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

Primary Purpose

Back Pain Lower Back Chronic

Status
Unknown status
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
MDcure
Mock Device
Sponsored by
Assuta Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Back Pain Lower Back Chronic

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Assuta Medical Centers - Ramat HahyalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

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

Full Information

First Posted
November 20, 2016
Last Updated
January 8, 2018
Sponsor
Assuta Medical Center
Collaborators
Aerotel Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT02971592
Brief Title
Estimation of Therapeutic Effect of MDcure on Patients With Chronic Lower Back Pain
Acronym
E_MDcure_LBP
Official Title
Estimation of Therapeutic Effect of MDcure on Patients With Chronic Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 2017 (undefined)
Primary Completion Date
November 2018 (Anticipated)
Study Completion Date
November 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assuta Medical Center
Collaborators
Aerotel Ltd

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Back Pain Lower Back Chronic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Device
Intervention Name(s)
MDcure
Intervention Description
reception of real working MDcure - device that does apply the electromagnetic field
Intervention Type
Other
Intervention Name(s)
Mock Device
Intervention Description
reception of device that does not apply the electromagnetic field
Primary Outcome Measure Information:
Title
Improvement in pain in experiment group
Description
Assessment of rate of patients from the experiment group who report improvement in pain above 20% in Oswestry scale
Time Frame
6 weeks
Title
Improvement in pain in placebo group
Description
Assessment of rate of patients from the placebo group who report improvement in pain above 20% in Oswestry scale
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Assess period of time to attain improvement
Description
Assess the duration period of improvement, starting from the beginning of the experiment up to the point where 20% improvement is attained
Time Frame
maximum of 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Or Harel
Phone
0097237645282
Email
orh@assuta.co.il
First Name & Middle Initial & Last Name or Official Title & Degree
Mickey Scheinowitz, Prof.
Email
mickeys@aerotel.co.il
Facility Information:
Facility Name
Assuta Medical Centers - Ramat Hahyal
City
Tel Aviv
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Or Harel
Phone
0097237645282

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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