search
Back to results

Effect of Cannabis Extract on Acute Radicular Pain and on Analgesic Requirement

Primary Purpose

Acute Radicular Back Pain, Cannabis

Status
Unknown status
Phase
Phase 3
Locations
Israel
Study Type
Interventional
Intervention
Single-dose of cannabis oil
Control
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Radicular Back Pain focused on measuring Acute radicular back pain, Cannabis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18 - 70 years
  • ASA 1 or 2
  • Acute Radicular Pain < 12 weeks
  • Pain of VAS 6 or more/ VRS moderate or more
  • Radicular pain: Dermatomal pain that corresponds to physical exam and CT/MRI in the last year

Exclusion Criteria:

  • Age < 18 or > 70 years
  • ASA 3 or more
  • Chronic radicular pain > 12 weeks
  • Past spine surgery
  • Intermittent Claudication due to Vascular Disease
  • Diagnosed Diabetic Neuropathy
  • Regular Cannabis use in past 6 months (more than once a week) OR once in last 2 weeks
  • Regular opioid use in past week (Targin, Percocet, Tramadol) (Equivalent to Oxycodone 20 mg/day or more)
  • Pregnancy or Lactating
  • Ischemic heart disease
  • Renal or hepatic failure
  • History of psychiatric illness
  • Cognitive impairment or inability to answer questions
  • Known allergy to opioids
  • Potential Loss to follow up

Sites / Locations

  • Hadassah Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

High dose cannabis oil

Low dose cannabis oil

Control

Arm Description

Single-dose 20.0 mg tetrahydrocannabinol + 20 mg cannabidiol, Sub-linguistic.

Single-dose 10 mg tetrahydrocannabinol + 10 mg cannabidiol, Sub-linguistic.

Single-dose Olive oil that is similar in appearance and taste to cannabis oil

Outcomes

Primary Outcome Measures

Radicular pain- VAS
Self-reported visual analog scale (VAS 0 - 100 mm) at rest and on movement.
opioid consumption via - Patient controlled administration (PCA)
Count of patient-controlled analgesia pushes.

Secondary Outcome Measures

Nausea and vomiting (PONV) score
PONV score (0 - 4). Before administering baseline, after 0.5, 1, 2, 4, 8 12, 18, 24 h.
Anxiety - VAS
Self-assessed anxiety visual analog scale (0-100 mm). Before administering baseline, after 0.5, 1, 2, 4, 8 12, 18, 24 h.

Full Information

First Posted
February 8, 2021
Last Updated
March 24, 2021
Sponsor
Hadassah Medical Organization
search

1. Study Identification

Unique Protocol Identification Number
NCT04816994
Brief Title
Effect of Cannabis Extract on Acute Radicular Pain and on Analgesic Requirement
Official Title
Effect of Cannabis Extract on Acute Radicular Pain and on Analgesic Requirement: A Double Blinded, Randomized, 24 Hours Follow-up Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 7, 2018 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hadassah Medical Organization

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Clinical evidence about the effects of cannabis in the management of acute pain is rather scarce, mostly consisting of case report-based opinions on adverse events during or after general anesthesia after smoking cannabis, experimental pain trials in healthy volunteers, and a few clinical trials using different drugs, dosages and routes of administration. It is difficult to draw strong conclusions from the available evidence, that may seem sometimes even contradictory, mainly due -the investigators believe- to the many sources of variability in the study designs (e.g.: heterogeneity of the study samples, underpowered, unblinding, lack of randomization, timing of the therapeutic intervention, different experimental pain models, inclusion of different kind of surgical pain, etc.). Nevertheless, expert's opinion after a critical review of the literature is that cannabis and cannabinoids may have a beneficial role in the management of acute pain, at least for a selected group of patients and through an appropriate therapeutic intervention. Cannabis oil seem to be most suitable to our investigation. The co-administration of tetrahydrocannabinol (THC) with cannabidiol (CBD) may translate into additional therapeutic benefits with an attenuation of adverse effects. And will help treat acute radicular back pain

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Radicular Back Pain, Cannabis
Keywords
Acute radicular back pain, Cannabis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Sequential Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High dose cannabis oil
Arm Type
Experimental
Arm Description
Single-dose 20.0 mg tetrahydrocannabinol + 20 mg cannabidiol, Sub-linguistic.
Arm Title
Low dose cannabis oil
Arm Type
Experimental
Arm Description
Single-dose 10 mg tetrahydrocannabinol + 10 mg cannabidiol, Sub-linguistic.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Single-dose Olive oil that is similar in appearance and taste to cannabis oil
Intervention Type
Drug
Intervention Name(s)
Single-dose of cannabis oil
Intervention Description
Single-dose of cannabis oil in order to treat acute radicular pain
Intervention Type
Drug
Intervention Name(s)
Control
Intervention Description
Giving a sub-linguistic olive oil that is similar in appearance and taste to cannabis oil
Primary Outcome Measure Information:
Title
Radicular pain- VAS
Description
Self-reported visual analog scale (VAS 0 - 100 mm) at rest and on movement.
Time Frame
The change over 24 hours
Title
opioid consumption via - Patient controlled administration (PCA)
Description
Count of patient-controlled analgesia pushes.
Time Frame
The change over 24 hours
Secondary Outcome Measure Information:
Title
Nausea and vomiting (PONV) score
Description
PONV score (0 - 4). Before administering baseline, after 0.5, 1, 2, 4, 8 12, 18, 24 h.
Time Frame
The change over 24 hours
Title
Anxiety - VAS
Description
Self-assessed anxiety visual analog scale (0-100 mm). Before administering baseline, after 0.5, 1, 2, 4, 8 12, 18, 24 h.
Time Frame
The change over 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 - 70 years ASA 1 or 2 Acute Radicular Pain < 12 weeks Pain of VAS 6 or more/ VRS moderate or more Radicular pain: Dermatomal pain that corresponds to physical exam and CT/MRI in the last year Exclusion Criteria: Age < 18 or > 70 years ASA 3 or more Chronic radicular pain > 12 weeks Past spine surgery Intermittent Claudication due to Vascular Disease Diagnosed Diabetic Neuropathy Regular Cannabis use in past 6 months (more than once a week) OR once in last 2 weeks Regular opioid use in past week (Targin, Percocet, Tramadol) (Equivalent to Oxycodone 20 mg/day or more) Pregnancy or Lactating Ischemic heart disease Renal or hepatic failure History of psychiatric illness Cognitive impairment or inability to answer questions Known allergy to opioids Potential Loss to follow up
Facility Information:
Facility Name
Hadassah Medical Center
City
Jerusalem
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elyad M Davidson, M.D
Phone
972-2-6776911
Ext
54211
Email
edavidson@hadassah.org.il
First Name & Middle Initial & Last Name & Degree
Elyad M Davidson, M.D

12. IPD Sharing Statement

Learn more about this trial

Effect of Cannabis Extract on Acute Radicular Pain and on Analgesic Requirement

We'll reach out to this number within 24 hrs