Additionally, these medications often cause stomach pain.

In recent years, the FDA has issued stronger warnings about the increased risk of heart attack and stroke due to oral NSAIDs ( 3). Oral NSAIDs, such as ibuprofen, naproxen and aspirin, alleviate pain and swelling, but can increase blood pressure and exacerbate heart conditions. Topical NSAIDs, including gels, liquids and patches are as effective as oral NSAIDs, but generally carry fewer risks and side effects ( 2).

Investigators will be blinded to treatment, and will evaluate pain relief and functional/disability status.Diclofenac gel can treat pain from a range of musculoskeletal conditions and has a favorable side effect profile relative to oral NSAID medications.

One hundred six patients presenting to the Cleveland Clinic Pain Management Department for the treatment of knee pain will be randomly assigned to topical diclofenac cream 8% or diclofenac gel 1%, with the designated medication applied the symptomatic area of the knee over 6 weeks. Specifically, the investigators propose to test the hypothesis that efficacy of topical diclofenac 8% exceeds that of diclofenac 1%, without any increase in systemic toxicity. The investigators will therefore compare the efficacy of available topical diclofenac 1% gel to that of diclofenac 8% cream. Higher concentrations presumably provide higher tissue concentration leading to better and longer pain relief, along with a more prominent anti-inflammatory effect. The best-studied commercially available products are diclofenac 1% compounds. Though much less studied than oral NSAIDs, topical NSAID preparations are currently prescribed for a variety of arthritic and musculoskeletal types of pain. There is little systemic absorption of NSAIDs with topical administration, and consequently less likelihood of systemic side effects. For example, they are often used for knee pain. In recent years, topical preparations of NSAIDs have been used for localized pain as an alternate to oral administration with reported good analgesic efficacy. These types of oral medications are utilized by millions of Americans on a fairly regular basis in both over-the-counter preparations and prescription compounds. Though this form of systemic therapy is highly effective, it causes substantial side effects including gastritis and gastric ulcer disease, renal impairment, hypertension, and thrombotic events.

Non-steroidal anti-inflammatory medication (NSAID) therapy is a mainstay treatment for joint pain and painful musculoskeletal disorders.

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