Topical Use of 20% Beta Caryophyllene Alone And In Combination With 0.025% Capsaicin for Pain Caused by Osteoarthritis Of The Knee

Inclusion criteria

• Osteoarthritis of the knee according to American College of Rheumatology criteria: Knee pain with 3 of the following:

• age >50 years
• stiffness less than 30 min
• crepitus,
• bony tenderness,
• bony enlargement,
• no palpable warmth
• Moderate to severe pain, as defined by an average 7-day pain score of greater than 4.0 on an 11-point numerical rating scale for pain intensity (NRS-PI).
• All concurrent medications taken for any reason stable for 14 days
• Ability to follow protocol with reference to cognitive and situational factors (e.g. stable housing, ability to attend visits)
• Ability to read and write English
• Willing and able to give informed consent

Exclusion criteria

• Currently using other topical agents for treatment of pain or inflammation
• Use of glucosamine, methysulfonylmethane or other regular anti-inflammatories within 2 weeks prior to completing baseline pain measure and during the trial
• Presence of significant medical disorder that would compromise the participant's safety to take part in the trial (e.g. cancer, immunosuppressed)
• Pregnant and breastfeeding women.
• Type I or Type II diabetes and other endocrine disorders
• Use of exercise or transcutaneous electrical nerve stimulation prior to and during the trial
• A history or present disease (i.e. inflammatory, infectious joint disease) which may affect the outcome of the trial
• Currently taking NHPs for joint health
• Currently enrolled in other clinical trial involving a pharmaceutical treatment