Condition or diseaseĪ potentially more effective approach is to provide a combination of analgesic and anti-inflammatory agents through a topical delivery system. Topical polytherapy will be employed in this study to see if it will be effective against the pain of OA. However none of these measures have proven sufficiently effective to meet patient needs. The leading example of the latter is Diclofenac sodium gel which was shown to reduce pain intensity and improve hand function in a double blind controlled trial. To achieve some symptomatic benefit while limiting systemic toxicity, topical therapies have been developed which either act as counter irritants, seek to reduce substance P (capsaicin), or to deliver an NSAID locally through the skin. Therapeutic options include acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs), and a variety of physical measures such as physical therapy, bracing, and heat and cold applications. The joints affected typically are the first carpometacarpal (CMC-1) joint, the distal interphalangeal (DIP) joints, and the proximal interphalangeal (PIP) joints. Among the elderly, radiographic hand OA has been found in over half of such individuals and as many as a quarter of them suffer from pain and functional incapacitation. In radiographic surveys about a quarter of the total US population has changes consistent with OA involving the hands. OA involving the hands represents a major part of the overall burden of this disease. Clearly OA is a major factor that demands better solutions as the health care system is redesigned. Recognition of toxicities of non-steroidal anti-inflammatory drugs (NSAIDs) and narcotic-based analgesics has narrowed the presently available armamentarium for pain control in OA.
To make matters worse, investigators have experienced only setbacks in use of medications aimed at symptom control. Weight control, exercise and some physical therapy measures are the only interventions short of total joint replacement that alter the course of this disease. Presently investigators have no medications that alter the natural history of OA. Importantly, several recent studies have demonstrated that OA is an independent risk factor for cardiovascular disease. Largely as a consequence of this disease, the number of patients undergoing joint replacement surgery will quadruple over the next 17 years.
Data for the years between 1996-2005, indicate that OA raised overall health care costs by $185.5 billion annually. Osteoarthritis (OA) affects over 30 million people in the United States and represents our nation's leading cause of disability.
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