- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02375386
Feasibility Assessment of Neurophysiological Measurement in Veterans With LBP
CENTRAL MECHANISMS OF BODY BASED INTERVENTION FOR MUSCULOSKELETAL LOW BACK PAIN: Feasibility Assessment of Neurophysiological Measurement in Veterans With Low Back Pain
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Participants will be enrolled from VA pain clinical at the North Florida/South George VA Medical Center.
The investigators will collect functional magnetic resonance imaging data of resting state and pain-related events (i.i. during thermal pain sensitivity testing, as well as psychophysical data to determine pain sensitivity. Pain sensitivity will be measured using thermal and mechanical stimuli. These data will be collected before and after the interventions, in addition to two follow-up sessions after intervention.
In addition, clinical measures of pain intensity in the low back, as well as trunk range of motion and strength will also be collected.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Florida
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Gainesville, Florida, Estados Unidos, 32610-0154
- University of Florida
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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:
- complaints of current back pain that they rate at least 40 on a 101-point numeric rating scale
- Participants must able to understand written and spoken English
Exclusion Criteria:
- currently receiving treatment for LBP or have received SMT for LBP in the past year
- Quebec Task Force on Spinal Disorders (QTFSD) to identify patients with pre-existing nerve root compression, spinal stenosis, or post-surgery
- any chronic medical conditions that may affect pain perception (e.g., diabetes, high blood pressure, fibromyalgia, headaches)
- any contraindication to MRI
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Spinal manipulation
Participants will receive a lumbar SMT technique previously described in the literature and commonly utilized for the treatment of low back pain .
The SMT will be performed four times (two times on each side) in a 5-minute period.
In addition, the following will be performed: Functional MRI (fMRI), Behavioral: Pain Sensitivity Testing, Questionnaires,Behavioral: Physical Impairment.
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Participants will receive a lumbar SMT technique previously described in the literature and commonly utilized for the treatment of low back pain .
The SMT will be performed four times (two times on each side) in a 5-minute period.
In addition, the following will be performed: Functional MRI, Behavioral: Pain Sensitivity Testing, Questionnaires,Behavioral: Physical Impairment.
Both groups will receive an fMRI.
Otros nombres:
Both groups will receive an Pain Sensitivity Testing
Both groups will receive Questionnaires
Both groups will receive testing on physical impairment.
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Comparador falso: Therapeutic touch
Participants in this group will lie prone.
The therapist will place both hands in contact with the participants' pelvis across the top of the posterior aspect of the sacrum and ilia and apply a downward force to keep the pelvis in contact with the table.
This group accounts for effects of time and personal contact.
The amount of "hands-on" contact will be equivalent between groups.
Both groups will be given the same verbal instructions regarding the techniques performed.
In addition, the following will be performed: Functional MRI (fMRI), Behavioral: Pain Sensitivity Testing, Questionnaires,Behavioral: Physical Impairment.
|
Both groups will receive an fMRI.
Otros nombres:
Both groups will receive an Pain Sensitivity Testing
Both groups will receive Questionnaires
Both groups will receive testing on physical impairment.
Participants in this group will lie prone.
The therapist will place both hands in contact with the participants' pelvis across the top of the posterior aspect of the sacrum and ilia and apply a downward force to keep the pelvis in contact with the table.
This group accounts for effects of time and personal contact.
The amount of "hands-on" contact will be equivalent between groups.
Both groups will be given the same verbal instructions regarding the techniques performed.
In addition, the following will be performed: Functional MRI, Behavioral: Pain Sensitivity Testing, Questionnaires,Behavioral: Physical Impairment.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
fMRI during testing of pain changes from approximately Day 3 and Day 5
Periodo de tiempo: Change from approximately Day 3 and Day 5
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Change from approximately Day 3 and Day 5
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fMRI during quite rest changes from approximately Day 3 and Day 5
Periodo de tiempo: Change from approximately Day 3 and Day 5
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Change from approximately Day 3 and Day 5
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Pain Sensitivity Testing changes from Day 3, Day 4 and Day 5
Periodo de tiempo: Change from Day 3, Day 4 and Day 5
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This measure thermal threshold and tolerance using continuous heat stimulus delivered to the participants' dominant arm.
The stimulus will start at 35°C and will be increased at a rate of 0.5°C with participants terminating the stimulus when the temperature reached pain threshold ("when the sensation first transitions from heat to pain") and tolerance ("when the sensation becomes so strong you want to remove it from your skin").
Threshold and tolerance measures will also be collected using mechanical pressure applied using a Fischer Dolorimeter.
During Dolorimeter testing, force is slowly increased until the subject indicates that the sensation changes from pressure to pain.
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Change from Day 3, Day 4 and Day 5
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Pain Intensity
Periodo de tiempo: Change from Day 3, Day 4 and Day 5
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Pain visual analog scale is a 10cm long line.
The line is anchored at one end with 'none' or 'not bad at all' and at the other with 'worst imaginable.' Participants are asked to rate their pain at rest by placing a mark along the 10cm line.
Participants will also rate pain during active trunk range of motion using the same scale.
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Change from Day 3, Day 4 and Day 5
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McGill Pain Questionnaire-2
Periodo de tiempo: Change from Day 3, Day 4 and Day 5
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This is 22-item questionnaire that asks participants to describe the intensity of varies qualities of the pain that he or she is experiencing; for example, throbbing or itching.
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Change from Day 3, Day 4 and Day 5
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Physical Impairment
Periodo de tiempo: Change from Day 3, Day 4 and Day 5
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A physical impairment scale consists of 7 different examination procedures that assess lumbar and hip range of motion, muscle performance of trunk musculature, and response to palpation.
Scores is 0 - 8, Range is 0 is no impairment and 8 is completely impaired.
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Change from Day 3, Day 4 and Day 5
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Oswestry Disability Questionnaire (ODQ)
Periodo de tiempo: Change from Day 3, Day 4 and Day 5
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The ODQ has a range of 0 (no disability due to back pain) to 100 (completely disabled due to back pain), so higher scores indicate higher disability from LBP.
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Change from Day 3, Day 4 and Day 5
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Mark D Bishop, PhD, University of Florida
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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 (Estimar)
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
- IRB201300827-N
- 3R01AT006334-02S1 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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