SBIR/STTR Award attributes
Project SummaryOsteoarthritisOAis the most common type of arthritisaffecting overmillion adults in the United States inand represents overof medical office visits according to the Centers for Disease Control and Prevention and the National Institutes of HealthOverof individuals overhave symptomatic OA and reduced mobility due to the diseaseOA pain is often mitigated with conservative treatment approaches such as water therapywalkingcyclingand pharmaceuticalsRegular use of NSAIDs can have adverse side effects on cardiovasculargastrointestinal and renal systemsAs suchtopical NSAIDs are often used and provide similar pain relief to oral NSAIDsLong duration ultrasound has been used to reduce pain and improve joint function in patients with knee OAWhen ultrasound is used in conjunction with topical pharmaceuticalssonophoresis drives the molecules deeper into tissueproviding improved pain relief compared to ultrasound alone or topical application of NSAIDs aloneThis proposal will develop and evaluate a sonophoresis patch that couples with a long durationlow intensity ultrasound wearable deviceThis battery poweredwearable sonophoresis patch can be self applied and administers ultrasound through novel NSAID enriched hydrogel coupling patch for extended treatment durationsdriving NSAIDs deeper into tissue and providing superior pain relief to topical NSAIDs or ultrasound aloneKey Features of the Proposed WorkFirst ZetrOZ SystemsLLC will design and evaluate a sonophoresis coupling patchenriched with NSAIDspiroxicamCritical ultrasound coupling specifications will be evaluated under bench testing conditions including thermal properties and acoustic couplingZetOZ SystemsLLC will assess human factor engineering considerationsA sample ofparticipants will be instructed how to apply the sonophoresis patch and ultrasound device to the OA affected knee during aminute demonstrationThenparticipants will apply the sonophoresis patch for five treatment sessions of four hourswith a maximum of one treatment session per dayAll five treatment sessions will be performed within aday periodAfter each treatment session participants will fill out a questionnaire relating to the ease of userepeatabilitymobility limitationsor otherwise adverse effectsHuman factors considerations are an integral factor in the design process and any necessary changes will be implemented prior to clinical efficacy studies following this projectAnweekpatientdouble blind randomized clinical efficacy pilot study will be conducted to evaluate the sonophoresis patch compared to long duration ultrasound treatmentThe primary outcome of the study will be pain scoreevaluated daily using the numerical rating scaleNRSBaseline NRS score will include the first two weeks of the study without interventionIntervention phase will separate two demographically equivalent groups ofassigned to use either the sonophoresis or standard gel coupling patch with daily self applied ultrasound treatment for six weeksThe proposed combination therapy has the potential to deliver a safeeffectiveand conservative treatment approach for OA in the aging population Project NarrativeThis project proposes to develop and evaluate the first home use NSAID enhanced sonophoresis patch for use by an aging population with osteoarthritisWe will finalize development of the ultrasound based drug delivery systemand evaluate the sonophoresis patch in human factor study and pilot clinical trial on knee osteoarthritis
