- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07672197
Psoas Major Muscle Intervention on Chronic Lumbar Pain in Cleaning Professionals.
Influence of the Stretching Technique on the Psoas Major Muscle on Chronic Lumbar Pain in Cleaning Professionals: Randomized Controlled Trial.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Cleaning professionals are particularly vulnerable to musculoskeletal pain, predominantly low back pain due to intense occupational hazards like repetitive movements, heavy lifting in awkward postures, and prolonged standing. The psoas major muscle plays a critical role in this clinical context; morphological changes, such as muscle atrophy and fat infiltration, are commonly observed in low back pain patients. Furthermore, a shortened or asymmetrical psoas alters spinal biomechanics-often increasing lumbar lordosis and overloading facet joints-which strongly predisposes individuals to chronic pain and instability. Furthermore, a shortened or asymmetrical psoas alters spinal biomechanics-often increasing lumbar lordosis and overloading facet joints-which strongly predisposes individuals to chronic pain and instability.
This study aims to highlight the biomechanical importance of the iliopsoas muscle and evaluate the therapeutic impact of the stretching technique in reducing symptoms, improving mobility, and preventing functional limitations associated with iliopsoas dysfunction.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Natália MO Campelo, PhD
- Número de teléfono: +351 222 061 000
- Correo electrónico: nmc@ess.ipp.pt
Ubicaciones de estudio
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Porto, Portugal, 4200-072
- Escola Superior de Saúde do Porto
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Contacto:
- Natália MO Campelo, PhD
- Número de teléfono: +35122 206 1000
- Correo electrónico: nmc@ess.ipp.pt
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Being a cleaning professional for at least 4 years
- Report at least 1 episode of lumbar pain in the last 3 months
Exclusion Criteria:
- Any severe spinal condition (such as spondylolisthesis, spine fracture, etc.)
- Any severe neurological or rheumatological condition
- Pregnancy
- Daily use of pain medication
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 de placebos: Grupo de control
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Patient is positioned supine at the edge of the table.
The investigator places one hand on the participant's ipsilateral knee without applying any pressure or force, and the other hand on the contralateral knee for stabilization.
This position is maintained for 30 seconds to match the duration of the experimental intervention.
The technique was performed bilaterally (once on each side) to the control group.
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Experimental: Experimental group
Psoas major stretching
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The patient is positioned supine at the edge of the table.
The investigator places their hands on both of the participant's knees, applying gentle downward pressure on the ipsilateral knee to stretch the psoas major muscle.
This stretch is held for 30 seconds and performed bilaterally (once on each side) to the experimental group.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Low Back Pain Intensity at Rest Assessed Using the Numeric Pain Rating Scale (NPRS, 0-10)
Periodo de tiempo: Baseline and immediately after completion of the intervention.
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Low back pain intensity at rest will be assessed using the Numeric Pain Rating Scale (NPRS), a self-reported scale ranging from 0 to 10, where 0 indicates "no pain" and 10 indicates "worst imaginable pain."
Higher scores indicate greater pain intensity and therefore a worse outcome.
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Baseline and immediately after completion of the intervention.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Lumbar Range of Motion Assessed Using the Schober Test
Periodo de tiempo: Baseline and immediately after completion of the intervention.
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Lumbar range of motion (ROM) will be assessed using the Schober Test at rest and during anterior lumbar flexion.
The test measures lumbar spine mobility by quantifying the increase in distance between predefined anatomical landmarks during trunk flexion.
Higher values indicate greater lumbar mobility and therefore a better outcome.
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Baseline and immediately after completion of the intervention.
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Hip Flexion Range of Motion Assessed Using a Digital Goniometer
Periodo de tiempo: Baseline and immediately after completion of the intervention.
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Hip flexion range of motion (ROM) will be assessed with the participant in the supine position using a digital goniometer.
Measurements will be recorded in degrees (°).
Higher values indicate greater hip flexion mobility and therefore a better outcome.
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Baseline and immediately after completion of the intervention.
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Natália MO Campelo, ESS
Publicaciones y enlaces útiles
Publicaciones Generales
- Koes BW, van Tulder MW, Thomas S. Diagnosis and treatment of low back pain. BMJ. 2006 Jun 17;332(7555):1430-4. doi: 10.1136/bmj.332.7555.1430. No abstract available.
- Pourahmadi M, Asadi M, Dommerholt J, Yeganeh A. Changes in the macroscopic morphology of hip muscles in low back pain. J Anat. 2020 Jan;236(1):3-20. doi: 10.1111/joa.13086. Epub 2019 Sep 1.
- Abdol Rahman, M. N., Muhamad Jaffar, M. S., Hassan, M. F., Ngali, M. Z., & Pauline, O. Exposure level of ergonomic risk factors in hotel industries. IOP Conference Series: Materials Science and Engineering. 2017. 226, 012018.
- Badarin K, Hemmingsson T, Hillert L, Kjellberg K. Physical workload and increased frequency of musculoskeletal pain: a cohort study of employed men and women with baseline occasional pain. Occup Environ Med. 2021 Jan 17;78(8):558-66. doi: 10.1136/oemed-2020-107094. Online ahead of print.
- Mallio CA, Russo F, Vadala G, Papalia R, Pileri M, Mancuso V, Bernetti C, Volpecina M, Di Gennaro G, Beomonte Zobel B, Denaro V. The importance of psoas muscle on low back pain: a single-center study on lumbar spine MRI. N Am Spine Soc J. 2024 May 1;18:100326. doi: 10.1016/j.xnsj.2024.100326. eCollection 2024 Jun.
- Scherzer T, Rugulies R, Krause N. Work-related pain and injury and barriers to workers' compensation among Las Vegas hotel room cleaners. Am J Public Health. 2005 Mar;95(3):483-8. doi: 10.2105/AJPH.2003.033266.
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
Otros números de identificación del estudio
- OST1-022
Plan de datos de participantes individuales (IPD)
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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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