- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01938131
Study of Effectiveness of rMV (Repeated Muscle Vibration) in Knee Osteoarthritis
9 september 2013 uppdaterad av: Carlo Bertolini, Catholic University of the Sacred Heart
Effectiveness of Treatment With rMV (Repeated Muscle Vibration) in Patients Affected by Knee Osteoarthritis: a Prospective Randomized Clinical Trial
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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
60
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
-
Rome, Italien
- University Hospital "A. Gemelli", Catholic University of the Sacred Heart
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Placebo-jämförare: 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
|
|
|
Experimentell: 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
|
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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
changing in patients' ability (as measured by WOMAC scale)
Tidsram: 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
|
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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
assessment of changing of patients' balance and risk of falling (as measured by the Tinetti scale)
Tidsram: 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
|
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
|
|
assessment of changing of patients' quality of life (as measured by EQ-VAS)
Tidsram: 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
|
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
|
Samarbetspartners och utredare
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Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 augusti 2012
Primärt slutförande (Faktisk)
1 december 2012
Avslutad studie (Faktisk)
1 januari 2013
Studieregistreringsdatum
Först inskickad
5 september 2013
Först inskickad som uppfyllde QC-kriterierna
9 september 2013
Första postat (Uppskatta)
10 september 2013
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
10 september 2013
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
9 september 2013
Senast verifierad
1 september 2013
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 1346/2012
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