Estimation of Therapeutic Effect of MDcure on Patients With Chronic Lower Back Pain (E_MDcure_LBP)

Assuta Medical Center

Status and phase

Unknown

Phase 4

Conditions

Back Pain Lower Back Chronic

Treatments

Device: MDcure

Other: Mock Device

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02971592

0047-16-ASM

Details and patient eligibility

About

This study will assess the therapeutic effect of MDcure® device. MDcure® is an FDA Class 1 listed medical device, produced to ISO-13485 standards, that delivers extremely low intensity (nano Tesla; 10-9) and low frequencies (1-100 Hertz) electromagnetic fields (EMF) intended to reduce muscular aches and pains particularly of the lower back.

assessing the reduction of lower back pain. Half of participants will receive the MDcure device, while the other half will receive a mock device.

Enrollment

40 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Men and women aged 18-75
Patients with chronic lower back for more then 3 month
Patients who scored over 21% and below 60% in the Oswestry questionnaire

Exclusion criteria

A neurological deficient in lower limbs
Patients who scored more than 60% on the Oswestry questionnaire.
Patients who underwent surgical intervention in spine including metal implant in lower back
Patients diagnosed with cancer
Patients with any type of vertebral fracture
Patients who received steroid injection less then a month prior to starting the experiment
Patients treated with steroids as a preventive treatment on a regular basis
Patients using narcotic drugs for over a six month period or cannabis or any other sort of narcotic drug for over a six month period prior to their enrollment in the study
Pregnant women