The Role of Extracorporeal Shock Wave Therapy in the Treatment of Trapezial-Metacarpal Osteoarthritis. A Double Blind Randomized Controlled Study.

Study Overview
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Brief Summary
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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.

Official Title
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The Role of Extracorporeal Shock Wave Therapy in the Treatment of Trapezial-Metacarpal Osteoarthritis.

Conditions
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Osteoarthritis Trapezial-metacarpal Joint

Intervention / Treatment
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* Device: Extracorporeal shock wave therapy STORZ MEDICAL Modulith SLK
* Device: Device: Sham extracorporeal shock wave therapy STORZ MEDICAL Modulith SLK


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Extracorporeal shock wave therapy<br>an energy level of 0.09 mJ/mm2, 2400 pulses once a week for 4 weeks. | Device: Extracorporeal shock wave therapy STORZ MEDICAL Modulith SLK<br>* an energy level of 0.09 mJ/mm2, 2400 pulses once a week for 4 weeks.<br>|
| Placebo Comparator: sham extracorporeal shock wave therapy<br>The second grouop of patients received 0.04 mJ/mm2, 2400 pulses once a week for 4 weeks. | Device: Device: Sham extracorporeal shock wave therapy STORZ MEDICAL Modulith SLK<br> <br> * Other names: an energy level of 0.09 mJ/mm2, 2400 pulses once a week for 4 weeks.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |