Rapid Extremity Pain Relief by Battlefield Acupuncture After Orthopedic Surgery
1 other identifier
interventional
279
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable pain
Started Aug 2013
Longer than P75 for not_applicable pain
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 11, 2013
CompletedStudy Start
First participant enrolled
August 1, 2013
CompletedFirst Posted
Study publicly available on registry
March 21, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2017
CompletedAugust 11, 2017
August 1, 2017
3.5 years
July 11, 2013
August 9, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Pain score
1 month
Study Arms (3)
Placebo acupuncture
PLACEBO COMPARATORPlacebo 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).
Battlefield Acupuncture
EXPERIMENTALUsual 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.
standard therapy
NO INTERVENTIONstandard therapy
Interventions
Eligibility Criteria
You may qualify if:
- Male and female subjects (DoD beneficiaries), 18 years or older who are scheduled for lower extremity surgery below the hip.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
David Grant Medical Center
Travis Air Force Base, California, 94535, United States
Mike O'Callaghan Federal Medical Center
Nellis Air Force Base, Nevada, 89191, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paul Crawford, MD
MOFMC
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 11, 2013
First Posted
March 21, 2014
Study Start
August 1, 2013
Primary Completion
February 1, 2017
Study Completion
February 1, 2017
Last Updated
August 11, 2017
Record last verified: 2017-08