The Analgesic Activity of a Topical Formulation in Patients With Osteoarthritis of the Hands
Osteoarthritis of the Hands

About this trial
This is an interventional treatment trial for Osteoarthritis of the Hands focused on measuring Topical, Hand osteoarthritis
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
A/B
B/A
In this crossover trial, the A/B group will receive the test product (A) and then the placebo (B). The topical product contains the following: Diclofenac 3%, Baclofen 2%, Orphenadrine Citrate 5% and Bupivacaine 2% in a VersaPro cream, while the placebo is the VersaPro cream alone. Participants will use the test product for 7 days, applying the topical product to the hands twice a day. There will be a 7 day washout period, and then participants will be given the placebo cream, which will be used for 7 days, applying the topical placebo to the hands twice a day.
In this crossover trial, the B/A group will receive the placebo (B) and then the test product (A). The product contains the following: Diclofenac 3%, Baclofen 2%, Orphenadrine Citrate 5% and Bupivacaine 2% in a VersaPro cream, while the placebo is the VersaPro cream alone. Participants will use the placebo product for 7 days, applying the placebo product to the hands twice a day. There will be a 7 day washout period, and then participants will be given the test cream, which will be used for 7 days, applying the topical product to the hands twice a day.