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The purpose of this study is to see if using a device called the Resonator, that puts out very low level electromagnetic fields will help symptoms of painful hip(s)
The purpose of this pilot study is to assess the efficacy of the Resonator™ device, manufactured by Pico-Tesla, the MAGNECEUTICAL® company (the Sponsor), as an adjunctive therapy to reducing pain and improving function for individuals with osteoarthritis of the hip.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| Resonator Device | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resonator device | Device | low level magnetic fields |
|
| Measure | Description | Time Frame |
|---|---|---|
| The mean change from baseline to study endpoint in the 3-recording average of the subject's Daily Pain Rating on the 0-100 VAS for the study hip recorded each morning upon waking and prior to consuming any pain medication for the day. | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Daily morning recordings of pain intensity ratings for the study hip on the 0-100 VAS | 14 days |
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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):
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.
Exclusion Criteria:
> Neither the right nor the left hip satisfies BOTH of the following criteria for a diagnosis of osteoarthritis of the hip (as outlined in the STUDY TEST BATTERY section):
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Innovative Research | Clearwater | Florida | 33756 | United States |
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| ID | Term |
|---|---|
| D015207 | Osteoarthritis, Hip |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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