Ignite Creation Date:
2025-12-24 @ 3:22 PM
Ignite Modification Date:
2026-01-18 @ 4:47 PM
Study NCT ID:
NCT02971592
Status:
UNKNOWN
Last Update Posted:
2018-01-09
First Post:
2016-11-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Estimation of Therapeutic Effect of MDcure on Patients With Chronic Lower Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2018-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-01-08', 'studyFirstSubmitDate': '2016-11-20', 'studyFirstSubmitQcDate': '2016-11-20', 'lastUpdatePostDateStruct': {'date': '2018-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement in pain in experiment group', 'timeFrame': '6 weeks', 'description': 'Assessment of rate of patients from the experiment group who report improvement in pain above 20% in Oswestry scale'}, {'measure': 'Improvement in pain in placebo group', 'timeFrame': '6 weeks', 'description': 'Assessment of rate of patients from the placebo group who report improvement in pain above 20% in Oswestry scale'}], 'secondaryOutcomes': [{'measure': 'Assess period of time to attain improvement', 'timeFrame': 'maximum of 6 weeks', 'description': 'Assess the duration period of improvement, starting from the beginning of the experiment up to the point where 20% improvement is attained'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Back Pain Lower Back Chronic']}, 'descriptionModule': {'briefSummary': '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.\n\nassessing the reduction of lower back pain. Half of participants will receive the MDcure device, while the other half will receive a mock device.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women aged 18-75\n* Patients with chronic lower back for more then 3 month\n* Patients who scored over 21% and below 60% in the Oswestry questionnaire\n\nExclusion Criteria:\n\n* A neurological deficient in lower limbs\n* Patients who scored more than 60% on the Oswestry questionnaire.\n* Patients who underwent surgical intervention in spine including metal implant in lower back\n* Patients diagnosed with cancer\n* Patients with any type of vertebral fracture\n* Patients who received steroid injection less then a month prior to starting the experiment\n* Patients treated with steroids as a preventive treatment on a regular basis\n* 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\n* Pregnant women'}, 'identificationModule': {'nctId': 'NCT02971592', 'acronym': 'E_MDcure_LBP', 'briefTitle': 'Estimation of Therapeutic Effect of MDcure on Patients With Chronic Lower Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'Assuta Medical Center'}, 'officialTitle': 'Estimation of Therapeutic Effect of MDcure on Patients With Chronic Back Pain', 'orgStudyIdInfo': {'id': '0047-16-ASM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental', 'interventionNames': ['Device: MDcure']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Other: Mock Device']}], 'interventions': [{'name': 'MDcure', 'type': 'DEVICE', 'description': 'reception of real working MDcure - device that does apply the electromagnetic field', 'armGroupLabels': ['Experimental']}, {'name': 'Mock Device', 'type': 'OTHER', 'description': 'reception of device that does not apply the electromagnetic field', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tel Aviv', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Or Harel', 'role': 'CONTACT', 'phone': '0097237645282'}], 'facility': 'Assuta Medical Centers - Ramat Hahyal', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}], 'centralContacts': [{'name': 'Or Harel', 'role': 'CONTACT', 'email': 'orh@assuta.co.il', 'phone': '0097237645282'}, {'name': 'Mickey Scheinowitz, Prof.', 'role': 'CONTACT', 'email': 'mickeys@aerotel.co.il'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assuta Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Aerotel Ltd', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dr. Eran Segal', 'investigatorAffiliation': 'Assuta Medical Center'}}}}