Acupuncture for Pain Management After Hip or Knee Arthroplasty

NCT ID: NCT00455182

Last Updated: 2015-03-19

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2011-06-30

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.

Conditions

Pain; Postoperative Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1

Standard medical care

Group Type: PLACEBO_COMPARATOR

Standard medical care

Intervention Type: PROCEDURE

Standard medical care at Woodwinds Hospital includes guided imagery, essential oils and massage.

2

Acupuncture

Group Type: EXPERIMENTAL

Acupuncture

Intervention Type: PROCEDURE

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.

3

Sham acupuncture

Group Type: SHAM_COMPARATOR

Sham Acupuncture

Intervention Type: PROCEDURE

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)

Interventions

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.

Intervention Type: 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)

Intervention Type: PROCEDURE

Standard medical care

Standard medical care at Woodwinds Hospital includes guided imagery, essential oils and massage.

Intervention Type: PROCEDURE

Other Intervention Names

The Park Sham Device

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Minnesota

OTHER

Sponsor Role: collaborator

Northwestern Health Sciences University

OTHER

Sponsor Role: collaborator

HealthEast Care System

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel Hoeffel, M.D.

Role: PRINCIPAL_INVESTIGATOR

Summit Orthopedics

Locations

HealthEast Woodwinds Hospital

Woodbury, Minnesota, United States

Countries

United States

References

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

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 12798078 (View on PubMed)

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.

Reference Type: RESULT

PMID: 15777857 (View on PubMed)

Other Identifiers

HE 06 10 007

Identifier Type: -

Identifier Source: org_study_id