Ignite Creation Date:
2025-12-24 @ 6:49 PM
Ignite Modification Date:
2026-04-08 @ 4:33 PM
Study NCT ID:
NCT02421757
Status:
COMPLETED
Last Update Posted:
2021-11-23
First Post:
2015-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Treatment of Back Pain Using Transcutaneous Magnetic Stimulation (TCMS)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}], 'ancestors': [{'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'prock@som.umaryland.edu', 'phone': '410-328-6933', 'title': 'Dr. Peter Rock', 'organization': 'University of Maryland School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The population of patients (chronic pain) proved to be difficult to get in for treatment and follow-up. This lead to small enrollment numbers.'}}, 'adverseEventsModule': {'timeFrame': 'We collected information on adverse event data during the enrollment period of 30 days.', 'description': 'This study had no risk of mortality', 'eventGroups': [{'id': 'EG000', 'title': 'Transcutaneous Magnetic Stimulation', 'description': 'Transcutaneous Magnetic Stimulation\n\nFischell Transcutaneous Magnetic Stimulation Pain Treatment Device: Transcutaneous Magnetic Stimulation', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 0, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Sham Device', 'description': 'Sham Device\n\nPlacebo: The placebo Transcutaneous device', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 0, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Immediate Pain Measured by Numeric Pain Rating Scale (NPRS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Transcutaneous Magnetic Stimulation', 'description': 'Transcutaneous Magnetic Stimulation\n\nFischell Transcutaneous Magnetic Stimulation Pain Treatment Device: Transcutaneous Magnetic Stimulation'}, {'id': 'OG001', 'title': 'Sham Device', 'description': 'Sham Device\n\nPlacebo: The placebo Transcutaneous device'}], 'classes': [{'categories': [{'measurements': [{'value': '4.89', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '5.18', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '10'}]}]}], 'paramType': 'MEAN', 'timeFrame': '60 minutes', 'description': 'Immediate relief measured by Numeric Pain Rating Scale (NPRS)\n\nScale from 0-10 0=No pain 10= Worse possible pain', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Durable Pain Measured by Numeric Pain Rating Scale (NPRS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Transcutaneous Magnetic Stimulation', 'description': 'Transcutaneous Magnetic Stimulation\n\nFischell Transcutaneous Magnetic Stimulation Pain Treatment Device: Transcutaneous Magnetic Stimulation'}, {'id': 'OG001', 'title': 'Sham Device', 'description': 'Sham Device\n\nPlacebo: The placebo Transcutaneous device'}], 'classes': [{'categories': [{'measurements': [{'value': '6.00', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '6.57', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '10'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 days', 'description': 'Durable pain relief measured by Numeric Pain Rating Scale (NPRS) 0= No pain 10= Worse imaginable pain', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Transcutaneous Magnetic Stimulation', 'description': 'Transcutaneous Magnetic Stimulation\n\nFischell Transcutaneous Magnetic Stimulation Pain Treatment Device: Transcutaneous Magnetic Stimulation'}, {'id': 'FG001', 'title': 'Sham Device', 'description': 'Sham Device\n\nPlacebo: The placebo Transcutaneous device'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Recruited at the Pain Management Center at University of Maryland Rehabilitation \\& Orthopaedic Institute from 8/22/2016-4/27/2017.', 'preAssignmentDetails': 'Patients who agreed to participate were provided with a pain diary and were instructed to document their average pain each day for a week using the Numeric Pain Rating Scale (NPRS) to establish their baseline level of pain. Patients were also given the Global Pain Scale (GPS) to complete and return on the day of treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Transcutaneous Magnetic Stimulation', 'description': 'Transcutaneous Magnetic Stimulation\n\nFischell Transcutaneous Magnetic Stimulation Pain Treatment Device: Transcutaneous Magnetic Stimulation'}, {'id': 'BG001', 'title': 'Sham Device', 'description': 'Sham Device\n\nPlacebo: The placebo Transcutaneous device'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-04-25', 'size': 571218, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-03-13T14:14', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'dispFirstSubmitDate': '2018-07-18', 'completionDateStruct': {'date': '2017-06-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-26', 'studyFirstSubmitDate': '2015-04-10', 'dispFirstSubmitQcDate': '2018-10-24', 'resultsFirstSubmitDate': '2021-09-27', 'studyFirstSubmitQcDate': '2015-04-20', 'dispFirstPostDateStruct': {'date': '2018-10-25', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2021-11-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-10-26', 'studyFirstPostDateStruct': {'date': '2015-04-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-11-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Immediate Pain Measured by Numeric Pain Rating Scale (NPRS)', 'timeFrame': '60 minutes', 'description': 'Immediate relief measured by Numeric Pain Rating Scale (NPRS)\n\nScale from 0-10 0=No pain 10= Worse possible pain'}], 'secondaryOutcomes': [{'measure': 'Durable Pain Measured by Numeric Pain Rating Scale (NPRS)', 'timeFrame': '30 days', 'description': 'Durable pain relief measured by Numeric Pain Rating Scale (NPRS) 0= No pain 10= Worse imaginable pain'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Transcutaneous Magnetic Stimulation', 'placebo'], 'conditions': ['Lower Back Pain']}, 'descriptionModule': {'briefSummary': "This is a single-site, randomized, Single-blinded, placebo-controlled, trial of Transcutaneous Magnetic Stimulation (TCMS) for the treatment of lower back pain. TCMS will be applied locally to the back in the location of a patient's pain.", 'detailedDescription': "Approximately one third of Americans suffer from acute and chronic pain and pain has been called a silent epidemic. Treatment of pain often involves opioid medications with a significant potential for abuse, addiction and adverse reactions such as respiratory depression and death. Magnetic brain stimulation has been used for the treatment of pain. There are reports of its use in phantom-limb pain and in the treatment of central and peripheral pain syndromes.