Incorporation of Photobiomodulation Therapy in an Exercise Program With Blood Flow Restriction for Knee Osteoarthritis
29 janvier 2020 mis à jour par: Cid André Fidelis de Paula Gomes, University of Nove de Julho
Knee osteoarthritis (OA) is one of the most common musculoskeletal disorders in the world.
The aim of this project is to evaluate the additional effect of photobiomodulation therapy on the quadriceps muscle and knee joint in a blood flow restriction exercise program for individuals with knee OA.
To this end, volunteers will be selected at random, aged between 40 and 65 years with pain in one knee, at least in the last 6 months, diagnosed with unilateral knee OA based on the criteria established by the American College of Rheumatology and radiographic confirmation for grades 2 or 3 of the Kellgren-Lawrence Classification, will be randomized into the following groups: (Exercises with blood flow restriction, n = 20), (Exercises with blood flow restriction + photobiomodulation, n = 20) and Exercises with blood flow restriction + placebo photobiomodulation (n = 20).
12 consecutive weeks of treatment will be carried out, with the volunteers being evaluated before and after, using the following instruments: The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), sit and stand test, Timed up and Go (TUG), numerical scale pain assessment (END), pain-to-pressure threshold (LDP), skin temperature: quadriceps musculature, knee joint and maximum voluntary isometric contraction (MVIC) of the muscles: quadriceps, middle gluteus.
For data analysis, normality test will be used to verify the data distribution and statistical test consistent with the appropriate comparisons within and between groups, thus, two factors are considered in the comparisons, time and group.
A significance level of 5% will be adopted.
Aperçu de l'étude
Statut
Inconnue
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Anticipé)
60
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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São Paulo, Brésil, 01504-001
- University of Nove de Julho
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
40 ans à 65 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Femelle
La description
Inclusion Criteria:
- knee pain to at least six months and minimum of 4 points in pain scale
- diagnosis of unilateral knee OA based on criteria established by the American College of Rheumatology and radiographic confirmation for grades 2 or 3 of the Kellgren-Lawrence Classification.
Exclusion Criteria:
- Score on the numerical visual analog of knee pain less than 1 or greater than 8;
- knee trauma;
- Cognitive impairment;
- Psychological disorder;
- Neurological disorder (sensory or motor);
- Cancer;
- Diabetes any acute adverse health condition;
- Signs of hip OA;
- Sings cardiopulmonary disease that could prevent exercise and use of a walking assist device.
- Have undergone any form of treatment involving: physiotherapy, intra-articular corticosteroids, anti-inflammatories or chondroprotectors in the last year.
- If the size of the circumference of the thigh and knee does not allow the proper positioning of the photobiomodulation mesh.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Comparateur actif: Exercises with blood flow restriction
Exercise: 10 minutes of heating on a treadmill without changing the inclination and adopting a standardized speed; Supine bridge, Supine unilateral bridge, Flexion of the hip with the knee extended, Knee extension, volunteer in sedation; Prone knee flexion; Squat on the wall associated with isometric contraction; Abduction of the hip, lateral rotation and knee extension in lateral decubitus associated with isometric contraction; Abduction, lateral rotation of the hip, slight knee and hip flexion performing abduction with the feet together: associated with isometric contraction; Abduction of the hip in orthostatic associated with isometric contraction.Device: The blood flow restriction in mmHg will be performed using a vascular occlusion training manometer, positioned in the thigh inguinal region and inflated to the point where the auscultatory pulse of the tibial artery is interrupted.
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Occlusion training is an exercise approach whereby resistance exercise or aerobic exercise is performed whilst an occlusion cuff is applied to proximal aspect of the muscle.
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Expérimental: Exercises with blood flow restriction + photobiomodulation
Exercise: 10 minutes of heating on a treadmill without changing the inclination and adopting a standardized speed; Supine bridge, Supine unilateral bridge, Flexion of the hip with the knee extended, Knee extension, volunteer in sedation; Prone knee flexion; Squat on the wall associated with isometric contraction; Abduction of the hip, lateral rotation and knee extension in lateral decubitus associated with isometric contraction; Abduction, lateral rotation of the hip, slight knee and hip flexion performing abduction with the feet together: associated with isometric contraction; Abduction of the hip in orthostatic associated with isometric contraction.Devices: The blood flow restriction in mmHg will be performed using a vascular occlusion training manometer, positioned in the thigh inguinal region and inflated to the point where the auscultatory pulse of the tibial artery is interrupted.Photobiomodulation a mesh composed of multiple diodes containing 50 Infrared LEDs.
