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Effects and Mechanisms of Specific Trunk Exercises in Low Back Pain

16 de octubre de 2017 actualizado por: Sharon M. Henry, University of Vermont
Low back pain affects 80% of Americans at some time during their lives. Although recovery usually occurs within 6 months, there is a 50% recurrence within one year's time. It has long been thought that poor control of trunk muscle may lead to abnormal forces across the spine, which then damage local spinal structures, thus, leading to low back pain. However, the investigators know little about the function of specific trunk muscles in healthy subjects during various activities of daily life. Furthermore, the precise muscle dysfunction associated with low back pain has not been well characterized at all. In addition, the investigators know little about which exercise protocol is most beneficial for particular subgroups of people with low back pain. Thus, the purposes of this study are to learn more about: 1) how trunk muscles are affected by low back pain; 2) which exercises might be most beneficial for people with certain kinds of low back pain; and 3) how these exercises influence trunk muscle function. By having a better understanding of which trunk muscles are affected by low back pain, rehabilitation specialists can design exercise programs and therapeutic interventions that are more specific and more effective.

Descripción general del estudio

Tipo de estudio

Intervencionista

Inscripción (Actual)

58

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

    • Vermont
      • Burlington, Vermont, Estados Unidos, 05405
        • Human Motion Analysis Laboratory

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

21 años a 55 años (Adulto)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • a history of chronic LBP with or without recurrences for a minimum of 12 months
  • between 21 - 55 years of age
  • able to stand and walk without assistance
  • have an Oswestry Disability Score of 19% or higher

Exclusion Criteria:

  • any major structural spinal deformity including scoliosis, kyphosis, or stenosis
  • spinal fracture or dislocation
  • osteoporosis
  • ankylosing spondylitis
  • rheumatoid arthritis
  • disc herniation with corroborating clinical signs and symptoms
  • serious spinal complications such as tumor or infection
  • previous spinal surgery
  • frank neurological loss, i.e., weakness and sensory loss
  • pain or paresthesia below the knee
  • etiology of LBP other than the lumbar spine, e.g., hip joint
  • history of neurological disease which required hospitalization
  • active treatment for cancer
  • history of unresolved cancer
  • pregnancy or less than 6 months post-partum or less than 6 months post weaning
  • magnified symptom-behavior
  • worker's compensation or disability case
  • in litigation for the LBP problem
  • have a BMI ≥ 30

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
Experimental: Stabilization
The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles as well as deep dorsal trunk muscles. Then patients were progressed to exercises that added leverage of the limbs while maintaining the co-contraction of the deeper abdominal muscles and deep dorsal trunk muscles while breathing normally. Various positions (e.g., supine and quadruped positions) were used to challenge the patients based on their tolerance. Finally, patients were progressed to exercises in more functional positions that included tasks/activities that were reported as challenging and/or painful; patients performed the tasks at the speed demanded by the particular task. Maintenance of the co-contraction of deep trunk muscles was emphasized during these functional activities.
Otros nombres:
  • Ejercicios de estabilización del tronco
  • Ejercicios de estabilización segmentaria
Comparador activo: Strengthening and Conditioning
This protocol contained trunk strengthening and endurance exercises. It consisted of 3 phases: 1) initial strengthening of trunk flexors/extensors in single plane movements, 2) trunk and lower-extremity stretching as well as progression of trunk-strengthening exercises to include multi-planar trunk movements. Aerobic exercises were progressed as tolerated and patient education about body biomechanics were reinforced, and 3) trunk-strengthening exercises under dynamic conditions (e.g., unstable support surface and in multi-planar trunk movements). During the 10 week protocol, exercises became more challenging, and each subject had to complete at least the first phase before moving onto the next phase in order to be included in post-testing analyses. There was no specific focus on the deep abdominal or deep dorsal trunk muscles during any of these exercises.
Otros nombres:
  • General trunk exercise
  • General strength training

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change From Baseline to 11 Weeks in Oswestry Disability Scale (0-100%)
Periodo de tiempo: Baseline and 11 weeks
Disability; Scale 0-100% Lower score is considered better/improved Negative value indicates improvement
Baseline and 11 weeks
Change From Baseline to 6 Months in Oswestry Disability Scale (0-100%)
Periodo de tiempo: Baseline and 6 Months
Disability; Sacle 0-100% Lower score is considered better/improved; Negative value indicates improvement
Baseline and 6 Months
Change From 11 Weeks to 6 Months in Oswestry Disability Scale (0-100%)
Periodo de tiempo: 11 Weeks and 6 Months
Disability; Sacle 0-100% Lower score is considered better/improved; Negative value indicates improvement
11 Weeks and 6 Months
Change From Baseline to 11 Weeks in Numeric Pain Rating Scale (0-10 Points)
Periodo de tiempo: Baseline and 11 weeks
Current Pain Scale 0-10 Lower score is better/improved; Negative value indicates improvement
Baseline and 11 weeks
Change From Baseline to 6 Months in Numeric Pain Rating Scale (0-10 Points)
Periodo de tiempo: Baseline and 6 months
Current Pain Scale 0-10 Lower score is better/improved; Negative value indicates improvement
Baseline and 6 months
Change From 11 Weeks to 6 Months in Numeric Pain Rating Scale (0-10 Points)
Periodo de tiempo: 11 weeks and 6 months
Current Pain Scale 0-10 Lower score is better/improved; Negative value indicates improvement
11 weeks and 6 months

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Investigador principal: Sharon M Henry, PT, PhD, University of Vermont

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.

Publicaciones Generales

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 marzo de 2003

Finalización primaria (Actual)

1 de junio de 2008

Finalización del estudio (Actual)

1 de junio de 2008

Fechas de registro del estudio

Enviado por primera vez

1 de junio de 2012

Primero enviado que cumplió con los criterios de control de calidad

4 de junio de 2012

Publicado por primera vez (Estimar)

5 de junio de 2012

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

18 de octubre de 2017

Última actualización enviada que cumplió con los criterios de control de calidad

16 de octubre de 2017

Última verificación

1 de octubre de 2017

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • NIH/NCMRR/R01-HD040909

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

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. .

Ensayos clínicos sobre Lumbalgia

Ensayos clínicos sobre Stabilization exercise protocol

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