POST-PROCEDURE ACTIVITIES

DAILY MEASURES: DAYS 15 THROUGH 21

During each of the 7 days of the one-week post-procedure phase, the subject will record at home the same daily measures as during the baseline standardization and during-procedure administration phases of the study, as follows:

i) Current overall pain rating on the 0-100 VAS upon waking each morning and prior to taking the first dose of permissible pain medication on that day, as needed. The average of the pain ratings for the first three post-procedure mornings (days 15, 16 and 17), will form the study endpoint measurement that will be compared to the standardization phase three-day average that formed the baseline evaluation.

(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.

ONE-WEEK POST-PROCEDURE ASSESSMENT: DAY 21

One week after the final procedure administration, the subject will record the following measures in his or her home, and mail or fax the completed materials to the test site, along with his or her completed daily recorded materials:

(i) Lequesne Index of Severity for Osteoarthritis of the Hip

ONE-MONTH POST-PROCEDURE ASSESSMENT: DAY 40-42

One month after the final procedure administration, the subject will record the following measures in his or her own home for 3 consecutive days, and mail or fax the completed materials to the test site:

(i) Current overall pain rating on the 0-100 VAS upon waking each morning and prior to taking the first dose of permissible pain medication on that day, as needed, on days 40, 41 and 42.

(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 pain medication.

(iv) Body Pain Diary: The subject will complete the Body Pain Diary upon waking each morning and retiring to bed each night, having refrained from taking a dose of pain medication for 4 hours prior to each recording.

(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.

(vii) Lequesne Index of Severity for Osteoarthritis of the Hip

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