- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07700589
Comparison of Traditional, Synchronous, and Asynchronous Telerehabilitation in Office Workers With Chronic Nonspecific Low Back Pain
Comparison of the Effectiveness of Traditional, Synchronous, and Asynchronous Telerehabilitation Approaches in Chronic Nonspecific Low Back Pain in Office Workers
Chronic Nonspecific Low Back Pain (NLBP) is a common condition that occurs without a specific underlying pathology, resulting in muscle tension, pain, and a decreased quality of life. Office workers are particularly at risk due to prolonged sitting, ergonomic errors, and low physical activity. While exercise therapy is a primary approach for management, low adherence rates often limit its effectiveness. Telerehabilitation (remote, technology-supported physiotherapy) stands out for its potential to increase access and support continuity of care.
This study is a randomized controlled trial that will be conducted with 45 office workers aged 18-65 diagnosed with chronic NLBP. Participants will be randomly assigned to three parallel groups: traditional exercise (brochure-based), synchronous telerehabilitation (live sessions), and asynchronous telerehabilitation (pre-recorded videos). The intervention protocol will be implemented for 8 weeks. Evaluations will be performed before and after the 8-week period using the Visual Analog Scale (VAS) for pain intensity, Oswestry Disability Index (ODI) for functional disability, Short Form-36 (SF-36) for health-related quality of life, and a Patient Satisfaction Questionnaire.
The aim of this study is to compare the effects of traditional, synchronous, and asynchronous telerehabilitation approaches on pain, disability, quality of life, and satisfaction to determine the most effective management model for office workers with chronic nonspecific low back pain.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Özge Mine YILMAZ, Ass Prof
- Número de teléfono: +90 5075091175
- Correo electrónico: ozgemineyilmaz@aydin.edu.tr
Ubicaciones de estudio
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Istanbul, Turquía (Türkiye), 34295
- Istanbul Aydin University, Faculty of Health Sciences
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Contacto:
- Özge Mine YILMAZ, Ass Prof
- Número de teléfono: +90 5075091175
- Correo electrónico: ozgemineyilmaz@aydin.edu.tr
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Investigador principal:
- Özge Mine YILMAZ, Ass Prof
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Being an office worker aged between 18 and 65 years.
- Diagnosed with chronic non-specific low back pain (symptoms persisting for more than 3 months).
- Volunteering to participate in the study and signing the informed consent form.
- Having a computer, smartphone, or tablet with a stable internet connection capable of supporting video calls.
Exclusion Criteria:
- - History of spinal surgery, structural spinal deformities (e.g., severe scoliosis), or specific causes of low back pain (e.g., disc herniation with severe radiculopathy, spinal stenosis, spondylolisthesis).
- Diagnosis of systemic, rheumatological, neurological, or inflammatory diseases affecting the musculoskeletal system.
- Serious cardiovascular or pulmonary conditions that contraindicate physical exercise.
- Currently receiving active physical therapy or regular medical intervention for low back pain elsewhere.
- Pregnancy.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador activo: Traditional Exercise Group
Participants will receive a standard physiotherapy program including stretching, core stabilization, and motor control exercises for low back pain, delivered face-to-face by a physiotherapist in a clinical environment at Istanbul Aydın University
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The exercise protocol consists of stretching, core stabilization, and motor control exercises for low back pain.
Frequency: Performed 3 days a week for 8 weeks, consisting of 2 sets of 10 repetitions (approximately 45-60 minutes per session).
It will be delivered face-to-face by a physiotherapist in a clinical environment at Istanbul Aydin University.
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Experimental: Synchronous Telerehabilitation Group
Participants will participate in the same exercise program (stretching, core stabilization, and motor control exercises) via live, real-time online video sessions supervised by a physiotherapist.
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The exercise protocol consists of stretching, core stabilization, and motor control exercises for low back pain.
Frequency: Performed 3 days a week for 8 weeks, consisting of 2 sets of 10 repetitions (approximately 45-60 minutes per session).
It will be delivered via live, real-time online video sessions supervised by a physiotherapist.
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Experimental: Asynchronous Telerehabilitation Group
Participants will be provided with pre-recorded instructional exercise videos containing the same program.
They will follow and perform the exercises individually at their own convenience.
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The exercise protocol consists of stretching, core stabilization, and motor control exercises for low back pain.
Frequency: Performed 3 days a week for 8 weeks, consisting of 2 sets of 10 repetitions (approximately 45-60 minutes per session).
Participants will be provided with pre-recorded instructional exercise videos and follow the exercises individually at their own convenience.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Functional Disability Level
Periodo de tiempo: Baseline and Post-intervention (Week 8)
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Evaluated using the Oswestry Disability Index (ODI) to measure functional disability related to low back pain.
The questionnaire consists of 10 items, and the total score is expressed as a percentage ranging from 0% to 100%.
A score of 0% indicates no disability, while 100% represents the highest possible level of functional disability.
Higher percentages mean a worse functional outcome.
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Baseline and Post-intervention (Week 8)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Health-Related Quality of Life
Periodo de tiempo: Baseline and Post-intervention (Week 8)
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Evaluated using the Short Form-36 (SF-36) questionnaire, which measures 8 health domains.
Scores range from 0 to 100 for each domain, where higher scores represent a better health-related quality of life.
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Baseline and Post-intervention (Week 8)
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Pain Intensity Assessed via Visual Analog Scale (VAS)
Periodo de tiempo: Baseline and Post-intervention (Week 8)
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Measured using the Visual Analog Scale (VAS) for low back pain, where participants rate their pain on a 10-centimeter horizontal line.
Scores range from 0 to 10, where 0 indicates no pain and 10 indicates the most severe imaginable pain.
Higher scores represent worse pain outcomes.
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Baseline and Post-intervention (Week 8)
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Patient Satisfaction
Periodo de tiempo: Post-intervention (Week 8)
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Measured using the Physiotherapy and Rehabilitation Patient Satisfaction Questionnaire.
Total scores range from 0 to 100 (converted from the multi-item scale), where 0 indicates total dissatisfaction and 100 indicates the highest level of satisfaction.
Higher scores mean a better outcome.
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Post-intervention (Week 8)
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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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- TUBITAK-1919B012522773
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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