Exercise and Steroid in Knee Osteoarthritis
Combined Intra Articular Corticosteroid and Physiotherapeutic Exercise in Patients With Osteoarthritis of the Knee: A Random-ised Clinical Trial
Osteoarthritis (OA) of the knee is a very common chronic joint disorder associated pain and disability. As no cure exists, management aims to reduce pain, improve function, and enhance quality of life. The recommended hierarchy of management should consist of exercise in first line, then the add-on of drugs if necessary, and ultimately, if necessary, surgery.
The effect size of exercise therapy is of the same magnitude as most pharmacological treatments but is often without adverse effects. Local pharmacological treatment of the afflicted knee joint is recommended by means of intra-articular injections of corticosteroids, which is considered as a standard medical treatment of knee OA and are included in established guidelines for management of knee OA. While the two treatment approaches have been investigated separately in numerous clinical trials, the efficacy of a combined pharmacological and non-pharmacological approach is not known, despite the high rank of such combined treatment approach on the recommended hierarchy of management.
The purpose of this study is to assess the effects of exercise therapy in combination with intra-articular corticosteroid injections on patient reported pain and function in patients with knee OA.
The hypothesis is that the combined treatment approach (exercise therapy preceded by intra-articular injection of corticosteroid) enhances the clinical outcome compared to exercise therapy preceded by a placebo injection.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Copenhagen, Dinamarca, 2000
- The Parker Institute, Frederiksberg Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- age 40 years or above
- clinical knee osteoarthritis verified by radiography
- pain during level walking of at least 40 mm on a 0-100 mm visual analog scale
- clinical signs of local inflammation
- body mass index between 20 and 35
Exclusion Criteria:
- Exercise therapy within 3 months
- Intraarticular corticosteroid within 3 months
- Counter indications to exercise
- Counter indications to corticosteroid
- pregnant or breast feeding
- Auto immune disease
- Planned surgery in the study period
- significant cardiovascular disease
- significant neuroloigal disease
- significant psychiatric disease
- regional pain syndromes (e.g. fibromyalgia)
- spinal nerve root compression syndromes
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Intraarticular steroid + Exercise
Intra-articular corticosteroid treatment with subsequent exercise therapy.
Exercise therapy is commenced 2 weeks after injection
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1 ml methylprednisolon corticosteroid (40 mg Depo-Medrol®) mixed with 4 ml Lidocain (10 mg/ml) without adrenalin.
Injections are done ultrasound guided.
The exercise is commenced 2 weeks after injection. The exercise includes a 10 minute warm up phase (ergometer bicycling) followed by strengthening and coordination exercises focusing on trunk, hip and knees. In case of pain or symptom exacerbation, a rescue exercise program is administered, excluding weight bearing activities. |
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Comparador activo: Intraarticular saline+Exercise
Combined intra-articular saline injection and subsequent exercise therapy.
Exercise therapy is commenced 2 weeks after injection
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The exercise is commenced 2 weeks after injection. The exercise includes a 10 minute warm up phase (ergometer bicycling) followed by strengthening and coordination exercises focusing on trunk, hip and knees. In case of pain or symptom exacerbation, a rescue exercise program is administered, excluding weight bearing activities.
1 ml isotonic saline mixed with 4 ml Lidocain (10 mg/ml) without adrenalin.
Injections are done ultrasound guided
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Knee pain
Periodo de tiempo: Change from baseline to week 14
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Self-reported pain assessed by the pain subdomain in the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire
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Change from baseline to week 14
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Knee pain
Periodo de tiempo: Change from baseline to week 2 and week 26
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Self-reported pain assessed by the pain subdomain in the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire
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Change from baseline to week 2 and week 26
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Knee symptoms
Periodo de tiempo: Change from baseline to week 2, 14, and 26
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Self-reported knee symptoms, knee related function, quality of life and, function during sports and recreation assessed by the pain subdomain in the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire
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Change from baseline to week 2, 14, and 26
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Functional pain test
Periodo de tiempo: Change from baseline to week 14, and 26
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Knee OA pain is associated with movement of the afflicted knee.
Therefore we assess pain intensity and movement tolerance during repeated squatting.
The test has 3 outcomes: 1) The number of pain free squatting movements that can be done in 30 seconds; 2) the number of painful squatting movements that can be done in 30 seconds; and 3) the average pain intensity during the squatting movements assessed on a 0-10 numeric rating scale.
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Change from baseline to week 14, and 26
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Knee Muscle strength
Periodo de tiempo: Change from baseline to week 14, and 26
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Assessed by an isokinetic dynamometer
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Change from baseline to week 14, and 26
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6 minute walk distance
Periodo de tiempo: Change from baseline to week 14, and 26
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The distance covered during 6 minutes of fast walking
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Change from baseline to week 14, and 26
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Systemic markers of inflammation in blood
Periodo de tiempo: Change from baseline to week 14, and 26
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Blood sample
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Change from baseline to week 14, and 26
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MRI based inflammation
Periodo de tiempo: Change from baseline to week 14, and 26
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To assess the severity and extent of local inflammation in the knee and surrounding tissues magnetic resonance imaging (MRI) are done before and after intravenous injection of a Gadolinium contrast agent.
Contrast agents are only administered to participants with normal kidney function assessed from a standard blood sample
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Change from baseline to week 14, and 26
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Marius Henriksen, PhD, Frederiksberg University Hospital
Publicaciones y enlaces útiles
Publicaciones Generales
- Dall CH, Andersen H, Povlsen TM, Henriksen M. Evaluation of a technology assisted physical activity intervention among hospitalised patients: A randomised study. Eur J Intern Med. 2019 Nov;69:50-56. doi: 10.1016/j.ejim.2019.08.019. Epub 2019 Sep 4.
- Bartholdy C, Klokker L, Bandak E, Bliddal H, Henriksen M. A Standardized "Rescue" Exercise Program for Symptomatic Flare-up of Knee Osteoarthritis: Description and Safety Considerations. J Orthop Sports Phys Ther. 2016 Nov;46(11):942-946. doi: 10.2519/jospt.2016.6908. Epub 2016 Sep 28.
- Henriksen M, Christensen R, Klokker L, Bartholdy C, Bandak E, Ellegaard K, Boesen MP, Riis RG, Bartels EM, Bliddal H. Evaluation of the benefit of corticosteroid injection before exercise therapy in patients with osteoarthritis of the knee: a randomized clinical trial. JAMA Intern Med. 2015 Jun;175(6):923-30. doi: 10.1001/jamainternmed.2015.0461.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 101.04
- 2012-002607-18 (Número EudraCT)
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