Effect of Central Sensitization on Response to Physical Therapy in Patients With Partial Supraspinatus Tear
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This prospective observational study aims to investigate the impact of central sensitization on treatment response in patients with supraspinatus partial-thickness tears undergoing a standardized physical therapy and rehabilitation program. Central sensitization is characterized by an increased responsiveness of the central nervous system to sensory stimuli and may contribute to persistent pain and functional impairment beyond the extent of structural tissue damage. Understanding its role may help explain the variability in clinical outcomes among patients receiving similar conservative treatments.
Adult patients diagnosed with a supraspinatus partial-thickness tear by clinical examination and magnetic resonance imaging (MRI) will be enrolled. Before treatment, demographic characteristics, clinical findings, pain intensity, shoulder function, and the presence of central sensitization will be assessed using validated outcome measures. All participants will receive the same standardized physical therapy protocol according to institutional practice.
After completion of the treatment program (e.g., 6 weeks), clinical assessments will be repeated to evaluate changes in pain and functional status. The primary objective is to compare treatment response between patients with and without central sensitization. Secondary analyses will examine the relationship between baseline central sensitization scores and the magnitude of improvement in clinical outcomes while adjusting for potential confounding variables such as age, sex, body mass index, symptom duration, and tear characteristics.
The study is observational in nature, and no experimental intervention, randomization, or additional invasive procedure will be performed beyond routine clinical evaluation and rehabilitation. The findings are expected to provide evidence regarding the prognostic significance of central sensitization in patients with supraspinatus partial-thickness tears and may contribute to the development of more individualized rehabilitation strategies.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Zeynep Karakuzu Güngör, M.D
- Número de teléfono: +90 (212) 404 15 00.
- Correo electrónico: zeynepkarakuzu@hotmail.com.tr
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
Adults aged 18 to 65 years. Diagnosis of supraspinatus partial-thickness tear confirmed by clinical examination and magnetic resonance imaging (MRI).
Presence of shoulder pain for at least 6 weeks. Candidates for a standardized physical therapy and rehabilitation program. Ability to understand the study procedures and provide written informed consent.
Exclusion Criteria:
Full-thickness rotator cuff tear or history of previous shoulder surgery on the affected side.
Acute fracture, shoulder dislocation, or other major traumatic injury involving the affected shoulder.
Inflammatory rheumatic diseases, active infection, or malignancy affecting the musculoskeletal system.
Neurological disorders that may influence pain perception or upper extremity function (e.g., stroke, cervical myelopathy, peripheral neuropathy).
Severe glenohumeral or acromioclavicular osteoarthritis requiring surgical treatment.
Receipt of corticosteroid injection or any invasive shoulder intervention within the previous 3 months.
Participation in another structured rehabilitation program for the affected shoulder within the previous 3 months.
Pregnancy or inability to comply with the study protocol or complete the required questionnaires.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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Patients with Central Sensitization
Patients with supraspinatus partial-thickness tears who are classified as having central sensitization based on the Central Sensitization Inventory (CSI) at baseline and who receive the standardized physical therapy program.
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All participants will receive the same standardized physical therapy and rehabilitation program administered according to routine clinical practice.
The treatment program will include therapeutic exercises, stretching, strengthening, range-of-motion exercises, and appropriate physical therapy modalities as determined by the rehabilitation protocol.
No experimental intervention or additional procedure will be performed for research purposes.
The study is observational and aims to evaluate whether the presence of central sensitization influences the clinical response to the standardized rehabilitation program.
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Patients without Central Sensitization
Patients with supraspinatus partial-thickness tears who are classified as not having central sensitization based on the Central Sensitization Inventory (CSI) at baseline and who receive the same standardized physical therapy program.
|
All participants will receive the same standardized physical therapy and rehabilitation program administered according to routine clinical practice.
The treatment program will include therapeutic exercises, stretching, strengthening, range-of-motion exercises, and appropriate physical therapy modalities as determined by the rehabilitation protocol.
No experimental intervention or additional procedure will be performed for research purposes.
The study is observational and aims to evaluate whether the presence of central sensitization influences the clinical response to the standardized rehabilitation program.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Shoulder Pain and Disability Index (SPADI) Total Score
Periodo de tiempo: Baseline, Week 3, and Week 6
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The Shoulder Pain and Disability Index (SPADI) total score will be assessed at baseline, the end of treatment, and 6 weeks after completion of treatment to evaluate changes in pain and shoulder-related disability.
A greater reduction in the SPADI total score indicates a better treatment response.
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Baseline, Week 3, and Week 6
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Visual Analog Scale (VAS) Pain Score
Periodo de tiempo: Baseline, Week 3, and Week 6
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Pain intensity will be assessed using the Visual Analog Scale (VAS).
Changes in VAS scores will be evaluated to determine the effect of treatment over time.
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Baseline, Week 3, and Week 6
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Colaboradores e Investigadores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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
- KSUH-SS-RCPT-2026-01
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan 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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