Nabilone and THC/CBD for the Treatment of FBSS Refractory Pain
NCT ID: NCT03210766
Last Updated: 2019-01-16
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Total Enrollment
20 participants
Study Classification
OBSERVATIONAL
Study Start Date
2014-09-01
Study Completion Date
2016-01-31
Brief Summary
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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.
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Detailed Description
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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.
Several 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.
Can 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.
In FBSS symptoms are the persistence of low back pain, deterioration or recurrence of radiculopathy, sensory and/or motor deficit, sphincter dysfunction.
Chronic 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.
Pain could be treated by drugs modulating endocannabinoid system and it could represent a pharmacological option in a multimodal treatment approach for neuropathic pain.
Authors 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.
Cannabinoids agonists were administered in association with the practice of spinal cord stimulation (SCS).
Other analgesic therapies were discontinued before the beginning of the treatment.
The study was performed during the period between September 2014 and January 2016 and the duration was up to 12 months.
Characteristics 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.
Patients 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.
The 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.
Several 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.
Can 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.
In FBSS symptoms are the persistence of low back pain, deterioration or recurrence of radiculopathy, sensory and/or motor deficit, sphincter dysfunction.
Chronic 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.
Pain could be treated by drugs modulating endocannabinoid system and it could represent a pharmacological option in a multimodal treatment approach for neuropathic pain.
Authors 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.
Cannabinoids agonists were administered in association with the practice of spinal cord stimulation (SCS).
Other analgesic therapies were discontinued before the beginning of the treatment.
The study was performed during the period between September 2014 and January 2016 and the duration was up to 12 months.
Characteristics 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.
Patients 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.
The 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.
Conditions
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FBSS
Study Design
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Observational Model Type
COHORT
Study Time Perspective
RETROSPECTIVE
Study Groups
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Nabilone
Patients affected by Failed Back Surgery Syndrome (FBSS)
Nabilone
Intervention Type
DRUG
THC/CBD
Patients affected by Failed Back Surgery Syndrome (FBSS)
THC/CBD
Intervention Type
DRUG
Interventions
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Nabilone
Intervention Type
DRUG
THC/CBD
Intervention Type
DRUG
Other Intervention Names
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Spinal Cord Stimulation
Spinal Cord Stimulation
Eligibility Criteria
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Inclusion Criteria
* FBSS with refractory pain
* DN-4 score of 4 or +
* DN-4 score of 4 or +
Exclusion Criteria
* Adverse Drug Reaction
* Subject suffers from FBSS that could not quit the previous pharmacological therapy
* Subject suffers from FBSS that could not quit the previous pharmacological therapy
Minimum Eligible Age
45 Years
Maximum Eligible Age
70 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Azienda Ospedaliera Universitaria Policlinico "G. Martino"
OTHER
Sponsor Role
lead
Responsible Party
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Gioacchino Calapai
Full Professor of Pharmacology
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Domenico Quattrone, MD
Role: PRINCIPAL_INVESTIGATOR
S. Vincenzo Hospital ASP Messina
References
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Other Identifiers
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CAN 01
Identifier Type: -
Identifier Source: org_study_id
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COMPLETED
NA
Study to Evaluate the Efficacy of Lithium Carbonate in Spinal Cord Injury Patients With Neuropathic Pain
NCT01855594
COMPLETED
PHASE2
Neuropathic Pain in Patients With Cancer
NCT00474916
COMPLETED
PHASE2
Efficacy Study of Botox to Treat Neuropathic Pain
NCT00527202
COMPLETED
PHASE4
Intrathecal Therapy for Chronic Non-Cancer Pain: An Analysis of Its Efficacy
NCT01564069
COMPLETED
Efficacy of Inhaled Cannabis in Diabetic Painful Peripheral Neuropathy
NCT00781001
COMPLETED
PHASE1/PHASE2
Low Dose Naltrexone Therapy for Complex Regional Pain Syndrome
NCT06306157
ENROLLING_BY_INVITATION
PHASE4
Clinical Trial Exploring the Outpatient Treatment of Phantom Limb Pain With Ketamine Administration in a Six Month Study With a Minimum Remission Period of 7 Days Between Treatment Session. 25-30 Subjects With an Ongoing History of Significant PLP.--FDA and IRB Approved.
NCT07276542
NOT_YET_RECRUITING
PHASE2/PHASE3
Treatment of Pain Associated With Lumbosacral Radiculopathy in Adults
NCT03727100
COMPLETED
PHASE3
Efficacy of Transdermal Fentanyl for Chronic Neuropathic Pain
NCT00181246
COMPLETED
NA
Central Pain Study for ABX-1431
NCT03138421
COMPLETED
PHASE1
Naltrexone and Clonidine Combination (ATNC05) in the Treatment of Chronic Back Pain
NCT01415895
COMPLETED
PHASE2
Adipose Stem/Stromal Cells in RSD, CRPS, Fibromyalgia
NCT02987855
WITHDRAWN
PHASE1/PHASE2