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.

Study Overview

• Status: Withdrawn
• Conditions: Pain; Postoperative Complications
• Intervention / Treatment: Procedure: Standard medical care; Procedure: Acupuncture; Procedure: Sham Acupuncture

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Woodbury, Minnesota, United States, 55125
      • HealthEast Woodwinds Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: The Park Sham Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pain intensity as measured by the Visual Analog Scale	Before and immediately following treatment
Pain medication use	before and after treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
Cost of pain treatment	Annually

Collaborators and Investigators

• Sponsor: HealthEast Care System
• Collaborators: University of Minnesota; Northwestern Health Sciences University
• Investigators: Principal Investigator: Daniel Hoeffel, M.D., Summit Orthopedics

Publications and helpful links

General Publications

• N van Arendonk. Does the inclusion of acupuncture improve pain and functional outcome following total knee arthroplasty? Physiotherapy 90:168, 2004.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2007
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: March 29, 2007
• First Submitted That Met QC Criteria: April 2, 2007
• First Posted (Estimate): April 3, 2007

Study Record Updates

• Last Update Posted (Estimate): March 19, 2015
• Last Update Submitted That Met QC Criteria: March 17, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Acupuncture; Knee Arthroplasty; Hip Arthroplasty; Pain Management
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: HE 06 10 007