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NCT02093637 Clinical Trial

Rapid Extremity Pain Relief by Battlefield Acupuncture After Orthopedic Surgery

Pain Clinical Trial

Official title:
Rapid Extremity Pain Relief by Battlefield Acupuncture After Orthopedic Surgery: A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02093637
Other study ID # FDG20120024H
Secondary ID
Status Completed
Phase N/A
First received July 11, 2013
Last updated August 9, 2017
Start date August 2013
Est. completion date February 2017

Study information
Verified date August 2017
Source Mike O'Callaghan Federal Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine if the addition of Battlefield Auricular Acupuncture (BFA) to standard therapy causes reduction in pain, medication use, time to ambulation without assistance, hours missed from work and increases quality of life after lower extremity surgery at two Air Force Medical Centers.

Description:

We will recruit 429subjects into this research study, for an expected 309 completing the study. We estimate 120 subjects will either withdraw consent or become ineligible for the study. Subjects will be ≥18 years or older and scheduled for lower extremity surgery. To randomize subjects, we will employ a random number generator, which will minimize difference between study groups. Additionally, we will collect data about patients' length of hospital stay, which will allow for statistical control of the variable, complexity of surgical procedure. The Research Assistants/Coordinators will be responsible for obtaining Informed Consent and HIPAA Authorization from subjects, collecting data, and de-identifying data prior to review and analysis by the Investigators. The Investigators will be responsible for ongoing protocol monitoring, insertion of needles, verifying inclusion/exclusion criteria, and analyzing data.

Recruitment information / eligibility
Status Completed
Enrollment 279
Est. completion date February 2017
Est. primary completion date February 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility THIS STUDY IS BEING CONDUCTED AT A MILITARY INSTALLATION. YOU MUST HAVE MILITARY INSURANCE IN ORDER TO PARTICIPATE IN THIS STUDY.

Inclusion Criteria:

Male and female subjects (DoD beneficiaries), 18 years or older who are scheduled for lower extremity surgery below the hip.

Exclusion Criteria:

Pregnant or breastfeeding Absence of their ear Active cellulitis of their ear Ear anatomy precluding identification of acupuncture landmarks Non-English speaking Use of Hearing Aids that preclude the insertion of ASP needles Inability to comply with study protocol

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Placebo acupuncture
Placebo Comparator
• Battlefield Acupuncture
Experimental

Locations
Country Name City State
United States Mike O'Callaghan Federal Medical Center Nellis Air Force Base Nevada
United States David Grant Medical Center Travis Air Force Base California

Sponsors (1)
Lead Sponsor Collaborator
Mike O'Callaghan Federal Hospital

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pain score 1 month
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