- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01993355
Chronic Low Back Pain: A Multidisciplinary Approach (CLBP-HUVH)
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
-
Barcelona, Espanha, 08035
- Hospital Universitari Vall d'Hebron Institut de Recerca Vall d'Hebron
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Comparador Ativo: TAU
Control group.
Treatment as usual (TAU): Physiotherapy program for CLBP.
|
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.
Outros nomes:
|
Experimental: Intervention 1 Relaxation techniques-sophrology
Intervention group 1: TAU + relaxation techniques-sophrology program.
|
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.
Outros nomes:
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.
Outros nomes:
|
Experimental: Intervention 2 Cognitive-behavioral therapy
Intervention group 2: TAU + cognitive-behavioral therapy.
|
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.
Outros nomes:
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.
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
The SF-12v2 Health Status Questionnaire (change is being assessed)
Prazo: Baseline, 6 and 12 months
|
The SF-12 measures health-related quality of life including items from various domains both physical and psychological.
|
Baseline, 6 and 12 months
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
VAS for Self-perceived Pain
Prazo: Baseline, 6 and 12 months
|
Visual Analogue Scale to rate self-perceived pain.
Recall period: last 4 weeks.
|
Baseline, 6 and 12 months
|
Oswestry-15 Disability Index
Prazo: Baseline, 6 and 12 months
|
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).
|
Baseline, 6 and 12 months
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
LISAT-8
Prazo: Baseline, 6 and 12 months
|
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.
|
Baseline, 6 and 12 months
|
STAI
Prazo: Baseline, 6 and 12 months
|
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.
|
Baseline, 6 and 12 months
|
BDI-13
Prazo: Baseline, 6 and 12 months
|
The Beck Depression Inventory (BDI) is a 13-item (short-form), self-report rating inventory that measures characteristic attitudes and symptoms of depression.
|
Baseline, 6 and 12 months
|
PSQI
Prazo: Baseline, 6 and 12 months
|
The Pittsburgh Sleep Quality Index (PSQI) assesses sleep quality during the previous month.
|
Baseline, 6 and 12 months
|
CAD
Prazo: Baseline and 12 months
|
The CAD (Cuestionario para el Afrontamiento al Dolor) is a coping questionnaire to chronic pain developed in a Spanish sample.
|
Baseline and 12 months
|
TAS-20
Prazo: Baseline and 12 months
|
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).
|
Baseline and 12 months
|
PSS-14
Prazo: Baseline and 12 months
|
The Perceived Stress Scale (PSS) is a 14-item questionnaire that measures the degree to which life events are considered stressful.
|
Baseline and 12 months
|
DUKE-11
Prazo: Baseline and 12 months
|
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.
|
Baseline and 12 months
|
VAS for patient satisfaction with treatment received
Prazo: Baseline, 6 and 12 months
|
Visual Analogue Scale to rate patients' satisfaction with treatment, attention received and outcomes.
|
Baseline, 6 and 12 months
|
Medical and demographics
Prazo: Baseline
|
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.
|
Baseline
|
Colaboradores e Investigadores
Investigadores
- Investigador principal: Carmina Castellano-Tejedor, PhD, Hospital Universitari Vall d'Hebron - Institut de Recerca Vall d'Hebron
- Diretor de estudo: Elisa Barnola-Serra, MD, Hospital Vall d'Hebron
- Cadeira de estudo: Gemma Costa-Requena, MsC, Hospital Vall d'Hebron
- Cadeira de estudo: Pilar Lusilla-Palacios, MD, PhD, Hospital Vall d'Hebron
- Cadeira de estudo: Alex Ginés-Puertas, Hospital Universitario Vall d'Hebron - Parc Sanitari Pere i Virgili
- Cadeira de estudo: Laura Camprubí-Roca, Hospital Universitario Vall d'Hebron - Parc Sanitari Pere i Virgili
- Cadeira de estudo: Mª Lluisa Torrent-Bertran, MD, Hospital Vall d'Hebron
- Cadeira de estudo: Ana Palacios-González, Hospital Universitario Vall d'Hebron - Parc Sanitari Pere i Virgili
- Cadeira de estudo: Tamara Biedermann-Villagra, MD, Hospital Vall d'Hebron
Publicações e links úteis
Publicações Gerais
- 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.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- CLBP-PT_ATR_274-2012
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .