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New treatment option for Acute Radicular Back Pain
Official title Effect of Cannabis Extract on Acute Radicular Pain and on Analgesic Requirement
ClinicalTrials.gov ID: NCT04816994
What this study is testing
What is Single-dose of cannabis oil?
Single-dose of cannabis oil is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for acute radicular back pain.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.).
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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
You likely can't join if
- Age \ 70 years
- ASA 3 or more
- Chronic radicular pain \> 12 weeks
- Past spine surgery
- Intermittent Claudication due to Vascular Disease
- Diagnosed Diabetic Neuropathy
See the full eligibility 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
- Age \ 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
The study team makes the final eligibility decision.
Where it's taking place
- Jerusalem, Israel
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jerusalem, Israel. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.