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Physical Therapy After Reverse Total Shoulder Arthroplasty

31 gennaio 2022 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

100

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • Alabama
      • Birmingham, Alabama, Stati Uniti, 35205
        • UAB Hospital Highlands

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 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.
Sperimentale: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Forward Flexion Range of Motion 1
Lasso di tempo: 3 months followup
Active range of motion in the shoulder joint in forward flexion (measured in degrees)
3 months followup

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Strength 1
Lasso di tempo: 3 months followup
Strength measured using a dynamometer
3 months followup
Simple Shoulder Test Patient Reported Outcome 1
Lasso di tempo: 3 months followup
12 question questionnaire, scores are 0-12, 12 is best score (normal)
3 months followup
Strength 2
Lasso di tempo: 6 month followup
Strength measured using a dynamometer
6 month followup
Strength 3
Lasso di tempo: 12 months followup
Strength measured using a dynamometer
12 months followup
Internal Rotation Range of Motion 1
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Amit M Momaya, MD, University of Alabama at Birmingham

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

27 febbraio 2019

Completamento primario (Effettivo)

18 gennaio 2022

Completamento dello studio (Effettivo)

19 gennaio 2022

Date di iscrizione allo studio

Primo inviato

29 aprile 2018

Primo inviato che soddisfa i criteri di controllo qualità

4 giugno 2018

Primo Inserito (Effettivo)

6 giugno 2018

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

1 febbraio 2022

Ultimo aggiornamento inviato che soddisfa i criteri QC

31 gennaio 2022

Ultimo verificato

1 gennaio 2022

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • F11223344

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

Indeciso

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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