Mechanical Low Back PainNCT04726579
CBD Oil in Mechanical Back Pain
An observational study of Mechanical Low Back Pain, run by perceiveMD.
Trial summary
This study is a 12-week open-label, prospective, observational study to assess how subjects with chronic mechanical back pain respond to cannabidiol (CBD) Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Mechanical Low Back Pain
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2021to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 1. This study will be based out of PerceiveMD, a clinic with expertise in CBD therapy. Patients will be approached for enrollment at rheumatology, physiatry, and pain clinics as well as PerceiveMD. Baseline screening visit and follow will be done online using a PIPA/PIPEDA compliant video or audio conference. Prospective patients are those who have decided to take CBD oil for the treatment of MBP. 2. Flyers will be given to health care providers at rheumatology, physiatry, and pain clinics as well as PerceiveMD. Flyers will also be directly available to patients at these locations and they can contact Dr. Lim if they would like to participate in the study. 3. Prospective patients will be identified using the following criteria: Equal to or older than 21 years old Back pain for more than 3 months (self-reported) prior to screening visit 4. The study will be conducted at PerceiveMD, 603 Gorge Rd. E Victoria, BC
Who may be able to join
- 1) Must be able to communicate well with the Investigator(s), understand and comply with the requirements of the study, and provide written consent
- 2. Age ≥21 years
- 3. Diagnosed with MBP with symptom onset >3 months prior to screening visit
- 4. Must have pain severity ≥4/10 on VAS for at least 3 months as reported by the patient
- 5. Decided to take CBD oil for the treatment of MBP
- 6. Must have access to a computer or laptop and be able to operate the required video conference platform
Who cannot join
- 1. Cause of pain due to malignancy, infection, fracture, or spondylarthritis
- 2. Recent (within the last 3 months) spinal trauma
- 3. Leg dominant/radicular pain
- 4. Current active fibromyalgia
- 5. Female who is pregnant, nursing, or plan to become pregnant during the study
- 6. Allergies to CBD or any components of the CBD oil to be used in the study
Show all 9Show fewer
- 7. Active significant medical and/or psychological illness which, in the opinion of the Investigator,
- is not suitable to participate in the study (e.g. malignancy, hepatic disease, CAD, COPD, schizophrenia, etc.)
- 8. Changes in doses of baseline analgesics such as acetaminophen, pregabalin, gabapentin, opioids, or glucocorticoids within 1 month prior to the study
About this study
Official title: An Open-Label, Prospective, Observational Study to Assess the Response to Cannabidiol (CBD) Oil in Subjects With Chronic Mechanical Back Pain (MBP)
This study is a 12-week open-label, prospective, observational study to assess how subjects with chronic mechanical back pain respond to cannabidiol (CBD)
Read the detailed description
Purpose: To Assess the Response to Cannabidiol (CBD) Oil in Subjects with Chronic Mechanical Back Pain (MBP)
Hypothesis: Cannabis use provides many patients with significant low back pain relief.
Justification: Mechanical back pain is a condition affecting around 30% of the general adult population. It is the second most common reason to see a family physician and the most common reason patients end up on work disability. Long term chronic pain is associated with mood and anxiety disorders in a lot of patients, which suggests that a successful plan for the treatment of chronic pain must also consider the treatment of possible co-existing psychiatrist conditions.
Objectives:
To assess the change in pain measured by 0 to 10 point visual analogue scale (VAS) for patients with chronic mechanical back pain treated with CBD oil
Research Design:
52 patients with pain severity ≥4/10 on Visual Analog Scale (VAS) for at least 3 months who have decided to take CBD oil (up to 50 mg SL BID) to manage their symptoms will be recruited to participate. As per standard of care, patients will be encouraged to keep baseline doses of analgesics (if any) stable for the first 6 weeks of the study to monitor their response to CBD oil. Analgesic medications will be allowed to be adjusted between weeks 6 to 12.
