OSTEOARTHRITIS OF THE KNEE
Conditions
Keywords
Osteoarthritis, Pain, Cannabinoids, Cannabinoid safety, Tetrahydrocannabinol, Cannabidiol
Brief summary
Osteoarthritis (OA) is the most prevalent joint disease in humans, often causing disability in affected individuals, especially the elderly. OA is characterized by mechanical joint pain, crepitus and short-term post-immobilization stiffness. OA pain has a variable pathophysiology and, despite the many pharmacological options available, its treatment is often ineffective and has significant side effects. The search for more effective and safer treatments is therefore essential in the field of OA. Among the possible treatments are substances derived from cannabis. Cannabis plants have been used for various purposes by humankind for thousands of years. Its best-known species, Cannabis sativa, has more than a hundred substances called cannabinoids or, more specifically, phytocannabinoids, the most important of which is cannabidiol (CBD). Although many pre-clinical studies indicate the usefulness of phytocannabinoids, clinical evidence for their application is currently scarce. Therefore, this project aims to investigate the effects of a CBD-rich extract of Cannabis sativa on the pain of patients with knee OA, as well as the possible adverse events of this treatment.
Interventions
DIETARY_SUPPLEMENTMedium Chain Triglyceride solution
Placebo
OTHERCannabis Sativa
Group 2: Cannabis sativa extract with CBD (45mg/day).
Sponsors
Federal University of Latin American Integration
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Have a diagnosis of knee osteoarthritis, according to the ACR classification criteria (ALTMAN, 1986); * Have a moderate or high level of pain induced by osteoarthritis (visual analog scale scale equal to or greater than 5); * Voluntarily agree to take part in the study by signing the Informed Consent Form (ICF); * For women of reproductive age, a negative Beta-HCG test, and use of a contraceptive method throughout the study. * For women of reproductive age, a negative Beta-HCG test, and use of a contraceptive method throughout the study and 3 months after its conclusion. * Age range of thirty (30) to seventy (70) years.
Exclusion criteria
* People with heart failure, hypertension or any heart disease; * People with chronic kidney disease or liver failure; * Patients with chronic inflammatory diseases; * Patients with severe psychiatric illnesses, such as severe mood disorders and psychotic disorders; * Current use of cannabinoids by any route of administration. * Pregnant women * Lactating women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain levels | 2 months | Change in pain levels, according to the score in the pain domain of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), using the Likert scale to assign a value to the answers obtained from the participants. The pain levels according to the score are 0-8 mild, greater than 8-14 moderate, greater than 14- 20 high. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Depression | 2 months | Changes in levels of depression using the Beck Depression scale. Changes in depression levels using the Beck depression scale. The disease level values range from 0-9 indicating that the individual is not depressed, 10-18 indicating mild to moderate depression, 19-29 indicating moderate to severe depression and 30-63 indicating severe depression. |
| Adverse events | 2 months | presence of adverse events (AE) - proportion of patients with AE in the placebo and intervention groups; |
| Serious adverse events | 2 months | presence of serious adverse events (AEs) - description of the serious AEs that may appear in each group. |
| Short Form Health Survey (SF-12) | 2 months | Change in the Short Form Health Survey (SF-12) quality of life scores, according to the maximal walking and activities of daily living domains, where a score of 0 is the worst quality of life and 100 the best. |
| Renal Function Panel | 2 months | Used as form to identify any renal impairment in pacientes that could result in any need of adjusting the dose or need to leave the study. |
| Visual Analogue Scale (VAS) | 2 month | It is used in the healthcare field to measure the intensity of pain a person feels, usually on a scale from 0 to 10, where 0 means 'no pain' and 10 means 'the worst pain imaginable |
| Hepatic Panel | 2 month | Used to monitor liver function in patients, as pacientes are receiving an oil-based medication that may overload the liver. |
| Change in sleep quality | 2 months | The Pittsburgh scale was used to see if there was any change in the participants' quality of sleep. The scale used classifies sleep quality as follows: * Good 0-4 * Bad -10 * Presence of sleep disturbance greater than 10 |
Countries
Brazil
Outcome results
None listed