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

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
repeated Muscle Vibration (rMV) (Cro ® System)
Sponsored by
Catholic University of the Sacred Heart
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring knee, osteoarthritis, muscle vibration

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

placebo

repeated Muscle Vibration

Arm Description

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

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

Outcomes

Primary Outcome Measures

changing in patients' ability (as measured by WOMAC scale)
administration of WOMAC scale for patient's ability evaluation

Secondary Outcome Measures

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
assessment of changing of patients' quality of life (as measured by EQ-VAS)
administration of EQ-VAS scale for patient's pain evaluation

Full Information

First Posted
September 5, 2013
Last Updated
September 9, 2013
Sponsor
Catholic University of the Sacred Heart
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1. Study Identification

Unique Protocol Identification Number
NCT01938131
Brief Title
Study of Effectiveness of rMV (Repeated Muscle Vibration) in Knee Osteoarthritis
Official Title
Effectiveness of Treatment With rMV (Repeated Muscle Vibration) in Patients Affected by Knee Osteoarthritis: a Prospective Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Catholic University of the Sacred Heart

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
knee, osteoarthritis, muscle vibration

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
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
Arm Title
repeated Muscle Vibration
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
repeated Muscle Vibration (rMV) (Cro ® System)
Intervention Description
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
Primary Outcome Measure Information:
Title
changing in patients' ability (as measured by WOMAC scale)
Description
administration of WOMAC scale for patient's ability evaluation
Time Frame
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 Measure Information:
Title
assessment of changing of patients' balance and risk of falling (as measured by the Tinetti scale)
Description
administration of Tinetti scale for patient's balance and risk of falling evaluation
Time Frame
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
Title
assessment of changing of patients' quality of life (as measured by EQ-VAS)
Description
administration of EQ-VAS scale for patient's pain evaluation
Time Frame
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University Hospital "A. Gemelli", Catholic University of the Sacred Heart
City
Rome
Country
Italy

12. IPD Sharing Statement

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

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