Pain Detecting and Analgesic Stimulating Device on Low Back Pain
8 de enero de 2016 actualizado por: Jo Nijs, Vrije Universiteit Brussel
The Effects of a Pain Detecting and Analgesic Stimulating Device on Low Back Pain Patients' Clinical Outcomes
Purpose of study is to test in a randomized controlled trial (RCT) the effects of the Nervomatrix device on various clinical outcomes of patients with low back pain, as well as its mechanisms of action.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
This will be a matched randomized-controlled trial - RCT.
Using random numbers from a random number generator, pairs of patients will be randomized to either the Nervomatrix stimulation (experimental group) or to sham stimulation (controls).
Matching of pairs will be done based on the baseline data of the primary outcomes - pain and disability, as well as on other treatments received.
Tipo de estudio
Intervencionista
Inscripción (Actual)
39
Fase
- No aplica
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
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Brussel, Bélgica, 1050
- Vrije Universiteit Brussel
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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
18 años a 65 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- chronic low back pain persisting for at least 3 months
Exclusion Criteria:
- patho-anatomical diagnosis (such as fractures, tumors, rheumatic diseases and neurological diseases)
- initiated a new conventional therapy during the study period
- pregnant
- patients having a cardiac pacemaker, implanted defibrillator, or other implanted metallic or electronic device
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
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Stimulation
Patients will undergo 6 sessions, each including 20 minutes of stimulation.
These are given after the Nervomatrix device determines the peak pain regions for each patient, and selects to stimulate the top 10 regions with least skin resistance.
The frequency of stimulation is 8Hz, at an intensity matched for each patient's tolerance, without inflicting any pain.
The location of the stimulations will change in accordance to the changes in the peak pain regions, reflecting changes in tissue physiology possibly linked to clinical improvements.
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The Nervomatrix device first measures skin impedance, and then creates a digital pain matrix map of the back.
Regions with low resistance are then selected for brief electric stimulation, thus targeting the treatment to specific peak pain regions.
Preliminary evidence supports the effectiveness of this device in reducing pain and disability over 6 sessions
Otros nombres:
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Comparador falso: sham stimulation
Patients will undergo 6 sessions, each including 20 minutesof sham stimulation (no stimulation).
These are given after the Nervomatrix device determines the peak pain regions for each patient, and selects to stimulate the top 10 regions with least skin resistance.
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The Nervomatrix device first measures skin impedance, and then creates a digital pain matrix map of the back.
Regions with low resistance are then selected for brief mechanical pressure.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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The change in the amount of steps climbed during one minute
Periodo de tiempo: measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks)
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Stair climbing: Participants were asked to climb up and down 5 stairs for 1 minute, using the rail for support if required.
The total amount of steps climbed will be recorded
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measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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The change in central sensitization inventory
Periodo de tiempo: measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks)
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Part A of 25 statements related to current health symptoms.
Each of these items is measured on a 5-point temporal Likert scale, with the following numeric rating scale: never (0), rarely (1), sometimes (2), often (3), and always (4).
A cumulative score ranges from 0 to 100.
Additionally information is collected in Part B on previously diagnosed central sensitivity syndromes and related conditions.
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measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks)
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The change in Pain Catastrophizing Scale
Periodo de tiempo: measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks)
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will be used to assess pain catastrophizing.
It consists of 13 items describing different thoughts and feelings that individuals may experience when they are experiencing pain.
Items are scored on a 5-point scale, and total scores are counted by adding up all individual items scores.
Higher scores correspond to more severe catastrophic thoughts about pain.
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measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks)
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The change in revised Illness perception questionnaire
Periodo de tiempo: measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks)
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will be used for assessing the patients' illness perceptions, as it is known that patients with maladaptive illness perceptions (e.g.
expecting that their back problem will last for a long time, or holding weak beliefs in the controllability of their back problem) are more likely to have poor clinical outcomes 6 months after they consulted their physician
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measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks)
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The change in average pain intensity
Periodo de tiempo: measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks)
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average pain rating in the last seven days using a 100 mm Visual Analogue Scale (VAS)
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measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks)
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The change in Quebec Back Pain Disability Scale
Periodo de tiempo: measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks)
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This questionnaire consists of 20 activity related questions which the patient has to score on a six points scale (0= no; 5= not capable to perform the activity).
The total score represents a percentage of functional limitations the patient experiences during daily life.
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measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks)
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The change in Tampa Scale of Kinesiophobia
Periodo de tiempo: measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks)
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Tampa Scale of Kinesiophobia is a 17-item questionnaire developed to measure the fear of movement and (re)injury.
Each item is scored on a four-point Likert scale ranging from "strongly disagree" [1] to "strongly agree" [4].
Ratings are added up to give a total score ranging from 17-68 points, with the higher values reflecting greater fear of (re)injury
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measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks)
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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
1 de diciembre de 2013
Finalización primaria (Actual)
1 de diciembre de 2014
Finalización del estudio (Actual)
1 de febrero de 2015
Fechas de registro del estudio
Enviado por primera vez
13 de diciembre de 2013
Primero enviado que cumplió con los criterios de control de calidad
2 de octubre de 2014
Publicado por primera vez (Estimar)
3 de octubre de 2014
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
12 de enero de 2016
Última actualización enviada que cumplió con los criterios de control de calidad
8 de enero de 2016
Última verificación
1 de enero de 2016
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- NeMaLBP
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