Battlefield Acupuncture for the Treatment of Low Back Pain in the Emergency Department

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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Other: Battlefield Acupuncture

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Battlefield Acupuncture Plus Standard of Care; Patients with low back pain that will receive ear acupuncture based on the Battlefield Acupuncture protocol.	Other: Battlefield Acupuncture; Patients with low back pain will be randomized to receive Battlefield Acupuncture, ASP indwelling needles in 5 auricular (ear) points plus standard of care, or patients will be randomized to receive standard of care alone.; Other Names: ear acupuncture, BFA
No Intervention: Standard of Care Alone; Patients with low back pain that will receive standard of care without study intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Get up and go test	Time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down, will be monitored in seconds. If a person cannot get up in 30 seconds to ambulate, they will be cut off.	baseline
Get up and go test	Time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down, will be monitored in seconds. If a person cannot get up in 30 seconds to ambulate, they will be cut off.	immediately post-treatment in the BFA group only
Get up and go test	Time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down, will be monitored in seconds. If a person cannot get up in 30 seconds to ambulate, they will be cut off.	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numeric Rating Scale (NRS) for Pain	Patients will be asked "On a scale of 0 to 10, with 0 being no pain at all and 10 being the worst pain imaginable, how would you rate your pain right now"	baseline
Numeric Rating Scale (NRS) for Pain	Patients will be asked "On a scale of 0 to 10, with 0 being no pain at all and 10 being the worst pain imaginable, how would you rate your pain right now"	immediately post-treatment in the BFA group only
Numeric Rating Scale (NRS) for Pain	Patients will be asked "On a scale of 0 to 10, with 0 being no pain at all and 10 being the worst pain imaginable, how would you rate your pain right now"	1 hour
Range of motion of the lumbar spine	Active ROM (Flexion and Extension) will be measured using a goniometer	baseline
Range of motion of the lumbar spine	Active ROM (Flexion and Extension) will be measured using a goniometer	immediately post-treatment in the BFA group only
Range of motion of the lumbar spine	Active ROM (Flexion and Extension) will be measured using a goniometer	1 hour

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of stay		up to 1 week
medications administered	Medications prescribed in the department and at discharge	up to 1 week
Adverse events	Any adverse events reported by subjects will be recorded	up to 6 months

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Investigators: Principal Investigator: Alex F Manini, MD, MS, FACMT, Icahn School of Medicine at Mount Sinai

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: March 23, 2015
• First Submitted That Met QC Criteria: March 25, 2015
• First Posted (Estimate): March 26, 2015

Study Record Updates

• Last Update Posted (Estimate): May 5, 2016
• Last Update Submitted That Met QC Criteria: May 4, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: Low back pain; Acupuncture therapy; Acupuncture, ear
• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Disease Attributes; Emergencies; Back Pain; Low Back Pain
• Other Study ID Numbers: GCO 15-0360