Assessment of Confidence in the Ability to Perform Movements in Patients With Low Back Pain and Its Relationship With the Characteristics and Evolution of Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 141
- 试验地点
- 1
- 主要终点
- Change from Baseline Confidence at 3 months
研究概览
简要总结
The goals of this observational study are:
To determine the validity and reliability of the OPTIMAL-confidence scale in people with chronic low back pain.
To assess the influence of confidence and fear of movement on the evolution of low back pain.
The main question it aims to answer is if people with chronic low back pain present different psychoemotional variables around fear of movement and decreased confidence in their ability to perform movement that may influence their low back pain.
For this purpose, a two-phase study was designed. In the first phase, the OPTIMAL-confidence scale will be validated in patients with chronic low back pain, determining its internal consistency and validity. In the second phase, a prospective study will be carried out with patients with low back pain who attend physiotherapy centres to determine how confidence and fear of movement influence the characteristics of pain and its evolution. Data will be collected at the beginning of the physiotherapy treatment, at the end of the treatment and after three months. The data will be analysed using learning machine techniques.
详细描述
In the first phase of the study, a sample of patients diagnosed with chronic low back pain will bwe selected, as well as a general population of convenience. The scope of the study is the health centres of the Primary Care Management of León and El Bierzo. To calculate the optimal sample size, the criteria included in the COSMIN20 guide (Consensus-based standards for the selection of health measurement instruments) were taken into account, taking as a reference the maximum quality criterion for hypotheses testing, which states that they should be equal to or greater than 100 subjects.
The second phase will consist of a prospective observational study among patients with low back pain selected by physiotherapists and interested in participating in the study. Data will be collected at three different times: at recruitment and at the end of treatment, in person, and three months after the end of treatment, by telephone.
The scope of the study will be the Primary and Specialised Health Care Departments of León and El Bierzo.
In both cases participants will sign an informed consent form and the physiotherapists who will collect the data will be trained by researchers.
Patients will complete socio-demographic and health questions as well as validated questionnaires on confidence, self-efficacy, fear of movement, risk of chronification and disability. Participants in the second phase will complete the questionnaires not only at the beginning, but two more times.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with low back pain.
- •Be able to read and understand Spanish.
- •Acceptance and signature of the informed consent.
排除标准
- •Tumor and/or infection related to the back.
- •Cauda equina syndrome.
- •Vertebral compression fracture.
- •Abdominal aneurysm.
- •Central nervous system disorders.
- •Confirmed diagnosis of active neoplasm.
- •Presence of cognitive deficits that prevented participation in the study.
- •Pregnant patients in the last year.
结局指标
主要结局
Change from Baseline Confidence at 3 months
时间窗: Recruitment, "physiotherapy discharge" (week 3) and 3 months later.
Outpatient Physical Therapy Improvement in Movement Assessment Log (OPTIMAL) instrument, confidence scale, spanish version. Total score ranges from 0-100 points, with higher scores indicating worse outcome (lower confidence).
次要结局
- Change from Baseline Disability at 3 months.(Recruitment, "physiotherapy discharge" (week 3) and 3 months later.)
- Change from Baseline Intensity of pain at 3 months.(Recruitment, "physiotherapy discharge" (week 3) and 3 months later.)
- Change from Baseline Risk at 3 months.(Recruitment, "physiotherapy discharge" (week 3) and 3 months later.)
- Change from Baseline Kinesiophobia at 3 months.(Recruitment, "physiotherapy discharge" (week 3) and 3 months later.)
研究者
Arrate Pinto Carral
Ph. Dr. Teacher
Universidad de León