- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07567703
Comparison of Laser and Shockwave Therapy for Piriformis Syndrome With Adjunctive Exercise (LASWEX-PS)
A Comparative Study of Laser Therapy and Shockwave Therapy in the Treatment of Piriformis Syndrome: The Role of Exercise as an Adjunctive Treatment
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Piriformis syndrome is a common musculoskeletal condition that contributes to chronic low back and gluteal pain, often leading to functional limitations. This prospective randomized controlled trial was conducted to compare the effectiveness of low-level laser therapy (LLLT) combined with therapeutic exercise versus radial extracorporeal shockwave therapy (rESWT) combined with exercise in patients with piriformis syndrome.
A total of 70 participants were randomly assigned into two equal groups. Both interventions were administered over a period of four weeks, with follow-up assessment conducted one month post-treatment. Outcome measures included pain intensity using the Visual Analog Scale (VAS), functional disability using the Oswestry Disability Index (ODI), hip range of motion (ROM), and quality of life using the Short Form-36 (SF-36).
Inclusion criteria:
Adults aged 18 to 65 years who had a confirmed diagnosis of piriformis syndrome. piriformis syndrome required a positive FAIR test and EMG evidence of sciatic nerve involvement. Eligible participants had chronic symptoms lasting at least three months and a baseline Visual Analog Scale (VAS) pain score of ≥4.
Exclusion criteria:
Participants were excluded if they had a history of surgical interventions involving the lumbar spine, sacroiliac joint, or hip; systemic inflammatory diseases such as ankylosing spondylitis or rheumatoid arthritis; neurological disorders impairing lower limb function; or were pregnant or lactating. Individuals with malignancy, bleeding disorders, or pacemaker implantation Pain Intensity measured by Visual Analogue Scale (VAS), Functional Disability - Oswestry Disability Index (ODI) was used to assess functional impairment in lower back pain and functional limitations., Range of Motion (ROM):It had been used to assess joint mobility will be assessed using a standard goniometer, Quality of Life - Short Form-36 (SF-36): Health-related quality of life will be assessed using the Short Form-36 (SF-36) questionnaire assessment performed at baseline , posttreatment after 4 weeks and 3 months follow up post treatment
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Cairo, Egipto
- Outpatient clinics of the Faculty of Physical Therapy, Beni Suef University
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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 to 65 years who had a confirmed diagnosis of piriformis syndrome. piriformis syndrome required a positive FAIR test and EMG evidence of sciatic nerve involvement. Eligible participants had chronic symptoms lasting at least three months and a baseline Visual Analog Scale (VAS) pain score of ≥4.
Exclusion Criteria:
- Participants were excluded if they had a history of surgical interventions involving the lumbar spine, sacroiliac joint, or hip; systemic inflammatory diseases such as ankylosing spondylitis or rheumatoid arthritis; neurological disorders impairing lower limb function; or were pregnant or lactating. Individuals with malignancy, bleeding disorders, or pacemaker implantation
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 |
|---|---|
|
Experimental: Laser + Exercise
Participants receive low-level laser therapy combined with therapeutic exercise for management of piriformis syndrome.
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Participants receive low-level laser therapy combined with a structured therapeutic exercise program for management of piriformis syndrome.
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Experimental: Shockwave + Exercise Group
Participants receive radial extracorporeal shockwave therapy combined with therapeutic exercise.
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Participants receive radial extracorporeal shockwave therapy combined with a structured therapeutic exercise program for management of piriformis syndrome.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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1. Pain Intensity
Periodo de tiempo: 1. Baseline, post-intervention (4 weeks), and 3-month follow-up
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1. Pain intensity will be assessed using the Visual Analog Scale (VAS), a 10-cm scale ranging from 0 (no pain) to 10 (worst imaginable pain).
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1. Baseline, post-intervention (4 weeks), and 3-month follow-up
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2. Hip Range of Motion
Periodo de tiempo: Baseline, post-intervention (4 weeks), and 3-month follow-up
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Hip joint range of motion will be measured in degrees using a standard universal goniometer.
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Baseline, post-intervention (4 weeks), and 3-month follow-up
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3. Quality of Life
Periodo de tiempo: Baseline, post-intervention (4 weeks), and 3-month follow-up
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Health-related quality of life will be assessed using the SF-36 questionnaire.
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Baseline, post-intervention (4 weeks), and 3-month follow-up
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Functional Disability
Periodo de tiempo: Baseline, post-intervention (4 weeks), and 3-month follow-up
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Functional disability will be evaluated using the Oswestry Disability Index (ODI), which measures disability related to low back and gluteal pain.
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Baseline, post-intervention (4 weeks), and 3-month follow-up
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Sahar M Abdelmutilibe, PHD, Faculty of Physical Therapy, Beni Suef University, Cairo, Egypt
Publicaciones y enlaces útiles
Publicaciones Generales
- MF DEO, Johnson DS, Demchak T, Tomazoni SS, Leal-Junior EC. Low-intensity LASER and LED (photobiomodulation therapy) for pain control of the most common musculoskeletal conditions. Eur J Phys Rehabil Med. 2022;58(2):282-9.
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
Palabras clave
Términos MeSH relevantes adicionales
- Dolor
- Manifestaciones neurológicas
- Enfermedades del Sistema Nervioso
- Enfermedades Neuromusculares
- Enfermedades del Sistema Nervioso Periférico
- Neuralgia
- Dolor pélvico
- Mononeuropatías
- Síndromes de compresión nerviosa
- Neuropatía ciática
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Síndrome del músculo piriforme
- Terapéutica
- Modalidades de fisioterapia
- Atención al paciente
- Rehabilitación
- Cuidado por los convalecientes
- Continuidad de la atención al paciente
- Terapia con láser
- Fototerapia
- Terapia de ejercicio
- Terapia de luz de bajo nivel
Otros números de identificación del estudio
- FPTBSUREC/0212/15426 (Otro identificador: Faculty of Physical Therapy, Beni Suef University)
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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