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

Back Pain Lower Back Chronic Clinical Trial

— E_MDcure_LBP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02971592
• Other study ID #: 0047-16-ASM
• Status: Recruiting
• Phase: Phase 4
• First received: November 20, 2016
• Last updated: January 8, 2018
• Start date: January 2017
• Est. completion date: November 2018

Study information

• Verified date: January 2018
• Source: Assuta Medical Center
• Contact: Or Harel
• Phone: 0097237645282
• Email: orh[@]assuta.co.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: November 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Back Pain Lower Back Chronic

Intervention

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

Other:
• Mock Device
reception of device that does not apply the electromagnetic field

Locations

Country	Name	City	State
Israel	Assuta Medical Centers - Ramat Hahyal	Tel Aviv

Sponsors (2)

Lead Sponsor	Collaborator
Assuta Medical Center	Aerotel Ltd

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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