Chronic Low Back Pain: A Multidisciplinary Approach (CLBP-HUVH)
15 de junio de 2015 actualizado por: Hospital Universitari Vall d'Hebron Research Institute
A Multidisciplinary Approach to Treat and Rehabilitate Patients With Chronic Low Back Pain
Introduction: Non-specific chronic low back pain (CLBP) is one of the most frequent causes for patient disability and a general recurrent cause for medical consultation with high costs to public health. From rehabilitative medicine, physiotherapy is commonly offered. Although this treatment is aimed to reduce disability, pain severity and pain-related anxiety-depressive symptoms, many patients report partial improvement and recurrent intensive and disabling pain episodes. Therefore, a new approach in the treatment and rehabilitation of this pathology that takes into account psychosocial aspects that might be modulating pain is necessary.
Material and methods: This project aims to assess the efficacy of two complementary interventions to standard physical therapy, such as relaxation techniques and cognitive-behavioral intervention, to improve health-related quality of life (HRQoL) among patients with CLBP. It is hypothesized that groups receiving these complementary interventions will significantly improve their adherence to physiotherapy and the control of their pain and, ultimately, these aspects will facilitate a decreasing of pain intensity and better HRQoL.
For these purposes, a pre-post longitudinal design will be carried out, with follow-up assessments at 6 and 12 months in a sample of 66 participants. This sample will be divided into: control group (physiotherapy), intervention group 1 (physiotherapy and relaxation techniques-sophrology) and intervention group 2 (physiotherapy and cognitive-behavioral intervention).
Expected impact: Study results are not available yet. However, if working hypotheses are confirmed, a multidisciplinary model of care for CLBP will be empirically justified. This approach is expected to benefit HRQoL among these patients implying a significant short-mid term reduction of public health costs.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
66
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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Barcelona, España, 08035
- Hospital Universitari Vall d'Hebron Institut de Recerca Vall d'Hebron
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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
30 años a 80 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Non-specific chronic (> 6 months of evolution) low back pain diagnosis
- Ability to read and speak in Spanish
Exclusion Criteria:
- Addictive behaviors (DAST-10 > 3, alcoholism, drug addiction or other drug abuse)
- Psychiatric contraindications (BDI > 15 or other severe psychiatric disorder not stabilized)
- Neurological impairment
- No mental competence (MEC < 23)
- Fibromyalgia and/or chronic fatigue
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: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: TAU
Control group.
Treatment as usual (TAU): Physiotherapy program for CLBP.
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Physical therapy exercise program for CLBP patients.
Its goal is to reduce pain and improve patients' health-related quality of life, functional capacity and well-being.
Otros nombres:
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Experimental: Intervention 1 Relaxation techniques-sophrology
Intervention group 1: TAU + relaxation techniques-sophrology program.
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Physical therapy exercise program for CLBP patients.
Its goal is to reduce pain and improve patients' health-related quality of life, functional capacity and well-being.
Otros nombres:
Relaxation techniques-sophrology consists of a set of physical and relaxation exercises that include breathing methods, visualization, modification of states of consciousness, etc. with the goal to enhance balance between body and mind to improve health-related quality of life, reduce pain and foster patients' well-being.
Otros nombres:
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Experimental: Intervention 2 Cognitive-behavioral therapy
Intervention group 2: TAU + cognitive-behavioral therapy.
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Physical therapy exercise program for CLBP patients.
Its goal is to reduce pain and improve patients' health-related quality of life, functional capacity and well-being.
Otros nombres:
Cognitive-behavioral therapy (in combination with motivational interviewing principles) is aimed to facilitate psychological adjustment and self-management of CLBP with the ultimate goal of increasing patients' health-related quality of life and well-being.
Otros nombres:
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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 SF-12v2 Health Status Questionnaire (change is being assessed)
Periodo de tiempo: Baseline, 6 and 12 months
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The SF-12 measures health-related quality of life including items from various domains both physical and psychological.
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Baseline, 6 and 12 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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VAS for Self-perceived Pain
Periodo de tiempo: Baseline, 6 and 12 months
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Visual Analogue Scale to rate self-perceived pain.
Recall period: last 4 weeks.
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Baseline, 6 and 12 months
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Oswestry-15 Disability Index
Periodo de tiempo: Baseline, 6 and 12 months
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The Oswestry Disability Index (aka: Oswestry Low Back Pain Disability Questionnaire) is a time-tested outcome assessment tool that is used to measure a patient's impairment and quality of life (i.e., how badly the pain has affected their life).
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Baseline, 6 and 12 months
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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LISAT-8
Periodo de tiempo: Baseline, 6 and 12 months
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The LISAT is a domain-specific measure of life satisfaction, which corresponds to Box E (subjective evaluations and reactions; life satisfaction) of Dijker's Model.
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Baseline, 6 and 12 months
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STAI
Periodo de tiempo: Baseline, 6 and 12 months
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The State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety.
It can be used in clinical settings to screen anxiety and to distinguish it from depressive syndromes.
