Clinical trial: The Analgesic Activity of a Topical Formulation in Patients With Osteoarthritis of the Hands (NCT02485145)

Eligibility criteria:
Inclusion Criteria:

          -  OA in at least one hand as defined by ACR Criteria (nodal enlargement in two or more
             of 10 defined joints, CMC-1, MCP=1, PIPs and DIPs).

          -  Hand pain duration greater than one year.

          -  History of NSAID use for hand pain on at least one occasion during the last year.

          -  Age 40 to 79 years.

          -  Ability to understand the English language and to comprehend written material at the
             5th grade level.

        Exclusion Criteria:

          -  History of psoriasis

          -  Other painful rheumatic disease, measured by a blood draw that will test for RF factor
             and ESR.

          -  Rheumatoid arthritis, as measured by hand x-rays.

          -  Any diagnosis of fibromyalgia or neurovascular disease.

          -  Presence of Raynaud's disease.

          -  -Presence of Raynaud's disease.

          -  Presence of any peripheral neuropathy.

          -  Presence of cervical radiculopathy.

          -  Pregnancy in females (pregnancy test will be administered at intake to females of
             reproductive capability and their method of birth control recorded.)

          -  Persons under age 40. Insufficient data are available in adults to judge potential
             risk in children.

          -  Those who are not capable of providing informed consent.

          -  Known allergy to analgesic drugs and the drugs used in this study.

          -  Those who do not comprehend English. As this is a short-term Pilot study, the
             potential benefits to the participants is currently unknown. Based upon this
             knowledge, we believe we are exempt from the requirement to translate the informed
             consent form into Spanish.

          -  Those with renal and/or gastrointestinal impairments, i.e. with a creatinine level of
             2 and GFS level 4.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
Subject must be at most 79 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