Battlefield Acupuncture for Acute/Subacute Back Pain in the Emergency Department
Condition: Low Back Pain, Mechanical
MeSH terms: Back Pain; Emergencies; Low Back Pain
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Battlefield Acupuncture; Acetaminophen; Diclofenac; Diazepam; Hydrocodone; Ketorolac
Intervention type(s): Device; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 1-10 needles inserted in systematic nature as described by Battlefield acupuncture protocol.; 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
Other intervention name(s): Tylenol; Voltaren; Valium; Norco; Toradol
Intervention MeSH terms: Acetaminophen; Diclofenac; Ketorolac; Diazepam; Hydrocodone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Battlefield Acupuncture; Auricular Acupuncture; Complementary Alternative Medicine; Military, Service Members; Emergency Medicine; Back Pain; Acute Back Pain; Chronic Back Pain; Alternative Medicine,