Osteoarthritis Trapezial-metacarpal Joint Clinical Trial
Official title:
The Role of Extracorporeal Shock Wave Therapy in the Treatment of Trapezial-Metacarpal Osteoarthritis.
| Verified date | January 2013 |
| Source | University of Roma La Sapienza |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Italy: La Sapienza University |
| Study type | Interventional |
Evaluate if extracorporeal shock wave therapy is more effective than sham treatment in patients with trapezial-metacarpal osteoarthritis in pain relief and functional improvement.
| Status | Completed |
| Enrollment | 0 |
| Est. completion date | |
| Est. primary completion date | June 2011 |
| Accepts healthy volunteers | |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - according to the Eaton et al. classification the inclusion criteria involved those patients with stage III, participants had to have a history 6 months of pain and they were 18 years of age or older. Exclusion criteria were also the presence of degenerative or non-degenerative neurologic conditions, in which pain perception is altered, a history of coagulopathy, cancer, cardiac pacemaker, calcaneal fracture, and pregnancy. Exclusion Criteria: - Exclusion criteria were also the presence of degenerative or non-degenerative neurologic conditions, in which pain perception is altered, a history of coagulopathy, cancer, cardiac pacemaker, calcaneal fracture, and pregnancy. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Italy | La Sapienza University | Rome |
| Lead Sponsor | Collaborator |
|---|---|
| University of Roma La Sapienza |
Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | Disabilities of the Arm, Shoulder, and Hand questionnaire | It is a 30-item scale that addresses dif?culty 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 | |
| Secondary | 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 |