Clinical trial NCT01938131: 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
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: knee, osteoarthritis, muscle vibration
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
First posted: 2013-09-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: changing in patients' ability (as measured by WOMAC scale)
timeFrame: 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 outcomes:
measure: assessment of changing of patients' balance and risk of falling (as measured by the Tinetti scale)
timeFrame: 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
measure: assessment of changing of patients' quality of life (as measured by EQ-VAS)
timeFrame: 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
Other outcomes:
Locations:
city: Rome
country: Italy
facility: University Hospital "A. Gemelli", Catholic University of the Sacred Heart
Study officials:
References: