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

NCT ID: NCT02399969

Last Updated: 2016-05-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2016-04-30

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.

Conditions

Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Battlefield Acupuncture Plus Standard of Care

Patients with low back pain that will receive ear acupuncture based on the Battlefield Acupuncture protocol.

Group Type: EXPERIMENTAL

Battlefield Acupuncture

Intervention Type: OTHER

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.

Standard of Care Alone

Patients with low back pain that will receive standard of care without study intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

ear acupuncture, BFA

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alex F Manini, MD, MS, FACMT

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 29550099 (View on PubMed)

Other Identifiers

GCO 15-0360

Identifier Type: -

Identifier Source: org_study_id