Mirror Image Spine Correction Exercises Versus Conservative Physiotherapy for Lumbar Radiculopathy (MIRROR-LR)
Randomized, Parallel-Group, Superiority Trial of Mirror Image Spine Correction Exercises Versus Conservative Physiotherapy for Lumbar Nerve Root Microstructural Integrity Assessed by Diffusion Tensor Imaging in Adults With Lumbar Radiculopathy
Lumbar radiculopathy is a common condition caused by irritation or compression of a lumbar nerve root, often resulting in radiating leg pain, numbness, weakness, and functional limitation. Conservative physiotherapy is commonly used as first-line treatment, but outcomes vary among patients.
This randomized controlled trial will compare Mirror Image Spine Correction Exercises with standardized conservative physiotherapy in adults with lumbar radiculopathy. Participants will be randomly assigned to one of two treatment groups for 12 weeks.
The primary outcome is lumbar nerve root microstructural integrity measured using Diffusion Tensor Imaging (DTI), including Fractional Anisotropy and other diffusion parameters. Secondary outcomes include pain intensity, disability, spinal alignment, and adverse events.
The purpose of this study is to determine whether a targeted posture-correction exercise approach provides greater improvement than conventional physiotherapy.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
Lumbar radiculopathy is a neuromusculoskeletal disorder commonly caused by lumbar disc herniation or foraminal stenosis leading to nerve root irritation or compression. Symptoms commonly include radiating leg pain, paresthesia, weakness, altered reflexes, and reduced physical function.
Conservative physiotherapy is recommended as first-line management and may include education, graded exercise, mobility restoration, strengthening, neural mobilization, and symptom management. However, treatment response is heterogeneous, and many patients continue to experience persistent symptoms.
Most previous rehabilitation studies have relied primarily on patient-reported outcomes such as pain and disability. These measures are clinically important but may not fully reflect biological recovery of the affected nerve root.
Diffusion Tensor Imaging (DTI) is an advanced magnetic resonance imaging technique that can quantify neural tissue microstructure. Parameters such as Fractional Anisotropy (FA), Mean Diffusivity (MD), Axial Diffusivity (AD), and Radial Diffusivity (RD) may provide objective markers of nerve recovery.
Mirror Image Spine Correction Exercises are individualized posture-based exercises designed to move the trunk or pelvis opposite to identified alignment deviations. This approach may improve biomechanics, reduce abnormal loading, and decrease neural irritation.
This study is a prospective randomized, parallel-group, superiority trial. Eligible adults with unilateral lumbar radiculopathy will be randomly allocated in a 1:1 ratio to:
Mirror Image Spine Correction Exercise group Standardized Conservative Physiotherapy group Both groups will receive supervised treatment sessions three times per week for 12 weeks.
Primary Outcome:
Change in lumbar nerve root microstructural integrity measured by DTI at baseline and week 12.
Secondary Outcomes:
Pain intensity Disability (Oswestry Disability Index) Spinal alignment Safety outcomes and adverse events The study aims to determine whether Mirror Image Spine Correction Exercises produce superior clinical and imaging outcomes compared with conservative physiotherapy.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: fatima A Alowais, PT
- Número de teléfono: +971566663372
- Correo electrónico: fatimaalowais7@gmail.com
Copia de seguridad de contactos de estudio
- Nombre: Tamer shousha, PhD
- Número de teléfono: +971562224469
- Correo electrónico: tshousha@sharjah.ac.ae
Ubicaciones de estudio
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Emirate of Sharjah
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Sharjah city, Emirate of Sharjah, Emiratos Árabes Unidos
- Al Qassimi Hospital
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Contacto:
- fatima A Alowais, PT
- Número de teléfono: +971566663372
- Correo electrónico: fatimaalowais7@gmail.com
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Contacto:
- Tamer shousha, PhD
- Número de teléfono: +971562224469
- Correo electrónico: tshousha@sharjah.ac.ae
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Investigador principal:
- Tamer Shousha, Phd
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Sub-Investigador:
- fatima Alowais, PT
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Adults aged 18 years or older. Clinical diagnosis of unilateral lumbar radiculopathy. Presence of at least two of the following: dermatomal radiating leg pain, neurological deficit, positive neural tension test.
MRI-confirmed lumbar nerve root compression or irritation consistent with symptoms.
Pain intensity of 3/10 or greater. Able to undergo MRI and Diffusion Tensor Imaging (DTI). Able to understand study procedures and provide written informed consent.
Exclusion Criteria:
- Previous lumbar spine surgery. Bilateral radiculopathy or unclear diagnosis. Tumor, infection, fracture, inflammatory spinal disease, or cauda equina syndrome.
Severe progressive neurological deficit requiring urgent treatment. Contraindications to MRI (pacemaker, incompatible implants, severe claustrophobia).
Recent lumbar injections or surgery. Other neurological or musculoskeletal disorders affecting outcomes. Pregnancy if MRI contraindicated by local policy. Cognitive impairment or inability to follow instructions.
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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Experimental: Mirror Image Spine Correction Exercises
Participants will receive a supervised individualized Mirror Image Spine Correction Exercise program three sessions per week for 12 weeks.
Exercises will be based on postural alignment findings and include a prescribed home exercise program.
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Participants will receive an individualized supervised exercise program based on identified postural alignment deviations.
Treatment will be delivered three sessions per week for 12 weeks and may include trunk and pelvic corrective movements, mobility, stabilization, and a prescribed home exercise program.
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Comparador activo: Conservative Physiotherapy
Participants will receive standardized conservative physiotherapy three sessions per week for 12 weeks including education, graded exercise, mobility training, strengthening, and clinically indicated adjunctive techniques.
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Participants will receive standardized conservative physiotherapy three sessions per week for 12 weeks including education, graded exercise, mobility exercises, strengthening, neural mobilization, and clinically indicated adjunctive non-invasive techniques.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Lumbar Nerve Root Fractional Anisotropy
Periodo de tiempo: Baseline and Week 12
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Change in lumbar nerve root microstructural integrity measured using Diffusion Tensor Imaging (DTI) Fractional Anisotropy.
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Baseline and Week 12
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Pain Intensity
Periodo de tiempo: Baseline and Week 12
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Measured using Numeric Pain Rating Scale (0-10).
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Baseline and Week 12
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Spinal Alignment
Periodo de tiempo: Baseline and Week 12
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Measured using digital posture analysis.
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Baseline and Week 12
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Additional DTI Parameters
Periodo de tiempo: Baseline and Week 12
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Mean Diffusivity, Axial Diffusivity, and Radial Diffusivity.
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Baseline and Week 12
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
Enlaces Útiles
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
- Dolor
- Manifestaciones neurológicas
- Enfermedades del Sistema Nervioso
- Enfermedades Neuromusculares
- Enfermedades del Sistema Nervioso Periférico
- Neuralgia
- Dolor de espalda
- Mononeuropatías
- Neuropatía ciática
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Radiculopatía
- Lumbalgia
- Ciática
- Enfermedad del disco intervertebral
Otros números de identificación del estudio
- UOS-PHD-LRDTI-2026-01
- U25103971 (Otro identificador: University of Sharjah)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Marco de tiempo para compartir IPD
Criterios de acceso compartido de IPD
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
- CÓDIGO_ANALÍTICO
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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