The Efficacy of Radial Extracorporeal Shockwave Therapy on Knee Osteoarthritis

Study Overview
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Brief Summary
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This is a double-blind placebo controlled trial whose objective is to understand how much the radial extracorporeal shockwave therapy can improve function of patients with knee osteoarthritis. For this trial, patients with knee osteoarthritis, after signing the informed consent form and having their demographic and baseline information collected, will be randomly allocated into one of both treatment arms: radial extracorporeal shockwave therapy (rESWT) or sham radial extracorporeal shockwave therapy. Then, they will undertake three sessions of rESWT, for three weeks, i.e. one session per week. Patients will be assessed prior to the therapy, one week after the end of the therapy and three months after the end of the therapy, and the primary outcome of this study is the functional change measured by the Knee injury and Osteoarthritis Outcome Score (KOOS) validated in Portuguese, three months after the end of the therapy. Secondary outcomes, will be the change of pain, the change of pressure pain tolerance threshold, change in diffuse noxious inhibitory control (DNIC), and thermographic changes.

Official Title
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The Efficacy of Radial Extracorporeal Shockwave Therapy (RESWT) for Functional Improvement of Patients With Knee Osteoarthritis - A Double-blind Randomized Trial

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Device: Active rESWT
* Device: Sham rESWT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of knee osteoarthritis; Onset knee pain with moderate or severe intensity: Visual Analogue Scale (VAS) > 4; Onset knee pain over 3 months prior to the inclusion; Exclusion Criteria: Presence of psychiatric disease; Presence of fibromyalgia; Presence of systemic inflammatory rheumatic diseases; History of neoplasia; Presence of clinical diseases in other joints; Ongoing use of anticoagulant drugs.

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active rESWT<br>Application of 5,000 pulses of rESWT by a pneumatic generator, with 0.16mJ/mm2 (millijoule per squared millimeter) of energy at a frequency of 20Hz on the most painful spot of the knee. The applications will be given once a week for three weeks. | Device: Active rESWT<br>* 5,000 pulses of rESWT, with 0.16mJ/mm2 of energy at a frequency of 20Hz once a week for three weeks.<br>|
| Sham Comparator: Sham rESWT<br>Application of 5,000 pulses of rESWT by a pneumatic generator, at a frequency of 20Hz on the most painful spot of the knee with 0 mJ/mm2 energy. The applications will also be given once a week for three weeks. | Device: Sham rESWT<br>* 5,000 pulses of rESWT, with 0.0 mJ/mm2 of energy at a frequency of 20Hz once a week for three weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Change | Functional change from baseline, measured by KOOS. | At baseline and three months after the end of the treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short Term Functional Changes | Functional change from baseline, measured by KOOS | At baseline and one week after the end of the treatment. | 
| Knee pain reduction | Knee pain changes from baseline, measured by KOOS | At baseline, one week and three months after the end of the treatment | 
| Pain pressure threshold tolerance changes | Changes in pain pressure threshold tolerance over time, measured by algometer | At baseline, one week and three months after the end of the treatment | 
| Diffuse noxious inhibitory control alterations | Changes in diffuse noxious inhibitory control over time, measured by algometer | At baseline, one week and three months after the end of the treatment | 
| Thermography evaluation | Changes thermographic characteristics of lower limbs and knee over time, measured by Infrared Thermography | At baseline, one week and three months after the end of the treatment |