but do not penetrate it. The sham needles are strategically placed on the scalp, trunk, arms or legs (not near the surgical site)
Other Name: The Park Sham Device
- Pain intensity as measured by the Visual Analog Scale [ Time Frame: Before and immediately following treatment ]
- Pain medication use [ Time Frame: before and after treatment ]
- Cost of pain treatment [ Time Frame: Annually ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00455182
|United States, Minnesota|
|HealthEast Woodwinds Hospital|
|Woodbury, Minnesota, United States, 55125|
|Principal Investigator:||Daniel Hoeffel, M.D.||Summit Orthopedics|