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

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ClinicalTrials.gov Identifier: NCT01938131
Recruitment Status : Completed
First Posted : September 10, 2013
Last Update Posted : September 10, 2013
Sponsor:
Information provided by (Responsible Party):
Carlo Bertolini, Catholic University of the Sacred Heart

Tracking Information
First Submitted Date  ICMJE September 5, 2013
First Posted Date  ICMJE September 10, 2013
Last Update Posted Date September 10, 2013
Study Start Date  ICMJE August 2012
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 9, 2013)
changing in patients' ability (as measured by WOMAC scale) [ 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 ]
administration of WOMAC scale for patient's ability evaluation
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 9, 2013)
  • assessment of changing of patients' balance and risk of falling (as measured by the Tinetti scale) [ 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 ]
    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) [ 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 ]
    administration of EQ-VAS scale for patient's pain evaluation
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Effectiveness of rMV (Repeated Muscle Vibration) in Knee Osteoarthritis
Official Title  ICMJE Effectiveness of Treatment With rMV (Repeated Muscle Vibration) in Patients Affected by Knee Osteoarthritis: a Prospective Randomized Clinical Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Knee Osteoarthritis
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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
    Intervention: Device: repeated Muscle Vibration (rMV) (Cro ® System)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 9, 2013)
60
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2013
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01938131
Other Study ID Numbers  ICMJE 1346/2012
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Carlo Bertolini, Catholic University of the Sacred Heart
Study Sponsor  ICMJE Catholic University of the Sacred Heart
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Catholic University of the Sacred Heart
Verification Date September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP