Ignite Creation Date:
2025-12-24 @ 4:41 PM
Ignite Modification Date:
2026-01-05 @ 6:49 PM
Study NCT ID:
NCT03210766
Status:
COMPLETED
Last Update Posted:
2019-01-16
First Post:
2017-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nabilone and THC/CBD for the Treatment of FBSS Refractory Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055111', 'term': 'Failed Back Surgery Syndrome'}, {'id': 'D010148', 'term': 'Pain, Intractable'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C011941', 'term': 'nabilone'}, {'id': 'D062187', 'term': 'Spinal Cord Stimulation'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2016-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-15', 'studyFirstSubmitDate': '2017-07-05', 'studyFirstSubmitQcDate': '2017-07-05', 'lastUpdatePostDateStruct': {'date': '2019-01-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Brief Pain Inventory (BPI)', 'timeFrame': '2015/1 to 2016/1', 'description': 'The Brief Pain Inventory allows patients to rate the severity of their pain and the degree to which their pain interferes with common dimensions of feeling and function. BPI has been shown to be an appropriate measure for pain caused by a wide range of clinical conditions. The BPI is an 11-item questionnaire that consists of four 0- to-10 numeric rating scale (NRS) items asking patients to rate their pain at its "worst in the last 24-hours," least in the last 24-hours," "average," and "now," with a 0 indicating "no pain" and 10 representing "pain as bad as you could imagine." The remaining seven BPI items probe the degree to which pain interferes with general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life, again using a 0-to-10 value scale. For these interference items, 0 represents "does not interfere" and 10 indicates "interferes completely."'}, {'measure': 'Douleur Neuropathique-4 (DN-4)', 'timeFrame': '2015/1 to 2016/1', 'description': 'The DN4 questionnaire consists of a total of 10 items: 7 items related to the characteristics of pain (burning, painful cold, electric shocks) and its association with abnormal sensations (tingling, pins and needles, numbness, itching), and 3 related to neurological examination in the painful area (touch hypesthesia, pinprick hypesthesia, tactile allodynia). The value of 1 was given to each positive item, and 0 value to each negative item. The total score was calculated as the sum of all 10 items and the cutoff value for the diagnosis of neuropathic pain is established as a total score of 4/10.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cannabinoids, nabilone, FBSS, THC/CBD, refractory pain'], 'conditions': ['FBSS']}, 'referencesModule': {'references': [{'pmid': '7249453', 'type': 'BACKGROUND', 'citation': 'Burton CV, Kirkaldy-Willis WH, Yong-Hing K, Heithoff KB. Causes of failure of surgery on the lumbar spine. Clin Orthop Relat Res. 1981 Jun;(157):191-9.'}, {'pmid': '15102214', 'type': 'BACKGROUND', 'citation': 'Waguespack A, Schofferman J, Slosar P, Reynolds J. Etiology of long-term failures of lumbar spine surgery. 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Pain Res Manag. 2005 Autumn;10 Suppl A:44A-6A. doi: 10.1155/2005/894781.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the efficacy of oral administration of nabilone or THC/CBD administration in combination with spinal cord stimulation (SCS) in FBSS patients refractory to other available therapeutic strategies.', 'detailedDescription': "Failed Back Surgery Syndrome (FBSS) is defined as: spinal pain of unknown origin either persisting despite surgical intervention or appearing after surgical intervention for spinal pain originally in the same topographical location.\n\nSeveral conditions have been identified as causes of FBSS: epidural fibrosis, canal stenosis (global or lateral), foraminal stenosis, retained disc fragment, recurrent disc herniation or degeneration, spinal instability, facet joint pain, sacroiliac joint pain, discitis, adhesive arachnoiditis and others.\n\nCan involve 20% to 40% of patients who have undergone lumbar spine surgery and 0.02% to 2% of the general population suffer from this syndrome.\n\nIn FBSS symptoms are the persistence of low back pain, deterioration or recurrence of radiculopathy, sensory and/or motor deficit, sphincter dysfunction.\n\nChronic opioid therapy does not improve long-term pain management. Similar issues can occur with conservative measures like peridural injections of steroids, intrathecal analgesic infusion and local anesthetics injections. Despite a large part of FBSS patients benefit of radio-frequency treatment and/or spinal cord stimulation (SCS), a small percentage of them doesn't report benefits.\n\nPain could be treated by drugs modulating endocannabinoid system and it could represent a pharmacological option in a multimodal treatment approach for neuropathic pain.\n\nAuthors present a retrospective case series documenting the efficacy and safety of oral administration of cannabinoids agonists (THC/CBD and nabilone) in 20 FBSS patients, presenting moderate to severe chronic pain that not responding to other treatment regimens.\n\nCannabinoids agonists were administered in association with the practice of spinal cord stimulation (SCS).\n\nOther analgesic therapies were discontinued before the beginning of the treatment.\n\nThe study was performed during the period between September 2014 and January 2016 and the duration was up to 12 months.\n\nCharacteristics and severity of neuropathic pain were measured using the Douleur Neuropathique 4 questionnaire. The Brief Pain Inventory allows patients to rate the severity of their pain and the degree to which pain interferes with common dimensions of feeling and function.\n\nPatients aged between 45 and 69. All patients received a fixed dose of cannabinoid agonists: treatment was initiated with nabilone 1mg/day or an oleic suspension for oral administration of THC/CBD 25mg/day.\n\nThe basal dose was increased depending on effects on pain control. Adverse reactions were treated by decreasing the subscripted dose. If adverse events required the suspension of the administration of the initially prescribed drug, the same was switched with the other available in the study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '45 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients that comes to the pain unit, suffer from FBSS refractory pain', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* FBSS with refractory pain\n* DN-4 score of 4 or +\n\nExclusion Criteria:\n\n* Adverse Drug Reaction\n* Subject suffers from FBSS that could not quit the previous pharmacological therapy'}, 'identificationModule': {'nctId': 'NCT03210766', 'briefTitle': 'Nabilone and THC/CBD for the Treatment of FBSS Refractory Pain', 'organization': {'class': 'OTHER', 'fullName': 'Azienda Ospedaliera Universitaria Policlinico "G. Martino"'}, 'officialTitle': 'Nabilone and THC/CBD for the Treatment of FBSS Refractory Pain', 'orgStudyIdInfo': {'id': 'CAN 01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Nabilone', 'description': 'Patients affected by Failed Back Surgery Syndrome (FBSS)', 'interventionNames': ['Drug: Nabilone']}, {'label': 'THC/CBD', 'description': 'Patients affected by Failed Back Surgery Syndrome (FBSS)', 'interventionNames': ['Drug: THC/CBD']}], 'interventions': [{'name': 'Nabilone', 'type': 'DRUG', 'otherNames': ['Spinal Cord Stimulation'], 'armGroupLabels': ['Nabilone']}, {'name': 'THC/CBD', 'type': 'DRUG', 'otherNames': ['Spinal Cord Stimulation'], 'armGroupLabels': ['THC/CBD']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Domenico Quattrone, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'S. Vincenzo Hospital ASP Messina'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda Ospedaliera Universitaria Policlinico "G. Martino"', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Full Professor of Pharmacology', 'investigatorFullName': 'Gioacchino Calapai', 'investigatorAffiliation': 'Azienda Ospedaliera Universitaria Policlinico "G. Martino"'}}}}