| |
| |
|
|
|
STUDY PROCEDURE PROTOCOL
INCLUSION CRITERIA
- Diagnosis of osteoarthritis of the hip for at least one hip (right or left hip, or both hips) determined by satisfaction of BOTH of the following (as outlined in the STUDY TEST BATTERY section above):
- the American College of Rheumatology (ACR) Classification Criteria for osteoarthritis of the hip, AND
- Rating of current Degree of Pain in the hip on the 0-100 Visual Analog Scale of 40 or greater.
N.B.: If both hips satisfy both of the above criteria for diagnosis of osteoarthritis of the hip, the hip with the highest VAS pain rating will be selected for evaluation in this study. That is, only one hip per subject will be evaluated in this study.
- Hip pain was present on most days of the prior three months.
- Subject is ambulatory.
- Subject‘s use of pain relief medication(s) has been stable over the past 30 days, and the subject is willing and able to maintain this existing use of pain relief medication(s) as his or her sole pain relief medication use, as needed, throughout study participation.
- Subject has been on current non-pain relief medication regimen (for any indication or condition such as hypertension, pulmonary disease or cardiac disease), unchanged, or on no current non-pain relief medication regimen, for at least 30 days prior to study enrollment, and is willing and able to maintain his or her regular non-pain relief medication regimen, unchanged, throughout the course of his or her study participation unless the subject‘s physician states that a medication change is needed for the subject‘s safety and well-being, in which case the subject agrees to inform the study PI of the change(s) made ,.
- Willing and able to abstain from partaking in other/new treatments (other than the study procedures) to improve osteoarthritis of the hip pain and other symptoms during the course of participation in the study. Such treatments include new medications, dietary/herbal supplements/ minerals, weight loss programs, water or other new exercise programs, physical therapy, occupational therapy, surgical procedures, and alternative therapies such as acupuncture, massage, or hypnotherapy.
- Adequate contraceptive measures for female subjects.
- 18 years of age or older.
- Male or female
|
|
|
