Extracorporeal Focused Shock Wave Therapy for Primary Knee Osteoarthritis
13 september 2016 uppdaterad av: Linamara Rizzo Battistella, MD PhD, University of Sao Paulo General Hospital
The Efficacy of Extracorporeal Focused Shock Wave Therapy for Patients With Primary Knee Osteoarthritis
The purpose of this study is to determine whether Extracorporeal Focused Shock Wave Therapy reduces knee pain and enhance function in patients with primary knee osteoarthritis.
Studieöversikt
Status
Okänd
Betingelser
Intervention / Behandling
Detaljerad beskrivning
This study is a placebo controlled Randomized Clinical Trial (RCT) in which the primary outcome is to determine whether Extracorporeal Focused Shock Wave Therapy (ESWT) reduces knee pain comparing the VAS at baseline and one month after the end of the treatment. Function assessment and progression of pain along the treatment are the secondary outcomes. Function will be assessed with the Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC), the Lequesne's Algofunctional Questionnaire for Osteoarthritis of Knee (Lequesne) and the Timed up and Go (TUG).
The ESWT applications will be performed once a week for four consecutive weeks, the patients will be assessed for pain and function before the beginning of the treatment and one week after every application of the ESWT.
The treatment groups will be randomized. The allocation of the patients is sealed and will not be disclosed to the patients nor to the evaluators.
Studietyp
Interventionell
Inskrivning (Förväntat)
30
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Sao Paulo, Brasilien, 04116-030
- Rekrytering
- Centro de Pesquisa Clínica do Instituto de Medicina Física e Reabilitação do HCFMUSP
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Kontakt:
- Fabíola Cavalieri, MD
- Telefonnummer: 55-11-99212-3999
- E-post: fabiola.cavalieri@hc.fm.usp.br
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Kontakt:
- Artur C Santos
- Telefonnummer: 55-11-5180-7897
- E-post: artur.santos@hc.fm.usp.br
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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
45 år till 80 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Clinical and radiologic diagnosis of primary knee osteoarthritis (Kellgren & Lawrence I, II or III);
- Capability to understand the Informed Consent Form;
- Chronic pain for at least 3 months prior to inclusion, measured by VAS. (VAS 4 or above);
- Absence of skin injures, infections or tumor in the target knee;
- Availability to comply with the visits.
Exclusion Criteria:
- History of spinal cord stenosis or clinical symptoms of lumbar radiculopathy;
- History or onset neurological diseases;
- Generalized pain or fibromyalgia;
- Inability to walk;
- History of knee surgery in the target knee;
- Secondary causes of osteoarthritis;
- Use of statins and quinolones in the previous year;
- Uncontrolled and ongoing psychiatric diseases;
- Invasive knee treatments with hyaluronic acid infusion, corticosteroids and anaesthetics, in the target knee, up to 6 months previous to study inclusion.
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 |
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Experimentell: Extracorporeal Shock Waves
Focused shock waves delivered by an electromagnetic generator with a focus of 5.0cm deep on the affected knee in three different positions.
A total of 7000 pulses will be delivered on a weekly session for four weeks.
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Patients receive instructions for physical activities for strengthening of femoral quadriceps and stretching of hamstring muscles.
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Sham Comparator: Sham Extracorporeal Shock Waves
Sham focused shock waves delivered by an electromagnetic generator on the affected knee in three different positions.
A total of 7000 pulses will be delivered on a weekly session for four weeks.
A foam will be placed in the probe as to stop the energy to be transmitted to the patient's knee, so no focused shockwaves will be delivered.
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Patients receive instructions for physical activities for strengthening of femoral quadriceps and stretching of hamstring muscles.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Knee Pain after one month
Tidsram: One month
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Mean change in Visual Analogue Scale (VAS) score one month after the end of the treatment compared to baseline.
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One month
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Knee pain progression
Tidsram: One week after each of four weekly ESWT applications
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Mean change in VAS score one week after each application compared to baseline.
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One week after each of four weekly ESWT applications
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Knee Pain after three months
Tidsram: Three months
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Mean change in VAS score three months after the end of the treatment compared to baseline.
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Three months
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Lequesne Knee Function progression
Tidsram: One week after each of four weekly ESWT applications
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Mean change in Lequesne score one week after each application compared to baseline.
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One week after each of four weekly ESWT applications
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Lequesne Knee Function after three months
Tidsram: Three months
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Mean change in Lequesne three months after the end of the treatment compared to baseline.
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Three months
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WOMAC Knee Function progression
Tidsram: One week after each of four weekly ESWT applications
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Mean change in WOMAC score one week after each application compared to baseline.
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One week after each of four weekly ESWT applications
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TUG Knee Function progression
Tidsram: One week after each of four weekly ESWT applications
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Mean change in TUG score one week after each application compared to baseline.
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One week after each of four weekly ESWT applications
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WOMAC Knee Function after three months
Tidsram: Three months
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Mean change in WOMAC score three months after the end of the treatment compared to baseline.
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Three months
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TUG Knee Function after three months
Tidsram: Three months
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Mean change in TUG score three months after the end of the treatment compared to baseline.
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Three months
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Linamara R Battistella, PhD, MD, University of Sao Paulo
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 maj 2016
Primärt slutförande (Förväntat)
1 oktober 2016
Avslutad studie (Förväntat)
1 december 2016
Studieregistreringsdatum
Först inskickad
29 juni 2016
Först inskickad som uppfyllde QC-kriterierna
13 september 2016
Första postat (Uppskatta)
19 september 2016
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
19 september 2016
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
13 september 2016
Senast verifierad
1 september 2016
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 54013616.1.0000.0068
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
OBESLUTSAM
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