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SECONDARY EFFICACY OUTCOME MEASURES The following measures will be evaluated for change across relevant measurement time points:
b) Pain intensity ratings for the study hip on the 0-100 VAS recorded pre- and post-procedure administration for each of the 8 Resonator™ device procedure administrations c) Daily ratings on the Patient Global Assessment scales for each of the 4 aspects of daily function evaluated d) Daily ratings in the Body Pain Diary for each of the joints evaluated e) Separate index and total severity scores on the Lequesne Index f) Range of motion rating as recorded by the physician g) Erythrocyte sedimentation rate (ESR) levels h) High-sensitivity C-Reactive Protein (hs-CRP) levels i) Adverse events evaluation In addition, the following will be evaluated:
b) Any reported deviations in subject compliance to medication and therapy abstinence and relation to study outcome. c) The role of concomitant medication and therapy use d) Blinding efficacy for subjects and the sub-PI e) Subject responses to study outcome satisfaction |
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The Resonator™ device is an Investigational Device limited by Federal (or United States) |
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