¿Qué grupo de pacientes muestra una mayor mejoría con la educación del paciente sola en el dolor de hombro relacionado con el manguito rotador? - Un estudio de cohortes
¿Qué grupo de pacientes muestra una mayor mejoría únicamente con educación al paciente en el dolor de hombro relacionado con el manguito rotador? - Un estudio de cohorte
The primary aim of this study is to determine the clinical effectiveness of patient education alone in individuals with rotator cuff-related shoulder pain and to identify which patient subgroups benefit more from this approach. In addition, the translation and cultural adaptation of the "Patient Knowledge Questionnaire (PKQ-RCRSP)" into Turkish will be carried out to measure the level of patient knowledge regarding patient education.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Individuals who present with shoulder pain to the Orthopedics and Traumatology Department, Shoulder-Elbow Surgery Outpatient Clinic of Göztepe Prof. Dr. Süleyman Yalçın City Hospital and who volunteer to participate will be included in our study. Before beginning the study, the purpose of the study will be explained to the participants, and all information regarding the study will be provided both verbally and in writing. Informed consent will be obtained from participants, confirming that they voluntarily agree to take part in the study. A total of 116 participants will be included in the study, and the PKQ-RCRSP questionnaire will be administered at baseline and after one week. Following the validation process, participants will receive two face-to-face patient education sessions. After the first patient education session, pain will be assessed at the 4th, 12th, and 24th week follow-ups using the Numerical Pain Rating Scale (NPRS); functional limitation will be assessed using the Shoulder Pain and Disability Index (SPADI); clinical improvement using the Global Rating of Change Scale (GRC); illness perception using the Brief Illness Perception Questionnaire (B-IPQ); patient knowledge level using the PKQ-RCRSP; health literacy using the European Health Literacy Survey-Short Form (HLS-EU-Q6); and physical activity level using the International Physical Activity Questionnaire (IPAQ).
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Merve KOYUNCU CENİKLİ Research asistant, MSc
- Número de teléfono: +90(0212) 414 15 00
- Correo electrónico: merve.cenikli@iuc.edu.tr
Ubicaciones de estudio
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Istanbul, Turquía (Türkiye)
- Reclutamiento
- İstanbul University Cerrahpasa Faculty of Health Sciences, İstanbul
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Contacto:
- Merve Koyuncu Cenikli Research Asistant, MSc
- Número de teléfono: +90(0212) 414 15 00
- Correo electrónico: merve.cenikli@iuc.edu.tr
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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:
- Individuals aged 18-65 years
- Shoulder pain persisting for at least 4 weeks
- Diagnosed by an orthopedic physician with impingement, subacromial bursitis, rotator cuff (RC) tendinopathy, or partial tear
- Activity-related pain ≥3 on the NPRS
- Cognitively able to understand the education and provide written informed consent
Exclusion Criteria:
- History of shoulder surgery
- Diagnosis of frozen shoulder, full-thickness or massive rotator cuff (RC) tear, or instability
- Presence of neurological or psychiatric conditions that prevent exercise
- History of physical therapy-rehabilitation or injection treatment within the past 6 months
- Pain persisting for more than 12 months
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Patient Education
Participants in this study will receive structured patient education sessions for rotator cuff-related shoulder pain. |
During the Turkish adaptation of the PKQ-RCRSP questionnaire, written permission was obtained from the original developer. At least two experts independently translated the questionnaire into Turkish, and a single reconciled version was created. This version was back-translated by an independent translator to ensure semantic and conceptual equivalence. Revisions were made following expert panel review and pilot testing. For validation, the PKQ-RCRSP will be administered to participants at baseline (V0). One week later (V1), the questionnaire will be repeated, and participants will be asked if their shoulder problem or knowledge has significantly changed in the past week. Those answering "Yes," who do not return, or who receive any intervention will be excluded from the test-retest analysis. Results from participants answering "No" will complete the test-retest analysis, and all participants' data will be included in other validity analyses. This concludes the validation phase. Participants in this arm will receive structured patient education sessions for rotator cuff-related shoulder pain. The program consists of two 30-minute face-to-face sessions delivered by a physiotherapist with at least 5 years of experience in orthopedic rehabilitation. Educational topics include disease information, symptom management, treatment options, reducing fear of movement, exercise promotion, pain and stress management, physical activity recommendations, nutrition advice, and lifestyle-specific guidance. Informational brochures will be provided after the first session. The second session, delivered two weeks later, focuses on reviewing progress and enhancing motivation; no new information will be provided. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Numerical Pain Rating Scale (NPRS)
Periodo de tiempo: İmmediately before the first education session, and at 4 weeks, 12 weeks, and 24 weeks after the start of the education program.
