Ignite Creation Date:
2025-12-24 @ 2:22 PM
Ignite Modification Date:
2026-01-01 @ 9:48 AM
Study NCT ID:
NCT00370695
Status:
TERMINATED
Last Update Posted:
2020-12-17
First Post:
2006-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Spinal Cord Stimulation for Chronic and Intractable Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D011843', 'term': 'Radiculopathy'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'roshini.jain@bsci.com', 'phone': '6619494350', 'title': 'Director, Clinical Research Sciences', 'organization': 'Boston Scientific'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Insufficient data collected to report results'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected from enrollment through 52 weeks post-activation or withdrawal.', 'eventGroups': [{'id': 'EG000', 'title': 'Precision Spinal Cord Stimulation System', 'description': 'Single arm Precision Spinal Cord Stimulation System.\n\nPrecision Spinal Cord Stimulation System: Stimulation turned on from implant throughout the Study', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 2, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Increased falling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Orbital Ecchymosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin tear', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Popliteal Aneurysm and Clot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Leg pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Primary Objective of This Study is to Evaluate Back Pain Severity at 12 Weeks Post-activation as Compared to Baseline.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Precision Spinal Cord Stimulation System', 'description': 'Single arm Precision Spinal Cord Stimulation System.\n\nPrecision Spinal Cord Stimulation System: Stimulation turned on from implant throughout the Study'}], 'timeFrame': '12 weeks', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated and efforts were made to locate data. No study data are available.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Precision Spinal Cord Stimulation System', 'description': 'Single arm Precision Spinal Cord Stimulation System.\n\nPrecision Spinal Cord Stimulation System: Stimulation turned on from implant throughout the Study'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': '12 Weeks Post-activation', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Precision Spinal Cord Stimulation System', 'description': 'Single arm Precision Spinal Cord Stimulation System.\n\nPrecision Spinal Cord Stimulation System: Stimulation turned on from implant throughout the Study'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'whyStopped': 'Insufficient Data Collected', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-21', 'studyFirstSubmitDate': '2006-08-30', 'resultsFirstSubmitDate': '2019-12-04', 'studyFirstSubmitQcDate': '2006-08-30', 'lastUpdatePostDateStruct': {'date': '2020-12-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-11-21', 'studyFirstPostDateStruct': {'date': '2006-09-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-12-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Primary Objective of This Study is to Evaluate Back Pain Severity at 12 Weeks Post-activation as Compared to Baseline.', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Chronic back pain', 'Intractable neuropathic back pain', 'Lumbar radiculopathy', 'Spinal cord stimulation'], 'conditions': ['Back Pain']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy of spinal cord stimulation (SCS) using the Precision implantable neurostimulation device for chronic and intractable back pain in subjects who are not candidates for surgery or who have chosen to seek alternative therapy.', 'detailedDescription': 'Management of symptoms of chronic back pain and/or lumbar radiculopathy is often difficult and inadequate. Current treatment options include pharmacological treatments, physical therapy, nerve blocks, surgical interruption of the pain pathway, or back surgery. Many patients either do not have adequate pain management with conventional treatments or are not able to tolerate the treatments due to significant side effects. Similarly, many patients are either not candidates for surgical interventions, or are unwilling to undergo such procedures. Spinal cord stimulation has proven to be an effective treatment for patients with pain following a failed back surgery, and this study will investigate spinal cord stimulation as a treatment option for the treatment of chronic back pain in patients who have never had back surgery. A successful study outcome will establish spinal cord stimulation as a less-invasive treatment option to be considered prior to surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have chronic and intractable neuropathic back pain and/or lumbar radiculopathy of moderate to severe intensity and have elected Spinal Cord Stimulation (SCS) as next line of treatment.\n* Be 18 years of age or older.\n* Be an appropriate candidate for the surgical procedures required for SCS implant.\n* Be willing and able to comply with all study related procedures and visits.\n* Be capable of reading and understanding patient information materials and giving written informed consent.\n\nExclusion Criteria:\n\n* Have had any back or spine surgery.\n* Have any evidence of neurologic instability or any anatomic problem of the spine that requires surgery.\n* Have any other chronic pain conditions likely to confound evaluation of study endpoints.\n* Are a current substance abuser (including alcohol and illicit drugs).\n* Have a significant psychiatric disorder.\n* Have a condition currently requiring or likely to require the use of MRI or diathermy.\n* Have an active implantable device.\n* Are pregnant or lactating or planning to become pregnant in the next year.\n* Have participated in any drug or device trial in the last 4 weeks or plan to participate in any other study during the year.'}, 'identificationModule': {'nctId': 'NCT00370695', 'briefTitle': 'Spinal Cord Stimulation for Chronic and Intractable Back Pain', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boston Scientific Corporation'}, 'officialTitle': 'Spinal Cord Stimulation for Chronic and Intractable Back Pain in Patients Who Are Not Surgical Candidates', 'orgStudyIdInfo': {'id': 'SCS-03-05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Precision Spinal Cord Stimulation System', 'description': 'Single arm Precision Spinal Cord Stimulation System.', 'interventionNames': ['Device: Precision Spinal Cord Stimulation System']}], 'interventions': [{'name': 'Precision Spinal Cord Stimulation System', 'type': 'DEVICE', 'description': 'Stimulation turned on from implant throughout the Study', 'armGroupLabels': ['Precision Spinal Cord Stimulation System']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92108', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Huntley Pain Specialists', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}], 'overallOfficials': [{'name': 'Roshini Jain', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Boston Scientific Neuromodulation Corporation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston Scientific Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}