Battlefield Acupressure for Acute Back Pain Management in the Emergency Department

NCT07771686 | Not Yet Recruiting

• 1 other identifier: Pro2026-0039
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Back Pain

Keywords

Acute Back Pain; Battlefield Acupressure; Auricular Acupressure

Outcome Measures

Primary Outcomes (1)

• Change in Pain Score

  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.

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

Secondary Outcomes (6)

• Change in Pain Score at 24 Hours

  24 hours post intervention

• Incidence of Any Analgesic Medication Use

  From intervention until ED disposition (on average 3.5 hours)

• Incidence of Opioid Medication Use

  From intervention until ED disposition (on average 3.5 hours)

• Incidence of Non-Opioid Analgesic Medication Use

  From intervention until ED disposition (on average 3.5 hours)

• Total Opioid Consumption in Morphine Milligram Equivalents (MME)

  From intervention until ED disposition (on average 3.5 hours)

Study Arms (2)

Battlefield auricular acupressure

EXPERIMENTAL

Battlefield auricular acupressure: a needle-free five-point technique on the outer ear using single-use vaccaria ear seeds.

Procedure: Battlefield auricular acupressure

Sham acupressure intervention

PLACEBO COMPARATOR

The control group will receive a sham acupressure intervention.

Procedure: Sham

Interventions

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.

Battlefield auricular acupressure

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.

Sham acupressure intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hackensack Meridian Health: lead
• New Jersey Health Foundation: collaborator

Study Sites (1)

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

MeSH Terms

Interventions

salicylhydroxamic acid

Study Officials

• Biren Bhatt, MD

  Hackensack Meridian Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Diana McCarthy, MSN, RN

CONTACT

551-996-3209; Diana.McCarthy@hmhn.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2026
• First Posted: August 18, 2026
• Study Start (Estimated): September 10, 2026
• Primary Completion (Estimated): September 10, 2028
• Study Completion (Estimated): September 10, 2028
• Last Updated: August 18, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)