- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01938131
Study of Effectiveness of rMV (Repeated Muscle Vibration) in Knee Osteoarthritis
9. september 2013 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
60
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
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Rome, Italien
- University Hospital "A. Gemelli", Catholic University of the Sacred Heart
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / 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
|
|
|
Eksperimentel: 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
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. august 2012
Primær færdiggørelse (Faktiske)
1. december 2012
Studieafslutning (Faktiske)
1. januar 2013
Datoer for studieregistrering
Først indsendt
5. september 2013
Først indsendt, der opfyldte QC-kriterier
9. september 2013
Først opslået (Skøn)
10. september 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
10. september 2013
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
9. september 2013
Sidst verificeret
1. september 2013
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 1346/2012
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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