NCT03053375

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: University of Bridgeport · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Low Back Pain

Interventions

Type	Name	Description
DEVICE	MDCure	Battery powered portable pulsed electromagnetic therapy device

Timeline

• Start date: 2017-02-08
• Primary completion: 2017-08-30
• Completion: 2018-06-30
• First posted: 2017-02-15
• Last updated: 2017-02-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study