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Rapid Extremity Pain Relief by Battlefield Acupuncture After Orthopedic Surgery

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02093637
Enrollment
279
Registered
2014-03-21
Start date
2013-08-31
Completion date
2017-02-28
Last updated
2017-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

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.

Interventions

OTHERPlacebo acupuncture

Placebo Comparator

Experimental

Sponsors

Mike O'Callaghan Military Hospital
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Pain score1 month

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026