Unilateral Primary Osteoarthritis of Knee Clinical Trial
Official title:
The Efficacy of Extracorporeal Focused Shock Wave Therapy for Patients With Primary Knee Osteoarthritis
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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