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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Copenhagen, Danemark, 2000
- The Parker Institute, Frederiksberg Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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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Comparateur actif: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Knee pain
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Knee pain
Délai: 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
|
Change from baseline to week 2 and week 26
|
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Knee symptoms
Délai: Change from baseline to week 2, 14, and 26
|
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
|
Change from baseline to week 2, 14, and 26
|
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Functional pain test
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chaise d'étude: Marius Henriksen, PhD, Frederiksberg University Hospital
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 101.04
- 2012-002607-18 (Numéro EudraCT)
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