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