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Baseline, 6 and 12 months
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BDI-13
Periodo de tiempo: Baseline, 6 and 12 months
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The Beck Depression Inventory (BDI) is a 13-item (short-form), self-report rating inventory that measures characteristic attitudes and symptoms of depression.
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Baseline, 6 and 12 months
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PSQI
Periodo de tiempo: Baseline, 6 and 12 months
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The Pittsburgh Sleep Quality Index (PSQI) assesses sleep quality during the previous month.
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Baseline, 6 and 12 months
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CAD
Periodo de tiempo: Baseline and 12 months
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The CAD (Cuestionario para el Afrontamiento al Dolor) is a coping questionnaire to chronic pain developed in a Spanish sample.
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Baseline and 12 months
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TAS-20
Periodo de tiempo: Baseline and 12 months
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The Toronto Alexithymia Scale (TAS) 20-item is one of the most commonly used measures of alexithymia (people who have trouble identifying and describing emotions and who tend to minimise emotional experience and focus attention externally).
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Baseline and 12 months
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PSS-14
Periodo de tiempo: Baseline and 12 months
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The Perceived Stress Scale (PSS) is a 14-item questionnaire that measures the degree to which life events are considered stressful.
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Baseline and 12 months
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DUKE-11
Periodo de tiempo: Baseline and 12 months
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The DUKE 11-item social support questionnaire measures an individual's perception of the amount and type of personal social support.
The original instrument included 14 items, grouped into 4 subscales: Quantity of Support, Confidant Support, Affective Support, and Instrumental Support.
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Baseline and 12 months
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VAS for patient satisfaction with treatment received
Periodo de tiempo: Baseline, 6 and 12 months
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Visual Analogue Scale to rate patients' satisfaction with treatment, attention received and outcomes.
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Baseline, 6 and 12 months
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Medical and demographics
Periodo de tiempo: Baseline
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Medical (medical and psychopathological history, physical exploration of LBP and possible substance abuse or other toxic habits such as alcohol or tobacco) and demographics (age, gender, immediate family network, education, job and SES) of patients are collected according to standard procedures.
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Baseline
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Investigadores
- Investigador principal: Carmina Castellano-Tejedor, PhD, Hospital Universitari Vall d'Hebron - Institut de Recerca Vall d'Hebron
- Director de estudio: Elisa Barnola-Serra, MD, Hospital Vall d'Hebron
- Silla de estudio: Gemma Costa-Requena, MsC, Hospital Vall d'Hebron
- Silla de estudio: Pilar Lusilla-Palacios, MD, PhD, Hospital Vall d'Hebron
- Silla de estudio: Alex Ginés-Puertas, Hospital Universitario Vall d'Hebron - Parc Sanitari Pere i Virgili
- Silla de estudio: Laura Camprubí-Roca, Hospital Universitario Vall d'Hebron - Parc Sanitari Pere i Virgili
- Silla de estudio: Mª Lluisa Torrent-Bertran, MD, Hospital Vall d'Hebron
- Silla de estudio: Ana Palacios-González, Hospital Universitario Vall d'Hebron - Parc Sanitari Pere i Virgili
- Silla de estudio: Tamara Biedermann-Villagra, MD, Hospital Vall d'Hebron
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
- Group of pain for patients with chronic low back pain: A multidisciplinary intervention. Lusilla-Palacios, P, Castellano-Tejedor, C, Barnola-Serra, E, Ramos-Rondón, C, Biedermann-Villagra, T, Torrent-Bertran, M.L, Costa-Requena, G, Camprubí-Roca, L, Palacios-González, A, Cuxart-Fina, A, Ginés-Puertas, A, Bosch-Graupera, A. Poster communication on the 21th European Congress of Psychiatry, Nice, France, 25-29/05/2010.
- Castellano-Tejedor, C., Costa-Requena, G., Lusilla-Palacios, P., Biedermann-Villagra, T., Barnola-Serra, E. Calidad del sueño en pacientes con lumbalgia crónica inespecífica. Rehabilitación 48(4): 219-225, 2014. DOI: 10.1016/j.rh.2014.05.003
- Castellano-Tejedor, C., Costa-Requena, G., Lusilla-Palacios, P., Barnola-Serra, E. Calidad de vida en pacientes con dolor lumbar crónico: efectos de un programa de intervención multidisciplinar a los 6 meses de seguimiento. Comunicació tipus pòster presentada a les II Jornades BiblioPro del Parc de Recerca Biomédica de Barcelona, Barcelona 19 de febrer de 2015.
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 2013
Finalización primaria (Actual)
1 de noviembre de 2014
Finalización del estudio (Actual)
1 de enero de 2015
Fechas de registro del estudio
Enviado por primera vez
11 de noviembre de 2013
Primero enviado que cumplió con los criterios de control de calidad
19 de noviembre de 2013
Publicado por primera vez (Estimar)
25 de noviembre de 2013
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
16 de junio de 2015
Última actualización enviada que cumplió con los criterios de control de calidad
15 de junio de 2015
Última verificación
1 de junio de 2015
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CLBP-PT_ATR_274-2012
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. .