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Study suspended due to Covid-19 pandemic.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active rESWT | Experimental | Application of 5,000 pulses of rESWT by a pneumatic generator, with 0.16mJ/mm2 (millijoule per squared millimeter) of energy at a frequency of 20Hz on the most painful spot of the knee. The applications will be given once a week for three weeks. |
|
| Sham rESWT | Sham Comparator | Application of 5,000 pulses of rESWT by a pneumatic generator, at a frequency of 20Hz on the most painful spot of the knee with 0 mJ/mm2 energy. The applications will also be given once a week for three weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active rESWT | Device | 5,000 pulses of rESWT, with 0.16mJ/mm2 of energy at a frequency of 20Hz once a week for three weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Functional Change | Functional change from baseline, measured by KOOS. | At baseline and three months after the end of the treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Short Term Functional Changes | Functional change from baseline, measured by KOOS | At baseline and one week after the end of the treatment. |
| Knee pain reduction | Knee pain changes from baseline, measured by KOOS |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marta Imamura, MD | Instituto de Medicina FÃsica e Reabilitação HCFMUSP | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto de Medicina Fisica e Reabilitacao HCFMUSP | São Paulo | 05716-150 | Brazil |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| Sham rESWT | Device | 5,000 pulses of rESWT, with 0.0 mJ/mm2 of energy at a frequency of 20Hz once a week for three weeks. |
|
| 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 | 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 | 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 | At baseline, one week and three months after the end of the treatment |
| D012216 |
| Rheumatic Diseases |