- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04918238
Effect of Muscle Energy Techniques on Functional Abilities in Patients With Discogenic Unilateral Sciatica
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
Disability and emotional distress among patients with lumbar spondylosis has a negative impact on well-being. Anxiety and depression are common emotional problems among patients with LBP.
The experience of pain interferes with different aspects of the patient's life, negatively affecting their daily activities, physical and mental health, family and social relationships, and their interactions in the workplace.
This problem also affects the health care system and what is known as economic well-being, the strong burden associated with Chronic Pain not only deriving from healthcare costs but also from the loss of productivity and from compensatory payments to patients as a result of the disability that pain produces.
Movement research has vast implications for muscle energy techniques for individuals with chronic low back pain and sciatica, the thoracolumbar normal range of motion plays an essential role in transferring the body weight and performing daily activities. Poor spinal range of motion and tightness of paraspinal muscles have previously been noted in individuals with chronic low back pain and sciatica.
Most of the previous studies focused on dealing with chronic low back pain and sciatica through using different medications and physical therapy modalities for the symptoms such as TENS. Since muscle energy techniques can decrease the tension of the muscles of the lumbar spine and gives a real chance to improve the flexibility of those muscles which might inhibit the severity of sciatica with low costs so it's recommended to study its effect on the functional abilities of the patients so that it can be the main part of physical therapy rehabilitation protocol.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Damietta, Egipto, 34518
- Outpatient clinic - Faculty of Physical Therapy - Horus University
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
History of sciatica for more than 12 weeks or has at least 3 episodes of intermittent sciatica, each last for morethan 1 week eitheraccompanied with low back pain during the 3 months before thestudy. Medically and radiologically diagnosed as discogenic chronic sciatica with mild to moderate disability according to modified Rolland and Morris scale.
- Both males and females, aged from 25 to 40 years old.
- Be able to understand and follow the instructions during testing and treatment procedures
Exclusion Criteria:
Fracture of pelvis, spine or lower extremities.
- Hospitalization for severe trauma.
- Peripheral neuropathy of diabetes or any other autoimmune disease.
- Systematic autoimmune disease such as rheumatoid arthritis, systematic lupus
- People with red flags such as cancer or severe osteoporosis.
- Symptoms provoked while doing active hip joint extension and abduction.
- Previous surgery to the lumbar spine, abdomen, pelvis, or hip.
- Any contraindication for exercise therapy (e.g. uncontrolled hypertension, previous myocardial infarction, cardiovascular disease, peripheral vascular disease, respiratory disorders).
- Any pain originated because of SI pathology.
- Menstruation during testing days.
- Individuals incapable of understanding and answering the Questionnaire.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador activo: conventional treatment Arm
All the participants will receive the conventional physical therapy protocol per session as following: Infrared radiation on the low back area for 15 minutes, Ultrasound waves (Digi sonic device) for 10 minutes on the trigger areas of the low back, Myofascial release of the thoracolumbar fascia, Stretching of the Paraspinal muscles and the hamstrings, Mobilization of the lumbar and thoracic spine from a prone lying position and strengthening of abdominal muscles, multifidus and transversal's abdominal muscle.
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All the participants will receive the conventional physical therapy protocol per session as following: Infrared radiation on the low back area for 15 minutes, Ultrasound waves (Digi sonic device) for 10 minutes on the trigger areas of the low back, Myofascial release of the thoracolumbar fascia, Stretching of the Paraspinal muscles and the hamstrings, Mobilization of the lumbar and thoracic spine from a prone lying position and strengthening of abdominal muscles, multifidus and transversal's abdominal muscle.
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Experimental: muscle energy technique arm
Group A received muscle energy technique with lateral recumbent positioning along with Conventional Physiotherapy Program
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All the participants will receive the conventional physical therapy protocol per session as following: Infrared radiation on the low back area for 15 minutes, Ultrasound waves (Digi sonic device) for 10 minutes on the trigger areas of the low back, Myofascial release of the thoracolumbar fascia, Stretching of the Paraspinal muscles and the hamstrings, Mobilization of the lumbar and thoracic spine from a prone lying position and strengthening of abdominal muscles, multifidus and transversal's abdominal muscle.
The patient was in the lateral recumbent position on the side opposite to his, her side-bending dysfunction while the physiotherapist stood facing the subject.
The physiotherapist monitored the lumbar area with one hand while with the other hand flexed the subject's knees and hips until the barrier was engaged at the vertebral segment being treated.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Visual analogue scale (VAS)
Periodo de tiempo: "through study completion, an average of 2 months"
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Change from baseline Pain and at 2 months
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"through study completion, an average of 2 months"
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Oswestry disability index scale
Periodo de tiempo: "through study completion, an average of 2 months"
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Change from baseline disability and at 2 months
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"through study completion, an average of 2 months"
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
- Basem_MSc
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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