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Physical Therapy After Reverse Total Shoulder Arthroplasty

31 janvier 2022 mis à jour par: Amit Momaya, University of Alabama at Birmingham

Physical Therapy After Reverse Total Shoulder Arthroplasty: A Randomized Clinical Trial

A common operation for various shoulder conditions is a total shoulder arthroplasty (TSA). In cases with severe rotator cuff tears or other conditions, a variant of the procedure called a reverse total shoulder arthroplasty may be performed. It is unclear whether or not patients require formal physical therapy (as opposed to no physical therapy with recommended avoided movements) after reverse TSA. Orthopaedic surgeons have varying opinions on the postoperative rehabilitation protocol for reverse TSA, with some surgeons not prescribing any physical therapy. The purpose of this study is to randomize patients into two groups: one that sees a physical therapist after their reverse TSA, and one that is provided with actions not to perform and are allowed to self-rehabilitate.

Aperçu de l'étude

Statut

Complété

Les conditions

Description détaillée

A common operation for various shoulder conditions is a total shoulder arthroplasty (TSA). In cases with severe rotator cuff tears or other conditions, a variant of the procedure called a reverse total shoulder arthroplasty may be performed. It is unclear whether or not patients require formal physical therapy (as opposed to no physical therapy with recommended avoided movements) after reverse TSA. Orthopaedic surgeons have varying opinions on the postoperative rehabilitation protocol for reverse TSA, with some surgeons not prescribing any physical therapy. The purpose of this study is to randomize patients into two groups: one that sees a physical therapist after their reverse TSA, and one that is provided with actions not to perform and are allowed to self-rehabilitate.

There is very limited orthopaedic literature focusing on the postoperative rehabilitation after reverse TSA. The majority of research is in the physical therapy literature focusing on the actual rehabilitation protocol. However, there has never been a large, randomized clinical trial that asks the question of whether or not physical therapy after reverse TSA is even necessary, or if patients will have comparable outcomes if they perform their own at home rehabilitation. There are surgeons nationwide that are on either end of the spectrum. Some encourage patients to see a therapist for a prolonged period of time with a set regimen of exercises, while others do not encourage any formal physical therapy and instead give patients a list of movements not to perform and allow them to recover at their own pace. We hypothesize that there will be comparable clinical outcomes between patients randomized to receive physical therapy versus an at home, self-led rehabilitation protocol. There are no deleterious effects of either treatment wing.

Patients who agree to undergo reverse TSA after a preoperative appointment with their attending surgeon will be invited to participate in the study. They will complete the below mentioned survey instruments. They will receive their procedure and appropriate postoperative treatment. Patients will then be randomized to either the physical therapy or self-rehab group. Both groups will receive the standard postoperative physical therapy protocol. The only difference between the groups will be if a physical therapist sees the patients in their clinic, or if the patients self-rehabilitate with a list of limitations throughout their recovery course. The physical therapy protocol provided to the physical therapists and patients is attached.

Clinical outcomes will be measured using the attached survey instruments: Simple Shoulder Test (SST), American Shoulder and Elbow Surgeons Shoulder Score (ASES-SS), and the Single Assessment Numeric Evaluation score (SANE). These are commonly used, validated survey instruments in the setting of orthopaedic shoulder research.

The physical exam component of the study will include range of motion testing (measuring the degrees of movement using a goniometer) and strength testing (measured using the dynamometer) in both shoulders.

These survey instruments and measurements will be performed at 3, 6, and 12 month postoperative follow up.

Type d'étude

Interventionnel

Inscription (Réel)

100

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

    • Alabama
      • Birmingham, Alabama, États-Unis, 35205
        • UAB Hospital Highlands

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

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • • Patients who agree to receive a reverse total shoulder arthroplasty by one of our participating surgeons

Exclusion Criteria:

  • • Revision shoulder replacement surgery

    • Mentally incompetent to provide informed consent
    • Non-english speaking
    • Minors (<18)
    • Pregnant women
    • Prison population
    • Acute Shoulder Fractures

