Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2025-12-29 @ 9:01 AM
Study NCT ID:
NCT01564069
Status:
COMPLETED
Last Update Posted:
2018-07-11
First Post:
2012-03-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intrathecal Therapy for Chronic Non-Cancer Pain: An Analysis of Its Efficacy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 125}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2013-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-10', 'studyFirstSubmitDate': '2012-03-23', 'studyFirstSubmitQcDate': '2012-03-23', 'lastUpdatePostDateStruct': {'date': '2018-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-03-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment Efficacy of Intrathecal Infusions', 'timeFrame': 'March 2014', 'description': 'The primary objective of this study is to evaluate the treatment efficacy of intrathecal infusions for chronic pain and compare this form of therapy to systemic opioid therapy and non-opioid therapy for chronic pain \\> 6 months duration.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Chronic pain', 'Intrathecal pain management'], 'conditions': ['Chronic Pain']}, 'descriptionModule': {'briefSummary': 'Our hypothesis is that patients with intrathecal delivery systems for chronic non-cancer pain will report no improvement treatment efficacy when compared to patients with chronic pain managed with oral or systemic opioid therapies. Our secondary hypothesis is that patients with intrathecal delivery systems for chronic non-cancer pain will report no improvement in treatment efficacy when compared to patients with chronic pain who are managed with non-opioid therapies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Males or females greater than 18 years of age History of chronic pain greater than 6 months Patient in the BWH Pain Center for greater than 6 months', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Males or females greater than 18 years of age with legal decision making ability.\n* Subjects receiving care at the Brigham and Women's Hospital Pain Management Center.\n* Subjects must have a history of chronic pain \\> 6 months and must have been a patient in the BWH Pain Center \\> 6 months.\n\nExclusion Criteria:\n\n* Pain due to metastatic cancer or to cancer that is locally invasive\n* Patients with a primary diagnosis of spasticity, receiving intrathecal baclofen\n* Evidence of psychosis or hospitalization for psychiatric illness during study\n* Pregnancy at any time during the study\n* Altered mental status that would make subject unable to complete outcome questionnaires\n* Significant chronic medical illness, such that requires frequent hospitalization or health care utilization (ie: renal failure requiring dialysis, heart failure or cardiac disease requiring surgery or intensive care admission, pulmonary disease requiring intubation or hospitalization, pancreatitis requiring hospitalization, vascular disease requiring surgery or hospitalization, etc.)"}, 'identificationModule': {'nctId': 'NCT01564069', 'briefTitle': 'Intrathecal Therapy for Chronic Non-Cancer Pain: An Analysis of Its Efficacy', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'Intrathecal Therapy for Chronic Non-Cancer Pain: An Analysis of Its Efficacy', 'orgStudyIdInfo': {'id': '2007P000874'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'IT opioids', 'description': 'Patients with IT pumps receiving IT opioids'}, {'label': 'Systemic opioids', 'description': 'Patients taking oral or transdermal opioids for chronic pain'}, {'label': 'Non-opioid management', 'description': 'Patients managing chronic pain without taking opioids'}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Srdjan S Nedeljkovic, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Srdjan Nedeljkovic', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}