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- Ensayo clínico NCT07648927
Evaluation of the Effectiveness of Physical Therapy for Low Back Pain According to Magnetic Resonance Imaging Findings
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Low back pain is one of the leading causes of disability worldwide and represents a major public health burden. Magnetic resonance imaging (MRI) is commonly used to evaluate lumbar spine pathologies such as disc herniation, disc degeneration, Modic changes, facet joint arthropathy, and spinal stenosis. However, previous studies have demonstrated that many degenerative MRI findings are also present in asymptomatic individuals, raising questions regarding their clinical significance and prognostic value.
Physical therapy is a cornerstone of conservative management for low back pain and has been shown to improve pain and functional outcomes. Nevertheless, treatment response varies considerably among patients, and factors influencing these differences remain incompletely understood. Baseline MRI findings may represent one potential predictor of treatment outcome, yet studies investigating this relationship are limited.
The present retrospective study will evaluate whether treatment outcomes following a standardized physical therapy program differ according to lumbar MRI findings. Medical records of patients aged 18-65 years who presented with low back pain to the Physical Medicine and Rehabilitation Clinic of Medical Park Göztepe Hospital between January 2022 and February 2026 will be reviewed. Eligible patients must have undergone lumbar MRI and completed a standardized 15-session physical therapy program consisting of hot pack application, ultrasound therapy, interferential current therapy, and transcutaneous electrical nerve stimulation (TENS).
Patients will be categorized into three MRI groups: disc herniation, disc degeneration and non-specific MRI findings. MRI images will be reviewed and classified by an experienced physiatrist. Pain intensity and functional disability routinely recorded before and after treatment using the Visual Analog Scale (VAS) and Oswestry Disability Index (ODI) will be extracted from medical records.
The primary outcome will be the change in VAS pain score following treatment. Secondary outcomes will include changes in ODI scores. Comparisons of treatment response among MRI groups will be performed using appropriate parametric or non-parametric statistical tests. Multivariable regression analyses will be conducted to determine whether MRI findings independently predict treatment outcomes after adjustment for potential confounding factors.
The results of this study may improve understanding of the prognostic value of lumbar MRI findings and contribute to the development of more personalized rehabilitation approaches for patients with low back pain.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: zeynep Iyigun, Prof. MD
- Número de teléfono: +905056987368
- Correo electrónico: znperdogan@gmail.com
Ubicaciones de estudio
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Istanbul, Turquía (Türkiye)
- Bahçeşehir University
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Contacto:
- Zeynep İyigün
- Número de teléfono: +905056987368
- Correo electrónico: znperdogan@gmail.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Age between 18 and 65 years.
- Completion of 15 sessions of physical therapy.
- Availability of accessible MRI images in the medical records.
- No history of lumbar spine surgery.
- Absence of conditions that may cause low back pain, including fibromyalgia, neuropathy, spondyloarthropathy, or scoliosis.
Exclusion Criteria:
- Presence of comorbid conditions that may cause low back pain (fibromyalgia, rheumatologic diseases, scoliosis, herpes zoster, polyneuropathy, central pain syndromes).
- Presence of systemic neuromuscular disorders.
- Acute disc herniation or vertebral fracture.
- Receipt of fewer or more than 15 sessions of physical therapy.
- Missing data in follow-up records.
- Use of analgesic medications during the treatment period.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Otro: Patients with Low Back Pain Receiving Standard Physical Therapy
Patients aged 18-65 years who presented with low back pain, underwent lumbar MRI examination, and completed a standardized 15-session physical therapy program consisting of hot pack application, ultrasound therapy, interferential current therapy, and transcutaneous electrical nerve stimulation (TENS).
Participants will be retrospectively classified according to baseline MRI findings into disc herniation, disc degeneration, Modic changes, facet arthropathy, spinal stenosis, and non-specific MRI groups for outcome analyses.
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Participants received a standardized physical therapy program consisting of 15 treatment sessions.
The treatment protocol included hot pack application, therapeutic ultrasound, interferential current therapy, and transcutaneous electrical nerve stimulation (TENS).
All interventions were administered as part of routine clinical care for low back 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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Change in disability measured by the Oswestry Disability Index (ODI)
Periodo de tiempo: Baseline and immediately after completion of the 15-session physical therapy program (approximately 3 weeks).
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Functional disability will be assessed using the Oswestry Disability Index (ODI), which ranges from 0 to 100, where higher scores indicate greater disability and worse functional status.
A reduction in score indicates improvement.
The outcome measure will be the change in ODI score from baseline to completion of the 15-session physical therapy program.
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Baseline and immediately after completion of the 15-session physical therapy program (approximately 3 weeks).
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in pain intensity measured by the Visual Analog Scale (VAS)
Periodo de tiempo: Baseline and after completion of 15 physical therapy sessions (approximately 3 weeks)
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Pain intensity will be assessed using the Visual Analog Scale (VAS), a 10-centimeter scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
A reduction in score indicates improvement.
The outcome measure will be the change in VAS score from baseline to completion of the 15-session physical therapy program.
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Baseline and after completion of 15 physical therapy sessions (approximately 3 weeks)
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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
Términos MeSH relevantes adicionales
- Dolor
- Manifestaciones neurológicas
- Enfermedades óseas
- Enfermedades musculoesqueléticas
- Condiciones Patológicas, Anatómicas
- Enfermedades de la columna
- Hernia
- Dolor de espalda
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Desplazamiento del disco intervertebral
- Lumbalgia
- Degeneración del disco intervertebral
Otros números de identificación del estudio
- BAU-FTR-2026-07/03
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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