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Pain intensity assessed using the Numerical Pain Rating Scale (NPRS). |
İmmediately before the first education session, and at 4 weeks, 12 weeks, and 24 weeks after the start of the education program.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Patient Knowledge Questionnaire (PKQ-RCRSP)
Periodo de tiempo: Baseline, immediately before the first education session, and at 4 weeks, 12 weeks, and 24 weeks after the start of the education program.
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Patient knowledge regarding rotator cuff-related shoulder pain assessed |
Baseline, immediately before the first education session, and at 4 weeks, 12 weeks, and 24 weeks after the start of the education program.
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Shoulder Pain and Disability Index (SPADI)
Periodo de tiempo: Baseline, and at 4 weeks, 12 weeks, and 24 weeks after the start of the education program.
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Shoulder pain and functional disability assessed using the Shoulder Pain and Disability Index (SPADI). |
Baseline, and at 4 weeks, 12 weeks, and 24 weeks after the start of the education program.
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Sociodemographic Characteristics
Periodo de tiempo: Baseline.
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Sociodemographic characteristics including age, sex, education level, occupation, and other relevant demographic variables collected using a Sociodemographic Assessment Form. |
Baseline.
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Patient-Reported Global Change Assessed by the Global Rating of Change Scale (GRC)
Periodo de tiempo: 4 weeks, 12 weeks, and 24 weeks after the start of the education program
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Patient-perceived overall change in condition assessed using the Global Rating of Change Scale (GRC). |
4 weeks, 12 weeks, and 24 weeks after the start of the education program
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Illness Perceptions Assessed by the Brief Illness Perception Questionnaire (B-IPQ)
Periodo de tiempo: Baseline and at 4 weeks, 12 weeks, and 24 weeks after the start of the education program.
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Patient perceptions of illness assessed using the Brief Illness Perception Questionnaire (B-IPQ). |
Baseline and at 4 weeks, 12 weeks, and 24 weeks after the start of the education program.
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European Health Literacy Survey - Short Form (HLS-EU-Q6)
Periodo de tiempo: Baseline, and at 4 weeks, 12 weeks, and 24 weeks after the start of the education program.
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Health literacy level assessed using the European Health Literacy Survey - Short Form (HLS-EU-Q6). |
Baseline, and at 4 weeks, 12 weeks, and 24 weeks after the start of the education program.
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European Health Literacy Survey - Short Form (HLS-EU-Q6).
Periodo de tiempo: Baseline and at 12 weeks and 24 weeks after the start of the education program.
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Health literacy level assessed using the European Health Literacy Survey - Short Form (HLS-EU- |
Baseline and at 12 weeks and 24 weeks after the start of the education program.
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International Physical Activity Questionnaire - Short Form (IPAQ-SF / UFAA-KF)
Periodo de tiempo: Baseline and at 12 weeks and 24 weeks after the start of the education program.
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Physical activity level assessed using the International Physical Activity Questionnaire - Short Form (IPAQ-SF). |
Baseline and at 12 weeks and 24 weeks after the start of the education program.
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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
- 2150061
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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