FBSSNCT03210766
Nabilone and THC/CBD for the Treatment of FBSS Refractory Pain
An observational study of FBSS, run by Azienda Ospedaliera Universitaria Policlinico "G. Martino".
Trial summary
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. Read more about this study
- Who is it for?
- Ages 45 to 70 years
- Conditions the study is for
- FBSS
- What is being tested?
- Nabilone and THC/CBD
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2014to 31 Jan 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients that comes to the pain unit, suffer from FBSS refractory pain
Who may be able to join
- FBSS with refractory pain
- DN-4 score of 4 or +
Who cannot join
- Adverse Drug Reaction
- Subject suffers from FBSS that could not quit the previous pharmacological therapy
About this study
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.
Read the detailed description
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.
- Conditions
- FBSS
- Being tested
- Nabilone, THC/CBD
- Keywords
- Cannabinoids, nabilone, FBSS, THC/CBD, refractory pain
- Medical subject headings
- Failed Back Surgery Syndrome, Pain, Intractable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NabiloneDrug
Also called Spinal Cord Stimulation
THC/CBDDrug
Also called Spinal Cord Stimulation
| Study group | Role | What they receive |
|---|---|---|
| Nabilone | Patients affected by Failed Back Surgery Syndrome (FBSS) Receives: Drug: Nabilone | |
| THC/CBD | Patients affected by Failed Back Surgery Syndrome (FBSS) Receives: Drug: THC/CBD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief Pain Inventory (BPI)
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."
Measured: 2015/1 to 2016/1
Douleur Neuropathique-4 (DN-4)
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.
Measured: 2015/1 to 2016/1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2017
- Study start1 Sep 2014
- Primary completion1 Jan 2015
- Study completion31 Jan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (61)Papers the sponsor has linked to this study.
- Other trials for FBSSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Universitaria Policlinico "G. Martino"
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gioacchino Calapai, Azienda Ospedaliera Universitaria Policlinico "G. Martino"
- Investigators
- Domenico Quattrone, MD, Principal investigator, S. Vincenzo Hospital ASP Messina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03210766
- Sponsor's protocol ID
- CAN 01
- Status last verified
- Jan 2019
- First submitted
- 5 Jul 2017
- Last updated
- 16 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 7249453Waguespack A, Schofferman J, Slosar P, Reynolds J. Etiology of long-term failures of lumbar spine surgery. Pain Med. 2002 Mar;3(1):18-22. doi: 10.1046/j.1526-4637.2002.02007.x.
PubMed 15102214Slipman CW, Shin CH, Patel RK, Isaac Z, Huston CW, Lipetz JS, Lenrow DA, Braverman DL, Vresilovic EJ Jr. Etiologies of failed back surgery syndrome. Pain Med. 2002 Sep;3(3):200-14; discussion 214-7. doi: 10.1046/j.1526-4637.2002.02033.x.
PubMed 15099254Krishna M, Pollock RD, Bhatia C. Incidence, etiology, classification, and management of neuralgia after posterior lumbar interbody fusion surgery in 226 patients. Spine J. 2008 Mar-Apr;8(2):374-9. doi: 10.1016/j.spinee.2006.09.004. Epub 2006 Dec 22.
PubMed 17433779Hussain A, Erdek M. Interventional pain management for failed back surgery syndrome. Pain Pract. 2014 Jan;14(1):64-78. doi: 10.1111/papr.12035. Epub 2013 Feb 3.
PubMed 23374545Choi HS, Chi EH, Kim MR, Jung J, Lee J, Shin JS, Ha IH. Demographic characteristics and medical service use of failed back surgery syndrome patients at an integrated treatment hospital focusing on complementary and alternative medicine: a retrospective review of electronic medical records. Evid Based Complement Alternat Med. 2014;2014:714389. doi: 10.1155/2014/714389. Epub 2014 Nov 4.
PubMed 25530787Shapiro CM. The failed back surgery syndrome: pitfalls surrounding evaluation and treatment. Phys Med Rehabil Clin N Am. 2014 May;25(2):319-40. doi: 10.1016/j.pmr.2014.01.014.
PubMed 24787336Thomson S. Failed back surgery syndrome - definition, epidemiology and demographics. Br J Pain. 2013 Feb;7(1):56-9. doi: 10.1177/2049463713479096.
