Clinical trial NCT02399969: Battlefield Acupuncture for the Treatment of Low Back Pain in the Emergency Department
Official title: Battlefield Acupuncture for the Treatment of Low Back Pain in the Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Low Back Pain
Keywords: Low back pain
Acupuncture therapy
Acupuncture, ear
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2015-03-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to study acupuncture for the treatment of low back pain in the emergency department. Current treatments for low back pain in the emergency department generally include pills or injections of medications to treat pain and relax muscles. However, it is known that many of these medications have risks and toxicities which may limit their safe use in some patients. Therefore, new types of treatments are needed.

Acupuncture is an ancient form of healing that has been practiced in some form for centuries. In modern times, acupuncture has been studied for the long-term treatment of low back pain and some research suggests it may be effective. However, very little research has examined the use of acupuncture for immediate pain relief in the emergency department.

This research will study a type of acupuncture called Battlefield Acupuncture (BFA). Battlefield acupuncture was designed by a physician in the US military with the purpose of providing immediate pain relief. It involves the placement of 5 small needles in each ear. The needles may be removed at any time. The hypothesis of this study is that battlefield acupuncture may improve mobility and pain of patients with low back pain in the emergency department.

Detailed description: The researchers will review the chief complaints of patients arriving to the emergency department in epic. Subjects will be identified and recruited in the emergency department based on chief complaint of "back pain". Subjects will be approached by a researcher who will then recruit them to participate in the study using the attached informed consent form. Researchers will not be acting as treating physicians at the time of the study.

50 patients that present to the emergency setting with the complaint of low back pain will be randomized to standard care or standard care plus Battlefield Acupuncture. The patients randomized to receive Battlefield Acupuncture will receive the treatment according to the defined protocol, which involves placement of ASP indwelling needles in up to 5 auricular points. One ear will be selected, and the areas which will be needled will identified and prepped with alcohol to reduce risks of infection. Up to 5 sterile ASP semi- permanent needles will be placed. Treatments will be provided by MDs or PAs who have been trained to administer the Battlefield Acupuncture technique.

All patients will complete pre- and post- treatment surveys regarding their pain rating and functional limitation from pain. Additional data will be collected from EPIC regarding demographic information, medication administration, and length of stay.

Data will be collected from the subject at the time of enrollment, and again one hour following enrollment. No further data will be collected directly from subjects. Additional follow-up data regarding medications prescribed and length of stay will be collected from the chart after patient discharge.

Eligibility criteria: Inclusion criteria:

* adult
* English-speaking participants
* over the age of 18
* come to the emergency department with the chief complaint of low back pain.

Exclusion criteria:

* any focal neurological deficit
* prior back surgery, acute trauma,
* new weakness
* new loss bowel/bladder control
* back pain above T12
* receiving coumadin or plavix
* Pregnancy. Female patients will be offered pregnancy testing which they can elect to take.
* Temperature \>38C,
* positive urinalysis (UTI or pregnancy). Urinalysis will not be requested if not deemed clinically relevant by the treating team, as this may delay patient care and discharge.

Primary outcomes:
measure: Get up and go test
timeFrame: baseline
measure: Get up and go test
timeFrame: immediately post-treatment in the BFA group only
measure: Get up and go test
timeFrame: 1 hour
Secondary outcomes:
measure: Numeric Rating Scale (NRS) for Pain
timeFrame: baseline
measure: Numeric Rating Scale (NRS) for Pain
timeFrame: immediately post-treatment in the BFA group only
measure: Numeric Rating Scale (NRS) for Pain
timeFrame: 1 hour
measure: Range of motion of the lumbar spine
timeFrame: baseline
measure: Range of motion of the lumbar spine
timeFrame: immediately post-treatment in the BFA group only
measure: Range of motion of the lumbar spine
timeFrame: 1 hour
Other outcomes:
measure: Length of stay
timeFrame: up to 1 week
measure: medications administered
timeFrame: up to 1 week
measure: Adverse events
timeFrame: up to 6 months
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Alex F Manini, MD, MS, FACMT
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fox LM, Murakami M, Danesh H, Manini AF. Battlefield acupuncture to treat low back pain in the emergency department. Am J Emerg Med. 2018 Jun;36(6):1045-1048. doi: 10.1016/j.ajem.2018.02.038. Epub 2018 Feb 27.