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

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02399969
• Other study ID #: GCO 15-0360
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 23, 2015
• Last updated: May 4, 2016
• Start date: March 2015
• Est. completion date: April 2016

Study information

• Verified date: May 2016
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

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.

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Length of stay		up to 1 week	No
Other	medications administered	Medications prescribed in the department and at discharge	up to 1 week	No
Other	Adverse events	Any adverse events reported by subjects will be recorded	up to 6 months	Yes
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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"	baseline	No
Secondary	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"	immediately post-treatment in the BFA group only	No
Secondary	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"	1 hour	No
Secondary	Range of motion of the lumbar spine	Active ROM (Flexion and Extension) will be measured using a goniometer	baseline	No
Secondary	Range of motion of the lumbar spine	Active ROM (Flexion and Extension) will be measured using a goniometer	immediately post-treatment in the BFA group only	No
Secondary	Range of motion of the lumbar spine	Active ROM (Flexion and Extension) will be measured using a goniometer	1 hour	No