Back Pain Lower Back Chronic
Conditions
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.
Interventions
DEVICEMDcure
reception of real working MDcure - device that does apply the electromagnetic field
OTHERMock Device
reception of device that does not apply the electromagnetic field
Sponsors
Aerotel Ltd
Assuta Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in pain in experiment group | 6 weeks | 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 | 6 weeks | Assessment of rate of patients from the placebo group who report improvement in pain above 20% in Oswestry scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assess period of time to attain improvement | 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 |
Countries
Israel
Contacts
Primary ContactOr Harel
Backup ContactMickey Scheinowitz, Prof.
Outcome results
None listed