NCT02904785

Extracorporeal Focused Shock Wave Therapy for Primary Knee Osteoarthritis

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University of Sao Paulo General Hospital · Academic / Other
• Sex: All
• Age: 45 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Unilateral Primary Osteoarthritis of Knee

Interventions

Type	Name	Description
DEVICE	Extracorporeal Shock Waves
DEVICE	Sham Extracorporeal Shock Waves
OTHER	Physical activities	Patients receive instructions for physical activities for strengthening of femoral quadriceps and stretching of hamstring muscles.

Timeline

• Start date: 2016-05-01
• Primary completion: 2016-10-01
• Completion: 2016-12-01
• First posted: 2016-09-19
• Last updated: 2016-09-19

Locations

1 site across 1 country: Brazil