Acupuncture for Pain Management After Hip or Knee Arthroplasty

This study has been withdrawn prior to enrollment.
(Inability to enroll subjects who were willing to be randomized to control group)
Sponsor:
Collaborators:
University of Minnesota - Clinical and Translational Science Institute
Northwestern Health Sciences University
Information provided by:
HealthEast Care System
ClinicalTrials.gov Identifier:
NCT00455182
First received: March 29, 2007
Last updated: June 21, 2011
Last verified: June 2011
  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.


Condition Intervention
Pain
Postoperative Complications
Procedure: Acupuncture
Procedure: Sham Acupuncture
Procedure: Standard medical care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Acupuncture for Pain Management After Hip or Knee Arthroplasty

Resource links provided by NLM:


Further study details as provided by HealthEast Care System:

Primary Outcome Measures:
  • Pain intensity as measured by the Visual Analog Scale [ Time Frame: Before and immediately following treatment ] [ Designated as safety issue: No ]
  • Pain medication use [ Time Frame: before and after treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cost of pain treatment [ Time Frame: Annually ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: March 2007
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Standard medical care
Procedure: Standard medical care
Standard medical care at Woodwinds Hospital includes guided imagery, essential oils and massage.
Experimental: 2
Acupuncture
Procedure: Acupuncture
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 The needles are withdrawn between 5 minutes and 30 minutes after insertion.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
Sham acupuncture
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00455182

Locations
United States, Minnesota
HealthEast Woodwinds Hospital
Woodbury, Minnesota, United States, 55125
Sponsors and Collaborators
HealthEast Care System
University of Minnesota - Clinical and Translational Science Institute
Northwestern Health Sciences University
Investigators
Principal Investigator: Daniel Hoeffel, M.D. Summit Orthopedics
  More Information

Publications:
Responsible Party: Daniel Hoeffel, HealthEast Care System
ClinicalTrials.gov Identifier: NCT00455182     History of Changes
Other Study ID Numbers: HE 06 10 007
Study First Received: March 29, 2007
Last Updated: June 21, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by HealthEast Care System:
Acupuncture
Hip Arthroplasty
Knee Arthroplasty
Pain Management

Additional relevant MeSH terms:
Postoperative Complications
Pathologic Processes

ClinicalTrials.gov processed this record on October 01, 2014