Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2025-12-25 @ 9:35 PM
Study NCT ID:
NCT03421951
Status:
TERMINATED
Last Update Posted:
2020-03-19
First Post:
2018-01-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Change in Pain and Quality of Life Following SCS for Chronic Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D013001', 'term': 'Somatoform Disorders'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Sponsor withdrew funding', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-17', 'studyFirstSubmitDate': '2018-01-30', 'studyFirstSubmitQcDate': '2018-01-30', 'lastUpdatePostDateStruct': {'date': '2020-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Pain Levels', 'timeFrame': '12 months post-permanent spinal cord stimulator implantation', 'description': 'Change in self-reported pain levels'}, {'measure': 'Change in quality of life', 'timeFrame': '12 months post-permanent spinal cord stimulator implantation', 'description': 'change in self-reported quality of life'}], 'secondaryOutcomes': [{'measure': 'Change in prescription pain medication use', 'timeFrame': '12 months post-permanent spinal cord stimulator implantation', 'description': 'change in opioid medication use to control pain'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['spine', 'lower limb'], 'conditions': ['Pain, Chronic', 'Pain, Radiating', 'Pain, Back', 'Pain Syndrome']}, 'descriptionModule': {'briefSummary': 'Study Title Subject-reported treatment efficacy and procedure satisfaction (steps) study.BURST study- a prospective observational clinical study examining the changes in quality of life and pain following spinal cord stimulation for the treatment of chronic intractable lower back and lower limb pain.', 'detailedDescription': 'Objectives The primary objective is changes in lower back and/or lower limb pain patient-reported satisfaction with procedure outcome and treatment efficacy to reduce pain levels following an orthopedic procedure for knees, hips, shoulders, elbows, wrists, or anklesspinal cord (SCS) stimulation. Secondary objectives include changes in physical health, quality of life, and quality of life and pain-related prescription medication usage.\n\nDesign and Outcomes This is a prospective observational single-arm study to access the primary outcome variable of lower back and/or lower limb patient satisfaction with procedure outcomes as measured using a modified MacNab scale. Patients will have presented to their healthcare providers with knee, hip, shoulder, elbow, wrist, or ankle pain and will have elected and been assigned a medically-appropriate surgical procedure as part of their standard of care. It is possible for subjects to have multiple areas of pain and subsequent surgeries, and subjects have the option of completing surveys for all medically-indicatedmedically indicated areas being treated.pain\n\nIIIntervention and Duration There will be no study intervention. Subjects will only be monitored and evaluated for pre and post-operative satisfaction, pain, physical activity levels, quality of life, and medication use levels. Subjects will be followed for 12 months following their SCS stimulation implant procedure.\n\nSample Size and Population Investigators aim for a minimum population size of 1,500 in order to give statistical significance with results. Subjects will be stratified by surgical procedurearea of chronic pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Study population will be patients who have already been prescribed a trial spinal cord stimulator implant procedure to treat their lower back or lower limb pain.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPrescribed spinal cord stimulator implant by their healthcare provider. Previous conservative care such as physical therapy or chiropractic care that failed to provide adequate pain relief.\n\nWilling and able to adhere to the protocol of the study including the survey timeline.\n\nBetween the ages of 18-85 years.\n\nExclusion Criteria:\n\nUnwilling to sign Informed Consent and comply with protocol'}, 'identificationModule': {'nctId': 'NCT03421951', 'acronym': 'BURST', 'briefTitle': 'Change in Pain and Quality of Life Following SCS for Chronic Pain', 'organization': {'class': 'INDUSTRY', 'fullName': 'KM Clinical Research Group'}, 'officialTitle': 'A Prospective Single-arm, Multi-center Clinical Study Examining the Changes in Quality of Life and Pain Following Dorsal Root Ganglion Stimulation for the Treatment of Chronic Intractable Pelvic and Lower Limb Pain', 'orgStudyIdInfo': {'id': '2017-PN-02'}}, 'contactsLocationsModule': {'locations': [{'zip': '92563', 'city': 'Murrieta', 'state': 'California', 'country': 'United States', 'facility': 'KM Clinical Research Group', 'geoPoint': {'lat': 33.55391, 'lon': -117.21392}}], 'overallOfficials': [{'name': 'Kate McLellan, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'KM Clinical Research Group'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'KM Clinical Research Group', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Kate McLellan', 'investigatorAffiliation': 'KM Clinical Research Group'}}}}