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

January 8, 2018 updated by: Dr. Eran Segal, Assuta Medical Center

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Tel Aviv, Israel
        • Recruiting
        • Assuta Medical Centers - Ramat Hahyal
        • Contact:
          • Or Harel
          • Phone Number: 0097237645282

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Other: Mock Device
reception of device that does not apply the electromagnetic field
EXPERIMENTAL: Experimental
Device: MDcure
reception of real working MDcure - device that does apply the electromagnetic field

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in pain in experiment group
Time Frame: 6 weeks
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
Time Frame: 6 weeks
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
Time Frame: 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
maximum of 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assuta Medical Center

Collaborators

Aerotel Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2017

Primary Completion (ANTICIPATED)

November 1, 2018

Study Completion (ANTICIPATED)

November 1, 2018

Study Registration Dates

First Submitted

November 20, 2016

First Submitted That Met QC Criteria

November 20, 2016

First Posted (ESTIMATE)

November 23, 2016

Study Record Updates

Last Update Posted (ACTUAL)

January 9, 2018

Last Update Submitted That Met QC Criteria

January 8, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0047-16-ASM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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