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

NCT02399969 | Completed Phase 1 DMC

• 1 other identifier: GCO 15-0360
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Keywords

Low back pain; Acupuncture therapy; Acupuncture, ear

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Numeric Rating Scale (NRS) for Pain

  baseline

• Numeric Rating Scale (NRS) for Pain

  immediately post-treatment in the BFA group only

• Numeric Rating Scale (NRS) for Pain

  1 hour

• Range of motion of the lumbar spine

  baseline

• Range of motion of the lumbar spine

  immediately post-treatment in the BFA group only

Other Outcomes (3)

• Length of stay

  up to 1 week

• medications administered

  up to 1 week

• Adverse events

  up to 6 months

Study Arms (2)

Battlefield Acupuncture Plus Standard of Care

EXPERIMENTAL

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

Other: Battlefield Acupuncture

Standard of Care Alone

NO INTERVENTION

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

Interventions

Battlefield Acupuncture 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.

Also known as: ear acupuncture, BFA

Battlefield Acupuncture Plus Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (1)

• 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.

  PMID: 29550099 DERIVED

MeSH Terms

Conditions

Low Back Pain

Interventions

Acupuncture, Ear

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acupuncture Therapy; Complementary Therapies; Therapeutics; Auriculotherapy

Study Officials

• Alex F Manini, MD, MS, FACMT

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2015
• First Posted: March 26, 2015
• Study Start: March 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: May 5, 2016

Record last verified: 2016-05

Locations

US (1)