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- Ensayo clínico NCT07661290
Effect of High-Power Laser Therapy on Disc Morphology and Functional Outcome in Patients With Cervical Radiculopathy
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
cervical radiculopathy is one of the most common and debilitating conditions. It occurs due to the compression or irritation of nerve roots, often caused by intervertebral disc herniation or degenerative disc disease. Patients with this condition typically experience neck pain radiating to the arms, accompanied by sensory disturbances, weakness, or diminished reflexes, which significantly impair functional ability and quality of life (Smith et al., 2020; Jones & Miller, 2019).
Conventional treatment approaches for cervical radiculopathy include conservative methods such as physiotherapy, pharmacological interventions, and in severe cases, surgical decompression. While these options may provide symptomatic relief, they often fail to address underlying structural and physiological changes, such as disc degeneration or nerve dysfunction. Additionally, surgical interventions carry inherent risks, including infection and nerve damage, and are not suitable for all patients. This has driven the search for alternative, non-invasive treatment modalities that can address both symptoms and the root causes of the condition.High-power laser therapy (HPLT) has emerged as a promising solution in this context. HPLT uses focused laser light to deliver high energy to tissues, stimulating cellular repair processes, reducing inflammation, and promoting analgesia through photo biomodulation. Unlike low-level laser therapy, HPLT delivers higher energy levels, allowing deeper tissue penetration and potentially greater therapeutic effects (Clark et al., 2021). These mechanisms make HPLT particularly suited for treating conditions like cervical radiculopathy, where inflammation, nerve irritation, and tissue degeneration coexist.
Despite its growing popularity, the evidence supporting the efficacy of HPLT in cervical radiculopathy is still limited. Current research mainly highlights its potential for pain reduction, but there is a lack of rigorous, controlled trials evaluating its impact on disc morphology and overall functional recovery. For instance, a recent study by Williams et al. (2022) demonstrated significant pain relief in patients treated with HPLT, yet did not assess structural or electrophysiological outcomes. This highlights the need for further investigation to establish HPLT as a comprehensive treatment modality.
This study aims to bridge this knowledge gap by systematically evaluating the effects of high-power laser therapy on key outcomes, including disc morphology, and functional activity in patients with cervical radiculopathy. By addressing these dimensions, the research seeks to provide a comprehensive understanding of HPLT's role in managing cervical radiculopathy. It also aims to contribute to the development of evidence-based guidelines for its clinical application, offering a safer and more effective alternative to traditional interventions.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Diana Aahed Mahmoud Mushtaha, M.Sc
- Número de teléfono: +201119221077
- Correo electrónico: daiana.mushtaha@gmail.com
Copia de seguridad de contactos de estudio
- Nombre: Ibrahim Mohamed Hamoda, Assistant Professor
Ubicaciones de estudio
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Cairo, Egipto
- Reclutamiento
- Al Kasr Al Aini French Teaching Hospital
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Contacto:
- Diana Aahed Mahmoud Mushtaha, M.Sc. in Physical Therapy
- Número de teléfono: +201119221077
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Contacto:
- Correo electrónico: Daiana.mushtaha@gmail.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Adults aged between 40 to 60 years.
• A Body Mass Index (BMI) range of 18.5-35 (normal to overweight) will be required.
• Diagnosed with cervical radiculopathy, confirmed by clinical examination and diagnostic imaging (e.g., MRI).
• Pain intensity level of at least 4 on the Visual Analog Scale (VAS).
• No previous history of surgery on the cervical spine.
• Able to provide informed consent and participate in the study protocol.
Exclusion Criteria:
- Pregnant women or those planning to become pregnant. • Individuals with severe comorbidities that could interfere with the study, such as uncontrolled diabetes, cancer, or systemic inflammatory diseases.
Individuals with severe cervical stenosis or spinal cord compression.
• Individuals any form of malignancy, active infection, or dermatological issues on the neck.
• Patients using opioid analgesics or other strong pain medications that could alter the results.
• Previous treatment with high-power laser therapy within the last six months.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: study group
This group will consist of 30 patients, who will receive high-power laser therapy (HPLT) for 8 weeks.
High-Power Laser Therapy (HPLT) Description: High-Power Laser Therapy (HPLT): parameters Wavelength: 1064 nm Power output: 8-10 W Frequency: Pulsed wave (CW) Treatment Duration: 10-20 minutes per session Treatment Frequency: 3 sessions per week for 8 weeks (total of 24 sessions).
Application: The laser is applied to the area of pain and nerve root compression, focusing on disc hydration, pain relief, and reduction of inflammation.
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High-Power Laser Therapy (HPLT): parameters Wavelength: 1064 nm Power output: 8-10 W Frequency: Pulsed wave (CW) Treatment Duration: 10-20 minutes per session Treatment Frequency: 3 sessions per week for 8 weeks (total of 24 sessions).
Application: The laser is applied to the area of pain and nerve root compression, focusing on disc hydration, pain relief, and reduction of inflammation.
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Comparador activo: Control Group
Control Group: This group will consist of 30 patients, who will receive Ultrasound, Interferential Current, and Hot Packs for eight weeks.
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- Ultrasound therapy: Frequency: 1 MHz (deep tissue penetration) Intensity: 1.5-2 W/cm² Duration: 8-10 minutes per session Application: Applied to the affected cervical region to enhance tissue healing and reduce pain and inflammation. - Interferential current therapy: Frequency: 4,000 Hz (with a beat frequency of 80-150 Hz) Intensity: Adjusted to produce a comfortable muscle contraction without causing pain Duration: 10-15 minutes per session Application: Applied to the cervical region to reduce pain and improve circulation. - Hot Packs: Temperature: 40°C - 45°C Duration: 15-20 minutes per session Application: Applied to the cervical region to promote muscle relaxation and alleviate discomfort. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Disc height
Periodo de tiempo: 8 weeks
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Disc height: Measured using sagittal images, comparing the anterior and posterior heights of the cervical disc, height in meters.
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8 weeks
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Disc hydration
Periodo de tiempo: 8 weeks
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Disc hydration: Assessing changes in the signal intensity of the intervertebral disc, which indicates water content.
This is typically measured on T2-weighted MRI sequences.
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8 weeks
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Disc protrusion
Periodo de tiempo: 8 weeks
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- Disc protrusion: Examined using both sagittal and axial views to detect any changes in the disc's morphology, including the presence of herniation or bulging
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8 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Functional outcome
Periodo de tiempo: 8 weeks
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Neck Disability Index (NDI) is used to assess disability related to neck pain and functional activity at baseline, and post-treatment.
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8 weeks
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Hussein Ahmed Shaker, Professor, Cairo University
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
Otros números de identificación del estudio
- P.T.REC/012/005800
Información sobre medicamentos y dispositivos, documentos del estudio
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