The randomized controlled study aims was to investigate the pain control of Battle Field
Acupuncture as Primary or Adjunctive Treatment in Back Pain (Acute Musculoskeletal pain)
in the (acute pain setting) Emergency Department vs stand of care pain medications.

Battlefield Acupuncture for Acute/Subacute Back Pain in the Emergency Department

Low Back Pain, Mechanical

Purpose: To evaluate the effectiveness of Battlefield Acupuncture versus standard care
(medicinal therapy) in an Emergency Room setting for acute/subacute back pain using the
Visual Analog Scale (VAS) and Numeric Rating Scale (NRS) to determine changes in pain
levels. Secondary outcomes will include performance using the back pain functional scale
(BPFS), satisfaction of treatment, and the need for further pain medication after
discharge from the emergency department.

Design and Methods: A prospective, randomized control trial, (un-blinded, non-placebo
controlled) with convenience sampling based on scheduled clinical shifts in the Emergency
Department.

The population consisted of active duty service members and Department of Defense
beneficiaries (dependents and retirees) at the DoD's sole Level I trauma center, San
Antonio Military Medical Center Emergency Department with acute/subacute, or
acute/subacute on chronic back pain as the chief complaint. The participants studied age
range was from 18-55 years old without concern for pathological back pain.

Subjects were selected based on their chief complaint identified by the triage nurse. A
randomized convenience sampling method was used while members of the research team were
on shift. Subjects were informed of the study once they were triaged at the Emergency
Department treatment area. Members were screened for pathological back pain by history
and physical, and if negative were offered enrollment into the study. After informed
consent and Health Insurance Portability and Accountability Act (HIPPA), demographics
were collected as well as an initial Visual Analog Score (VAS) score, Numeric Rating
Scale (NRS) score, and back pain functional scale (BPFS). Participants were randomly
assigned to either the treatment or control group based on a random number generator.
Subjects then received either BFA or the standard care, which was a pre-determined
medicinal treatment. Participants were reassessed at 30-40 minutes post intervention for
effectiveness of intervention for both pain and satisfaction. After initial pain control
was achieved subjects completed a questionnaire on their perceived effectiveness of BFA
as well as if they would repeat BFA in the future. If participants did not feel pain was
adequately controlled in the either treatment arm they were provided rescue pain
medications based on the preference of the treating provider. At discharge, participants
were given further instructions including a follow-up telephone interview between 48-72
hours. In the telephone follow-up, participants were assessed on a Numerical Rating Scale
(NRS), repeat functionality questionnaire, and if they used any other pain medications
since discharge to help improve their pain (either pain medications given at discharge
from the emergency department or their regularly prescribed pain medications).

Data Analysis: In this study, the independent variables were treatment for
musculoskeletal pain in the emergency department (standard care, battlefield acupuncture)
and time (before treatment, 30 to 40 minutes post-treatment and 48 to 72 hours
post-treatment). The dependent variable is pain measured on a VAS or NRS at 48-72 hours
post-treatment. The null hypothesis is that there is no statistically significant
difference in pain related to treatment or time between treatment groups. With 26
subjects per group (52 total), the investigator was able to detect a 1.0 standard
deviation (SD) difference measured by a 13mm change in the VAS or a 2 point change in the
NRS.

Battlefield Acupuncture

Acetaminophen

Diclofenac

Diazepam

Hydrocodone

Ketorolac

determine if there is any significant change in pain in the BFA treatment group at
specific time points using the Visual Analog scale (0-10 mm) scoring as well as the
Numeric Rating Scale (0-10) scoring

Using the Visual Analog scale which is a 10mm line, the patient will place a mark on the
graph which will be measured to determine if there is any significant difference between
the BFA treatment group pain at specific timepoints using the VAS. The lower the score
determined on the scale corresponds to a lower pain level for the patient and a higher
score corresponds to a higher pain level.

The Numeric Rating scale which is a scale that is verbally asked to determine the
patients pain response on a scale from 0 to 10 determine if there is any significant
difference between the BFA treatment group pain at specific timepoints using the NRS. The
lower the score determined on the scale corresponds to a lower pain level for the patient
and a higher score corresponds to a higher pain level.

Principal Investigator

Time response will determine change in pain associated with the Numeric Rating scale
(measured 0-10, 0 being least, 10 being most) from baseline, at 30-40 minutes after
treatment, and between 48-72 hours after discharge.

Stratford et al developed the Back Pain Function Scale (BPFS) (scored 0-60 with higher
scores showing no difficulty and lower scores showing patient is unable to perform
activity) to evaluation functional ability in patients with back pain. The authors are
from McMaster University Appalachian Physical Therapy (Georgia) and Virginia Commonwealth
University.

1 question regarding overall pain control satisfaction, and 2 specifically addressing
those in the acupuncture group

Number of patients that required any additional pain medications either in the Emergency
Room or at home to include over the counter or prescription

Battlefield Acupuncture (BFA) has a structured administration sequence that was utilized
to limit any variability between investigators administering the treatment. The BFA
technique has been suggested that the needles are placed not just in an acupoint but
actually "acupoint zones." BFA utilizes one to ten (maximum five points per ear) ASP
semi-permanent gold needles® placed in one or both ears. The ASP Gold needle® is a
sterile device which inserts a small 2 mm needle into the auricle. It is comprised in
single-needle applicator ensuring ease of insertion combined with excellent precision.
The needles remain in the ear and fall out spontaneously as early as two hours and up to
seven days. After administration of the BFA, if subjects felt that their pain was not
controlled based on verbal response, rescue medication could be administered to control
pain to a tolerable level for discharge.

Participants randomized to the standard care group were treated with one, or a
combination of selected medications to include oral Acetaminophen 500mg-1000mg,
Diclofenac 50mg-75 mg orally, Diazepam 5mg-10 mg intravenous or oral, Hydrocodone
5mg/325mg-10mg/650mg mg oral, or intramuscular Ketorolac 30mg-60 mg, as deemed
appropriate by the treating investigator (medical provider). Standard treatment was
administered by the investigators based on the patient's presentation and driving status
as many of the medications cannot be administered if the subject would operate a vehicle.
No standardized algorithm was specified and the route and dose of medications was
administered at the provider's discretion. After administration of the traditional
standard care medications, if subjects felt their pain was not controlled based on verbal
responses, rescue medication would be given to control pain to a more tolerable level for
discharge.

Battlefield Acupuncture for Acute/Subacute Back Pain in the Emergency Department

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Trial Timing

What is this trial about?

What are the participation requirements?