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Recruiting Phase 3

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

NCT04816994 · tracked via the Priya Life Science Israel tracker
Phase
Phase 3
Started
2018-01-07
Last updated
2025-10-02

Condition(s) studied

Acute Radicular Back PainCannabis

Investigational drug(s) / intervention(s)

Single-dose of cannabis oilControl

Single-dose of cannabis oil: Single-dose of cannabis oil in order to treat acute radicular pain

Control: Giving a sub-linguistic olive oil that is similar in appearance and taste to cannabis oil

Study 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 and for renal colic.

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • opioid consumption via - Patient controlled administration (PCA) — The change over 24 hours
    Count of patient-controlled analgesia pushes.

Trial sites (1)

FacilityCityRegionStatus
Hadassah Medical Center Jerusalem Israel Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04816994 on ClinicalTrials.gov ↗ ← All trials in Israel