- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07654894
Effect of Preoperative Kinesiophobia on Clinical Outcomes Following Arthroscopic Meniscus Surgery (MEN-KIN)
Effect of Preoperative Kinesiophobia on Clinical Success in Patients Undergoing Arthroscopic Surgery for Meniscal Tears
Meniscal tears are among the most common knee injuries and frequently require arthroscopic surgical treatment when conservative management fails or mechanical symptoms persist. Although surgical techniques have improved clinical outcomes, postoperative recovery is influenced not only by structural pathology but also by psychological factors. Kinesiophobia, defined as an excessive and debilitating fear of movement due to pain or the expectation of reinjury, may negatively affect rehabilitation adherence, functional recovery, and pain perception.
This prospective observational study aims to investigate the effect of preoperative kinesiophobia on postoperative clinical outcomes in patients undergoing arthroscopic surgery for meniscal tears. Adult patients diagnosed with a meniscal tear by clinical examination and magnetic resonance imaging and scheduled for arthroscopic surgery will be enrolled. Preoperative demographic and clinical characteristics, pain intensity, functional status, and kinesiophobia levels will be assessed using validated outcome measures. Postoperative evaluations will be performed three months after surgery to determine changes in pain and functional outcomes. The relationship between preoperative kinesiophobia and postoperative clinical success will be analyzed. The findings of this study may help identify patients at risk for suboptimal recovery and support the development of individualized rehabilitation strategies.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Meniscal tears are among the most common knee injuries encountered in orthopedic practice and represent a major cause of knee pain, mechanical symptoms, and functional impairment. Although conservative treatment may be effective in selected patients, arthroscopic surgery remains a widely performed procedure for individuals with persistent symptoms or mechanical dysfunction. Despite advances in surgical techniques and standardized rehabilitation protocols, postoperative recovery varies considerably among patients with similar structural pathology, suggesting that factors beyond the anatomical lesion may influence clinical outcomes.
Psychological factors have increasingly been recognized as important determinants of recovery after musculoskeletal injuries and orthopedic surgery. Among these, kinesiophobia, defined as an excessive and debilitating fear of movement resulting from pain or the anticipation of reinjury, may negatively affect rehabilitation adherence, physical activity, muscle performance, and overall functional recovery. Patients with high levels of kinesiophobia may avoid movement, resulting in delayed restoration of knee function and persistent disability. However, evidence specifically evaluating the influence of preoperative kinesiophobia on outcomes following arthroscopic meniscal surgery remains limited.
The present study is designed as a prospective, single-center, observational cohort study to investigate the effect of preoperative kinesiophobia on postoperative clinical success in patients undergoing arthroscopic surgery for meniscal tears. Adult patients aged 18 to 65 years with a diagnosis of a meniscal tear confirmed by clinical examination and magnetic resonance imaging (MRI) and scheduled for arthroscopic surgery will be consecutively enrolled.
Baseline assessments will include demographic characteristics, body mass index, symptom duration, affected side, meniscal tear localization, and the type of arthroscopic procedure performed. Pain intensity will be evaluated using the Visual Analog Scale (VAS), functional status will be assessed using the Lysholm Knee Score, and fear of movement will be measured using the Tampa Scale for Kinesiophobia (TSK). All outcome measures will be recorded preoperatively and at the postoperative third month, providing a standardized assessment of changes in pain, function, and kinesiophobia over the early recovery period.
Participants will be categorized according to their preoperative kinesiophobia levels, and postoperative clinical outcomes will be compared between groups. In addition, correlation analyses will be performed to determine the relationship between preoperative kinesiophobia and postoperative pain and functional recovery. Appropriate statistical methods will be used to evaluate between-group differences and associations, with statistical significance defined as p < 0.05.
The findings of this study are expected to clarify the role of preoperative kinesiophobia as a potential predictor of postoperative clinical success following arthroscopic meniscal surgery. Improved understanding of this relationship may facilitate the identification of patients at risk for suboptimal recovery and support the development of individualized perioperative rehabilitation strategies that incorporate both physical and psychological components.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Erdal Güngör, M.D
- Número de teléfono: +90 543 879 0630
- Correo electrónico: egungor_49@hotmail.com
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 meniscal tear confirmed by clinical examination and magnetic resonance imaging (MRI).
Patients scheduled to undergo arthroscopic meniscal surgery. Ability to understand and complete the study questionnaires. Willingness to participate and provide written informed consent. Availability for both preoperative assessment and postoperative 3-month follow-up.
Exclusion Criteria:
Previous surgery on the affected knee. Concomitant anterior cruciate ligament (ACL), posterior cruciate ligament (PCL), or collateral ligament injuries requiring surgical treatment.
Advanced knee osteoarthritis (e.g., Kellgren-Lawrence grade 3 or 4). History of inflammatory rheumatic disease or active joint infection. Neurological disorders affecting lower extremity function or balance. Severe psychiatric disorders or cognitive impairment preventing completion of questionnaires.
Pregnancy. Inability or unwillingness to provide written informed consent. Inability to attend the 3-month postoperative follow-up.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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High Kinesiophobia Group
Patients with meniscal tears scheduled for arthroscopic surgery who demonstrate high preoperative kinesiophobia based on the Tampa Scale for Kinesiophobia (TSK).
Participants will undergo standard surgical treatment and routine postoperative rehabilitation and will be evaluated preoperatively and at the postoperative third month for pain and functional outcomes.
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Low Kinesiophobia Group
Patients with meniscal tears scheduled for arthroscopic surgery who demonstrate low preoperative kinesiophobia based on the Tampa Scale for Kinesiophobia (TSK).
Participants will undergo the same standard surgical treatment and routine postoperative rehabilitation and will be evaluated preoperatively and at the postoperative third month for pain and functional outcomes.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Lysholm Knee Score
Periodo de tiempo: Baseline and postoperative 3 months
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To evaluate the change in knee function using the Lysholm Knee Score from baseline (preoperative assessment) to the postoperative 3-month follow-up in patients undergoing arthroscopic surgery for meniscal tears.
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Baseline and postoperative 3 months
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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 (preoperative) and postoperative 3 months.
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Assessment of postoperative pain intensity using the 10-cm Visual Analog Scale (VAS).
Lower scores indicate less pain.
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Baseline (preoperative) and postoperative 3 months.
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Change in Tampa Scale for Kinesiophobia (TSK) Score
Periodo de tiempo: Baseline (preoperative) and postoperative 3 months.
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Assessment of fear of movement using the Tampa Scale for Kinesiophobia.
Higher scores indicate greater kinesiophobia.
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Baseline (preoperative) and postoperative 3 months.
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Erdal Güngör, M.D, Istanbul Medipol University, Department of Orthopedics and Traumatology
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
Otros números de identificación del estudio
- MBH-ORTHO-2026-001
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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