Ignite Creation Date:
2024-05-05 @ 5:25 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00455182
Status:
WITHDRAWN
Last Update Posted:
2015-03-19
First Post:
2007-03-29
Brief Title:
Acupuncture for Pain Management After Hip or Knee Arthroplasty
Sponsor:
HealthEast Care System
Organization:
HealthEast Care System
Study Overview
Official Title:
Acupuncture for Pain Management After Hip or Knee Arthroplasty
Status:
WITHDRAWN
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Inability to enroll subjects who were willing to be randomized to control group
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 physiotherapyvan 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 111 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
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 physiotherapyvan 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 111 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None