Status:

RECRUITING

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

Lead Sponsor:

Hadassah Medical Organization

Conditions:

Acute Radicular Back Pain

Cannabis

Eligibility:

All Genders

18-70 years

Phase:

PHASE3

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 a...

Detailed Description

Suitable candidates who meet the inclusion criteria will be approached to participate. Patients hospitalized with a diagnosis of acute radicular pain or pain due to renal colic in the emergency depar...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

January 7 2018

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 31 2025

Estimated Enrollment :

200 Patients enrolled

Trial Details

Trial ID

NCT04816994

Start Date

January 7 2018

End Date

December 31 2025

Last Update

October 2 2025

Active Locations (1)

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Hadassah Medical Center

Jerusalem, Israel