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Physical Therapy After Reverse Total Shoulder Arthroplasty

31. januar 2022 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

100

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35205
        • UAB Hospital Highlands

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: 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.
Eksperimentel: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Forward Flexion Range of Motion 1
Tidsramme: 3 months followup
Active range of motion in the shoulder joint in forward flexion (measured in degrees)
3 months followup

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Strength 1
Tidsramme: 3 months followup
Strength measured using a dynamometer
3 months followup
Simple Shoulder Test Patient Reported Outcome 1
Tidsramme: 3 months followup
12 question questionnaire, scores are 0-12, 12 is best score (normal)
3 months followup
Strength 2
Tidsramme: 6 month followup
Strength measured using a dynamometer
6 month followup
Strength 3
Tidsramme: 12 months followup
Strength measured using a dynamometer
12 months followup
Internal Rotation Range of Motion 1
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Amit M Momaya, MD, University of Alabama at Birmingham

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

27. februar 2019

Primær færdiggørelse (Faktiske)

18. januar 2022

Studieafslutning (Faktiske)

19. januar 2022

Datoer for studieregistrering

Først indsendt

29. april 2018

Først indsendt, der opfyldte QC-kriterier

4. juni 2018

Først opslået (Faktiske)

6. juni 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. februar 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

31. januar 2022

Sidst verificeret

1. januar 2022

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • F11223344

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