Efficacy of Cannabidiol in Knee Osteoarthritis

Launched by MEDICAL UNIVERSITY OF VIENNA · Oct 22, 2020

Keywords

ClinConnect Summary

Painful symptomatic osteoarthritis (OA) of the knee is a very common disease, especially in older people (lifetime prevalence 9.5%). Current systemic pharmacological treatment options are limited. The Osteoarthritis Research Society International recommends paracetamol, duloxetine, oral non-selective non-steroidal anti-inflammatory drugs and oral COX-2 inhibitors (anti-inflammatory substances) in patients without relevant concomitant diseases. In individuals with relevant concomitant diseases (diabetes, advanced age, high blood pressure, cardiovascular diseases, renal failure, gastrointesti...

Gender

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Eligibility criteria

• Inclusion Criteria:
• • Patient must be willing and able to give informed consent for participation in the study
• • Age 18-80 years
• • Knee Pain
• • WOMAC Pain Subscale ≥ 5 during screening
• • Fulfilment of the clinical criteria of the American College of Rheumatology for knee OA 13
• • X-ray or MRI confirmation of knee osteoarthritis
• • All medications or interventions for pain due to knee osteoarthritis must have been stable for two weeks prior to screening and patient is willing to maintain a stable regimen throughout the study.
• Exclusion Criteria:
• Exclusion Criteria:
• • Current mood disorder (dysthymia, bipolar mood disorder)
• • Major Depression \> 12 months (Beck Depression Inventory Score ≥ 18)
• • History of a psychoactive substance use disorder within the preceding 12 months
• • Major coexisting medical illness (e.g. severe heart failure, pulmonary hypertension, renal insufficiency)
• • Glaucoma
• • Acute myocardial infarction
• • Uncontrolled hypertension
• • History of convulsion
• • Pregnancy; women of childbearing age will be required to use contraceptives during the duration of the study. Furthermore a pregnancy test will be performed prior to the beginning of the study and once a month during the study period.
• • Breast feeding
• • Participation in a clinical trial in the 3 weeks preceding the study
• • Allergy to study medication
• • Recent intra-articular corticosteroid or hyaluronic acid injection in the knee joint. Patients must be willing to abstain from such interventions during the entire study
• * Use of the following medication:
• • opioids except for tramadol,
• • benzodiazepines other than indicated at low doses for sleep disorders
• • NSAID
• • Corticosteroids
• • Impaired kidney function (Creatinine \> 1.5mg/dl)
• * Patient has significantly impaired hepatic function defined as any of the following:
• • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>5 × upper limit of normal (ULN).
• • ALT or AST \>3 × ULN and (total bilirubin \[TBL\] \>2 × ULN or international normalized ratio \[INR\] \>1.5).
• • ALT or AST \>3 × ULN with the presence of fatigue, nausea, vomiting, right upper quadrant pain or tenderness, fever, rash,and/or eosinophilia (\>5%).
• • Patient is currently using or has in the past used recreational or medicinal cannabis or synthetic cannabinoid based medications within 3 months prior to study entry
• • Patient is unwilling to abstain from using recreational or medicinal cannabis, or synthetic cannabinoid based medications during the study
• • Patients who are not able to understand the study measures and are not able to complete pain assessment forms.