- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07654023
Central Sensitization and Functional Outcomes in Chronic Shoulder Pain (SHOULDER-CS)
The Effects of Central Sensitization and Psychological Factors on Functional Outcomes Following Rehabilitation in Individuals With Chronic Shoulder Pain
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Chronic shoulder pain is one of the most common musculoskeletal disorders and is associated with pain, functional limitations, reduced quality of life, and work disability. Although structural abnormalities are often identified in clinical evaluation and imaging findings, the relationship between tissue pathology and symptom severity is not always clear. Therefore, factors beyond peripheral tissue damage may contribute to persistent shoulder pain and rehabilitation outcomes.
In recent years, central sensitization has become an important concept in chronic musculoskeletal pain conditions. Central sensitization refers to increased responsiveness of the central nervous system to sensory input, resulting in pain hypersensitivity and amplification of pain perception. Previous studies have demonstrated that individuals with chronic shoulder pain may present with symptoms related to central sensitization, which can negatively affect pain severity, disability, and treatment response.
Psychological factors such as pain catastrophizing, fear of movement, anxiety, and depression are also known to influence chronic pain experiences and rehabilitation outcomes. Higher levels of maladaptive psychological responses may contribute to increased pain perception, reduced treatment adherence, and poorer functional recovery. However, prospective studies evaluating the combined influence of central sensitization and psychological factors on rehabilitation outcomes in chronic shoulder pain remain limited.
This study is designed as a prospective observational cohort study. Individuals with chronic shoulder pain attending physiotherapy rehabilitation clinics will be recruited. Participants will undergo baseline assessments before treatment and follow-up assessments after a standardized 6-week rehabilitation program routinely applied in clinical practice.
The primary objective is to determine whether baseline central sensitization and psychological factors predict functional improvement following rehabilitation. The findings may contribute to a better understanding of the biopsychosocial mechanisms underlying treatment response and support the development of more individualized rehabilitation strategies for chronic shoulder pain management.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: ayşenur yılmaz, Assistant Professor, PT,PhD
- Número de teléfono: +905432833819
- Correo electrónico: fzt.aysenurgungor@gmail.com
Ubicaciones de estudio
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Türkiye
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Burdur, Türkiye, Turquía (Türkiye), 19300
- Burdur Mehmet Akif Ersoy Üniversitesi
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Contacto:
- Ayşenur Yılmaz, Assistant Professor
- Número de teléfono: 05432833819
- Correo electrónico: fzt.aysenurgungor@gmail.com
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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 years and older
- Presence of chronic shoulder pain lasting at least 3 months
- Clinical findings consistent with shoulder-related pain
- Willingness to participate in a 6-week physiotherapy rehabilitation program
- Ability to complete study assessments and questionnaires
- Provision of written informed consent
Exclusion Criteria:
- History of shoulder surgery within the previous 6 months
- Major shoulder trauma within the previous 6 months
- Serious pathology affecting the shoulder (e.g., infection, tumor, systemic inflammatory disease)
- Neurological disorders affecting the upper extremity (e.g., cervical radiculopathy, myelopathy, peripheral nerve injury)
- Severe cognitive impairment
- Communication problems preventing participation
- Shoulder injection within the previous 4 weeks
- Pregnancy
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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Physiotherapy Rehabilitation Program
A standardized 6-week exercise-based physiotherapy and rehabilitation program including patient education, scapular stabilization exercises, strengthening exercises, range of motion exercises, functional training, and home exercise recommendations routinely applied in clinical practice.
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A standardized 6-week exercise-based physiotherapy and rehabilitation program routinely applied in clinical practice, including patient education, scapular stabilization exercises, strengthening exercises, range of motion exercises, functional training, and home exercise recommendations for individuals with chronic shoulder pain.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Shoulder Pain and Disability Index (SPADI)
Periodo de tiempo: Baseline and 6 weeks after rehabilitation
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The Shoulder Pain and Disability Index (SPADI) is a validated questionnaire used to assess shoulder pain and disability.
Total scores range from 0 to 100, with higher scores indicating greater pain and disability.
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Baseline and 6 weeks after rehabilitation
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Central Sensitization Inventory (CSI)
Periodo de tiempo: Baseline and 6 weeks after rehabilitation
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The Central Sensitization Inventory is a self-reported questionnaire assessing symptoms related to central sensitization.
Scores range from 0 to 100, with higher scores indicating greater central sensitization symptoms.
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Baseline and 6 weeks after rehabilitation
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Pain Catastrophizing Scale (PCS)
Periodo de tiempo: Baseline and 6 weeks after rehabilitation
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The Pain Catastrophizing Scale (PCS) assesses exaggerated negative thoughts and emotional responses related to pain.
Total scores range from 0 to 52, with higher scores indicating greater pain catastrophizing.
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Baseline and 6 weeks after rehabilitation
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Pain Intensity (Visual Analog Scale)
Periodo de tiempo: Baseline and 6 weeks after rehabilitation
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Pain intensity will be assessed using a Visual Analog Scale (VAS) ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Higher scores indicate greater pain intensity.
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Baseline and 6 weeks after rehabilitation
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Shoulder Range of Motion
Periodo de tiempo: Baseline and 6 weeks after rehabilitation
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Shoulder range of motion will be assessed using standard goniometric measurements.
Higher values indicate greater shoulder joint mobility.
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Baseline and 6 weeks after rehabilitation
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Shoulder Muscle Strength
Periodo de tiempo: Baseline and 6 weeks after rehabilitation
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Shoulder muscle strength will be evaluated using standardized clinical strength assessment procedures.
Higher values indicate greater muscle strength.
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Baseline and 6 weeks after rehabilitation
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Colaboradores e Investigadores
Patrocinador
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
Palabras clave
Otros números de identificación del estudio
- CS-Shoulder-2026
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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