Battlefield Acupressure for Acute Back Pain Management in the Emergency Department

N/ANot Yet RecruitingNCT07771686

Hackensack Meridian Health50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Acute Back Pain

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

Change in Pain Score at 24 Hours

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).

Time frame: 24 hours post intervention

Incidence of Any Analgesic Medication Use

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.