An interventional study of Battlefield auricular acupressure and Sham in Acute Back Pain, sponsored by Hackensack Meridian Health. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Hackensack Meridian Health · Not applicable, Interventional, and Treatment
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.
728 studies on the registry are indexed under Back Pain; 109 are open to participants now.
This study's planned enrollment of 50 is below the median of 70 across 593 interventional studies indexed under Back Pain.
Browse Back Pain studies →Hackensack Meridian Health is the lead sponsor of 113 studies on the registry; 28 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 12 (71%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Battlefield auricular acupressure: a needle-free five-point technique on the outer ear using single-use vaccaria ear seeds.
Procedure: Battlefield auricular acupressure
The control group will receive a sham acupressure intervention.
Procedure: Sham
Battlefield auricular acupressure: Ear seeds will be applied to the five established BAA points: Cingulate Gyrus, Thalamus, Omega 2, Point Zero, and Shen Men.
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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: From intervention until ED disposition (on average 3.5 hours)
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for Dec 2028, 24 months later.
Of 259 non-industry interventional studies with no phase under Back Pain, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 33. This study's planned 24 months is above that.
Counting every sponsor, half of 294 studies reached it within 13 months; a quarter within 5 and three quarters within 34.
Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 3, 2026: start Sep 2026 → Dec 2026, primary completion Sep 2028 → Dec 2028 and completion Sep 2028 → Dec 2028.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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