Acute Radicular Back PainPhase 3NCT04816994
Effect of Cannabis Extract on Acute Radicular Pain and on Analgesic Requirement
A Phase 3 study testing Single-dose of cannabis oil in people with Acute Radicular Back Pain and Cannabis, run by Hadassah Medical Organization at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute Radicular Back Pain, Cannabis
- What is being tested?
- Single-dose of cannabis oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- 7 Jan 2018to 31 Dec 2025
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Hadassah Medical Center
Jerusalem
Elyad M Davidson, M.D, 972-2-6776911 ext. 54211, edavidson@hadassah.org.il
Elyad M Davidson, M.D
About this study
Official title: Effect of Cannabis Extract on Acute Radicular Pain and on Analgesic Requirement: A Double Blinded, Randomized, 24 Hours Follow-up Study
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.
Read the 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 department of the Hadassah Medical Center - Ein Kerem Hebrew University. The indications for performing the treatment are: strong (sharp) pain that lasts for several days and radiates from the back to the leg (ie radicular pain) or pain due to a renal colic. Patients that are suffering from severe enough pain that drives them to the emergency room. The study focuses on patients suffering from radiating nerve pain on the background of acute dyskopia = pain resulting from pressure and inflammation on a nerve root causing sciatic pain and also on patients suffering from renal colic.
This study aims to evaluate the efficacy of cannabis for the treatment of radicular pain and renal colic pain.
These patients will usually also be treated with opiate-type painkillers due to the intense pain. We will test whether there is pain relief and a reduction in the need to use opiates. After oral and written informed consent has been obtained, all patients will be admitted for observational treatment as is customary for a pain patient connected to a PCA pump for 24 hours. After Administering an initial loading dose of morphine 0.05-0.1 mg/kg intravenously, as is customary in a pain patient, the patient will be connected to an accepted protocol of morphine infusion for pain relief under the patient's control as follows: 1 mg upon request, 10 minutes downtime, no background , a maximum hourly dose of 6 mg. The patients will be randomly assigned to one of the following dose groups: 1. High dose of cannabis oil: drops of oil to administer under the tongue (21.6 mg THC, 20 mg CBD). 2. High dose of cannabis oil in split form: half a dose at time t0, half a dose an hour later. b oil drops to administer under the tongue (21.6 mg THC, 20 mg CBD). 3. Low dose of cannabis oil: oil drops to administer under the tongue (10.8 mg THC, 10 mg CBD. 4. Placebo control: A control group will receive olive oil, which is similar in taste and appearance to cannabis oil. The treatments will be given so that the subjects, the researchers-therapists and the results analysts will remain blinded until the end of the recruitment. Blinding of the research drug will be obtained by using similar bottles of the cannabis or placebo-olive oil which will be given in a similar container coated with the same cover and with the same taste. In order to maintain blinding even in the split dose, all other groups will receive the placebo after one hour. It should be noted that participants in the study will continue to receive the standard treatment currently given to patients in the same condition
- Conditions
- Acute Radicular Back Pain, Cannabis
- Being tested
- Single-dose of cannabis oil, Control
- Keywords
- Acute radicular back pain, Cannabis
- Medical subject headings
- Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-dose of cannabis oilDrug
Single-dose of cannabis oil in order to treat acute radicular pain
ControlDrug
Giving a sub-linguistic olive oil that is similar in appearance and taste to cannabis oil
| Study group | Role | What they receive |
|---|---|---|
| High dose cannabis oil | Experimental | Single-dose 20.0 mg tetrahydrocannabinol + 20 mg cannabidiol, Sub-linguistic. Receives: Drug: Single-dose of cannabis oil |
| Low dose cannabis oil | Experimental | Single-dose 10 mg tetrahydrocannabinol + 10 mg cannabidiol, Sub-linguistic. Receives: Drug: Single-dose of cannabis oil |
| Control | Placebo comparator | Single-dose Olive oil that is similar in appearance and taste to cannabis oil Receives: Drug: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
opioid consumption via - Patient controlled administration (PCA)
Count of patient-controlled analgesia pushes.
Measured: The change over 24 hours
Secondary outcomes (3)
Nausea and vomiting (PONV) score
PONV score (0 - 4). Before administering baseline, after 0.5, 1, 2, 4, 8 12, 18, 24 h.
Measured: The change over 24 hours
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.
Measured: The change over 24 hours
VAS
Self-reported visual analog scale (VAS 0 - 100 mm) at rest and on movement.
