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

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01938131
• Other study ID #: 1346/2012
• Status: Completed
• Phase: N/A
• First received: September 5, 2013
• Last updated: September 9, 2013
• Start date: August 2012
• Est. completion date: January 2013

Study information

• Verified date: September 2013
• Source: Catholic University of the Sacred Heart
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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

Locations

Country	Name	City	State
Italy	University Hospital "A. Gemelli", Catholic University of the Sacred Heart	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Catholic University of the Sacred Heart

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No