Effectiveness of Resistive Capacitive Diathermy in Patients Affected by Knee Osteoarthritis

Study Overview
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Brief Summary
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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.

Official Title
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The Effectiveness of Resistive Capacitive Diathermy in Patients Affected by Knee Osteoarthritis: a Sham-controlled Study

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Device: resistive capacitive diathermy treatment (resistive capacitive diathermy, Hcr 902, Unibell)
* Other: sham placebo resistive capacitive diathermy treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients affected by Knee osteoarthritis established by clinical examination and X-ray in postero-anterior and lateral views Exclusion Criteria: Neurologic Disorders involving the lower limbs Systemic inflammatory disorders pace-maker implantation Severe heart disease Acute infections or bone tuberculosis Acute skin diseases History of surgery on the affected knee Cognitive or psychiatric disorders

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: resistive capacitive diathermy<br>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 | Device: resistive capacitive diathermy treatment (resistive capacitive diathermy, Hcr 902, Unibell)<br>* 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.<br>|
| Sham Comparator: sham placebo group<br>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 | Other: sham placebo resistive capacitive diathermy treatment<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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physical therapy, diathermy, knee, osteoarthritis, pain, physical function