NCT00455182

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2007

Longer than P75 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

March 29, 2007

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 3, 2007

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

March 19, 2015

Status Verified

March 1, 2015

Enrollment Period

4.3 years

First QC Date

March 29, 2007

Last Update Submit

March 17, 2015

Conditions

PainPostoperative Complications

Keywords

AcupunctureHip ArthroplastyKnee ArthroplastyPain Management

Outcome Measures

Primary Outcomes (2)

  • Pain intensity as measured by the Visual Analog Scale

    Before and immediately following treatment

  • Pain medication use

    before and after treatment

Secondary Outcomes (1)

  • Cost of pain treatment

    Annually

Study Arms (3)

1

PLACEBO COMPARATOR

Standard medical care

Procedure: Standard medical care

2

EXPERIMENTAL

Acupuncture

Procedure: Acupuncture

3

SHAM COMPARATOR

Sham acupuncture

Procedure: Sham Acupuncture

Interventions

AcupuncturePROCEDURE

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 The needles are withdrawn between 5 minutes and 30 minutes after insertion.

2
Sham AcupuncturePROCEDURE

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)

Also known as: The Park Sham Device
3
Standard medical carePROCEDURE

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

1

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old
  • Undergoing total hip or total knee arthroplasty
  • Spinal anesthesia during surgery

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HealthEast Woodwinds Hospital

Woodbury, Minnesota, 55125, United States

Location

Related Publications (3)

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

    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.

    PMID: 12798078BACKGROUND

  • 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.

    PMID: 15777857RESULT

MeSH Terms

Conditions

PainPostoperative ComplicationsAgnosia

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic ProcessesPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Daniel Hoeffel, M.D.

    Summit Orthopedics

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2007

First Posted

April 3, 2007

Study Start

March 1, 2007

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

March 19, 2015

Record last verified: 2015-03

Locations

US(1)