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: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: Physical Therapy
This group of patients will receive a predetermined physical therapy regimen with guidance from a physical therapist.
These patients will receive a formal physical therapy protocol by seeing a physical therapist in clinic.
Expérimental: Self-Rehab
This group of patients will be provided with a list of actions not to perform during the stages of their rehab (to avoid injury), and allowed to rehab their shoulder at their own pace.
These patients will be provided with a list of actions NOT to perform and allowed to self rehabilitate. They will not see a physical therapist.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Forward Flexion Range of Motion 1
Délai: 3 months followup
Active range of motion in the shoulder joint in forward flexion (measured in degrees)
3 months followup

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Strength 1
Délai: 3 months followup
Strength measured using a dynamometer
3 months followup
Simple Shoulder Test Patient Reported Outcome 1
Délai: 3 months followup
12 question questionnaire, scores are 0-12, 12 is best score (normal)
3 months followup
Strength 2
Délai: 6 month followup
Strength measured using a dynamometer
6 month followup
Strength 3
Délai: 12 months followup
Strength measured using a dynamometer
12 months followup
Internal Rotation Range of Motion 1
Délai: 3 months followup
Active range of motion in the shoulder joint in internal rotation (measured in degrees)
3 months followup
External Rotation Range of Motion 1
Délai: 3 months followup
Active range of motion in the shoulder joint in external rotation (measured in degrees)
3 months followup
Internal Rotation Range of Motion 2
Délai: 6 month followup
Active range of motion in the shoulder joint in internal rotation (measured in degrees)
6 month followup
External Rotation Range of Motion 2
Délai: 6 month followup
Active range of motion in the shoulder joint in external rotation (measured in degrees)
6 month followup
Forward Flexion Range of Motion 2
Délai: 6 months followup
Active range of motion in the shoulder joint in forward flexion (measured in degrees)
6 months followup
Forward Flexion Range of Motion 3
Délai: 12 months followup
Active range of motion in the shoulder joint in forward flexion (measured in degrees)
12 months followup
Internal Rotation Range of Motion 2
Délai: 12 months followup
Active range of motion in the shoulder joint in internal rotation (measured in degrees)
12 months followup
External Rotation Range of Motion 2
Délai: 12 months followup
Active range of motion in the shoulder joint in external rotation (measured in degrees)
12 months followup
American Shoulder and Elbow Surgeons Shoulder Score 1
Délai: 3 month followup
17 question questionnaire, normalized to a 0-100 scale, 100 is normal
3 month followup
Simple Shoulder Test Patient Reported Outcome 2
Délai: 6 month followup
12 question questionnaire, scores are 0-12, 12 is best score (normal)
6 month followup
Simple Shoulder Test Patient Reported Outcome 3
Délai: 12 month followup
12 question questionnaire, scores are 0-12, 12 is best score (normal)
12 month followup
Single Assessment Numeric Evaluation (SANE) Score 1
Délai: 3 month followup
1 question questionnaire asking to rate overall shoulder function, scores can be 0-100, 100 is optimal score/normal shoulder
3 month followup
American Shoulder and Elbow Surgeons Shoulder Score 2
Délai: 6 month followup
17 question questionnaire, normalized to a 0-100 scale, 100 is normal
6 month followup
American Shoulder and Elbow Surgeons Shoulder Score 3
Délai: 12 month followup
17 question questionnaire, normalized to a 0-100 scale, 100 is normal
12 month followup
Single Assessment Numeric Evaluation (SANE) Score 2
Délai: 6 month followup
1 question questionnaire asking to rate overall shoulder function, scores can be 0-100, 100 is optimal score/normal shoulder
6 month followup
Single Assessment Numeric Evaluation (SANE) Score 3
Délai: 12 month followup
1 question questionnaire asking to rate overall shoulder function, scores can be 0-100, 100 is optimal score/normal shoulder
12 month followup

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Chercheur principal: Amit M Momaya, MD, University of Alabama at Birmingham

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 (Réel)

27 février 2019

Achèvement primaire (Réel)

18 janvier 2022

Achèvement de l'étude (Réel)

19 janvier 2022

Dates d'inscription aux études

Première soumission

29 avril 2018

Première soumission répondant aux critères de contrôle qualité

4 juin 2018

Première publication (Réel)

6 juin 2018

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

1 février 2022

Dernière mise à jour soumise répondant aux critères de contrôle qualité

31 janvier 2022

Dernière vérification

1 janvier 2022

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • F11223344

Plan pour les données individuelles des participants (IPD)

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Indécis

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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 .

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