Ignite Creation Date:
2025-12-26 @ 11:10 AM
Ignite Modification Date:
2026-02-22 @ 6:46 PM
Study NCT ID:
NCT02881112
Status:
COMPLETED
Last Update Posted:
2020-04-06
First Post:
2016-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Registry Study to Evaluate Outcomes of PEMF Therapy in Subjects With Various Pain Etiologies
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'heather.vanderploeg@regenesisbio.com', 'phone': '602-428-7041', 'title': 'Clinical Operations Manager', 'organization': 'Regenesis Biomedical'}, 'certainAgreement': {'otherDetails': "Publication Rights. Independent analysis and/or publication of data generated or arising from the performance of this Agreement is not permitted without the prior written consent of Regenesis. Such consent may be contingent on Regenesis' review and approval of any proposed analysis and manuscript. Institution will retain the right to review and analyze the database created from this study for its own scientific purposes so long as such scientific purposes are non-commercial in nature.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Through end of treatment, up to 20 weeks.', 'eventGroups': [{'id': 'EG000', 'title': 'Active Treatment Arm', 'description': 'Treatment with Provant Therapy System\n\nProvant Therapy System: Treatment with the Provant Therapy System', 'otherNumAtRisk': 180, 'deathsNumAtRisk': 180, 'otherNumAffected': 0, 'seriousNumAtRisk': 180, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pain Intensity Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Treatment Arm', 'description': 'Treatment with Provant Therapy System\n\nProvant Therapy System: Treatment with the Provant Therapy System'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.785', 'spread': '3.3039', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pain scores collected daily, up to 20 weeks.', 'description': 'Change in Pain from Baseline/Pre-treatment to End of Treatment/Last Available Observation. Pain captured using NPRS, 0-10 scale were 0 = no pain and 10 = worst pain, given to subjects as part of a daily diary.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects recording both a Baseline and End of Study score were included in the NPRS analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Active Treatment Arm', 'description': 'Treatment with Provant Therapy System\n\nProvant Therapy System: Treatment with the Provant Therapy System'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '180'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '152'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Active Treatment Arm', 'description': 'Treatment with Provant Therapy System\n\nProvant Therapy System: Treatment with the Provant Therapy System'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '105', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '75', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.48', 'groupId': 'BG000', 'lowerLimit': '24', 'upperLimit': '89'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '124', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '56', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '153', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '149', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '180', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-01-18', 'size': 883020, 'label': 'Study Protocol: Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-04-02T17:59', 'hasProtocol': True}, {'date': '2016-08-30', 'size': 567831, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_003.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-04-03T12:16', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2017-12-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-03', 'studyFirstSubmitDate': '2016-06-30', 'resultsFirstSubmitDate': '2019-09-23', 'studyFirstSubmitQcDate': '2016-08-23', 'lastUpdatePostDateStruct': {'date': '2020-04-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-11-04', 'studyFirstPostDateStruct': {'date': '2016-08-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-11-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Intensity Assessment', 'timeFrame': 'Pain scores collected daily, up to 20 weeks.', 'description': 'Change in Pain from Baseline/Pre-treatment to End of Treatment/Last Available Observation. Pain captured using NPRS, 0-10 scale were 0 = no pain and 10 = worst pain, given to subjects as part of a daily diary.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'The study is an open-label, non-controlled study of the safety and effectiveness of investigator determined Provant therapy in subjects with pain and/or edema from various pain etiologies. Information collected in the study will be entered into a registry database.', 'detailedDescription': 'This is an open-label, non-controlled trial in subjects with various pain etiologies at multiple centers in the US. Eligible subjects will include those ≥ 22 years of age that have been deemed appropriate for treatment with Provant by the study investigator (prescriber). Subjects will treat based on the treatment prescribed (location, frequency, duration) by the study investigator.