CBD Oil in Mechanical Back Pain

NCT04726579 | Unknown

• 1 other identifier: H20-02124
• Study Type: observational
• Target: 52
• Locations: 0 countries
• Sites: N/A

Brief 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)

Conditions

Mechanical Low Back Pain

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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

You may qualify if:

• \) Must be able to communicate well with the Investigator(s), understand and comply with the requirements of the study, and provide written consent
• \. Age ≥21 years
• \. Diagnosed with MBP with symptom onset \>3 months prior to screening visit
• \. Must have pain severity ≥4/10 on VAS for at least 3 months as reported by the patient
• \. Decided to take CBD oil for the treatment of MBP
• \. Must have access to a computer or laptop and be able to operate the required video conference platform

You may not qualify if:

• \. Cause of pain due to malignancy, infection, fracture, or spondylarthritis
• \. Recent (within the last 3 months) spinal trauma
• \. Leg dominant/radicular pain
• \. Current active fibromyalgia
• \. Female who is pregnant, nursing, or plan to become pregnant during the study
• \. Allergies to CBD or any components of the CBD oil to be used in the study
• \. 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.)
• \. Changes in doses of baseline analgesics such as acetaminophen, pregabalin, gabapentin, opioids, or glucocorticoids within 1 month prior to the study

Sponsors & Collaborators

• perceiveMD: lead

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 22, 2021
• First Posted: January 27, 2021
• Study Start: March 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: January 27, 2021

Record last verified: 2021-01