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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
30
Patients receive instructions for physical activities for strengthening of femoral quadriceps and stretching of hamstring muscles.
Centro de Pesquisa Clínica do Instituto de Medicina Física e Reabilitação do HCFMUSP
São Paulo, São Paulo, Brazil
RECRUITINGKnee Pain after one month
Mean change in Visual Analogue Scale (VAS) score one month after the end of the treatment compared to baseline.
Time frame: One month
Knee pain progression
Mean change in VAS score one week after each application compared to baseline.
Time frame: 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.
Time frame: Three months
Lequesne Knee Function progression
Mean change in Lequesne score one week after each application compared to baseline.
Time frame: 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.
Time frame: Three months
WOMAC Knee Function progression
Mean change in WOMAC score one week after each application compared to baseline.
Time frame: 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.
Time frame: One week after each of four weekly ESWT applications
WOMAC Knee Function after three months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Mean change in WOMAC score three months after the end of the treatment compared to baseline.
Time frame: Three months
TUG Knee Function after three months
Mean change in TUG score three months after the end of the treatment compared to baseline.
Time frame: Three months