Effectiveness of the Addition of Therapeutic Alliance to Minimal Intervention Treatment for Chronic Low Back Pain With Low Risk of Psychosocial Factors: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 222
- 试验地点
- 2
- 主要终点
- Pain intensity
研究概览
简要总结
This study aims to evaluate the effectiveness of minimal intervention and therapeutic alliance in pain, specific and general disability, global perceived effect, empathy, credibility and expectation of improvement in patients with chronic non-specific low back pain
详细描述
Low back pain remains a global public health problem. The classification of patients in low back pain subgroups aims to optimize the health system and provide the quantity and the type of proper technique for each patient. Several factors may influence physical therapy. The therapeutic alliance may be defined as harmony or social connection between the therapist and the patient and may influence the treatment effect. The aim of this study is to evaluate the effectiveness of the addition of the therapeutic alliance to a minimum intervention for the treatment of chronic non-specific low back pain with low risk of psychosocial factors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients waiting for treatment in the waiting list of physical therapy clinics
- •Diagnosis of chronic non-specific low back pain (over 12 weeks)
- •More than 18 years
- •Able to read and write the Portuguese language
- •Low risk of psychosocial factors (less than 3 points in the STarT Back Screening Tool).
排除标准
- •Spine surgery history
- •Nerve root compromise
- •Cognitive impairment related disorders
- •Pregnants
结局指标
主要结局
Pain intensity
时间窗: One month after randomization
Pain intensity will be measured by an 11-point Pain Numerical Rating Scale
Specific disability
时间窗: One month after randomization
Specific disability associated with low back pain will be measured by the 11-point Patient Specific Functional Scale.
次要结局
- Specific disability(Six and twelve months after randomization)
- Pain intensity(Six and twelve months after randomization)
- Disability(One, six and twelve months after randomization)
- Global impression of recovery(One, six and twelve months after randomization)
研究者
Cristina Maria Nunes Cabral
Professor PhD
Universidade Cidade de Sao Paulo