Battlefield Acupuncture for the Treatment of Low Back Pain in the Emergency Department
Primary Purpose
Low Back Pain
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Battlefield Acupuncture
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain focused on measuring Low back pain, Acupuncture therapy, Acupuncture, ear
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.
Sites / Locations
- Icahn School of Medicine at Mount Sinai
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Battlefield Acupuncture Plus Standard of Care
Standard of Care Alone
Arm Description
Patients with low back pain that will receive ear acupuncture based on the Battlefield Acupuncture protocol.
Patients with low back pain that will receive standard of care without study intervention.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Numeric Rating Scale (NRS) for Pain
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
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
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
Active ROM (Flexion and Extension) will be measured using a goniometer
Range of motion of the lumbar spine
Active ROM (Flexion and Extension) will be measured using a goniometer
Range of motion of the lumbar spine
Active ROM (Flexion and Extension) will be measured using a goniometer
Full Information
NCT ID
NCT02399969
First Posted
March 23, 2015
Last Updated
May 4, 2016
Sponsor
Icahn School of Medicine at Mount Sinai
1. Study Identification
Unique Protocol Identification Number
NCT02399969
Brief Title
Battlefield Acupuncture for the Treatment of Low Back Pain in the Emergency Department
Official Title
Battlefield Acupuncture for the Treatment of Low Back Pain in the Emergency Department
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Low back pain, Acupuncture therapy, Acupuncture, ear
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Battlefield Acupuncture Plus Standard of Care
Arm Type
Experimental
Arm Description
Patients with low back pain that will receive ear acupuncture based on the Battlefield Acupuncture protocol.
Arm Title
Standard of Care Alone
Arm Type
No Intervention
Arm Description
Patients with low back pain that will receive standard of care without study intervention.
Intervention Type
Other
Intervention Name(s)
Battlefield Acupuncture
Other Intervention Name(s)
ear acupuncture, BFA
Intervention Description
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.
Primary Outcome Measure Information:
Title
Get up and go test
Description
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.
Time Frame
baseline
Title
Get up and go test
Description
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.
Time Frame
immediately post-treatment in the BFA group only
Title
Get up and go test
Description
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.
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
Numeric Rating Scale (NRS) for Pain
Description
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"
Time Frame
baseline
Title
Numeric Rating Scale (NRS) for Pain
Description
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"
Time Frame
immediately post-treatment in the BFA group only
Title
Numeric Rating Scale (NRS) for Pain
Description
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"
Time Frame
1 hour
Title
Range of motion of the lumbar spine
Description
Active ROM (Flexion and Extension) will be measured using a goniometer
Time Frame
baseline
Title
Range of motion of the lumbar spine
Description
Active ROM (Flexion and Extension) will be measured using a goniometer
Time Frame
immediately post-treatment in the BFA group only
Title
Range of motion of the lumbar spine
Description
Active ROM (Flexion and Extension) will be measured using a goniometer
Time Frame
1 hour
Other Pre-specified Outcome Measures:
Title
Length of stay
Time Frame
up to 1 week
Title
medications administered
Description
Medications prescribed in the department and at discharge
Time Frame
up to 1 week
Title
Adverse events
Description
Any adverse events reported by subjects will be recorded
Time Frame
up to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alex F Manini, MD, MS, FACMT
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
29550099
Citation
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.
Results Reference
derived
Learn more about this trial
Battlefield Acupuncture for the Treatment of Low Back Pain in the Emergency Department
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