PubMed 26516498Peul WC, van Houwelingen HC, van den Hout WB, Brand R, Eekhof JA, Tans JT, Thomeer RT, Koes BW; Leiden-The Hague Spine Intervention Prognostic Study Group. Surgery versus prolonged conservative treatment for sciatica. N Engl J Med. 2007 May 31;356(22):2245-56. doi: 10.1056/NEJMoa064039.
PubMed 17538084Chan CW, Peng P. Failed back surgery syndrome. Pain Med. 2011 Apr;12(4):577-606. doi: 10.1111/j.1526-4637.2011.01089.x. Epub 2011 Apr 4.
PubMed 21463472Khosravi MB, Azemati S, Sahmeddini MA. Gabapentin versus naproxen in the management of failed back surgery syndrome; a randomized controlled trial. Acta Anaesthesiol Belg. 2014;65(1):31-7.
PubMed 24988825Zencirci B. Analgesic efficacy of oral gabapentin added to standard epidural corticosteroids in patients with failed back surgery. Clin Pharmacol. 2010;2:207-11. doi: 10.2147/CPAA.S12126. Epub 2010 Sep 30.
PubMed 22291506Abeloos L, De Witte O, Riquet R, Tuna T, Mathieu N. [Long-term outcome of patients treated with spinal cord stimulation for therapeutically refractory failed back surgery syndrome: a retrospective study]. Neurochirurgie. 2011 Jul;57(3):114-9. doi: 10.1016/j.neuchi.2011.07.001. Epub 2011 Sep 9. French.
PubMed 21907361Van Buyten JP, Al-Kaisy A, Smet I, Palmisani S, Smith T. High-frequency spinal cord stimulation for the treatment of chronic back pain patients: results of a prospective multicenter European clinical study. Neuromodulation. 2013 Jan-Feb;16(1):59-65; discussion 65-6. doi: 10.1111/ner.12006. Epub 2012 Nov 30.
PubMed 23199157North RB, Kidd D, Shipley J, Taylor RS. Spinal cord stimulation versus reoperation for failed back surgery syndrome: a cost effectiveness and cost utility analysis based on a randomized, controlled trial. Neurosurgery. 2007 Aug;61(2):361-8; discussion 368-9. doi: 10.1227/01.NEU.0000255522.42579.EA.
PubMed 17762749
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nabilone and THC/CBD for the Treatment of FBSS Refractory Pain
- ClinicalTrials.gov ID
- NCT03210766
- Acronym / sponsor ID
- CAN 01
- Conditions
- FBSS
- Keywords
- Cannabinoids, nabilone, FBSS, THC/CBD, refractory pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Azienda Ospedaliera Universitaria Policlinico "G. Martino"University, hospital or other
- Study start
- 1 Sep 2014 (actual)
- Primary completion
- 1 Jan 2015 (actual)
- Study completion
- 31 Jan 2016 (actual)
- First posted
- 7 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nabilone | – | Drug: NabilonePatients affected by Failed Back Surgery Syndrome (FBSS) |
| THC/CBD | – | Drug: THC/CBDPatients affected by Failed Back Surgery Syndrome (FBSS) |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients that comes to the pain unit, suffer from FBSS refractory pain
Key inclusion criteria (2 listed)
- FBSS with refractory pain
- DN-4 score of 4 or +
Key exclusion criteria (2 listed)
- Adverse Drug Reaction
- Subject suffers from FBSS that could not quit the previous pharmacological therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NabiloneAlso: Spinal Cord Stimulation | Drug | Nabilone |
| THC/CBDAlso: Spinal Cord Stimulation | Drug | THC/CBD |
Primary outcome
Brief Pain Inventory (BPI)
Time frame: 2015/1 to 2016/1
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."
Douleur Neuropathique-4 (DN-4)
Time frame: 2015/1 to 2016/1
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2019.
- Background: PubMed 7249453Burton 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.
- Background: PubMed 15102214Waguespack A, Schofferman J, Slosar P, Reynolds J. Etiology of long-term failures of lumbar spine surgery. Pain Med. 2002 Mar;3(1):18-22. doi: 10.1046/j.1526-4637.2002.02007.x.
- Background: PubMed 15099254Slipman CW, Shin CH, Patel RK, Isaac Z, Huston CW, Lipetz JS, Lenrow DA, Braverman DL, Vresilovic EJ Jr. Etiologies of failed back surgery syndrome. Pain Med. 2002 Sep;3(3):200-14; discussion 214-7. doi: 10.1046/j.1526-4637.2002.02033.x.
