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

NCT03996564 | Completed

• 1 other identifier: C.2016.017d
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Low Back Pain, Mechanical

Keywords

Battlefield Acupuncture; Auricular Acupuncture; Complementary Alternative Medicine; Military, Service Members; Emergency Medicine; Back Pain; Acute Back Pain; Chronic Back Pain; Alternative Medicine,

Outcome Measures

Primary Outcomes (3)

• 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

  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.

  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.

  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 Outcomes (4)

• time-response

  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

  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

  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

  recorded at the 48-72 hours from discharge for the follow up interview

Study Arms (2)

Acupuncture Group

ACTIVE COMPARATOR

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

Standard Care Group

ACTIVE COMPARATOR

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; Drug: Diclofenac; Drug: Diazepam; Drug: Hydrocodone; Drug: Ketorolac

Interventions

Battlefield Acupuncture DEVICE

1-10 needles inserted in systematic nature as described by Battlefield acupuncture protocol.

Acupuncture Group

Acetaminophen DRUG

Acetaminophen 500mg-1000mg,

Also known as: Tylenol

Standard Care Group

Diclofenac DRUG

Diclofenac 50mg-75 mg orally

Also known as: Voltaren

Standard Care Group

Diazepam DRUG

Diazepam 5mg-10 mg intravenous or oral

Also known as: Valium

Standard Care Group

Hydrocodone DRUG

Hydrocodone 5mg/325mg-10mg/650mg mg

Also known as: Norco

Standard Care Group

Ketorolac DRUG

oral, or intramuscular Ketorolac 30mg-60 mg

Also known as: Toradol

Standard Care Group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• San Antonio Military Medical Center: lead

Related Publications (27)

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MeSH Terms

Conditions

Low Back Pain; Back Pain

Interventions

Acetaminophen; Diclofenac; Diazepam; Hydrocodone; oxycodone-acetaminophen; Ketorolac; Ketorolac Tromethamine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Indomethacin; Indoles

Study Officials

• Timothy Bonjour, DSc

  Program Director

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 7, 2018
• First Posted: June 25, 2019
• Study Start: February 22, 2016
• Primary Completion: December 12, 2016
• Study Completion: December 12, 2016
• Last Updated: June 26, 2019

Record last verified: 2019-06