Acute Back PainEDNCT07771686
Battlefield Acupressure for Acute Back Pain Management in the Emergency Department
A study testing Battlefield auricular acupressure in people with Acute Back Pain, run by Hackensack Meridian Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Back Pain
- What is being tested?
- Battlefield auricular acupressure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Dec 2026to 10 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Diana McCarthy, MSN, RN, 551-996-3209, Diana.McCarthy@hmhn.org
Biren Bhatt, MD
About this study
Official title: Battlefield Acupressure for Acute Back Pain Management in the Emergency Department: Evaluating Whether Auricular Acupressure Can Reduce Opiate Administration for Painful Conditions
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
- Being tested
- Battlefield auricular acupressure, Sham
- Keywords
- Acute Back Pain, Battlefield Acupressure, Auricular Acupressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Battlefield auricular acupressureProcedure or 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.
ShamProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| Battlefield auricular acupressure | Experimental | Battlefield auricular acupressure: a needle-free five-point technique on the outer ear using single-use vaccaria ear seeds. Receives: Procedure: Battlefield auricular acupressure |
| Sham acupressure intervention | Placebo comparator | The control group will receive a sham acupressure intervention. Receives: Procedure: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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).
Measured: 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.
Measured: From intervention until ED disposition (on average 3.5 hours)
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.
Measured: From intervention until ED disposition (on average 3.5 hours)
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.
Measured: From intervention until ED disposition (on average 3.5 hours)
Total Opioid Consumption in Morphine Milligram Equivalents (MME)
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).
Measured: From intervention until ED disposition (on average 3.5 hours)
Frequency of Non-Opioid Analgesic Doses
A continuous variable representing the total number of doses of non-opioid analgesics administered stratified by drug class (NSAIDs vs acetaminophen).
Measured: From intervention until ED disposition (on average 3.5 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study start10 Dec 2026 (estimated)
- Primary completion10 Dec 2028 (estimated)
- Study completion10 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hackensack Meridian Health
- Sponsor type
- University, hospital or other
- Collaborators
- New Jersey Health Foundation
- Responsible party
- Sponsor
- Investigators
- Biren Bhatt, MD, Principal investigator, Hackensack Meridian Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07771686
- Sponsor's protocol ID
- Pro2026-0039
- Acronym
- ED
- Status last verified
- Nov 2026
- First submitted
- 30 Jul 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Battlefield Acupressure for Acute Back Pain Management in the Emergency Department: Evaluating Whether Auricular Acupressure Can Reduce Opiate Administration for Painful Conditions
- ClinicalTrials.gov ID
- NCT07771686
- Acronym / sponsor ID
- ED / Pro2026-0039
- Conditions
- Acute Back Pain
- Keywords
- Acute Back Pain, Battlefield Acupressure, Auricular Acupressure
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hackensack Meridian HealthUniversity, hospital or other
- Collaborators
- New Jersey Health Foundation
- Study start
- 10 Dec 2026 (estimated)
- Primary completion
- 10 Dec 2028 (estimated)
- Study completion
- 10 Dec 2028 (estimated)
- First posted
- 18 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Battlefield auricular acupressure | Experimental | Procedure: Battlefield auricular acupressureBattlefield auricular acupressure: a needle-free five-point technique on the outer ear using single-use vaccaria ear seeds. |
| Sham acupressure intervention | Placebo comparator | Procedure: ShamThe control group will receive a sham acupressure intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Battlefield auricular acupressureBattlefield auricular acupressure: Ear seeds will be applied to the five established BAA points: Cingulate Gyrus, Thalamus, Omega 2, Point Zero, and Shen Men. | Procedure or surgery | Battlefield auricular acupressure |
| ShamEar 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. | Procedure or surgery | Sham acupressure intervention |
Primary outcome
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.
6 secondary outcomes
Change in Pain Score at 24 Hours
Time frame: 24 hours post intervention
Incidence of Any Analgesic Medication Use
Time frame: From intervention until ED disposition (on average 3.5 hours)
Incidence of Opioid Medication Use
Time frame: From intervention until ED disposition (on average 3.5 hours)
Incidence of Non-Opioid Analgesic Medication Use
Time frame: From intervention until ED disposition (on average 3.5 hours)
Total Opioid Consumption in Morphine Milligram Equivalents (MME)
Time frame: From intervention until ED disposition (on average 3.5 hours)
Frequency of Non-Opioid Analgesic Doses
Time frame: From intervention until ED disposition (on average 3.5 hours)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Biren Bhatt, MD principal investigator
Hackensack Meridian Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Battlefield auricular acupressure in people with Acute Back Pain, run by Hackensack Meridian Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Diana McCarthy, MSN, RN (551-996-3209, Diana.McCarthy@hmhn.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.