Rapid Extremity Pain Relief by Battlefield Acupuncture After Orthopedic Surgery
Status: | Active, not recruiting |
---|---|
Conditions: | Chronic Pain |
Therapuetic Areas: | Musculoskeletal |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 2/8/2017 |
Start Date: | August 2013 |
End Date: | March 2017 |
Rapid Extremity Pain Relief by Battlefield Acupuncture After Orthopedic Surgery: A Randomized Clinical Trial
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.
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.
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.
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.
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
We found this trial at
2
sites
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Nellis AFB, Nevada 89191
Principal Investigator: Paul Crawford, MD
Phone: 702-653-3298
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