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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Extracorporeal Shock Waves | Experimental | 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. |
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| Sham Extracorporeal Shock Waves | Sham Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extracorporeal Shock Waves | Device |
| ||
| Sham Extracorporeal Shock Waves |
| Measure | Description | Time Frame |
|---|---|---|
| Knee Pain after one month | Mean change in Visual Analogue Scale (VAS) score one month after the end of the treatment compared to baseline. | One month |
| Measure | Description | Time Frame |
|---|---|---|
| Knee pain progression | Mean change in VAS score one week after each application compared to baseline. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gilson T Shinzato, MD | Contact | 55-11-99688-0698 | g.shinzato@hc.fm.usp.br | |
| FabĂola Cavalieri, MD | Contact | 55-11-99212-3999 | fabiola.cavalieri@hc.fm.usp.br |
| Name | Affiliation | Role |
|---|---|---|
| Linamara R Battistella, PhD, MD | University of Sao Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro de Pesquisa ClĂnica do Instituto de Medicina FĂsica e Reabilitação do HCFMUSP | Recruiting | SĂŁo Paulo | SĂŁo Paulo | 04116-030 | Brazil |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Device |
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| Physical activities | Other | Patients receive instructions for physical activities for strengthening of femoral quadriceps and stretching of hamstring muscles. |
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| Three months |
| Lequesne Knee Function progression | Mean change in Lequesne score one week after each application compared to baseline. | 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. | Three months |
| WOMAC Knee Function progression | Mean change in WOMAC score one week after each application compared to baseline. | 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. | 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. | Three months |
| TUG Knee Function after three months | Mean change in TUG score three months after the end of the treatment compared to baseline. | Three months |