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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

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.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Device: repeated Muscle Vibration (rMV) (Cro ® System) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Treatment With rMV (Repeated Muscle Vibration) in Patients Affected by Knee Osteoarthritis: a Prospective Randomized Clinical Trial
Study Start Date : August 2012
Actual Primary Completion Date : December 2012
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01938131


Locations
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Italy
University Hospital "A. Gemelli", Catholic University of the Sacred Heart
Rome, Italy
Sponsors and Collaborators
Catholic University of the Sacred Heart

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Responsible Party: Carlo Bertolini, Principal Investigator, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier: NCT01938131     History of Changes
Other Study ID Numbers: 1346/2012
First Posted: September 10, 2013    Key Record Dates
Last Update Posted: September 10, 2013
Last Verified: September 2013

Keywords provided by Carlo Bertolini, Catholic University of the Sacred Heart:
knee, osteoarthritis, muscle vibration

Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases