Extracorporeal Focused Shock Wave Therapy for Primary Knee Osteoarthritis

Study Overview
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Brief Summary
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The purpose of this study is to determine whether Extracorporeal Focused Shock Wave Therapy reduces knee pain and enhance function in patients with primary knee osteoarthritis.

Detailed Description
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This study is a placebo controlled Randomized Clinical Trial (RCT) in which the primary outcome is to determine whether Extracorporeal Focused Shock Wave Therapy (ESWT) reduces knee pain comparing the VAS at baseline and one month after the end of the treatment. Function assessment and progression of pain along the treatment are the secondary outcomes. Function will be assessed with the Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC), the Lequesne's Algofunctional Questionnaire for Osteoarthritis of Knee (Lequesne) and the Timed up and Go (TUG). The ESWT applications will be performed once a week for four consecutive weeks, the patients will be assessed for pain and function before the beginning of the treatment and one week after every application of the ESWT. The treatment groups will be randomized. The allocation of the patients is sealed and will not be disclosed to the patients nor to the evaluators.

Official Title
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The Efficacy of Extracorporeal Focused Shock Wave Therapy for Patients With Primary Knee Osteoarthritis

Conditions
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Unilateral Primary Osteoarthritis of Knee

Intervention / Treatment
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* Device: Extracorporeal Shock Waves
* Device: Sham Extracorporeal Shock Waves
* Other: Physical activities


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical and radiologic diagnosis of primary knee osteoarthritis (Kellgren & Lawrence I, II or III); Capability to understand the Informed Consent Form; Chronic pain for at least 3 months prior to inclusion, measured by VAS. (VAS 4 or above); Absence of skin injures, infections or tumor in the target knee; Availability to comply with the visits. Exclusion Criteria: History of spinal cord stenosis or clinical symptoms of lumbar radiculopathy; History or onset neurological diseases; Generalized pain or fibromyalgia; Inability to walk; History of knee surgery in the target knee; Secondary causes of osteoarthritis; Use of statins and quinolones in the previous year; Uncontrolled and ongoing psychiatric diseases; Invasive knee treatments with hyaluronic acid infusion, corticosteroids and anaesthetics, in the target knee, up to 6 months previous to study inclusion.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 80 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Extracorporeal Shock Waves<br>Focused shock waves delivered by an electromagnetic generator with a focus of 5.0cm deep on the affected knee in three different positions. A total of 7000 pulses will be delivered on a weekly session for four weeks. | Device: Extracorporeal Shock Waves<br> <br> Other: Physical activities<br>* Patients receive instructions for physical activities for strengthening of femoral quadriceps and stretching of hamstring muscles.<br>|
| Sham Comparator: Sham Extracorporeal Shock Waves<br>Sham focused shock waves delivered by an electromagnetic generator on the affected knee in three different positions. A total of 7000 pulses will be delivered on a weekly session for four weeks. A foam will be placed in the probe as to stop the energy to be transmitted to the patient's knee, so no focused shockwaves will be delivered. | Device: Sham Extracorporeal Shock Waves<br> <br> Other: Physical activities<br>* Patients receive instructions for physical activities for strengthening of femoral quadriceps and stretching of hamstring muscles.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Pain after one month | Mean change in Visual Analogue Scale (VAS) score one month after the end of the treatment compared to baseline. | One month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee pain progression | Mean change in VAS score one week after each application compared to baseline. | One week after each of four weekly ESWT applications | 
| Knee Pain after three months | Mean change in VAS score three months after the end of the treatment compared to baseline. | Three months | 
| Lequesne Knee Function progression | Mean change in Lequesne score one week after each application compared to baseline. | One week after each of four weekly ESWT applications | 
| Lequesne Knee Function after three months | Mean change in Lequesne three months after the end of the treatment compared to baseline. | Three months | 
| WOMAC Knee Function progression | Mean change in WOMAC score one week after each application compared to baseline. | One week after each of four weekly ESWT applications | 
| TUG Knee Function progression | Mean change in TUG score one week after each application compared to baseline. | One week after each of four weekly ESWT applications | 
| WOMAC Knee Function after three months | Mean change in WOMAC score three months after the end of the treatment compared to baseline. | Three months | 
| TUG Knee Function after three months | Mean change in TUG score three months after the end of the treatment compared to baseline. | Three months |