The Effect of Pulsed Electromagnetic Field Therapy on Patients With Low Back Pain

Study Overview
=================
Brief Summary
-----------------
This study will examine the effects of a portable of pulsed electromagnetic field (PEMF) device (MD Cure, Aerotel, USA) compared with a sham device on patient-reported outcomes of pain and function in patients with either acute/subacute or chronic low back pain (LBP).

Detailed Description
-----------------
This study is a double-blind, placebo-controlled, randomized pilot study comparing usual care + PEMF with usual care + sham. The investigators will recruit patients with LBP from the University of Bridgeport chiropractic clinic, and will enroll 80 total subjects: 40 with acute or subacute LBP, and 40 with chronic LBP. Within each of those populations the investigators will assign 20 subjects to receive usual care + PEMF, and 20 to receive usual care + sham. The investigators will track any other treatments initiated or discontinued during the trial. Patients who agree to participate with be randomly given a functional PEMF device or a sham unit. Patients and clinicians will be blinded to the assignment. All subjects will be given the same instructions for daily use of the devices, and will continue to receive usual follow-up at the UBCC clinic as indicated. The investigators will collect patient-reported measures of pain and function pain at baseline, 6 weeks, and 12 weeks, and will collect data on adverse effects at each visit and at 6 and 12 weeks.

Official Title
-----------------
The Effect of Pulsed Electromagnetic Field Therapy on Patients With Low Back Pain

Conditions
-----------------
Low Back Pain

Intervention / Treatment
-----------------
* Device: MDCure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: UBCC patient complaint of LBP intensity 4/10 or greater on the Numerical Rating Scale diagnosis of a mechanical LBP condition age 18-70 years fluency in written and spoken English for female subjects, be postmenopausal, surgically sterile, abstinent, or agree to practice an effective method of birth control for the duration of the study if sexually active a willingness to participate in the study as evidenced by a signed informed consent form Exclusion Criteria: current LBP complaint of 3/10 or less on the Numerical Rating Scale diagnosis or suspicion of LBP caused by cancer, infection, referred visceral pain, inflammatory arthropathy, or other non-mechanical process current or planned pregnancy any electrically-based implanted devices such as pacemakers defibrillators, spinal cord stimulators, insulin pumps; metallic implants (e.g. surgical fusion constructs, disc replacements) in the low back status post any lumbosacral spine surgery; significant mental health co-morbidities such as severe depression, schizoaffective disorders, suicidal ideation inability to understand and/or complete all components of the informed consent process without the assistance of another person (e.g. without proxy) inability to adhere to and comply with the treatment protocol.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acute/subacute; active device<br>MDCure active device | Device: MDCure<br>* Battery powered portable pulsed electromagnetic therapy device<br>|
| Placebo Comparator: Acute/subacute; sham<br>MDCure sham device | Device: MDCure<br>* Battery powered portable pulsed electromagnetic therapy device<br>|
| Experimental: Chronic; active device<br>MDCure active device | Device: MDCure<br>* Battery powered portable pulsed electromagnetic therapy device<br>|
| Placebo Comparator: Chronic; sham<br>MDCure sham device | Device: MDCure<br>* Battery powered portable pulsed electromagnetic therapy device<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain intensity | Numerical Rating Scale | Baseline, weeks 6 and 12 | 
| Change in low back pain related disability | Oswestry Disability Index | Baseline, weeks 6 and 12 |