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

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

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.

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Device: repeated Muscle Vibration (rMV) (Cro ® System)

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Rome, Italy
    • University Hospital "A. Gemelli", Catholic University of the Sacred Heart

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo; 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; 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); 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Catholic University of the Sacred Heart

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: September 5, 2013
• First Submitted That Met QC Criteria: September 9, 2013
• First Posted (Estimate): September 10, 2013

Study Record Updates

• Last Update Posted (Estimate): September 10, 2013
• Last Update Submitted That Met QC Criteria: September 9, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: knee, osteoarthritis, muscle vibration
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 1346/2012