A Phase 2 interventional study of Extracorporeal Shock Waves and Sham Extracorporeal Shock Waves in Unilateral Primary Osteoarthritis of Knee, sponsored by University of Sao Paulo General Hospital. Status unknown at 1 site in Brazil. Open to participants aged 45 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-09-19.
Sponsored by University of Sao Paulo General Hospital · Phase 2, Interventional, and Treatment
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.
University of Sao Paulo General Hospital is the lead sponsor of 608 studies on the registry; 97 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Focused shock waves delivered by an electromagnetic generator with a focus of 5.0cm deep on the affected knee in three different positions. A total of 7000 pulses will be delivered on a weekly session for four weeks.
Device: Extracorporeal Shock Waves · Other: Physical activities
Sham focused shock waves delivered by an electromagnetic generator on the affected knee in three different positions. A total of 7000 pulses will be delivered on a weekly session for four weeks. A foam will be placed in the probe as to stop the energy to be transmitted to the patient's knee, so no focused shockwaves will be delivered.
Device: Sham Extracorporeal Shock Waves · Other: Physical activities
Patients receive instructions for physical activities for strengthening of femoral quadriceps and stretching of hamstring muscles.
Knee 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
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
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Sao Paulo General Hospital →