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Occlusion training is an exercise approach whereby resistance exercise or aerobic exercise is performed whilst an occlusion cuff is applied to proximal aspect of the muscle.
Photobiomodulation therapy is defined as the utilization of non-ionizing electromagnetic energy to trigger photochemical changes within cellular structures that are receptive to photons.
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Comparateur placebo: Blood flow restriction exercises + placebo photobiomodulation
Exercise: 10 minutes of heating on a treadmill without changing the inclination and adopting a standardized speed; Supine bridge, Supine unilateral bridge, Flexion of the hip with the knee extended, Knee extension, volunteer in sedation; Prone knee flexion; Squat on the wall associated with isometric contraction; Abduction of the hip, lateral rotation and knee extension in lateral decubitus associated with isometric contraction; Abduction, lateral rotation of the hip, slight knee and hip flexion performing abduction with the feet together: associated with isometric contraction; Abduction of the hip in orthostatic associated with isometric contraction.Devices: The blood flow restriction in mmHg will be performed using a vascular occlusion training manometer, positioned in the thigh inguinal region and inflated to the point where the auscultatory pulse of the tibial artery is interrupted.
Photobiomodulation turned off with a mesh composed of multiple diodes containing 50 Infrared LEDs.
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Occlusion training is an exercise approach whereby resistance exercise or aerobic exercise is performed whilst an occlusion cuff is applied to proximal aspect of the muscle.
Placebo photobiomodulation - photobiomodulation device turned off.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Functional pain
Délai: Change from Baseline in The Western Ontario and McMaster Universities Arthritis Index at 12 weeks
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The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation Knee Osteoarthritis.
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Change from Baseline in The Western Ontario and McMaster Universities Arthritis Index at 12 weeks
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Stiffness
Délai: Time Frame: Change from Baseline in The Western Ontario and McMaster Universities Arthritis Index at 12 weeks
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The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation Knee Osteoarthritis.
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Time Frame: Change from Baseline in The Western Ontario and McMaster Universities Arthritis Index at 12 weeks
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Physical functional
Délai: Change from Baseline in The Western Ontario and McMaster Universities Arthritis Index at 12 weeks
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The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation Knee Osteoarthritis.
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Change from Baseline in The Western Ontario and McMaster Universities Arthritis Index at 12 weeks
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Intensity of pain
Délai: Change from Baseline in The Numerical rating pain scale at 12 weeks
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The Numerical rating pain scale, a simple, easily administered scale evaluates the perceived intensity of pain, using an 11-point scale from 0, representing 'no pain', to 10, which is the 'worst possible pain'.
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Change from Baseline in The Numerical rating pain scale at 12 weeks
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Functional capacity for sitting and standing
Délai: Change from Baseline in The Functional capacity for sitting and standing at 12 weeks
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sitting-rising test
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Change from Baseline in The Functional capacity for sitting and standing at 12 weeks
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Level of pressure pain
Délai: Change from Baseline in ThePressure Pain Threshold at 12 weeks
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Pressure Pain Threshold in the knee with algometer dynamometer.
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Change from Baseline in ThePressure Pain Threshold at 12 weeks
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Muscle skin temperature
Délai: Change from Baseline in the muscle skin temperature at 12 weeks
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Infrared thermography, thermal imaging.
Thermography uses a type of infrared technology that detects and records temperature changes on the surface of the ski.
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Change from Baseline in the muscle skin temperature at 12 weeks
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Maximum voluntary isometric contraction
Délai: Change from Baseline in the Maximum voluntary isometric contraction at 12 weeks
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A portable dynamometer will be used to assess muscle contraction.
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Change from Baseline in the Maximum voluntary isometric contraction at 12 weeks
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Collaborateurs et enquêteurs
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Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Anticipé)
1 novembre 2020
Achèvement primaire (Anticipé)
1 novembre 2020
Achèvement de l'étude (Anticipé)
1 décembre 2022
Dates d'inscription aux études
Première soumission
27 janvier 2020
Première soumission répondant aux critères de contrôle qualité
27 janvier 2020
Première publication (Réel)
30 janvier 2020
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
31 janvier 2020
Dernière mise à jour soumise répondant aux critères de contrôle qualité
29 janvier 2020
Dernière vérification
1 janvier 2020
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 20123719.1.0000.5511
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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