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NCT Number: NCT07771686

Battlefield Acupressure for Acute Back Pain Management in the Emergency Department

Patients frequently present to the emergency department for treatment of acute pain. In the emergency department, analgesic medications, particularly opiates, are most often the primary and only means of treatment. Alternative therapies such as traditional acupuncture have been studied and utilized in acute care settings; however, the need for extensive training, the use of needles, and state-specific acupuncture licensing requirements have been barriers to widespread use. Battlefield Auricular Acupressure (BAA) is a needle-free five-point technique on the outer ear that has been developed and employed by the military for a variety of painful conditions.

The primary objective of this study is to determine if battlefield auricular acupressure (BAA), compared to a sham procedure, results in a reduction in pain score at 30 minutes and 60 minutes post-intervention, by at least 2 Numerical Rating Scale (NRS) points below their baseline pain score, compared to participants receiving a sham procedure, for adults who present to the emergency department with a chief complaint of back pain and/or low back.

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Key information

Conditions

Acute Back Pain

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location contact

Biren Bhatt, MD

PRINCIPAL_INVESTIGATOR

Diana McCarthy, MSN, RN

CONTACT

[email protected]

551-996-3209

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patient (Age ≥ 18) presenting to the ED
  • Chief complaint of back pain and/or low back pain
  • Pain score ≥ 4 on 0-10 NRS

Exclusion criteria

  • Pregnancy
  • Known allergy to adhesive
  • Presence of cochlear implants
  • Piercings at one or more of the BAA or sham sites
  • Having received analgesic medications within 4 hours of arrival to the ED or prior to intervention
  • Preferred language other than Spanish or English
  • Presence of a wound, sore, or active infection on the surface of the ear

Treatment and study plan

Battlefield auricular acupressure

Procedure

Battlefield auricular acupressure: Ear seeds will be applied to the five established BAA points: Cingulate Gyrus, Thalamus, Omega 2, Point Zero, and Shen Men.

Sham

Procedure

Ear seeds will be applied to five pre-defined, non-therapeutic points on the ear helix and lobe, chosen for their lack of known effect on pain. The procedure will be identical in duration and interaction to the BAA group.

Primary outcomes

  1. Change in Pain Score

    Time frame: Pain scores will be assessed at baseline (prior to intervention), 30 (± 5) minutes post-intervention and 60 (± 10) minutes post-intervention.

    Pain scores will be measured using the Numeric Rating Scale (NRS) ranging from 0 ("no pain") to 10 ("worst pain imaginable")10. This study will compare the mean pain scores between the BAA group and the sham group.

Secondary outcomes

  1. Change in Pain Score at 24 Hours

    Time frame: 24 hours post intervention

    To assess the lasting effect of the intervention, a delayed follow-up 24-hour assessment will be conducted.

    Pain scores will be measured using the Numeric Rating Scale (NRS) ranging from 0 ("no pain") to 10 ("worst pain imaginable")10. Delayed follow-up pain score will be calculated as (NRS at 24 hours) - (NRS at baseline).

  2. Incidence of Any Analgesic Medication Use

    Time frame: From intervention until ED disposition (on average 3.5 hours)

    The proportion of patients in each group (intervention vs. sham) who require any analgesic medication following the intervention. This will be analyzed as a dichotomous (yes/no) outcome.

  3. Incidence of Opioid Medication Use

    Time frame: From intervention until ED disposition (on average 3.5 hours)

    The proportion of patients in each group (intervention vs. sham) who are administered an opioid analgesic following the intervention. This is a specific subset of analgesia and will be analyzed as a dichotomous (yes/no) outcome.

  4. Incidence of Non-Opioid Analgesic Medication Use

    Time frame: From intervention until ED disposition (on average 3.5 hours)

    The proportion of patients in each group who require at least one dose of a non-opioid analgesic.

  5. Total Opioid Consumption in Morphine Milligram Equivalents (MME)

    Time frame: From intervention until ED disposition (on average 3.5 hours)

    A continuous variable representing the sum of all opioid doses received, converted to a standardized value. MME is a universal conversion system that turns all opioids into a single, standard unit using the formula: MME = (Dose of the Opioid in mg) x (Its Conversion Factor).

  6. Frequency of Non-Opioid Analgesic Doses

    Time frame: From intervention until ED disposition (on average 3.5 hours)

    A continuous variable representing the total number of doses of non-opioid analgesics administered stratified by drug class (NSAIDs vs acetaminophen).

Study contacts

Contact information is provided by the study sponsor or research team.

Diana McCarthy, MSN, RN

CONTACT

[email protected]

551-996-3209

Sponsors and collaborators

Lead sponsor

Hackensack Meridian Health

Other

Collaborators

  • New Jersey Health Foundation

Registry information

Official study title

Battlefield Acupressure for Acute Back Pain Management in the Emergency Department: Evaluating Whether Auricular Acupressure Can Reduce Opiate Administration for Painful Conditions

Acronym: ED

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 18, 2026
Registry last updated
Aug 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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