Unilateral Primary Osteoarthritis of Knee
Conditions
Brief 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.
Interventions
DEVICESham Extracorporeal Shock Waves
OTHERPhysical activities
Patients receive instructions for physical activities for strengthening of femoral quadriceps and stretching of hamstring muscles.
Sponsors
University of Sao Paulo General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Clinical and radiologic diagnosis of primary knee osteoarthritis (Kellgren & Lawrence I, II or III); * Capability to understand the Informed Consent Form; * Chronic pain for at least 3 months prior to inclusion, measured by VAS. (VAS 4 or above); * Absence of skin injures, infections or tumor in the target knee; * Availability to comply with the visits.
Exclusion criteria
* History of spinal cord stenosis or clinical symptoms of lumbar radiculopathy; * History or onset neurological diseases; * Generalized pain or fibromyalgia; * Inability to walk; * History of knee surgery in the target knee; * Secondary causes of osteoarthritis; * Use of statins and quinolones in the previous year; * Uncontrolled and ongoing psychiatric diseases; * Invasive knee treatments with hyaluronic acid infusion, corticosteroids and anaesthetics, in the target knee, up to 6 months previous to study inclusion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Knee Pain after one month | One month | Mean change in Visual Analogue Scale (VAS) score one month after the end of the treatment compared to baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Knee Pain after three months | Three months | Mean change in VAS score three months after the end of the treatment compared to baseline. |
| Lequesne Knee Function progression | One week after each of four weekly ESWT applications | Mean change in Lequesne score one week after each application compared to baseline. |
| Lequesne Knee Function after three months | Three months | Mean change in Lequesne three months after the end of the treatment compared to baseline. |
| Knee pain progression | One week after each of four weekly ESWT applications | Mean change in VAS score one week after each application compared to baseline. |
| TUG Knee Function progression | One week after each of four weekly ESWT applications | Mean change in TUG score one week after each application compared to baseline. |
| WOMAC Knee Function after three months | Three months | Mean change in WOMAC score three months after the end of the treatment compared to baseline. |
| TUG Knee Function after three months | Three months | Mean change in TUG score three months after the end of the treatment compared to baseline. |
| WOMAC Knee Function progression | One week after each of four weekly ESWT applications | Mean change in WOMAC score one week after each application compared to baseline. |
Countries
Brazil
Contacts
Primary ContactGilson T Shinzato, MD
Backup ContactFabíola Cavalieri, MD
Outcome results
None listed