Clinical trial to evaluate magnetically enhanced ibuprofen delivery in people with knee osteoarthitis

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Osteoarthritis is a long term degenerative disease process that affects the major joints. Osteoarthritis pain and inflammation is often treated using non-steroidal anti-inflammatory drugs (NSAIDs). In some cases these drugs can be applied through the skin to treat the affected joint below. The skin however provides a significant barrier to drug penetration. Various methods can be used to enhance drug penetration through the skin. In this case the method of enhancement will be by using a low level magnetic field (similar to a fridge magnet). The aim of this study is to evaluate changes in pain and function following short term (48 hours) use of ibuprofen (5%), a topical NSAID, administered in a patch with a magnetic backing strip. The magnetic backing is designed to enhance the absorption of ibuprofen. The ibuprofen patch will be compared to a placebo patch containing no drug and no magnetic backing. The main objective is to determine if the magnetically enhanced ibuprofen patch achieves superior outcomes to placebo in reducing pain and improving function over 48 hours. The primary hypothesis is that the transdermal ibuprofen magnetic patch will result in significantly lower ratings of pain on movement compared to placebo. The pilot study will recruit a group of 24 participants with knee osteoarthritis. Each participant will complete 2, 48 hour study periods. At the start of each study period they will have their current pain and function assessed in a University laboratory. Participants will then have a patch containing either ibuprofen or placebo applied to their knee(s). When this testing has been completed they will be given an iPad which they will use to complete further testing over a 48 hour period as they go about their normal activities while wearing the knee patch. The iPad will prompt them to complete a rating of their pain at rest and pain on movement approximately every 2.5 hours and it will remind them to change the patch approximately every five hours. After 48 hours they will return to the research laboratory and complete the other pain and function tests. After an interval of 1 week all participants will return to the laboratory and complete the full 48 hour testing process while wearing the alternative patch (placebo or ibuprofen). Neither the participants nor the researchers will know on which occasion they received the ibuprofen treatment. It is envisaged that the participants pain levels will be less and their function will be better during the period in which they are wearing the ibuprofen patch. This is a pilot study gathering preliminary data from a relatively small number of participants. The data from the study will be used by the company that has commissioned the research to inform a future large randomised, controlled clinical trial.

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