The Effect of Yoga and Stabilization Exercise in Patients With Chronic Low Back Pain
18 de septiembre de 2018 actualizado por: Muzeyyen Oz, Hacettepe University
Kronik Bel Ağrılı Bireylerde Yoga ve Spinal Stabilizasyon Egzersizlerinin Ağrı, Fonksiyon ve Stres Üzerine Etkisinin Karşılaştırılması
Identification of the effects of yoga, stabilization exercise and home exercise approaches on pain, function,stress and quality of life in individuals with low back pain.
Descripción general del estudio
Descripción detallada
44 patients participating in the study were divided three groups.
The patients in the stabilization exercise group were instructed to perform hotpack, Trans-cutaneous Electric Nerve Stimulation (TENS) and spinal stabilization exercises, the patients in the yoga group were instructed to perform yoga program consisting of breathing, relaxation and flexibility exercises.
The patients in the home exercise group were instructed to perform stabilization exercise.
The severity of the pain evaluated through visual analog scale, functional status and quality of life evaluated through Oswestry Disability Index(ODI), Nottingham Health Profile (NHP), respectively.
Assessments were repeated before and after the treatment.
Tipo de estudio
Intervencionista
Inscripción (Actual)
44
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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Altındag
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Ankara, Altındag, Pavo, 06100
- Hacettepe University, Health Sciences Faculty
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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
25 años a 55 años (Adulto)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Must be pain at least 3 months
- Must be visual analog scale rating 3 or more
Exclusion Criteria:
- History of any lumbar spine surgery
- Severe/progressive scoliosis
- Spinal stenosis
- Spondylolisthesis
- Cancer
- Diabetes
- Metabolic syndrome
- History of exercise programs or yoga at least 12 weeks before the onset of study
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: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: stabilization exercise group
Spinal stabilization exercise were applied all patients additional with hotpack, TENS application in this group accompanied by physiotherapist.
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All exercises programs applied three sessions per week, totally six week.
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Comparador activo: yoga group
Yoga program were applied all patients in this group accompanied by physiotherapist.
Sessions included selected breathing exercises, warm up, asana and relaxation.
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All exercises programs applied three sessions per week, totally six week.
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Comparador activo: home exercise group
Home exercise were applied all patients in this group supervised, controlled by physiotherapist every week.To make compliance easier for patients; a booklet including suggestions to prevent low back pain and description of exercises, were given.
Prescribed exercises were selected in this booklet and checked&progressed in each control sessions.
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All exercises programs applied three sessions per week, totally six week.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Changes in pain severity
Periodo de tiempo: change from baseline in pain severity at 6 weeks.
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Patients' average resting and activity pain intensities assessed by Visual Analog Scale. The visual analog scale is an 11-point scale ranging from 0 to 10, in which 0 defines absence of pain and 10 describes unbearable pain. Participants asked to rate the average pain levels a horizontal 10 cm straight line on a white sheet from, before and after treatment. |
change from baseline in pain severity at 6 weeks.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Changes in quality of life
Periodo de tiempo: Change from baseline in life quality levels at 6 weeks.
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Health-related quality of life assessed by Nottingham Health Profile (NHP).
The NSP contain 38 questions in 6 subareas: pain, physical abilities, energy level, sleep, social isolation and emotional reaction.
The scores range from 0 to 100, with each question assigned a weighted value; the sum of all weighted values in a given subarea adds up to 100.
Lower scores denoting a better quality of life.
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Change from baseline in life quality levels at 6 weeks.
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Changes of functional status
Periodo de tiempo: change from baseline in functional status at 6 weeks
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Patient's permanent functional disability measured by Oswestry Disability Index.
The scale is considered the 'gold standard' of low back functional outcome tools.
This scale contain questions related to functional activities of pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life and travelling.Interpretation of scale are 0% to 20% for minimal disability, 21% to 40% for moderate disability, 41 % to 60 % for severe disability 61% to 80 % for crippled and 81 % to 100 % Bed-bound.
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change from baseline in functional status at 6 weeks
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Changes of stress level
Periodo de tiempo: change from baseline in stress level at 6 weeks
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Patients' stress levels were measured with State Trait Anxiety Inventory.
State anxiety scale questions how does a person feel in a given moment and situation, mean while trait anxiety scale questions how does a person usually feel without depending on situation and moment.
Scale contain 40 questions, minimum and maximum score 20-80, respectively.
Scores below 36 accepted as "no-anxiety", between 37-42 accepted as "low-anxiety", 42 and above accepted as "high-anxiety.
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change from baseline in stress level at 6 weeks
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Changes of stress related biomarkers
Periodo de tiempo: change from baseline in serum level at 6 weeks
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Venous blood samples were taken from antecubital area between 08.30-09.00
am and stress related markers (DHEA(S) and cortisol) were analyzed.
All analyses were performed in the same laboratory.
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change from baseline in serum level at 6 weeks
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Özlem ÜLGER, Asc. Proff, Hacettepe University
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
- Inani SB, Selkar SP. Effect of core stabilization exercises versus conventional exercises on pain and functional status in patients with non-specific low back pain: a randomized clinical trial. J Back Musculoskelet Rehabil. 2013;26(1):37-43. doi: 10.3233/BMR-2012-0348.
- Nambi GS, Inbasekaran D, Khuman R, Devi S, Shanmugananth, Jagannathan K. Changes in pain intensity and health related quality of life with Iyengar yoga in nonspecific chronic low back pain: A randomized controlled study. Int J Yoga. 2014 Jan;7(1):48-53. doi: 10.4103/0973-6131.123481.
- Shirado O, Doi T, Akai M, Hoshino Y, Fujino K, Hayashi K, Marui E, Iwaya T; Japan Low back-pain Exercise Therapy Study; Investigators Japanese Orthopaedic Association; Japanese Society for Musculoskeletal Rehabilitation; Japanese Clinical Orthopaedic Association. Multicenter randomized controlled trial to evaluate the effect of home-based exercise on patients with chronic low back pain: the Japan low back pain exercise therapy study. Spine (Phila Pa 1976). 2010 Aug 1;35(17):E811-9. doi: 10.1097/BRS.0b013e3181d7a4d2.
- Cho I, Jeon C, Lee S, Lee D, Hwangbo G. Effects of lumbar stabilization exercise on functional disability and lumbar lordosis angle in patients with chronic low back pain. J Phys Ther Sci. 2015 Jun;27(6):1983-5. doi: 10.1589/jpts.27.1983. Epub 2015 Jun 30.
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 (Actual)
1 de marzo de 2015
Finalización primaria (Actual)
1 de agosto de 2016
Finalización del estudio (Actual)
1 de agosto de 2016
Fechas de registro del estudio
Enviado por primera vez
6 de agosto de 2018
Primero enviado que cumplió con los criterios de control de calidad
15 de septiembre de 2018
Publicado por primera vez (Actual)
18 de septiembre de 2018
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
19 de septiembre de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
18 de septiembre de 2018
Última verificación
1 de septiembre de 2018
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- GO15/81
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
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