Efficacy of Radial Shockwave Therapy for Treatment of Pain in Knee Osteoarthritis
4 oktober 2016 bijgewerkt door: Marta Imamura
The objective of this study is to compare the results of 2000 impulses of radius shockwaves per week with 2000 placebo shockwaves on the treatment of pain and functional incapacity of patients with severe primary knee osteoarthritis, who did not satisfactory respond to previous conventional treatments.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
- Prospective, placebo controlled randomized and double-blind study.
- Treatment Method:
Radial extracorporeal shockwaves will be applied using the Swiss Dolorclast (EMS Electro Medical Systems, Switzerland), generated by pneumatic waves.
Intervention:
- Group 1 - Intervention group Patients will receive 2,000 impulses of radial shockwave per week, with pressure of 2.5bar to 4.0bar, at the frequency of 8Hz. The impulses will be applied at the most painful site of the knee joint interface on manual palpation, for three consecutive weeks.
- Group 2 - Control Group:
Patients will receive 2,000 impulses of placebo radial shockwave per week, without any energy flow intensity. Frequency of 8Hz will appear in the screen. The impulses will be applied at the most painful site of the knee joint interface on manual palpation, for three consecutive weeks.
Post application program for both groups: Three consecutive days of:
- Hot packs (superficial heat) applied on the application site for 20 minutes;
- Simple analgesics, when needed (Acetaminophen 500mg every 6 hours, or analogue in case of allergy).
Outcome Evaluation:
The evaluation of pain intensity will be done according to the VAS (Visual Analog Scale) The influence of pain on the functional capacity of patients will be measured with WOMAC (Western Ontario and McMaster Osteoarthritis Index) for knee evaluation.
Another evaluation criteria will be the level of tolerance of pressure on several muscles and other parts as the pes anserinus and patellar tendon, the knee joint interface, and the supraspinal of L1 to S1 also on the dermatomal from T12 to S2. These measures will be done by the Fisher algometry.
The evaluations will be carried out before the treatment, immediately after the treatment and 3 months after the end of the treatment.
Analgesia drut will be prescribed, if patients feel pain during the days after the application.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
105
Fase
- Fase 2
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Sao Paulo, Brazilië, 05716-150
- Instituto de Medicina Fisica e Reabilitacao HCFMUSP
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Sao Paulo, Brazilië, 05403-010
- Instituto de Ortopedia e Traumatologia HCFMUSP
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
60 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- Clinical and radiological diagnosis of primary knee diagnosis.
- Pain intensity: Visual Analog Scale (VAS) ≥ 6;
- One of more failures with conventional treatment (drugs, Non-Steroidal Anti-inflammatory Drugs - NSAD, physiotherapy, stretching, acupuncture, orthosis and others);
- Age over 60 years;
- No use of corticosteroids in the prior 48 hours;
- No major osteoarthritis events in other joints of lower limbs (waist and ankle) and lower back;
- No clinical evidence of related neuropathy, including radiculopathy and peripheral neuropathy;
- Absence of systemic inflammatory disease (Rheumatoid arthritis, Reiter, ankylosing spondylitis, generalized polyarthritis, cancer);
- Absence of infection or cancer at the application site;
- Absence of related endocrine and metabolic diseases;
- Absence of fibromyalgia, diagnosed after the American College of Rheumatology, 1999;
- Absence of severe blood dyscrasias;
- Absence of severe psychiatric disturbances that requires psychiatric assessment;
- Availability to comply with the clinic visits and follow up evaluations along the treatment
Exclusion Criteria:
- Patients who withdraw the informed consent form at any time
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verdrievoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Extracorporeal radial shockwaves
Patients will receive 2,000 impulses of extracorporeal radial shockwave per week, with pressure of 2.5bar to 4.0bar, at the frequency of 8Hz.
The impulses will be applied at the most painful site of the knee joint interface on manual palpation, for three consecutive weeks.
|
Patients will receive 2,000 impulses of extracorporeal radial shockwaves or per week, with pressure of 2.5bar to 4.0bar, at the frequency of 8Hz.
The impulses will be applied at the most painful site of the knee joint interface on manual palpation, for three consecutive weeks.
|
|
Placebo-vergelijker: Placebo Radial Shockwaves
Patients will receive 2,000 impulses of placebo radial shockwave per week, without any energy flow intensity.
Frequency of 8Hz will appear in the screen.
The impulses will be applied at the most painful site of the knee joint interface on manual palpation, for three consecutive weeks.
|
Patients will receive 2,000 impulses of placebo extracorporeal radial shockwaves per week, without any pressure, therefore no energy will be applied, at the frequency of 8Hz.
The impulses will be applied at the most painful site of the knee joint interface on manual palpation, for three consecutive weeks.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Visual Analog Scale
Tijdsspanne: Before intervention and after 3 months of the end of intervention
|
The Visual Analog Scale consists of a straight line of 10cm length which presents the phrase "absence of pain" (0) at one extremity, and unbearable pain (10) at the other extremity.
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Before intervention and after 3 months of the end of intervention
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Level of tolerance of pain
Tijdsspanne: Immediately before the intervention, immediately after the intervention and 3 months after the intervention.
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Measures will be taken with the Fisher algometry in the following muscles: vastus medialis, vastus lateralis, rectus femoris, gracilis, adductor longus, tibialis anterior, fibularis longus, quadratus lumborum, iliopsoas and popliteus; also at the pes anserinus and patellar tendon, the knee joint interface, the supraspinal of L1 to S1 and on the dermatomal from T12 to S2.
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Immediately before the intervention, immediately after the intervention and 3 months after the intervention.
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Andere uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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The influence of pain over the functional capacity of patients based on the WOMAC questionnaire
Tijdsspanne: Immediately before the intervention and 3 months after the intervention.
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Immediately before the intervention and 3 months after the intervention.
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Medewerkers
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 mei 2010
Primaire voltooiing (Werkelijk)
1 december 2015
Studie voltooiing (Werkelijk)
1 december 2015
Studieregistratiedata
Eerst ingediend
17 juli 2014
Eerst ingediend dat voldeed aan de QC-criteria
21 juli 2014
Eerst geplaatst (Schatting)
23 juli 2014
Updates van studierecords
Laatste update geplaatst (Schatting)
5 oktober 2016
Laatste update ingediend die voldeed aan QC-criteria
4 oktober 2016
Laatst geverifieerd
1 oktober 2016
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- Radial Shockwave
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
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