Enrolled patients will be assessed at baseline, week 6, and week 12 for a total of 3 virtual visits. Patients will be asked to fill out online questionnaires and a medication diary to assess effectiveness and compliance. Safety will also be assessed throughout the study. Patients will be asked to report any adverse events (AEs) at study completion or earlier if they decide to withdraw. In addition, they will be provided a phone number to PerceiveMD where they can report any serious adverse events (SAEs) in between scheduled visits. Patients will be instructed to report any SAEs within 24 hours. PerceiveMD will then communicate this to one of the Investigators the same day. All adverse reactions will be recorded in the study electronic medical record (EMR), InputHealth.
Statistical Analysis:
The primary analysis will be measured in all enrolled patients who are dispensed drug. Patient data will be collected using online electronic questionnaires generated through InputHealth and stored within InputHealth. Patient data will additionally be collected at the time of their virtual visits with the Investigator(s) at PerceiveMD. This data will be recorded and stored within InputHealth. For descriptive summaries, the mean, sample size (n), standard deviation (SD), standard error (SE), median, minimum (min), and maximum (max) will be calculated for continuous variables. For categorical variables, frequency and percentage in each category will be provided. Change from baseline value will be calculated at each visit. No imputation will be made for missing values. Pain VAS, modified Oswestry Low Back Pain Disability, and GAD7 will be compared between groups, with mean values and 95% confidence interval provided. Percentage of patients with 30% and 50% improvement in pain VAS will also be assessed. Change in analgesic medication dose and use will be analyzed and reported. Based on the extent of missing data, additional analyses may be conducted (e.g. last observation carried forward (LOCF), non-responder index) as a sensitivity analysis to support the primary analysis
- Conditions
- Mechanical Low Back Pain
- Medical subject headings
- Low Back Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the change in pain measured by 0 to 10 point visual analogue scale (VAS) for patients with chronic mechanical back pain treated with CBD oil
52 patients with pain severity ≥4/10 on Visual Analog Scale (VAS) for at least 3 months who have decided to take CBD oil (up to 50 mg SL BID) to manage their symptoms will be recruited to participate. As per standard of care, patients will be encouraged to keep baseline doses of analgesics (if any) stable for the first 6 weeks of the study to monitor their response to CBD oil. Analgesic medications will be allowed to be adjusted between weeks 6 to 12.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start1 Mar 2021 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical Low Back PainStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- perceiveMD
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan Chan, perceiveMD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04726579
- Sponsor's protocol ID
- H20-02124
- Status last verified
- Jan 2021
- First submitted
- 22 Jan 2021
- Last updated
- 27 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Prospective, Observational Study to Assess the Response to Cannabidiol (CBD) Oil in Subjects With Chronic Mechanical Back Pain (MBP)
- ClinicalTrials.gov ID
- NCT04726579
- Acronym / sponsor ID
- H20-02124
- Conditions
- Mechanical Low Back Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- perceiveMDUniversity, hospital or other
- Study start
- 1 Mar 2021 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 27 Jan 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.
This study is a 12-week open-label, prospective, observational study to assess how subjects with chronic mechanical back pain respond to cannabidiol (CBD)
Detailed description
Purpose: To Assess the Response to Cannabidiol (CBD) Oil in Subjects with Chronic Mechanical Back Pain (MBP)
Hypothesis: Cannabis use provides many patients with significant low back pain relief.
Justification: Mechanical back pain is a condition affecting around 30% of the general adult population. It is the second most common reason to see a family physician and the most common reason patients end up on work disability. Long term chronic pain is associated with mood and anxiety disorders in a lot of patients, which suggests that a successful plan for the treatment of chronic pain must also consider the treatment of possible co-existing psychiatrist conditions.
Objectives:
To assess the change in pain measured by 0 to 10 point visual analogue scale (VAS) for patients with chronic mechanical back pain treated with CBD oil
Research Design:
52 patients with pain severity ≥4/10 on Visual Analog Scale (VAS) for at least 3 months who have decided to take CBD oil (up to 50 mg SL BID) to manage their symptoms will be recruited to participate. As per standard of care, patients will be encouraged to keep baseline doses of analgesics (if any) stable for the first 6 weeks of the study to monitor their response to CBD oil. Analgesic medications will be allowed to be adjusted between weeks 6 to 12.