Measured: The change over 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2021
- Study start7 Jan 2018
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Radicular Back PainStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04816994
- Sponsor's protocol ID
- 0092-17-HMO
- Status last verified
- Jul 2025
- First submitted
- 8 Feb 2021
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cannabis Extract on Acute Radicular Pain and on Analgesic Requirement: A Double Blinded, Randomized, 24 Hours Follow-up Study
- ClinicalTrials.gov ID
- NCT04816994
- Acronym / sponsor ID
- 0092-17-HMO
- Conditions
- Acute Radicular Back Pain, Cannabis
- Keywords
- Acute radicular back pain, Cannabis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- 7 Jan 2018 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 25 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 department of the Hadassah Medical Center - Ein Kerem Hebrew University. The indications for performing the treatment are: strong (sharp) pain that lasts for several days and radiates from the back to the leg (ie radicular pain) or pain due to a renal colic. Patients that are suffering from severe enough pain that drives them to the emergency room. The study focuses on patients suffering from radiating nerve pain on the background of acute dyskopia = pain resulting from pressure and inflammation on a nerve root causing sciatic pain and also on patients suffering from renal colic.
This study aims to evaluate the efficacy of cannabis for the treatment of radicular pain and renal colic pain.
These patients will usually also be treated with opiate-type painkillers due to the intense pain. We will test whether there is pain relief and a reduction in the need to use opiates. After oral and written informed consent has been obtained, all patients will be admitted for observational treatment as is customary for a pain patient connected to a PCA pump for 24 hours. After Administering an initial loading dose of morphine 0.05-0.1 mg/kg intravenously, as is customary in a pain patient, the patient will be connected to an accepted protocol of morphine infusion for pain relief under the patient's control as follows: 1 mg upon request, 10 minutes downtime, no background , a maximum hourly dose of 6 mg. The patients will be randomly assigned to one of the following dose groups: 1. High dose of cannabis oil: drops of oil to administer under the tongue (21.6 mg THC, 20 mg CBD). 2. High dose of cannabis oil in split form: half a dose at time t0, half a dose an hour later. b oil drops to administer under the tongue (21.6 mg THC, 20 mg CBD). 3. Low dose of cannabis oil: oil drops to administer under the tongue (10.8 mg THC, 10 mg CBD. 4. Placebo control: A control group will receive olive oil, which is similar in taste and appearance to cannabis oil. The treatments will be given so that the subjects, the researchers-therapists and the results analysts will remain blinded until the end of the recruitment. Blinding of the research drug will be obtained by using similar bottles of the cannabis or placebo-olive oil which will be given in a similar container coated with the same cover and with the same taste. In order to maintain blinding even in the split dose, all other groups will receive the placebo after one hour. It should be noted that participants in the study will continue to receive the standard treatment currently given to patients in the same condition
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High dose cannabis oil | Experimental | Drug: Single-dose of cannabis oilSingle-dose 20.0 mg tetrahydrocannabinol + 20 mg cannabidiol, Sub-linguistic. |
| Low dose cannabis oil | Experimental | Drug: Single-dose of cannabis oilSingle-dose 10 mg tetrahydrocannabinol + 10 mg cannabidiol, Sub-linguistic. |
| Control | Placebo comparator | Drug: ControlSingle-dose Olive oil that is similar in appearance and taste to cannabis oil |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (15 listed)
- Age < 18 or > 70 years
- ASA 3 or more
- Chronic radicular pain > 12 weeks
- Past spine surgery
- Intermittent Claudication due to Vascular Disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single-dose of cannabis oilSingle-dose of cannabis oil in order to treat acute radicular pain | Drug | High dose cannabis oil, Low dose cannabis oil |
| ControlGiving a sub-linguistic olive oil that is similar in appearance and taste to cannabis oil | Drug | Control |
Primary outcome
opioid consumption via - Patient controlled administration (PCA)
Time frame: The change over 24 hours
Count of patient-controlled analgesia pushes.
3 secondary outcomes
Nausea and vomiting (PONV) score
Time frame: The change over 24 hours
Anxiety - VAS
Time frame: The change over 24 hours
VAS
Time frame: The change over 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Single-dose of cannabis oil in people with Acute Radicular Back Pain and Cannabis, run by Hadassah Medical Organization at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
opioid consumption via - Patient controlled administration (PCA) (time frame: The change over 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.