- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01124201
Lumbar Stabilization, Strengthening and Stretching in Chronic Low Back Pain
Lumbar Segmental Stabilization, Strengthening and Stretching in Chronic Low Back Pain: a Comparative Study
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Objective: To contrast the efficacy of three exercise programs, segmental stabilization and strengthening of abdominal and trunk muscle and lumbar stretching on pain, functional impairment, and activation of the transversus abdominis muscle (TrA), in individuals with chronic low back pain.
Design: Forty-five patients were randomized into three groups namely: Segmental stabilization group (ES)(transversus abdominis and lumbar multifidus) (n=15, mean age 42,02 ± 8,15), superficial strengthening group (FS)(rectus abdominis, oblique abdominal muscles and erector spinae muscles) (n=15, mean age 41,71±6,41) and stretching group (AL) (erector spinae, posterior connective tissues and ischiotibials muscles) (n=15 mean age 41,53 ± 4,41). Groups were contrasted regarding pain (visual analogical scale and McGill pain questionnaire), functional disability (Oswestry disability questionnaire) and TrA muscle activation capacity (Pressure Biofeedback Unit = PBU). The program lasted 6 weeks, and sessions happened twice a week, with duration of 30 minutes each. Analysis of variance was used for inter and intragroup comparisons. Significance level was established at 5%.
Patients attended two weekly sessions during six weeks and were evaluated for pain (visual analogue scale and McGill Pain Questionnaire), functional disability (Oswestry disability index), and ability to contract the TrA (Pressure biofeedback unit) before and after the treatment. The treatment program consisted of 30 minutes sessions. The Anova one-way and Tukey´s Post Hoc were used to compare groups. The significance level adopted was 5%.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Sao Paulo, Brasil
- University of Sao Paulo General Hospital
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- low back pain for more than 3 months
- patients willing to participate and could participate in an exercise program safely and without cognitive impairments that would limit their participation.
Exclusion Criteria:
- past history of back surgery
- rheumatologic disorders
- spine infections
- spine exercise training in the 3 months before study onset.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Stabilization group
In the Segmental Stabilization group exercises focused on the transversus abdominis and lumbar multifidus muscles.
|
Interventions were conducted over 6 weeks, twice per week, lasting 30 minutes each.
Sessions were supervised by the investigator, and participants were instructed to report any adverse event.
Groups were instructed not to participate in any other physical program during the study.
Forty-five patients were randomized into three groups namely: Segmental stabilization group (ES)(transversus abdominis and lumbar multifidus), superficial strengthening group (FS)(rectus abdominis, oblique abdominal muscles and erector spinae muscles) and stretching group (AL) (erector spinae, posterior connective tissues and ischiotibials muscles).
Patients were evaluated for pain , functional disability,and ability to contract the TrA before and after the treatment.
Otros nombres:
|
Experimental: Strengthening group
In the Superficial Strengthening group, exercises focused on the rectus abdominis, abdominus obliquus internus, abdominus obliquus externus and erector spinae muscles.
|
Interventions were conducted over 6 weeks, twice per week, lasting 30 minutes each.
Sessions were supervised by the investigator, and participants were instructed to report any adverse event.
Groups were instructed not to participate in any other physical program during the study.
Forty-five patients were randomized into three groups namely: Segmental stabilization group (ES)(transversus abdominis and lumbar multifidus), superficial strengthening group (FS)(rectus abdominis, oblique abdominal muscles and erector spinae muscles) and stretching group (AL) (erector spinae, posterior connective tissues and ischiotibials muscles).
Patients were evaluated for pain , functional disability,and ability to contract the TrA before and after the treatment.
Otros nombres:
|
Experimental: Stretching group
Stretching group: erector spinae, posterior connective tissues and ischiotibials muscles
|
Interventions were conducted over 6 weeks, twice per week, lasting 30 minutes each.
Sessions were supervised by the investigator, and participants were instructed to report any adverse event.
Groups were instructed not to participate in any other physical program during the study.
Forty-five patients were randomized into three groups namely: Segmental stabilization group (ES)(transversus abdominis and lumbar multifidus), superficial strengthening group (FS)(rectus abdominis, oblique abdominal muscles and erector spinae muscles) and stretching group (AL) (erector spinae, posterior connective tissues and ischiotibials muscles).
Patients were evaluated for pain , functional disability,and ability to contract the TrA before and after the treatment.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Pain (visual analogical scale and McGill pain questionnaire)
Periodo de tiempo: Six weeks
|
Six weeks
|
Functional disability (Oswestry disability questionnaire)
Periodo de tiempo: Six weeks
|
Six weeks
|
TrA muscle activation capacity (Pressure Biofeedback Unit = PBU)
Periodo de tiempo: Six weeks
|
Six weeks
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Publicaciones y enlaces útiles
Publicaciones Generales
- Hayden JA, van Tulder MW, Malmivaara AV, Koes BW. Meta-analysis: exercise therapy for nonspecific low back pain. Ann Intern Med. 2005 May 3;142(9):765-75. doi: 10.7326/0003-4819-142-9-200505030-00013.
- Liddle SD, Baxter GD, Gracey JH. Exercise and chronic low back pain: what works? Pain. 2004 Jan;107(1-2):176-90. doi: 10.1016/j.pain.2003.10.017. Erratum In: Pain. 2004 May;109(1-2):200-1.
- Barr KP, Griggs M, Cadby T. Lumbar stabilization: a review of core concepts and current literature, part 2. Am J Phys Med Rehabil. 2007 Jan;86(1):72-80. doi: 10.1097/01.phm.0000250566.44629.a0.
- MacDonald DA, Moseley GL, Hodges PW. The lumbar multifidus: does the evidence support clinical beliefs? Man Ther. 2006 Nov;11(4):254-63. doi: 10.1016/j.math.2006.02.004. Epub 2006 May 23.
- Ferreira PH, Ferreira ML, Maher CG, Refshauge K, Herbert RD, Hodges PW. Changes in recruitment of transversus abdominis correlate with disability in people with chronic low back pain. Br J Sports Med. 2010 Dec;44(16):1166-72. doi: 10.1136/bjsm.2009.061515. Epub 2009 May 26.
- Franca FR, Burke TN, Hanada ES, Marques AP. Segmental stabilization and muscular strengthening in chronic low back pain: a comparative study. Clinics (Sao Paulo). 2010;65(10):1013-7. doi: 10.1590/s1807-59322010001000015.
Enlaces Útiles
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 (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 1249/06
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. .