Clinical trial: Topical Use of 20% Beta Caryophyllene Alone And In Combination With 0.025% Capsaicin for Pain Caused by Osteoarthritis Of The Knee (NCT03152578)

Eligibility criteria:
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
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years

Patient description (medical language): A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes.  The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief.  Past medical history is notable for hypertension and hypercholesteremia.  Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints.

Patient description (patient's own words): I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints.

Does the patient match the trial criteria? Entailment