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It is a double-blind randomized sham-controlled clinical trial to evaluate the effectiveness of resistive capacitive diathermy in subjects affected by knee osteoarthritis in comparison with a "sham" diathermy treatment. The resistive capacitive diathermy is a medical device supplying low (448 KHz) radiofrequencies with maximum output power of 200 W, used to reduce pain and inflammation and allowing healing processes. The sham diathermy treatment is administered with the device set on "on" but not active (not supplying energy). Each subject, randomly assigned to either resistive capacitive diathermy treatment (group 1) or sham-treatment (group 2) is submitted to a thirty minutes session, three times per week for a total of ten sessions. The outcome measures are the WOMAC scale (Western Ontario and McMaster Universities Arthritis Index) to assess pain and physical functioning, a visual analogic scale (VAS) for pain, the femoral quadriceps strength (MRC = Medical Research Council Scale). Outcome measures are administered at baseline (T0), at the end of the treatment protocol (T1), at 1 month (T2) and 3 months (T3) after the end of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| resistive capacitive diathermy | Experimental | in the resistive capacitive diathermy protocol patients are administered the resistive capacitive diathermy treatment for a thirty minutes session, three times per week for a total of ten sessions |
|
| sham placebo group | Sham Comparator | The sham treatment is administered with the resistive capacitive diathermy device set on "on" but not active (not supplying energy) with the same type of application, the same frequency and duration of experimental diathermy group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| resistive capacitive diathermy treatment (resistive capacitive diathermy, Hcr 902, Unibell) | Device | The resistive capacitive diathermy is a medical device supplying low (448 KHz) radiofrequencies with maximum output power of 200 W. It is used to reduce pain and inflammation and allowing healing processes. diathermy treatment is administered for a thirty minutes session, three times per week for a total of ten sessions. |
| Measure | Description | Time Frame |
|---|---|---|
| changing of the Western Ontario and McMaster Universities Arthritis Index WOMAC)scale | assessment of changing of pain and physical functioning in patients affected by osteoarthritis of lower limbs | baseline (T0), at the end of the treatment protocol (T1), at 1 month (T2) and 3 months (T3) after the end of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| changing of visual analogic scale (VAS) | assessment of changing of pain | baseline (T0), at the end of the treatment protocol (T1), at 1 month (T2) and 3 months (T3) after the end of treatment |
| MRC scale = Medical Research Council Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital "A. Gemelli", Catholic University of the Sacred Heart | Rome | Italy |
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| sham placebo resistive capacitive diathermy treatment | Other | The sham treatment is administered with the diathermy device set on "on" but not active (not supplying energy) and the treatment session has the same modalities, frequency and duration of experimental diathermy group |
|
assessment of changing of femoral quadriceps strength
| baseline (T0), at the end of the treatment protocol (T1), at 1 month (T2) and 3 months (T3) after the end of treatment |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D005334 | Fever |
| D010003 | Osteoarthritis |
| D010146 | Pain |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
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