Acupuncture for Pain Management After Hip or Knee Arthroplasty
Primary Purpose
Pain, Postoperative Complications
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acupuncture
Sham Acupuncture
Standard medical care
Sponsored by
About this trial
This is an interventional treatment trial for Pain focused on measuring Acupuncture, Hip Arthroplasty, Knee Arthroplasty, Pain Management
Eligibility 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.
Sites / Locations
- HealthEast Woodwinds Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Sham Comparator
Arm Label
1
2
3
Arm Description
Standard medical care
Acupuncture
Sham acupuncture
Outcomes
Primary Outcome Measures
Pain intensity as measured by the Visual Analog Scale
Pain medication use
Secondary Outcome Measures
Cost of pain treatment
Full Information
NCT ID
NCT00455182
First Posted
March 29, 2007
Last Updated
March 17, 2015
Sponsor
HealthEast Care System
Collaborators
University of Minnesota, Northwestern Health Sciences University
1. Study Identification
Unique Protocol Identification Number
NCT00455182
Brief Title
Acupuncture for Pain Management After Hip or Knee Arthroplasty
Official Title
Acupuncture for Pain Management After Hip or Knee Arthroplasty
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Withdrawn
Why Stopped
Inability to enroll subjects who were willing to be randomized to control group
Study Start Date
March 2007 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HealthEast Care System
Collaborators
University of Minnesota, Northwestern Health Sciences University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative Complications
Keywords
Acupuncture, Hip Arthroplasty, Knee Arthroplasty, Pain Management
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Placebo Comparator
Arm Description
Standard medical care
Arm Title
2
Arm Type
Experimental
Arm Description
Acupuncture
Arm Title
3
Arm Type
Sham Comparator
Arm Description
Sham acupuncture
Intervention Type
Procedure
Intervention Name(s)
Acupuncture
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Sham Acupuncture
Other Intervention Name(s)
The Park Sham Device
Intervention Description
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)
Intervention Type
Procedure
Intervention Name(s)
Standard medical care
Intervention Description
Standard medical care at Woodwinds Hospital includes guided imagery, essential oils and massage.
Primary Outcome Measure Information:
Title
Pain intensity as measured by the Visual Analog Scale
Time Frame
Before and immediately following treatment
Title
Pain medication use
Time Frame
before and after treatment
Secondary Outcome Measure Information:
Title
Cost of pain treatment
Time Frame
Annually
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Hoeffel, M.D.
Organizational Affiliation
Summit Orthopedics
Official's Role
Principal Investigator
Facility Information:
Facility Name
HealthEast Woodwinds Hospital
City
Woodbury
State/Province
Minnesota
ZIP/Postal Code
55125
Country
United States
12. IPD Sharing Statement
Citations:
Citation
N van Arendonk. Does the inclusion of acupuncture improve pain and functional outcome following total knee arthroplasty? Physiotherapy 90:168, 2004.
Results Reference
background
PubMed Identifier
12798078
Citation
Gilbertson B, Wenner K, Russell LC. Acupuncture and arthroscopic acromioplasty. J Orthop Res. 2003 Jul;21(4):752-8. doi: 10.1016/S0736-0266(03)00028-7.
Results Reference
background
PubMed Identifier
15777857
Citation
Usichenko TI, Dinse M, Hermsen M, Witstruck T, Pavlovic D, Lehmann C. Auricular acupuncture for pain relief after total hip arthroplasty - a randomized controlled study. Pain. 2005 Apr;114(3):320-327. doi: 10.1016/j.pain.2004.08.021.
Results Reference
result
Learn more about this trial
Acupuncture for Pain Management After Hip or Knee Arthroplasty
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