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STUDY PROCEDURE PROTOCOL
BASELINE ASSESSMENT
Baseline Assessment activities will occur right after the subject successfully qualifies for study participation, at the same visit.
BASELINE VARIABLES RECORDING: OSTEOARTHRITIS HISTORY; MEDICATIONS & THERAPIES; DEMOGRAPHICS
(i) Medication and Therapy Use
- Pain medication: all pain relief medication(s) the subject currently takes. These will be the sole medication(s) the subject may take for pain relief, as needed, throughout the duration of his or her study participation.
- All other medications – prescription and OTC – used by the subject upon study entry, for any indication.
N.B.: Subjects will be required to maintain consistent use of these medications throughout study participation.
- All therapies engaged in by the subject upon study entry, for any indication.
(ii) Osteoarthritis Symptoms and History
- Total number of years since subject believes osteoarthritis of the hip symptoms originated
- Total number of years since diagnosis of osteoarthritis of the hip
- Other pertinent osteoarthritis symptoms and history information, including other joints affected by osteoarthritis, and time since onset of symptoms/diagnosis
(iii) Demographic Variables
- Gender: male or female
- Age
- Ethnicity: Caucasian, Hispanic, African American, American Indian, Asian/Pacific Islander, Other
BASELINE MEASURES
The following measurement tools will be administered at baseline, as outlined in the STUDY TEST BATTERY section above:
- Patient Global Assessment Scales
- Lequesne Index of Severity for Osteoarthritis of the Hip
- Range of Motion of the study hip
- High sensitivity C-Reactive Protein (hs-CRP): N.B.: The same blood draw (as taken during study qualification evaluation) will be used to determine ESR and hs-CRP levels. There will not be another blood draw performed at this time.
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