- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01938131
Study of Effectiveness of rMV (Repeated Muscle Vibration) in Knee Osteoarthritis
9. september 2013 oppdatert 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
60
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
-
Rome, Italia
- University Hospital "A. Gemelli", Catholic University of the Sacred Heart
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-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Placebo komparator: 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
|
|
|
Eksperimentell: 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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
changing in patients' ability (as measured by WOMAC scale)
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
assessment of changing of patients' balance and risk of falling (as measured by the Tinetti scale)
Tidsramme: 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)
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
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Studierekorddatoer
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Studer hoveddatoer
Studiestart
1. august 2012
Primær fullføring (Faktiske)
1. desember 2012
Studiet fullført (Faktiske)
1. januar 2013
Datoer for studieregistrering
Først innsendt
5. september 2013
Først innsendt som oppfylte QC-kriteriene
9. september 2013
Først lagt ut (Anslag)
10. september 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
10. september 2013
Siste oppdatering sendt inn som oppfylte QC-kriteriene
9. september 2013
Sist bekreftet
1. september 2013
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 1346/2012
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