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

Sponsor

Icahn School of Medicine at Mount Sinai (Other)

Overall Status

Completed

CT.gov ID

NCT02399969

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

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 :

Mar 1, 2015

Actual Primary Completion Date :

Apr 1, 2016

Actual Study Completion Date :

Apr 1, 2016

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Get up and go test [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.
Get up and go test [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.
Get up and go test [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

Numeric Rating Scale (NRS) for Pain [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"
Numeric Rating Scale (NRS) for Pain [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"
Numeric Rating Scale (NRS) for Pain [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"
Range of motion of the lumbar spine [baseline]
Active ROM (Flexion and Extension) will be measured using a goniometer
Range of motion of the lumbar spine [immediately post-treatment in the BFA group only]
Active ROM (Flexion and Extension) will be measured using a goniometer
Range of motion of the lumbar spine [1 hour]
Active ROM (Flexion and Extension) will be measured using a goniometer

Other Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.