- Background: PubMed 17433779Krishna M, Pollock RD, Bhatia C. Incidence, etiology, classification, and management of neuralgia after posterior lumbar interbody fusion surgery in 226 patients. Spine J. 2008 Mar-Apr;8(2):374-9. doi: 10.1016/j.spinee.2006.09.004. Epub 2006 Dec 22.
- Background: PubMed 23374545Hussain A, Erdek M. Interventional pain management for failed back surgery syndrome. Pain Pract. 2014 Jan;14(1):64-78. doi: 10.1111/papr.12035. Epub 2013 Feb 3.
- Background: PubMed 25530787Choi HS, Chi EH, Kim MR, Jung J, Lee J, Shin JS, Ha IH. Demographic characteristics and medical service use of failed back surgery syndrome patients at an integrated treatment hospital focusing on complementary and alternative medicine: a retrospective review of electronic medical records. Evid Based Complement Alternat Med. 2014;2014:714389. doi: 10.1155/2014/714389. Epub 2014 Nov 4.
- Background: PubMed 24787336Shapiro CM. The failed back surgery syndrome: pitfalls surrounding evaluation and treatment. Phys Med Rehabil Clin N Am. 2014 May;25(2):319-40. doi: 10.1016/j.pmr.2014.01.014.
- Background: PubMed 26516498Thomson S. Failed back surgery syndrome - definition, epidemiology and demographics. Br J Pain. 2013 Feb;7(1):56-9. doi: 10.1177/2049463713479096.
- Background: PubMed 17538084Peul WC, van Houwelingen HC, van den Hout WB, Brand R, Eekhof JA, Tans JT, Thomeer RT, Koes BW; Leiden-The Hague Spine Intervention Prognostic Study Group. Surgery versus prolonged conservative treatment for sciatica. N Engl J Med. 2007 May 31;356(22):2245-56. doi: 10.1056/NEJMoa064039.
- Background: PubMed 21463472Chan CW, Peng P. Failed back surgery syndrome. Pain Med. 2011 Apr;12(4):577-606. doi: 10.1111/j.1526-4637.2011.01089.x. Epub 2011 Apr 4.
- Background: PubMed 24988825Khosravi MB, Azemati S, Sahmeddini MA. Gabapentin versus naproxen in the management of failed back surgery syndrome; a randomized controlled trial. Acta Anaesthesiol Belg. 2014;65(1):31-7.
- Background: PubMed 22291506Zencirci B. Analgesic efficacy of oral gabapentin added to standard epidural corticosteroids in patients with failed back surgery. Clin Pharmacol. 2010;2:207-11. doi: 10.2147/CPAA.S12126. Epub 2010 Sep 30.
- Individual participant dataSharing planned: No
Related trials for FBSS
RecruitingObservational study
Open and Closed Loop DTM SCS in Patients With PSPS Type 2: ENDLESS Study
Persistent Spinal Pain Syndrome Type 2, Failed Back Surgery Syndrome
RecruitingPhase 4
Success Rates and Safety of Steroid Injections in Managing Spinal and Sacro-Iliac Pain (CORTisone Injection Spine Study)
Back Pain Lower Back, Neck Pain
Not yet recruitingObservational study
SPINE-RISK VE: Multimodal Predictive Model for Failed Back Surgery Syndrome in Venezuelan Surgical Patients
Persistent Spinal Pain Syndrome Type 2 (PSPS-T) Lower Spine, Chronic Low Back Pain
Active, not recruiting
Restoring Segmental Lumbar Lordosis After Failed Previous Fusion at the Same Level
Failed Back Surgery Syndrome, Degeneration Lumbar Spine
Recruiting
Improvement of Gait by Spinal Stimulation in Patients With Postoperative Chronic Lumbosciatalgia: Pilot Study (GaitStim)
Failed Back Surgery Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Domenico Quattrone, MD principal investigator
S. Vincenzo Hospital ASP Messina
Questions about this trial
What is this clinical trial studying?
An observational study of FBSS, run by Azienda Ospedaliera Universitaria Policlinico "G. Martino".
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief Pain Inventory (BPI) (time frame: 2015/1 to 2016/1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03210766, which also lists 61 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2019.