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

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Estimation of Therapeutic Effect of MDcure on Patients With Chronic Back Pain

Conditions
-----------------
Back Pain Lower Back Chronic

Intervention / Treatment
-----------------
* Device: MDcure
* Other: Mock Device


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br> | Device: MDcure<br>* reception of real working MDcure - device that does apply the electromagnetic field<br>|
| Placebo Comparator: Placebo<br> | Other: Mock Device<br>* reception of device that does not apply the electromagnetic field<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in pain in experiment group | Assessment of rate of patients from the experiment group who report improvement in pain above 20% in Oswestry scale | 6 weeks | 
| Improvement in pain in placebo group | Assessment of rate of patients from the placebo group who report improvement in pain above 20% in Oswestry scale | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess period of time to attain improvement | Assess the duration period of improvement, starting from the beginning of the experiment up to the point where 20% improvement is attained | maximum of 6 weeks |