Osteoarthritis Trapezial-metacarpal Joint
Conditions
Brief summary
Evaluate if extracorporeal shock wave therapy is more effective than sham treatment in patients with trapezial-metacarpal osteoarthritis in pain relief and functional improvement.
Interventions
an energy level of 0.09 mJ/mm2, 2400 pulses once a week for 4 weeks.
DEVICEDevice: Sham extracorporeal shock wave therapy STORZ MEDICAL Modulith SLK
Sponsors
University of Roma La Sapienza
Study design
Allocation
RANDOMIZED
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale | The change in the mean Visual Analogic Scale scores from baseline to 3 and 6 months after the intervention | 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 |
| Duruöz Hand Index (DHI) | The change in the mean of DHI at 3 and 6 months follow up | 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 |
| Disabilities of the Arm, Shoulder, and Hand questionnaire | The changes in mean at 3 and 6 months follow up | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| grip and pinch tests | The change in mean at 3 and 6 months follow up | The measure of strength by hand grip and pinch tests, for continuous variables that were measured in kilograms with a standard dynamometer |
Countries
Italy
Outcome results
None listed