- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04646018
The Effect of Lumbopelvic Non-Thrust Spinal Manipulation on Individuals With Low Back Pain
The Effect of Lumbopelvic Non-Thrust Spinal Manipulation on Muscle Thickness of the Sacral Multifidi, Lumbar Motion, and Self-Reported Pain
The purpose of this experiment is to determine the effects of a non-thrust manipulation procedure on muscle function, spinal mobility, and pain level on those experiencing low back pain (LBP) in a sample of individuals who identify English as their primary language. The rationale for this language criterion is provided in Section 9:F of this application. Muscle function will be measured via the muscle thickness of a deep spinal stabilizing muscle (multifidus, MF) while in both a resting state and during a maximum voluntary contraction (MVC). Spinal mobility will be measured as the active range of motion of both forward and backward trunk bending. Pain level will be a self-report measure recorded during rest and active range of motion.
Hypothesis 1: A non-thrust manipulation procedure will increase the thickness of the sacral multifidus both at rest and during a maximum voluntary contraction
Hypothesis 2: A non-thrust manipulation procedure will result in greater low back active range of motion.
Hypothesis 3: A non-thrust manipulation procedure will result in a reduction in the participant's self-reported pain levels both at rest and during active range of motion movements.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Pennsylvania
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Reading, Pennsylvania, Estados Unidos, 19606
- Alvernia 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:
- Participants are individuals with current complaint of low back pain, defined as pain that is present in the region from just below the rib cage to just below the buttocks.
- Participants will be 18 years of age or older
- Participants must be experiencing an episode of low back pain at the present time that is at any level on a Numerical Pain Rating Scale & Pain Diagram (NPRS) from 1-10
- Participants must demonstrate the ability to maintain standing and prone postures for several minutes at a time and perform lumbar active range of motion in a standing position
- Participants must report the presence of their low back pain during performance of active forward and/or backward bending in standing
- Participants must demonstrate the ability to communicate in conversational English, that includes speaking, reading, and writing.
Exclusion Criteria:
- Participants who are currently involved in litigation that is directly related to the participant's current episode of low back pain
- Participants with known or suspected pregnancy
Participants with confirmed diagnosis of any of the following conditions:
- Central nervous system disorder
- Rheumatoid Arthritis
- Spinal Fracture
- Spondyloarthropathy (i.e., Ankylosing Spondylitis)
- Tumor or infection of the spine
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 |
---|---|
Experimental: Lumbar Manipulation Group
Group that receives experimental lumbar non-thrust manipulation
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Lumbar non-thrust manipulation is a passive movement that is performed with a rhythm and a grade in a manner in which the patient is able to prevent the technique from being performed.
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Comparador falso: Sham Manipulation Group
Group that receives sham lumbar non-thrust manipulation
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Lumbar non-thrust manipulation without force applied
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Changes in Sacral Multifidus Muscle Thickness
Periodo de tiempo: Change from Pre to immediately Post Manipulation/Sham
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Rehabilitation Ultrasound Images of Sacral Multifidus muscle thickness at rest and during a maximal isometric contraction
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Change from Pre to immediately Post Manipulation/Sham
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Changes in Lumbar Active Range of Motion
Periodo de tiempo: Change from Pre to immediately Post Manipulation/Sham
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Inclinometry of Lumbar Active Range of Motion in Standing
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Change from Pre to immediately Post Manipulation/Sham
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Changes in Low Back Pain
Periodo de tiempo: Change from Baseline to immediately Post Manipulation/Sham to 24-48 hours post session
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Visual Analogue Scale of Low Back Pain (0-10 scale with 0=least pain, 10=worst pain)
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Change from Baseline to immediately Post Manipulation/Sham to 24-48 hours post session
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Changes in Oswestry Disability Questionnaire (0-100 scale, 0=no disability, 100=bed bound, exaggerating symptoms)
Periodo de tiempo: Change from Baseline to 24-48 hours post session
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Self-assessment disability paper survey
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Change from Baseline to 24-48 hours post session
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Changes in Fear-Avoidance Beliefs Questionnaire (0-96, 96=maximum fear-avoidance beliefs)
Periodo de tiempo: Change from Baseline to 24-48 hours post session
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Self-assessment disability paper survey
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Change from Baseline to 24-48 hours post session
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Changes in Global Rating of Change (-7 to +7 scale, -7=a very great deal worse, +7=a very great deal better)
Periodo de tiempo: Change from Baseline to 24-48 hours post session
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Self-assessment disability paper survey
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Change from Baseline to 24-48 hours post session
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Joshua Cleland, PhD, Nova Southeastern University
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
- AlverniaU
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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