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Battlefield Acupressure for Acute Back Pain Management in the Emergency Department

ConditionAcute Back Pain
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHackensack Meridian Health

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Pregnancy

Known allergy to adhesive

Presence of cochlear implants

Piercings at one or more of the BAA or sham sites

Trial design

Design model

Parallel

Treatments tested in this trial

  • Battlefield auricular acupressure

    Procedure/Surgery

    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/Surgery

    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.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Battlefield auricular acupressureExperimental treatment 1 intervention
Group B: Sham acupressure interventionPlacebo comparator 1 intervention

Trial outcomes

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.

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

1

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
2

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.

Time frame
From intervention until ED disposition (on average 3.5 hours)
3

Incidence of Opioid Medication Use

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.

Time frame
From intervention until ED disposition (on average 3.5 hours)
4

Incidence of Non-Opioid Analgesic Medication Use

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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hackensack Meridian Health

Lead sponsor

New Jersey Health Foundation

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: