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DURING-PROCEDURE ACTIVITIES DAILY MEASURES: DAYS 1 THROUGH 14 During each of the 14 days of the 2-week procedure administration phase, the subject will record the following:
(ii) Patient Global Assessment Scales. (iii) Rescue Pain Medication Use: The subject will record each time that he or she takes a dose of the study permissible rescue pain medication. (iv) Body Pain Diary: The subject will record his or her body pain ratings for the body areas, at the times, specified. (v) Concomitant Medication and Therapy Use: The subject will record each use of concomitant medications and therapies. (vi) Recording of adverse events: The subject will record the occurrence of any perceived adverse event and contact the PI at once for evaluation of the perceived event. PRE- AND POST-PROCEDURE ADMINISTRATION MEASURES Within ten minutes just prior to initiation of each of the eight procedure administrations with the Resonator™ device, and again within ten minutes immediately following completion of each of the eight procedure administrations, the subject will record a VAS pain rating for the study hip and complete the Body Pain Diary. The subject will be required to refrain from taking a dose of his or her permissible pain medication within four hours of recording the VAS pain and Body Pain Diary entries, but may take a dose immediately after the post-procedure recording, if needed. END OF WEEK ONE: DAY 7 At the end of the first week of procedure administrations (after the 4th procedure administration), the subject will record the following measures, evaluated over the course of the prior week: (i) Lequesne Index of Severity for Osteoarthritis of the Hip |
4700 140th Ave. N., Suite 101 • Clearwater, FL 33762 • 727-474-3722 |
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The Resonator™ device is an Investigational Device limited by Federal (or United States) |
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