- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03547726
Physical Therapy After Reverse Total Shoulder Arthroplasty
Physical Therapy After Reverse Total Shoulder Arthroplasty: A Randomized Clinical Trial
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Alabama
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Birmingham, Alabama, Estados Unidos, 35205
- UAB Hospital Highlands
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Physical Therapy
This group of patients will receive a predetermined physical therapy regimen with guidance from a physical therapist.
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These patients will receive a formal physical therapy protocol by seeing a physical therapist in clinic.
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Experimental: 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.
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Forward Flexion Range of Motion 1
Periodo de tiempo: 3 months followup
|
Active range of motion in the shoulder joint in forward flexion (measured in degrees)
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3 months followup
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Strength 1
Periodo de tiempo: 3 months followup
|
Strength measured using a dynamometer
|
3 months followup
|
|
Simple Shoulder Test Patient Reported Outcome 1
Periodo de tiempo: 3 months followup
|
12 question questionnaire, scores are 0-12, 12 is best score (normal)
|
3 months followup
|
|
Strength 2
Periodo de tiempo: 6 month followup
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Strength measured using a dynamometer
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6 month followup
|
|
Strength 3
Periodo de tiempo: 12 months followup
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Strength measured using a dynamometer
|
12 months followup
|
|
Internal Rotation Range of Motion 1
Periodo de tiempo: 3 months followup
|
Active range of motion in the shoulder joint in internal rotation (measured in degrees)
|
3 months followup
|
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External Rotation Range of Motion 1
Periodo de tiempo: 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
Periodo de tiempo: 6 month followup
|
Active range of motion in the shoulder joint in internal rotation (measured in degrees)
|
6 month followup
|
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External Rotation Range of Motion 2
Periodo de tiempo: 6 month followup
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Active range of motion in the shoulder joint in external rotation (measured in degrees)
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6 month followup
|
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Forward Flexion Range of Motion 2
Periodo de tiempo: 6 months followup
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Active range of motion in the shoulder joint in forward flexion (measured in degrees)
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6 months followup
|
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Forward Flexion Range of Motion 3
Periodo de tiempo: 12 months followup
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Active range of motion in the shoulder joint in forward flexion (measured in degrees)
|
12 months followup
|
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Internal Rotation Range of Motion 2
Periodo de tiempo: 12 months followup
|
Active range of motion in the shoulder joint in internal rotation (measured in degrees)
|
12 months followup
|
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External Rotation Range of Motion 2
Periodo de tiempo: 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
Periodo de tiempo: 3 month followup
|
17 question questionnaire, normalized to a 0-100 scale, 100 is normal
|
3 month followup
|
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Simple Shoulder Test Patient Reported Outcome 2
Periodo de tiempo: 6 month followup
|
12 question questionnaire, scores are 0-12, 12 is best score (normal)
|
6 month followup
|
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Simple Shoulder Test Patient Reported Outcome 3
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Amit M Momaya, MD, University of Alabama at Birmingham
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- F11223344
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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