Comparative Effects of Focused and Radial Shock-Wave Therapies in Hip Osteoarthritis.

Study Overview
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Brief Summary
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There is no scientific study in the literature regarding the use of shock wave therapy in hip osteoarthritis. In this study, we aim to investigate both the effectiveness of ESWT and which type of ESWT can be more effective in hip osteoarthritis.

Official Title
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Comparative Effects of Focused (Large Focused) and Radial (Controlled Unfocused) Shock-Wave Therapies in Hip Osteoarthritis.

Conditions
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Hip Osteoarthritis

Intervention / Treatment
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* Device: Extracorporeal Shock Wave Therapy (ESWT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: unilateral or bilateral hip osteoarthritis Exclusion Criteria: other disorders that are contraindications for shockwave therapy, not have received ESWT treatment before

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Large-Focused Extracorporeal Shock Wave Therapy<br> | Device: Extracorporeal Shock Wave Therapy (ESWT)<br>* The ESWT device is product of Elettronica Pagani, Italy.<br>|
| Active Comparator: Controlled-Unfocused Extracorporeal Shock Wave Therapy<br> | Device: Extracorporeal Shock Wave Therapy (ESWT)<br>* The ESWT device is product of Elettronica Pagani, Italy.<br>|
| Sham Comparator: Sham Extracorporeal Shock Wave Therapy<br> | Device: Extracorporeal Shock Wave Therapy (ESWT)<br>* The ESWT device is product of Elettronica Pagani, Italy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale (VAS) | patient's self-assessment of pain, in the range of 0 to 10, higher scores mean a worse outcome. | at baseline. | 
| Visual Analogue Scale (VAS) | patient's self-assessment of pain, in the range of 0 to 10, higher scores mean a worse outcome | 4 weeks after baseline. | 
| Visual Analogue Scale (VAS) | patient's self-assessment of pain, in the range of 0 to 10, higher scores mean a worse outcome. | 8 weeks after baseline. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | 24-item questionnaire for osteoarthritis, in the range of 0 to 96, higher scores mean a worse outcome | at baseline. | 
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | 24-item questionnaire for osteoarthritis, in the range of 0 to 96, higher scores mean a worse outcome | 4 weeks after baseline. | 
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | 24-item questionnaire for osteoarthritis, in the range of 0 to 96, higher scores mean a worse outcome | 8 weeks after baseline. |