- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT04047056
Effectiveness of Laboral Kinesiotherapy in Prevention of Upper Limb Musculoskeletal Disorders
Analisys of the Effectiveness of Laboral Kinesiotherapy in Prevention of Upper Limb Musculoskeletal Disorders in the Workers of a University Hospital
ABSTRACT
Work-related musculoskeletal disorders are seen as a public health problem, and can often lead to temporary or permanent incapacity to work. Exercises can be indicated to prevent musculoskeletal disorders, allied to ergonomic intervention as a preventive approach. Objectives: The objective of this study is to analyze the effects of workplace muscle strengthening kinesiotherapy in the reduction of pain and discomfort in the upper limbs and cervical region perceived by the workers of a university hospital. Methods: After a priori sample size calculation based on pain numeric scale, 166 volunterrs will be recruted and assigned randomly to the "labor kinesiotherapy" group (GCL) or to the "control group" (CG), considering 10% sample size lost and intention to treat. The primary outcomes will be the pain perceived by the Numerical Pain Scale (NDT) and Nordic Questionnaire, and isokinetic muscle strength through the mean peak torque work of shoulder abduction. The discomfort and disability will be evaluated by the PSFS and QuickDASH questionnaires. The Ergonomic Analysis of Work will be evaluated by the manual "Ergonomic Analysis Focused on Activities" - EAFA and application of QEC, RULA, REBA and HARM tools. Statistical analysis will be performed through PASW Statistics ™, version 20.0. The independent sample T test will be used to compare the groups. The Cohen index will be set for the effect size calculation. All analyzes will be conducted with 95% confidence interval and p <0.05 significance.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
São Paulo
-
Ribeirão Preto, São Paulo, Brésil, 14031390
- Recrutement
- Natalia Claro da Silva
-
Contact:
- Marisa CR Fonseca
- Numéro de téléphone: +55 (16) 3602-4413
- E-mail: marisa@fmrp.usp.br
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Workers who have or do not have musculoskeletal complaints in the cervical, shoulder, elbow, wrist or hand and / or fingers, without clinical diagnosis and who are not away from their professional activities.
Exclusion Criteria:
Workers presenting:
- Pregnancy;
- Congenital abnormality of the spine and significant musculoskeletal deformities (such as amputation, dysmetria);
- Severe cervical spine disorders, postoperative conditions in the neck or upper limb region;
- Uncontrolled cardiovascular disease, cardiac arrhythmia, angina or related symptoms, and postural hypotension or other contraindications to exercise;
- Workers who engage in some form of regular physical activity involving muscle strengthening and endurance exercises.
- Workers who have a proven diagnosis of upper limb musculoskeletal dysfunction and are undergoing physical therapy treatment.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Comparateur placebo: Ergonomic Guidelines Manual
A manual of ergonomic occupational and daily living guidelines will be given to both control and labor kinesiotherapy groups, which is the only approach for the control group initially.
|
The intervention group will perform 5 minutes of warm-up with free active exercises, 10 minutes of specific resistance exercises for the cervical and upper limbs and 5 minutes of stretching and muscle relaxation.The initial free active exercises will be performed in 3 sets of 15 repetitions; Resistance exercises will be performed in 3 sets of 10 repetitions and stretching will be performed in 3 sets of 30 seconds. Regarding the intervals between exercises, active recovery will be adopted to counteract the effects of muscle fatigue. |
Comparateur actif: Labor Kinesiotherapy in group
The intervention will be performed by a physical therapist, which will consist of preparatory labor kinesiotherapy, which aims to prepare the workers' osteo-articular system for the beginning of the work activity, acting more specifically on those muscle groups that will be most required during the journey which will be identified in the evaluation.
Labor kinesiotherapy will be performed in the workplace before the workday and will last 20 minutes, 3 times a week, for 12 weeks.
|
The intervention group will perform 5 minutes of warm-up with free active exercises, 10 minutes of specific resistance exercises for the cervical and upper limbs and 5 minutes of stretching and muscle relaxation.The initial free active exercises will be performed in 3 sets of 15 repetitions; Resistance exercises will be performed in 3 sets of 10 repetitions and stretching will be performed in 3 sets of 30 seconds. Regarding the intervals between exercises, active recovery will be adopted to counteract the effects of muscle fatigue. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Numerical Pain Scale - NPS
Délai: 12 weeks.
|
Difference in numerical pain scale in the 3 evaluations.
The numerical pain scale score ranges from 0 to 10, with values closer to 10 indicating worse pain.
|
12 weeks.
|
shoulder abduction Torque peak in the Isokinetic Dynamometer
Délai: 12 weeks.
|
Mean difference in torque peak achieved by the Isokinetic Dynamometer at baseline and after 12 weeks.
|
12 weeks.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Quick Disabilities of de Arm, Shoulder and Hand (QuickDAS)
Délai: 12 weeks.
|
Difference in DASH questionnaire scores in 3 evaluations.
The QuickDASH score ranges from 0 to 100, with values closer to 100 indicating better health.
|
12 weeks.
|
Patient Specific Functional Scale (PSFS)
Délai: 12 weeks.
|
Difference in PSFS questionnaire scores in 3 evaluations.
The PSFS allows patients to report on their functional status at baseline and at a follow-up session, to determine if a meaningful change in functional status has occurred.
|
12 weeks.
|
Collaborateurs et enquêteurs
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- FMRPUSP3
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur Labor Kinesiotherapy
-
Healthy.io Ltd.ComplétéHypertension | DiabèteÉtats-Unis
-
Ohio State University Comprehensive Cancer CenterRecrutementUtilisation de la cigarette électroniqueÉtats-Unis
-
University of PittsburghNational Heart, Lung, and Blood Institute (NHLBI)ComplétéVIH | Vieillissement | Maladie pulmonaire | MPOCÉtats-Unis
-
Colorado Center for Reproductive MedicineAbbVieActif, ne recrute pasInfertilité | EndométrioseÉtats-Unis
-
OHSU Knight Cancer InstituteOregon Health and Science University; Progenics Pharmaceuticals, Inc.Pas encore de recrutementAdénocarcinome de la prostate | Cancer de la prostate résistant à la castration | Cancer de la prostate sensible à la castrationÉtats-Unis
-
University of Illinois at ChicagoUCB PharmaComplétéLa polyarthrite rhumatoïdeÉtats-Unis