Estimation of Therapeutic Effect of MDcure on Patients With Chronic Lower Back Pain
E_MDcure_LBP
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jan 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 20, 2016
CompletedFirst Posted
Study publicly available on registry
November 23, 2016
CompletedStudy Start
First participant enrolled
January 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2018
CompletedJanuary 9, 2018
January 1, 2018
1.8 years
November 20, 2016
January 8, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
Assess period of time to attain improvement
maximum of 6 weeks
Study Arms (2)
Experimental
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
reception of real working MDcure - device that does apply the electromagnetic field
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Assuta Medical Centerlead
- Aerotel Ltdcollaborator
Study Sites (1)
Assuta Medical Centers - Ramat Hahyal
Tel Aviv, Israel
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 20, 2016
First Posted
November 23, 2016
Study Start
January 1, 2017
Primary Completion
November 1, 2018
Study Completion
November 1, 2018
Last Updated
January 9, 2018
Record last verified: 2018-01
Data Sharing
- IPD Sharing
- Will not share