Enrolled patients will be assessed at baseline, week 6, and week 12 for a total of 3 virtual visits. Patients will be asked to fill out online questionnaires and a medication diary to assess effectiveness and compliance. Safety will also be assessed throughout the study. Patients will be asked to report any adverse events (AEs) at study completion or earlier if they decide to withdraw. In addition, they will be provided a phone number to PerceiveMD where they can report any serious adverse events (SAEs) in between scheduled visits. Patients will be instructed to report any SAEs within 24 hours. PerceiveMD will then communicate this to one of the Investigators the same day. All adverse reactions will be recorded in the study electronic medical record (EMR), InputHealth.
Statistical Analysis:
The primary analysis will be measured in all enrolled patients who are dispensed drug. Patient data will be collected using online electronic questionnaires generated through InputHealth and stored within InputHealth. Patient data will additionally be collected at the time of their virtual visits with the Investigator(s) at PerceiveMD. This data will be recorded and stored within InputHealth. For descriptive summaries, the mean, sample size (n), standard deviation (SD), standard error (SE), median, minimum (min), and maximum (max) will be calculated for continuous variables. For categorical variables, frequency and percentage in each category will be provided. Change from baseline value will be calculated at each visit. No imputation will be made for missing values. Pain VAS, modified Oswestry Low Back Pain Disability, and GAD7 will be compared between groups, with mean values and 95% confidence interval provided. Percentage of patients with 30% and 50% improvement in pain VAS will also be assessed. Change in analgesic medication dose and use will be analyzed and reported. Based on the extent of missing data, additional analyses may be conducted (e.g. last observation carried forward (LOCF), non-responder index) as a sensitivity analysis to support the primary analysis
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1. This study will be based out of PerceiveMD, a clinic with expertise in CBD therapy. Patients will be approached for enrollment at rheumatology, physiatry, and pain clinics as well as PerceiveMD. Baseline screening visit and follow will be done online using a PIPA/PIPEDA compliant video or audio conference. Prospective patients are those who have decided to take CBD oil for the treatment of MBP. 2. Flyers will be given to health care providers at rheumatology, physiatry, and pain clinics as well as PerceiveMD. Flyers will also be directly available to patients at these locations and they can contact Dr. Lim if they would like to participate in the study. 3. Prospective patients will be identified using the following criteria: Equal to or older than 21 years old Back pain for more than 3 months (self-reported) prior to screening visit 4. The study will be conducted at PerceiveMD, 603 Gorge Rd. E Victoria, BC
Key inclusion criteria (6 listed)
- 1) Must be able to communicate well with the Investigator(s), understand and comply with the requirements of the study, and provide written consent
- 2. Age ≥21 years
- 3. Diagnosed with MBP with symptom onset >3 months prior to screening visit
- 4. Must have pain severity ≥4/10 on VAS for at least 3 months as reported by the patient
- 5. Decided to take CBD oil for the treatment of MBP
Key exclusion criteria (9 listed)
- 1. Cause of pain due to malignancy, infection, fracture, or spondylarthritis
- 2. Recent (within the last 3 months) spinal trauma
- 3. Leg dominant/radicular pain
- 4. Current active fibromyalgia
- 5. Female who is pregnant, nursing, or plan to become pregnant during the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To assess the change in pain measured by 0 to 10 point visual analogue scale (VAS) for patients with chronic mechanical back pain treated with CBD oil
Time frame: 12 weeks
52 patients with pain severity ≥4/10 on Visual Analog Scale (VAS) for at least 3 months who have decided to take CBD oil (up to 50 mg SL BID) to manage their symptoms will be recruited to participate. As per standard of care, patients will be encouraged to keep baseline doses of analgesics (if any) stable for the first 6 weeks of the study to monitor their response to CBD oil. Analgesic medications will be allowed to be adjusted between weeks 6 to 12.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2021.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Mechanical Low Back Pain, run by perceiveMD.
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 6 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 27 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the change in pain measured by 0 to 10 point visual analogue scale (VAS) for patients with chronic mechanical back pain treated with CBD oil (time frame: 12 weeks). 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 27 Jan 2021; AzTrials last refreshed its copy on 2 Nov 2026.