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

NCT ID: NCT02971592

Last Updated: 2018-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2018-11-30

Brief Summary

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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

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Conditions

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Back Pain Lower Back Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Experimental

Group Type EXPERIMENTAL

MDcure

Intervention Type DEVICE

reception of real working MDcure - device that does apply the electromagnetic field

Placebo

Group Type PLACEBO_COMPARATOR

Mock Device

Intervention Type OTHER

reception of device that does not apply the electromagnetic field

Interventions

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MDcure

reception of real working MDcure - device that does apply the electromagnetic field

Intervention Type DEVICE

Mock Device

reception of device that does not apply the electromagnetic field

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aerotel Ltd

INDUSTRY

Sponsor Role collaborator

Assuta Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Dr. Eran Segal

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Assuta Medical Centers - Ramat Hahyal

Tel Aviv, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Or Harel

Role: CONTACT

0097237645282

Mickey Scheinowitz, Prof.

Role: CONTACT

Facility Contacts

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Or Harel

Role: primary

0097237645282

Other Identifiers

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0047-16-ASM

Identifier Type: -

Identifier Source: org_study_id

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