Pain Clinical Trial
Official title:
Acupuncture for Pain Management After Hip or Knee Arthroplasty
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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