Low Level Laser Therapy to Reduce Chronic Pain
2 de abril de 2014 actualizado por: Erchonia Corporation
Study of the Effect of Low Level Laser Light Therapy on the Reduction of Chronic Pain of the Neck and Shoulders
The purpose of this study was to determine whether low level laser light directed at the neck and shoulders could be effective in the temporary reduction of chronic pain in the neck and shoulder region.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
Chronic neck and shoulder pain arising from osteoarthritis, chronic muscle spasms or thoracic or cervical spine sprain strain can be seriously debilitating.
Currently available treatment options such as pain relief medication, ice pack, massage, physical therapy and chiropractic are typically of limited effectiveness.
More permanent options such as surgery are invasive with long recovery periods and side-effects and complications of their own.
Low level laser light therapy, with its proven anti-inflammatory ability, offers a simple non-invasive option for the reduction of chronic neck and shoulder pain.
Tipo de estudio
Intervencionista
Inscripción (Actual)
100
Fase
- No aplica
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:
- Muscular-skeletal pain in the neck/shoulder region
- Acute and chronic pain in the neck/shoulder region
- Restricted range of motion in the neck/shoulder region
- Fibrosis or scar tissue in the neck/shoulder region
- Inflammation in the neck/shoulder region
- Altered function in the neck/shoulder region
- Muscle strains in the neck/shoulder region
- Rating of 30 or greater on the 0-100 Visual Analog Scale (VAS) pain scale
- 18-65 years of age
Exclusion Criteria:
- Severely herniated disks
- Pregnancy
- Taken pain medication within the past 12 hours
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: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: Erchonia PL2000 Laser
Low level laser light energy comprised of 1 milliWatts (mW) of red light (635 nm).
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Low level laser light therapy device that emits 1 mW of red (635 nm wavelength) light.
It is a hand-held device that uses rechargeable batteries or a separate power adapter.
Otros nombres:
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Comparador de placebos: Placebo laser
inactive light
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Inactive laser light.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Number of Participants Whose Self-reported Degree of Pain on the Visual Analog Scale (VAS) in the Neck and Shoulder Area Decreased by 30% or More From Before to After Study Treatment.
Periodo de tiempo: baseline and one hour
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Self-reported degree of pain in the neck and shoulder region on the Visual Analog Scale (VAS).
The VAS is a 100 mm long horizontal line ranging from '0: no pain at all' on one end to '100: worst pain imaginable' on the other end.
Participants mark a point along the line that best represents the pain they are experiencing at that moment.
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baseline and one hour
|
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Change in Self-reported Degree of Pain in the Neck-shoulder Region on the 0-100 Visual Analog Scale (VAS)
Periodo de tiempo: baseline and one hour
|
Self-reported degree of pain in the neck and shoulder region on the Visual Analog Scale (VAS).
The VAS is a 100 mm long horizontal line ranging from '0: no pain at all' on one end to '100: worst pain imaginable' on the other end.
Participants mark a point along the line that best represents the pain they are experiencing at that moment.
The change is calculated as the difference from the VAS score recorded at baseline to the VAS score recorded one hour after study treatment administration.
A positive change (+) means that the pain got worse and a negative change (-) means that the pain got better.
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baseline and one hour
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Range of Motion (ROM) for the Left Side of the Neck From Baseline to One Hour After Study Treatment.
Periodo de tiempo: baseline and one hour
|
Range of motion (ROM) for the left side of the neck is a measure of how well the neck can move to the left side.
The participant gently tilts their neck to the left side as far as possible, and this distance is measured in degrees.
The change for ROM for the left side of the neck is measured as the difference in degrees of ROM recorded from baseline to one hour after study treatment.
If the change is positive (+), this means that ROM has gotten better and the neck can move further to the left side than before getting the treatment.
If the change is negative (-), this means that ROM has gotten worse and the neck can move less to the left side than before getting the treatment
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baseline and one hour
|
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Change in Range of Motion (ROM) for the Left Shoulder From Baseline to One Hour After Study Treatment.
Periodo de tiempo: one hour
|
Range of motion (ROM) for the left shoulder is a measure of how well the participant can move the left shoulder.
The participant gently raises the left shoulder (and left arm) as far as possible, and this distance is measured in degrees.
The change for ROM for the left shoulder is measured as the difference in degrees of ROM recorded from baseline to one hour after study treatment.
If the change is positive (+), this means that ROM has gotten better and can move the left shoulder better and further than before getting the treatment.
If the change is negative (-), this means that ROM has gotten worse and the left shoulder can move less easily and not as far than before getting the treatment
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one hour
|
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Change in Range of Motion (ROM) for the Right Side of the Neck From Baseline to One Hour After Study Treatment.
Periodo de tiempo: baseline and one hour
|
Range of motion (ROM) for the right side of the neck is a measure of how well the neck can move to the right side.
The participant gently tilts their neck to the right side as far as possible, and this distance is measured in degrees.
The change for ROM for the right side of the neck is measured as the difference in degrees of ROM recorded from baseline to one hour after study treatment.
If the change is positive (+), this means that ROM has gotten better and the neck can move further to the right side than before getting the treatment.
If the change is negative (-), this means that ROM has gotten worse and the neck can move less to the right side than before getting the treatment.
|
baseline and one hour
|
|
Change in Range of Motion (ROM) for the Right Shoulder From Baseline to One Hour After Study Treatment.
Periodo de tiempo: baseline and one hour
|
Range of motion (ROM) for the right shoulder is a measure of how well the participant can move the right shoulder.
The participant gently raises the right shoulder (with right arm) as far as possible, and this distance is measured in degrees.
The change for ROM for the right shoulder is measured as the difference in degrees of ROM recorded from baseline to one hour after study treatment.
If the change is positive (+), this means that ROM has gotten better and the right shoulder can move further more easily than before getting the treatment.
If the change is negative (-), this means that ROM has gotten worse and the right shoulder can move less and not as far to the left side than before getting the treatment.
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baseline and one hour
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Richard Amy, DC
- Investigador principal: George Gonzalez, DC
- Investigador principal: John Pinto, DC
- Investigador principal: Allen Wentworth, DC
- Investigador principal: Robert Stashko, DC
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
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 julio de 2000
Finalización primaria (Actual)
1 de septiembre de 2000
Finalización del estudio (Actual)
1 de septiembre de 2000
Fechas de registro del estudio
Enviado por primera vez
25 de junio de 2009
Primero enviado que cumplió con los criterios de control de calidad
26 de junio de 2009
Publicado por primera vez (Estimar)
29 de junio de 2009
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
2 de mayo de 2014
Última actualización enviada que cumplió con los criterios de control de calidad
2 de abril de 2014
Última verificación
1 de abril de 2014
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- ECP-001
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. .