Study of Effectiveness of rMV (Repeated Muscle Vibration) in Knee Osteoarthritis

Study Overview
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Brief Summary
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The rehabilitation protocols in knee osteoarthritis are often difficult to be applied in elderly patients because they are long lasting and need the constant participation of patients. To rapidly improve the motor performances of patients it is possible to use the mechanical vibration applied to individual muscles using a protocol called repeated muscle vibration (rMV). The purpose of this single-blind randomized placebo-controlled study is to evaluate the effectiveness of the repeated muscle vibration (rMV) in terms of increasing the ability of the patients affected by knee osteoarthritis, compared to an ineffective treatment, considered as a placebo. Each subject, randomly assigned to either the group 1 (study group) or placebo-treatment (group 2)is administered 3 daily applications of rMV of 10 minutes each, for 3 consecutive days. Between two successive applications it's observed a break of at least 15 seconds. The probe of the specific instrument (Cro ® System) is placed near the supero-medial margin of the patella, on both quadriceps. Patients in group 2 (control group) are subjected to a treatment with muscle released in which the probe of the same instrument is approached to the quadriceps, without making contact. The instrument in these conditions emits a buzz but not provokes muscle vibration. The primary outcome of the study is to determine the changing in patients' ability (as measured by WOMAC scale = Western Ontario and McMaster Universities Osteoarthritis Index) . The secondary outcomes of the study are the assessment of changing of patients' balance and risk of falling (as measured by the Tinetti scale) and assessment of changing of patients' quality of life (as measured by EQ-VAS= EuroQuality of Life-VAS scale).Outcome measures are administered at baseline (T0), at the end of the treatment protocol (T1), at 1 month (T2), 3 months (T3) after the end of treatment and 6 months (T4) after the end of the treatment.

Official Title
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Effectiveness of Treatment With rMV (Repeated Muscle Vibration) in Patients Affected by Knee Osteoarthritis: a Prospective Randomized Clinical Trial

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Device: repeated Muscle Vibration (rMV) (Cro ® System)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Knee Osteoarthritis Exclusion Criteria: Neurologic disease involving the lower limbs or causing balance problems Systemic inflammatory diseases Diabetic Neuropathy Severe heart disease. Acute infections or bone Tuberculosis Prosthetic lower limbs History of surgery on the affected knee in the last year History of cancer Cognitive impairment

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 |
| --- | --- |
| Placebo Comparator: placebo<br>Patients in this group will be subjected to a treatment with muscle released in which the probe of CroSystem instrument will be approached to the quadriceps, without making contact. The instrument in these conditions emits a buzz but not provokes muscle vibration | |
| Experimental: repeated Muscle Vibration<br>The patients will be subjected to 3 daily applications of rMV of 10 minutes each, for 3 consecutive days. Between two successive applications will be observed a break of at least 15 seconds. The probe of the specific instrument (Cro ® System) will be placed near the supero-medial margin of the patella, on both quadriceps | Device: repeated Muscle Vibration (rMV) (Cro ® System)<br>* The patients will be subjected to 3 daily applications of rMV of 10 minutes each, for 3 consecutive days. Between two successive applications will be observed a break of at least 15 seconds. The probe of the specific instrument (Cro ® System) will be placed near the supero-medial margin of the patella, on both quadriceps<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changing in patients' ability (as measured by WOMAC scale) | administration of WOMAC scale for patient's ability evaluation | baseline (T0), at the end of the treatment protocol (T1), at 1 month (T2), 3 months (T3) after the end of treatment, 6 months (T4) after the end of the treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assessment of changing of patients' balance and risk of falling (as measured by the Tinetti scale) | administration of Tinetti scale for patient's balance and risk of falling evaluation | baseline (T0), at the end of the treatment protocol (T1), at 1 month (T2), 3 months (T3) after the end of treatment, 6 months (T4) after the end of the treatment | 
| assessment of changing of patients' quality of life (as measured by EQ-VAS) | administration of EQ-VAS scale for patient's pain evaluation | baseline (T0), at the end of the treatment protocol (T1), at 1 month (T2), 3 months (T3) after the end of treatment, 6 months (T4) after the end of the treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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knee, osteoarthritis, muscle vibration