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Completed

NCT Number: NCT02399969

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Icahn School of Medicine at Mount Sinai

New York, 10029, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: ear acupuncture, BFA

Primary outcomes

  1. Get up and go test

    Time frame: baseline

    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.

  2. Get up and go test

    Time frame: immediately post-treatment in the BFA group only

    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.

  3. Get up and go test

    Time frame: 1 hour

    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.

Secondary outcomes

  1. Numeric Rating Scale (NRS) for Pain

    Time frame: baseline

    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"

  2. Numeric Rating Scale (NRS) for Pain

    Time frame: immediately post-treatment in the BFA group only

    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"

  3. Numeric Rating Scale (NRS) for Pain

    Time frame: 1 hour

    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"

  4. Range of motion of the lumbar spine

    Time frame: baseline

    Active ROM (Flexion and Extension) will be measured using a goniometer

  5. Range of motion of the lumbar spine

    Time frame: immediately post-treatment in the BFA group only

    Active ROM (Flexion and Extension) will be measured using a goniometer

  6. Range of motion of the lumbar spine

    Time frame: 1 hour

    Active ROM (Flexion and Extension) will be measured using a goniometer

Other outcomes

  1. Length of stay

    Time frame: up to 1 week

  2. medications administered

    Time frame: up to 1 week

    Medications prescribed in the department and at discharge

  3. Adverse events

    Time frame: up to 6 months

    Any adverse events reported by subjects will be recorded

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 26, 2015
Registry last updated
May 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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