Rapid Extremity Pain Relief by Battlefield Acupuncture After Orthopedic Surgery

NCT ID: NCT02093637

Last Updated: 2017-08-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 279 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2017-02-28

Brief 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.

Detailed 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.

Conditions

Pain

Study Design

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

Study Groups

Placebo acupuncture

Placebo acupuncture up to 5 acupuncture needles\* in each ear (up to 10 needles total) at points identified by point-finder to have no electrical conductance) plus usual operative and post-operative care (narcotic and non-narcotic pain medication).

Group Type: PLACEBO_COMPARATOR

Placebo acupuncture

Intervention Type: OTHER

Placebo Comparator

Battlefield Acupuncture

Usual operative and post-operative care (narcotic and non-narcotic pain medication) plus Battlefield Acupuncture (up to 5 acupuncture needles\* in each ear (up to 10 needles total), identified by a point-finder.

Group Type: EXPERIMENTAL

Battlefield Acupuncture

Intervention Type: OTHER

Experimental

standard therapy

standard therapy

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Placebo acupuncture

Placebo Comparator

Intervention Type: OTHER

Battlefield Acupuncture

Experimental

Intervention Type: OTHER

Other Intervention Names

ASP needles; ASP needles

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mike O'Callaghan Military Hospital

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul Crawford, MD

Role: PRINCIPAL_INVESTIGATOR

MOFMC

Locations

David Grant Medical Center

Travis Air Force Base, California, United States

Mike O'Callaghan Federal Medical Center

Nellis Air Force Base, Nevada, United States

Countries

United States

Other Identifiers

FDG20120024H

Identifier Type: -

Identifier Source: org_study_id