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

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ClinicalTrials.gov Identifier: NCT03996564
Recruitment Status : Completed
First Posted : June 25, 2019
Last Update Posted : June 26, 2019
Sponsor:
Information provided by (Responsible Party):
Kyle Johnston, San Antonio Military Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Low Back Pain, Mechanical Device: Battlefield Acupuncture Drug: Acetaminophen Drug: Diclofenac Drug: Diazepam Drug: Hydrocodone Drug: Ketorolac Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Battlefield Acupuncture for Acute/Subacute Back Pain in the Emergency Department
Actual Study Start Date : February 22, 2016
Actual Primary Completion Date : December 12, 2016
Actual Study Completion Date : December 12, 2016

Resource links provided by the National Library of Medicine


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 Name: Tylenol

Drug: Diclofenac
Diclofenac 50mg-75 mg orally
Other Name: Voltaren

Drug: Diazepam
Diazepam 5mg-10 mg intravenous or oral
Other Name: Valium

Drug: Hydrocodone
Hydrocodone 5mg/325mg-10mg/650mg mg
Other Name: Norco

Drug: Ketorolac
oral, or intramuscular Ketorolac 30mg-60 mg
Other Name: Toradol




Primary Outcome Measures :
  1. 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

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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

  4. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03996564


Sponsors and Collaborators
San Antonio Military Medical Center
Investigators
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Principal Investigator: Timothy Bonjour, DSc Program Director
Publications:
Burns, S., et al. (2013). "Moving Acupuncture to the Frontline of Military Medical Care: A Feasibility Study." Medical Acupuncture 25(1): 49-54.

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Responsible Party: Kyle Johnston, Principal Investigator, San Antonio Military Medical Center
ClinicalTrials.gov Identifier: NCT03996564    
Other Study ID Numbers: C.2016.017d
First Posted: June 25, 2019    Key Record Dates
Last Update Posted: June 26, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kyle Johnston, San Antonio Military Medical Center:
Battlefield Acupuncture
Auricular Acupuncture
Complementary Alternative Medicine
Military, Service Members
Emergency Medicine
Back Pain
Acute Back Pain
Chronic Back Pain
Alternative Medicine,
Additional relevant MeSH terms:
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Back Pain
Emergencies
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Disease Attributes
Pathologic Processes
Acetaminophen
Diclofenac
Ketorolac
Diazepam
Hydrocodone
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents