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| Name | Class |
|---|---|
| Aerotel Ltd | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MDcure | Device | reception of real working MDcure - device that does apply the electromagnetic field |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | maximum of 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Or Harel | Contact | 0097237645282 | orh@assuta.co.il | |
| Mickey Scheinowitz, Prof. | Contact | mickeys@aerotel.co.il |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assuta Medical Centers - Ramat Hahyal | Recruiting | Tel Aviv | Israel |
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| Mock Device | Other | reception of device that does not apply the electromagnetic field |
|