Efficacy of Radial Shockwave Therapy for Treatment of Pain in Knee Osteoarthritis
4 de octubre de 2016 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
- 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.
Tipo de estudio
Intervencionista
Inscripción (Actual)
105
Fase
- Fase 2
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Sao Paulo, Brasil, 05716-150
- Instituto de Medicina Fisica e Reabilitacao HCFMUSP
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Sao Paulo, Brasil, 05403-010
- Instituto de Ortopedia e Traumatologia HCFMUSP
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
60 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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.
|
|
Comparador de placebos: 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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Visual Analog Scale
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Level of tolerance of pain
Periodo de tiempo: Immediately before the intervention, immediately after the intervention and 3 months after the intervention.
|
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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Otras medidas de resultado
Medida de resultado |
Periodo de tiempo |
|---|---|
|
The influence of pain over the functional capacity of patients based on the WOMAC questionnaire
Periodo de tiempo: Immediately before the intervention and 3 months after the intervention.
|
Immediately before the intervention and 3 months after the intervention.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de mayo de 2010
Finalización primaria (Actual)
1 de diciembre de 2015
Finalización del estudio (Actual)
1 de diciembre de 2015
Fechas de registro del estudio
Enviado por primera vez
17 de julio de 2014
Primero enviado que cumplió con los criterios de control de calidad
21 de julio de 2014
Publicado por primera vez (Estimar)
23 de julio de 2014
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
5 de octubre de 2016
Última actualización enviada que cumplió con los criterios de control de calidad
4 de octubre de 2016
Última verificación
1 de octubre de 2016
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Radial Shockwave
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
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