Battlefield Acupressure for Acute Back Pain

(ED Trial)

DM
Overseen ByDiana McCarthy, MSN, RN
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Hackensack Meridian Health

What You Need to Know Before You Apply

What is the purpose of 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.

Who Is on the Research Team?

BB

Biren Bhatt, MD

Principal Investigator

Hackensack Meridian Health

Are You a Good Fit for This Trial?

This trial is for adults who come to the emergency department with sudden back pain. People with other major health issues or reasons that would prevent safe participation may not be eligible.

Inclusion Criteria

My pain level is 4 or higher on a scale of 0 to 10.
I am 18 years old or older and went to the emergency department.
I have back pain or lower back pain.

Exclusion Criteria

I received pain medication within 4 hours of arriving at the emergency room.
Preferred language other than Spanish or English
I have a wound, sore, or infection on my ear.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day
1 visit (in-person)

Treatment

Participants receive battlefield auricular acupressure or a sham procedure in the emergency department

1 day
1 visit (in-person)

Immediate Follow-up

Pain scores are assessed at 30 and 60 minutes post-intervention

1 hour
In-person monitoring

Extended Follow-up

Participants are monitored for opioid and non-opioid analgesic use until ED disposition

3.5 hours

Delayed Follow-up

A 24-hour follow-up assessment is conducted to evaluate the lasting effect of the intervention

24 hours post-intervention
1 follow-up contact (virtual or phone)

What Are the Treatments Tested in This Trial?

Interventions

  • Battlefield Auricular Acupressure

Trial Overview

The study compares a needle-free ear acupressure technique called Battlefield Auricular Acupressure (BAA) to a fake (sham) procedure, to see if BAA helps reduce back pain quickly in the emergency room.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Battlefield auricular acupressureExperimental Treatment1 Intervention
Group II: Sham acupressure interventionPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Hackensack Meridian Health

Lead Sponsor

Trials
141
Recruited
42,900+

New Jersey Health Foundation

Collaborator