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Evaluate if extracorporeal shock wave therapy is more effective than sham treatment in patients with trapezial-metacarpal osteoarthritis in pain relief and functional improvement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Extracorporeal shock wave therapy | Active Comparator | an energy level of 0.09 mJ/mm2, 2400 pulses once a week for 4 weeks. |
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| sham extracorporeal shock wave therapy | Placebo Comparator | The second grouop of patients received 0.04 mJ/mm2, 2400 pulses once a week for 4 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extracorporeal shock wave therapy STORZ MEDICAL Modulith SLK | Device | an energy level of 0.09 mJ/mm2, 2400 pulses once a week for 4 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Scale | It is a horizontal line, 10 cm in length with 0 cm labeled "no pain" and 10 cm labeled "worst pain I have ever had". The patient marks on the line the point that they feel represents their perception of their current state | The change in the mean Visual Analogic Scale scores from baseline to 3 and 6 months after the intervention |
| Duruöz Hand Index (DHI) | is a self-report questionnaire which measures hand functional ability detecting how much difficulty the patient has performing eighteen daily tasks of living in reference to hand function. Each item is scored from 0 (performed without difficulty) to 5 (impossible to do). A total score is obtained by adding the scores of all questions (range 0-90). A higher score indicates greater disability. It was found that this scale is reliable and valid in patients with osteoarthritis | The change in the mean of DHI at 3 and 6 months follow up |
| Disabilities of the Arm, Shoulder, and Hand questionnaire | It is a 30-item scale that addresses difficulty in performing various physical activities that require upper extremity function (physical function, 21 items); symptoms of pain, activity-related pain, tingling, weakness, and stiffness (pain symptoms, 5 items); or impact of disability and symptoms on social activities, work, sleep, and psychological well-being (emotional and social function, 4 items). The score ranges from 0 to 100, where 0 disability and 100 most severe disability. | The changes in mean at 3 and 6 months follow up |
| Measure | Description | Time Frame |
|---|---|---|
| grip and pinch tests | The measure of strength by hand grip and pinch tests, for continuous variables that were measured in kilograms with a standard dynamometer | The change in mean at 3 and 6 months follow up |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| La Sapienza University | Rome | Italy | 00185 | Italy |
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| Device: Sham extracorporeal shock wave therapy STORZ MEDICAL Modulith SLK | Device |
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