Measuring Reliability of Spine Mobilization in Low Back Pain
11 de mayo de 2026 actualizado por: University of Kansas Medical Center
This observational study aims to learn how to measure joint motion and tissue response when pressure is applied to the back and examine how the nervous system responds to the applied pressure. This pressure or mobilization technique is a standard care but we currently do not have a method to measure this technique. Through this study, we hope to validate a tool that allows physical therapists to measure the pressure applied during spinal mobilization.
Participants will be asked to:
- Receive spinal mobilization
- Participate in pain threshold testing
- Answer questionnaires
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
De observación
Inscripción (Actual)
50
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
Kansas
-
Kansas City, Kansas, Estados Unidos, 66103
- University of Kansas Medical Center
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Método de muestreo
Muestra no probabilística
Población de estudio
A convenience sample of healthy subjects (faculty and students, n=25) and subjects with chronic low back pain (n=25) will be recruited from the KUMC campus.
Subjects will be excluded if they report lumbar bony or joint pathology (i.e.
osteoporosis, rheumatoid arthritis), lumbar/sacral deformities (i.e.
spondylolisthesis, spina bifida), spinal surgery, have BMI >30, or are pregnant.
Descripción
Inclusion Criteria:
- Healthy individuals without current or recent history (within 6 months) of low back pain
- 18-70 years of age
- BMI between 18.5-29.9
- Ability to read and understand English
- For those with chronic low back pain: 1) low back pain more than 3 months and 2) a minimal pain level of 3 on the 0-10 pain numerical rating scale (NRS) in the last 7 days
Exclusion Criteria:
- Any signs or symptoms of lumbar pathology (as reported by the participant during interview such as low back pain, or lower limb neurological signs)
- History of any spinal surgery
- Lumbar/sacral conditions reported by the subject such as spondylolithesis, spina bifida or spinal fracture
- Bony pathology such as osteoporosis or rheumatoid arthritis as reported by the participant
- Pregnancy
- Spine cancer
- BMI >30
- Unable to lay on stomach
- Resting blood pressure more than 160/90 mmHg
- Currently taking blood thinning medications
- Uncontrolled diabetes
- A medical exclusion from having blood pressure taken such as a peripheral neuropathy
- Low signal to noise ratio fNIRS signal during calibration/setup
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
Healthy Participants
Spinal mobilization
|
The application of manual pressure to stiff spinal segments to improve mobility and control pain.
|
|
Chronic Low Back Pain Participants
Spinal mobilization
|
The application of manual pressure to stiff spinal segments to improve mobility and control pain.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Joint displacement as measured by the laboratory methods and from the lumbar mobilization feedback system.
Periodo de tiempo: Change from Baseline (day1) to immediately post-treatment (day 1)
|
The amount of joint motion for a given grade as measured by the laboratory methods and from the lumbar mobilization feedback system.
|
Change from Baseline (day1) to immediately post-treatment (day 1)
|
|
Applied forces as measured by the laboratory methods and lumbar mobilization feedback system
Periodo de tiempo: Change from Baseline (day1) to immediately post-treatment (day 1)
|
The magnitude of force produced by the clinician for each grade as measured by the laboratory methods and lumbar mobilization feedback system
|
Change from Baseline (day1) to immediately post-treatment (day 1)
|
|
Tissue resistance as measured by laboratory methods and the lumbar mobilization feedback system
Periodo de tiempo: Change from Baseline (day1) to immediately post-treatment (day 1)
|
The degree of stiffness of the joint measured as measured by laboratory methods and the lumbar mobilization feedback system
|
Change from Baseline (day1) to immediately post-treatment (day 1)
|
|
Change in muscle activation as measured by electromyography
Periodo de tiempo: Change from Baseline (day1) to immediately post-treatment (day 1)
|
Differences in recorded electromyography (EMG) activity before and after administration of the intervention
|
Change from Baseline (day1) to immediately post-treatment (day 1)
|
|
Change in pain threshold as measured by quantitative sensory testing.
Periodo de tiempo: Change from Baseline (day1) to immediately post-treatment (day 1)
|
The following tests will be used to test sensation threshold before and after grade I - IV mobilization/clinician: pressure pain threshold, conditioned pain modulation, and temporal summation.
|
Change from Baseline (day1) to immediately post-treatment (day 1)
|
|
Brain functional connectivity as measured by functional near infrared spectroscopy
Periodo de tiempo: Change from Baseline (day1) to immediately post-treatment (day 1)
|
Functional near infrared spectroscopy (fNIRS) is a portable, non-invasive, and inexpensive brain imaging method of monitoring cerebral hemodynamic activity.
|
Change from Baseline (day1) to immediately post-treatment (day 1)
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
2 de octubre de 2024
Finalización primaria (Actual)
2 de febrero de 2025
Finalización del estudio (Actual)
2 de febrero de 2025
Fechas de registro del estudio
Enviado por primera vez
12 de mayo de 2025
Primero enviado que cumplió con los criterios de control de calidad
11 de mayo de 2026
Publicado por primera vez (Actual)
13 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
13 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
11 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- STUDY00148661
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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