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临床试验/NCT01993355
NCT01993355已完成不适用

A Multidisciplinary Approach to Treat and Rehabilitate Patients With Chronic Low Back Pain

Hospital Universitari Vall d'Hebron Research Institute2 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2013年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
66
试验地点
2
主要终点
The SF-12v2 Health Status Questionnaire (change is being assessed)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
30 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Non-specific chronic (> 6 months of evolution) low back pain diagnosis
  • Ability to read and speak in Spanish

排除标准

  • 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

结局指标

主要结局

The SF-12v2 Health Status Questionnaire (change is being assessed)

时间窗: Baseline, 6 and 12 months

The SF-12 measures health-related quality of life including items from various domains both physical and psychological.

次要结局

  • Oswestry-15 Disability Index(Baseline, 6 and 12 months)
  • VAS for Self-perceived Pain(Baseline, 6 and 12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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