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.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Barcelona、西班牙、08035
- Hospital Universitari Vall d'Hebron Institut de Recerca Vall d'Hebron
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器：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.
其他名称：
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实验性的：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.
其他名称：
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.
其他名称：
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实验性的：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.
其他名称：
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.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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The SF-12v2 Health Status Questionnaire (change is being assessed)
大体时间：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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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VAS for Self-perceived Pain
大体时间：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
大体时间：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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其他结果措施
结果测量 |
措施说明 |
大体时间 |
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LISAT-8
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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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合作者和调查者
调查人员
- 首席研究员：Carmina Castellano-Tejedor, PhD、Hospital Universitari Vall d'Hebron - Institut de Recerca Vall d'Hebron
- 研究主任：Elisa Barnola-Serra, MD、Hospital Vall d'Hebron
- 学习椅：Gemma Costa-Requena, MsC、Hospital Vall d'Hebron
- 学习椅：Pilar Lusilla-Palacios, MD, PhD、Hospital Vall d'Hebron
- 学习椅：Alex Ginés-Puertas、Hospital Universitario Vall d'Hebron - Parc Sanitari Pere i Virgili
- 学习椅：Laura Camprubí-Roca、Hospital Universitario Vall d'Hebron - Parc Sanitari Pere i Virgili
- 学习椅：Mª Lluisa Torrent-Bertran, MD、Hospital Vall d'Hebron
- 学习椅：Ana Palacios-González、Hospital Universitario Vall d'Hebron - Parc Sanitari Pere i Virgili
- 学习椅：Tamara Biedermann-Villagra, MD、Hospital Vall d'Hebron
出版物和有用的链接
一般刊物
- 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.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
- CLBP-PT_ATR_274-2012
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