None listed
Conditions
Brief summary
The objective of this observational study is to examine whether there is a change or improvement in standardised and validated patient reported outcome measures, whilst using a standardized and pharmaceutical oral formulation of medicinal cannabis (MC) oil to treat Musculoskeletal (MSK) chronic pain over a 12-week period, or until they cease taking the medication. The study will also record any adverse outcomes that result whilst taking the medication. It is hoped conclusions will be drawn as to whether or not this particular medication warrants further and more rigorous clinical trial investigation as an interventional treatment for chronic pain, in this patient cohort.
Interventions
This observational study aims to conclude whether one of three medications change or improve chronic pain originating from Musculoskeletal conditions, and other quality of life measures, as observed and reported by each participant's own experience. There will be 1 of 3 products, either Levin Health CBD+, Levin Health Balance, or Levin health THC+, that the Principal Investigator will choose to prescribe for each participant, according to clinical discretion. The treatment medication itself is a
This observational study aims to conclude whether one of three medications change or improve chronic pain originating from Musculoskeletal conditions, and other quality of life measures, as observed and reported by each participant's own experience. There will be 1 of 3 products, either Levin Health CBD+, Levin Health Balance, or Levin health THC+, that the Principal Investigator will choose to prescribe for each participant, according to clinical discretion. The treatment medication itself is an exposure that is beyond the scope of this study. Standardized and validated electronic, web-based Patient Reported Outcome Measures (PROMs) will be completed by 100 participants, using their own home computers or devices on a weekly basis, whilst they are using a pharmaceutical oral formulation of medicinal cannabis (MC) oil to treat Musculoskeletal (MSK) chronic pain. Measures will be compared with those taken at baseline. PROMs will take around 10-15 minutes per week to complete. Any adverse events will also be reported and monitored via a PROM, as well as during study defined in-clinic or Telehealth consultations with the Principal Investigator, who is also a Medicinal Cannabis prescribing General Practitioner. The observed period will be 12-weeks, or until medication is ceased. The 3 different medications will not be compared to each other during data analysis.
Sponsors
Levin Health Limited
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Aged over 18 years • A diagnosis of treatment resistant chronic pain of musculoskeletal origin • Ability to give informed consent • Willing and able to follow study instructions and likely to complete all PROM requirements via study website • Able to provide informed consent • Have a life-expectancy of >3 months • Understand that there is a risk of prosecution if driving a car while under treatment • Patient has been identified as eligible to receive medicinal cannabis under the TGA Special Access Scheme/Authorised by the Principal Investigator for chronic pain • Participants must have been lawfully prescribed Levin Balance, Levin CBD+ or Levin THC+ by the Principal Investigator • Participants agree to abstain from using another cannabis product other than their Levin Health product for the duration of their enrolment in the study
Exclusion criteria
• have cognitive impairment • are pregnant • are unable to speak, read and/or write in English • are unable to provide informed consent • are unable to provide an email address • have received prescription medicinal cannabis within the last 4 weeks • are using illicit cannabis
Outcome results
None listed