\n\nData from assessments administered as part of standard of practice will be obtained at baseline and, at a minimum, at the end of treatment. If the investigator administers additional assessments during the course of treatment, the data will be collected.\n\nSafety will be assessed during office visits and through review of AE reports and concomitant treatments and medications. All concomitant drug or non-drug treatments used during the study will be recorded.\n\nInformation collected in the study will be entered into a registry database.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subject age is greater than or equal to 22 years.\n2. Subject has pain (chronic or acute) and/or edema that the prescriber deems treatment with Provant is warranted.\n3. Subject is willing and able to give written informed consent.\n4. Female subjects must be post-menopausal, surgically sterile, abstinent, or practicing (or agree to practice) an effective method of birth control if they are sexually active for the duration of the study. (Effective methods of birth control include prescription hormonal contraceptives, intrauterine devices, double-barrier methods, and/or male partner sterilization).\n\nExclusion Criteria:\n\n1. Subject requires or anticipates the need for surgery of any type during the duration of treatment.\n2. Subject has received any investigational drug or device within 30 days or 5 half-lives of the drug, whichever is longer, prior to the Screening Visit or is enrolled in another clinical trial.\n3. Subject has used systemic corticosteroids within 2 months of the Screening Visit.\n4. Subject has a history of a solid tumor that is not in complete remission for greater than 2 years other than successfully treated non-metastatic basal cell or squamous cell carcinomas of the skin in the treatment area.\n5. Subject has a history of blood cancer (e.g., leukemia, lymphoma, multiple myeloma).\n6. Subject has a serious psychosocial co-morbidity.\n7. Subject has a history of drug or alcohol abuse within one year prior to the Screening Visit.\n8. Subject has an implanted pacemaker, defibrillator, neurostimulator, spinal cord stimulator, bone stimulator, cochlear implant, or other implanted device with an implanted metal lead(s).\n9. Subject is currently pregnant or planning on becoming pregnant during the treatment period.\n10. Subject has been previously treated with the Provant Therapy System.\n11. Subject is unwilling or unable to follow study instructions, or comply with the treatment regimen and study visits.'}, 'identificationModule': {'nctId': 'NCT02881112', 'briefTitle': 'A Registry Study to Evaluate Outcomes of PEMF Therapy in Subjects With Various Pain Etiologies', 'organization': {'class': 'INDUSTRY', 'fullName': 'Regenesis Biomedical, Inc.'}, 'officialTitle': 'An Open-Label, Non-Controlled Study to Evaluate Outcomes of Pulsed Electromagnetic Field (PEMF) Therapy in Subjects With Various Pain Etiologies', 'orgStudyIdInfo': {'id': 'RBI.2015.005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active Treatment Arm', 'description': 'Treatment with Provant Therapy System', 'interventionNames': ['Device: Provant Therapy System']}], 'interventions': [{'name': 'Provant Therapy System', 'type': 'DEVICE', 'description': 'Treatment with the Provant Therapy System', 'armGroupLabels': ['Active Treatment Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35209', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'AOC-Research, LLC', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85251', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Coolbody Contours', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '85258', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': "Scottsdale Center for Women's Health", 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '34209', 'city': 'Bradenton', 'state': 'Florida', 'country': 'United States', 'facility': 'Coastal Orthopedics & Sports Medicine', 'geoPoint': {'lat': 27.49893, 'lon': -82.57482}}, {'zip': '83713', 'city': 'Boise', 'state': 'Idaho', 'country': 'United States', 'facility': 'Injury Care Research, LLC', 'geoPoint': {'lat': 43.6135, 'lon': -116.20345}}, {'zip': '83642', 'city': 'Meridian', 'state': 'Idaho', 'country': 'United States', 'facility': 'Exodus Pain Clinic', 'geoPoint': {'lat': 43.61211, 'lon': -116.39151}}, {'zip': '48197', 'city': 'Ypsilanti', 'state': 'Michigan', 'country': 'United States', 'facility': 'Biogenesis Group, LLC', 'geoPoint': {'lat': 42.24115, 'lon': -83.61299}}, {'zip': '99218', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': 'Spokane Joint Replacement Center', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Regenesis Biomedical, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}