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

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ClinicalTrials.gov Identifier: NCT02399969
Recruitment Status : Completed
First Posted : March 26, 2015
Last Update Posted : May 5, 2016
Sponsor:
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai

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.


Condition or disease Intervention/treatment Phase
Low Back Pain Other: Battlefield Acupuncture Phase 1 Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Battlefield Acupuncture for the Treatment of Low Back Pain in the Emergency Department
Study Start Date : March 2015
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine


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 Name: ear acupuncture, BFA

No Intervention: Standard of Care Alone
Patients with low back pain that will receive standard of care without study intervention.



Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02399969


Locations
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United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Investigators
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Principal Investigator: Alex F Manini, MD, MS, FACMT Icahn School of Medicine at Mount Sinai

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT02399969     History of Changes
Other Study ID Numbers: GCO 15-0360
First Posted: March 26, 2015    Key Record Dates
Last Update Posted: May 5, 2016
Last Verified: May 2016
Keywords provided by Icahn School of Medicine at Mount Sinai:
Low back pain
Acupuncture therapy
Acupuncture, ear
Additional relevant MeSH terms:
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Back Pain
Emergencies
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Disease Attributes
Pathologic Processes