Nabilone and THC/CBD for the Treatment of FBSS Refractory Pain

NCT03210766 | Completed DMC FDA Drug

• 1 other identifier: CAN 01
• Study Type: observational
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

FBSS

Keywords

Cannabinoids, nabilone, FBSS, THC/CBD, refractory pain

Outcome Measures

Primary Outcomes (2)

• 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."

  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.

  2015/1 to 2016/1

Study Arms (2)

Nabilone

Patients affected by Failed Back Surgery Syndrome (FBSS)

Drug: Nabilone

THC/CBD

Patients affected by Failed Back Surgery Syndrome (FBSS)

Drug: THC/CBD

Interventions

Nabilone DRUG

Also known as: Spinal Cord Stimulation

Nabilone

THC/CBD DRUG

Also known as: Spinal Cord Stimulation

THC/CBD

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients that comes to the pain unit, suffer from FBSS refractory pain

You may qualify if:

• FBSS with refractory pain
• DN-4 score of 4 or +

You may not qualify if:

• Adverse Drug Reaction
• Subject suffers from FBSS that could not quit the previous pharmacological therapy

Sponsors & Collaborators

• Azienda Ospedaliera Universitaria Policlinico "G. Martino": lead

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MeSH Terms

Conditions

Failed Back Surgery Syndrome; Pain, Intractable

Interventions

nabilone; Spinal Cord Stimulation

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Domenico Quattrone, MD

  S. Vincenzo Hospital ASP Messina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor of Pharmacology

Study Record Dates

• First Submitted: July 5, 2017
• First Posted: July 7, 2017
• Study Start: September 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: January 31, 2016
• Last Updated: January 16, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share