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

Phase 4

• Conditions: Back Pain Lower Back Chronic
• Interventions: Other: Mock Device; Device: MDcure

• Registration Number: NCT02971592
• Lead Sponsor: Assuta Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-20
• Study First Submitted QC: 2016-11-20
• Study First Posted: 2016-11-23
• Study Start: 2017-01
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-08
• Last Update Posted: 2018-01-09
• Primary Completion: 2018-11
• Study Completion: 2018-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Mock Device	-
Experimental	MDcure	-

Primary Outcome Measures

Name	Time	Method
Improvement in pain in placebo group	6 weeks	Assessment of rate of patients from the placebo group who report improvement in pain above 20% in Oswestry scale
Improvement in pain in experiment group	6 weeks	Assessment of rate of patients from the experiment group who report improvement in pain above 20% in Oswestry scale

Secondary Outcome Measures

Name	Time	Method
Assess period of time to attain improvement	maximum of 6 weeks	Assess the duration period of improvement, starting from the beginning of the experiment up to the point where 20% improvement is attained

Trial Locations

Locations (1)

Assuta Medical Centers - Ramat Hahyal; 🇮🇱 Tel Aviv, Israel