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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
44
5,000 pulses of rESWT, with 0.16mJ/mm2 of energy at a frequency of 20Hz once a week for three weeks.
5,000 pulses of rESWT, with 0.0 mJ/mm2 of energy at a frequency of 20Hz once a week for three weeks.
Instituto de Medicina Fisica e Reabilitacao HCFMUSP
São Paulo, Brazil
Functional Change
Functional change from baseline, measured by KOOS.
Time frame: At baseline and three months after the end of the treatment.
Short Term Functional Changes
Functional change from baseline, measured by KOOS
Time frame: At baseline and one week after the end of the treatment.
Knee pain reduction
Knee pain changes from baseline, measured by KOOS
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: At baseline, one week and three months after the end of the treatment
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