\n\nThe study will evaluate whether an experimental medical device (Fischell TCMS Pain Treatment Device) that emits pulses of a brief, intense magnetic field will relieve pain in the lower back. Transcutaneous Magnetic Stimulation (TCMS) is the name of this method of delivering magnetic pulses through the skin. TCMS has been approved by the FDA for peripheral nerve stimulation, treatment of migraine headaches and for depression but this type of device has not been studied scientifically for the treatment of back pain. No significant adverse reactions or side effects have been reported with the use of magnetic stimulation for headache treatment. Some patients who have migraine headaches have excellent pain relief with the magnetic treatment even if they do not get pain relief with medications. Other patients do not have headache relief with magnetic treatment. The current use of TCMS applied to the head requires special equipment and multiple treatment sessions. TCMS applied peripherally is easier to do, and may require fewer treatment sessions to achieve pain relief. Non-invasive treatment of pain would represent a significant advance in the field especially if its use both successfully treated pain and resulted in the reduction or elimination in the need for opioid medications.\n\nThe investigators do not know whether magnetic treatment will relieve back pain so the investigators will test this by applying a powerful electromagnet to the area of the back having pain. In some patients, the magnet will be turned on, but in other patients the magnet will not be turned on. Neither patients nor patient's treating doctor will know whether the magnet was turned on or not, although the study team will know which patients received treatment with magnetic pulses. The effect on pain will be recorded periodically for 2 days. If the patients' reported pain is reduced by having the magnet turned on compared to patients' who do not have the magnet turned on, then the magnet may have reduced the pain. Additional studies in patients will be needed to be sure that the magnet therapy is reducing low back pain."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adult, age \\>18 years of age\n2. Prescription pharmacologic treatment is insufficient for treatment of pain\n3. Pain duration of ≥ 6 months\n4. Pain limits physical activity\n5. Pain occurs daily\n6. Chronic low back pain, with or without leg pain, associated with MRI or other imaging study consistent with lumbo-sacral spine disease with or without nerve compression\n7. Pain intensity ≥ 5 at the time of enrollment a a self-reported pain score of ≥ 4 over the 7 preceding days.\n\nExclusion Criteria:\n\n1. Life expectancy ≤ 6 months for any reason\n2. Oral opiate dosing or type of opioid that has changed in past 12 months\n3. Received intraspinal (e.g., epidural, intrathecal) medication in the past 6 months\n4. Use of intravenous pain medication in the past 6 months\n5. Active use of a transcutaneous electrical nerve stimulator (TENS) \\[within 30 days\\]\n6. History of seizures\n7. History of implanted medical device, cardiac pacemaker or implantable cardiac defibrillator, or other implant (Cochlear etc)\n8. History of cardiac dysrhythmias\n9. Member of vulnerable population\n10. Current or potential legal action of disability claim related to back pain\n11. Body Mass Index (BMI) \\>35\n12. Another pain condition that might confound results, including back pain above the waistline\n13. Women of child-bearing potential\n14. Inability to undergo study assessments or complete questionnaires independently\n15. Metal objects in the body (i.e. Aneurysm clip, bullet fragment)\n16. Active psychological co-morbidites (i.e. uncontrolled schizophrenia)'}, 'identificationModule': {'nctId': 'NCT02421757', 'briefTitle': 'Treatment of Back Pain Using Transcutaneous Magnetic Stimulation (TCMS)', 'organization': {'class': 'OTHER', 'fullName': 'University of Maryland, Baltimore'}, 'officialTitle': 'Treatment of Back Pain Using Transcutaneous Magnetic Stimulation (TCMS)', 'orgStudyIdInfo': {'id': 'HP-00062233'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Transcutaneous Magnetic Stimulation', 'description': 'Transcutaneous Magnetic Stimulation', 'interventionNames': ['Device: Fischell Transcutaneous Magnetic Stimulation Pain Treatment Device']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Sham Device', 'description': 'Sham Device', 'interventionNames': ['Device: Placebo']}], 'interventions': [{'name': 'Fischell Transcutaneous Magnetic Stimulation Pain Treatment Device', 'type': 'DEVICE', 'description': 'Transcutaneous Magnetic Stimulation', 'armGroupLabels': ['Transcutaneous Magnetic Stimulation']}, {'name': 'Placebo', 'type': 'DEVICE', 'otherNames': ['Fischell Transcutaneous Magnetic Stimulation Pain Treatment Device (TCMS Placebo)'], 'description': 'The placebo Transcutaneous device', 'armGroupLabels': ['Sham Device']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'La Toya Stubbs', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Peter Rock, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Maryland, Baltimore'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Maryland, Baltimore', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Anesthesiology', 'investigatorFullName': 'Peter Rock', 'investigatorAffiliation': 'University of Maryland, Baltimore'}}}}