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

June 24, 2019 updated by: Kyle Johnston, San Antonio Military Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Individuals to be enrolled the study will be:

    • Emergency Room patient
    • Able to provide informed consent (of sound mind)
    • acute defined as less than 3 months, or acute on chronic musculoskeletal pain
    • Individuals will be between 18-55 years of age and include Active Duty (AD) service members and beneficiaries
    • Pain at prescreening will be greater than or equal to 3 based on the Visual Analogue Scale (VAS).
    • Non-pathological acute back pain

Exclusion Criteria:

  • The individuals eligible for the study will be in good health, as defined by the World Health Organization (WHO, 2006). "Health is a state of complete physical, mental, and social wellbeing and not merely the absence of disease or infirmity" (WHO, 2006). Specific exclusion criteria will include,

    • Participants presenting with open wound injuries
    • temperature >38.0 Celsius
    • suspected fractures
    • pain associated with diseases (flank/kidney pain)
    • concern for other than back pain (pyelonephritis, kidney stones, pathologic signs and symptoms)
    • bowel/bladder incontinence or retention
    • foot drop
    • known current/history of cancer
    • known bleeding disorders
    • active infection at the needled insertion site
    • If member is found to be pregnant at any time during screening process they will be removed from consideration before any treatment options are offered.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Acupuncture Group
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.
Device: Battlefield Acupuncture
1-10 needles inserted in systematic nature as described by Battlefield acupuncture protocol.
ACTIVE_COMPARATOR: Standard Care Group
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.
Drug: Acetaminophen
Acetaminophen 500mg-1000mg,
Other Names:
  • Tylenol
Drug: Diclofenac
Diclofenac 50mg-75 mg orally
Other Names:
  • Voltaren
Drug: Diazepam
Diazepam 5mg-10 mg intravenous or oral
Other Names:
  • Valium
Drug: Hydrocodone
Hydrocodone 5mg/325mg-10mg/650mg mg
Other Names:
  • Norco
Drug: Ketorolac
oral, or intramuscular Ketorolac 30mg-60 mg
Other Names:
  • Toradol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
time-response of BFA, and the association with pain level using the Visual Analog scale (0-10 mm) scoring as well as the Numeric Rating Scale (0-10) scoring
Time Frame: before treatment, 30-40 minutes post-treatment, and 48 to 72 hours post-treatment
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
before treatment, 30-40 minutes post-treatment, and 48 to 72 hours post-treatment
Evaluate the change of pain on Visual Analog scale (0-10mm) scoring with BFA administered in the emergency department for persons presenting with non-pathologic back pain.
Time Frame: baseline and at 30-40 minutes post treatment
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.
baseline and at 30-40 minutes post treatment
Evaluate the change of pain on Numeric Rating Scale (0-10) scoring with BFA administered in the emergency department for persons presenting with non-pathologic back pain.
Time Frame: baseline, 30-40 minutes, and 48-72 hours
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.
baseline, 30-40 minutes, and 48-72 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
time-response
Time Frame: 30-40 minutes after treatment, and between 48-72 hours after discharge
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.
30-40 minutes after treatment, and between 48-72 hours after discharge
Examine the functionality score changes at 3 time points using the Back Pain Functional Scale
Time Frame: baseline, at the time the patient is to be discharged from the Emergency Room (0-3 hrs post baseline assessment), and 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.
baseline, at the time the patient is to be discharged from the Emergency Room (0-3 hrs post baseline assessment), and 48-72 hours after discharge
Explore participant satisfaction of pain control in the BFA treatment group: 1 question
Time Frame: At discharge from the Emergency Room (0-3 hours post baseline assessment) and between 48-72 hours after discharge
1 question regarding overall pain control satisfaction, and 2 specifically addressing those in the acupuncture group
At discharge from the Emergency Room (0-3 hours post baseline assessment) and between 48-72 hours after discharge
The need for any additional pain medication outside of the treatment protocol
Time Frame: recorded at the 48-72 hours from discharge for the follow up interview
Number of patients that required any additional pain medications either in the Emergency Room or at home to include over the counter or prescription
recorded at the 48-72 hours from discharge for the follow up interview

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

San Antonio Military Medical Center

Investigators

  • Principal Investigator: Timothy Bonjour, DSc, Program Director

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 22, 2016

Primary Completion (ACTUAL)

December 12, 2016

Study Completion (ACTUAL)

December 12, 2016

Study Registration Dates

First Submitted

September 7, 2018

First Submitted That Met QC Criteria

June 20, 2019

First Posted (ACTUAL)

June 25, 2019

Study Record Updates

Last Update Posted (ACTUAL)

June 26, 2019

Last Update Submitted That Met QC Criteria

June 24, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C.2016.017d

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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