"Evaluation of the Effectiveness of the MDT Method (Mechanical Diagnosis and Therapy) in the Management of Low Back Pain in the Subacute Phase"
试验速览
- 阶段
- 不适用
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Evolution over time of patients' pain
研究概览
简要总结
The investigators propose to carry out a study evaluating the effectiveness of the MDT method (mechanical diagnosis and therapy) in the subacute phase of common low back pain.
Few studies have specifically evaluated the effectiveness of the MDT method in the subacute phase, a phase that appears to be crucial before the chronicization of low back pain.
The main objective of this study will be to evaluate the pain of patients managed by the MDT method.
The analysis of the main criterion (Visual Analog Scale) will be done using a type individual clinical trial specific: the Single Case Experimental Design or SCED in lines of multiple bases.
This type of study makes it possible to carry out a comparative test on a single subject acting as its own witness in order to obtain an acceptable level of evidence response for that particular patient.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consultant patients at the Picasso physiotherapy practice (5 rue Nina Simone - 44 000 NANTES)
- •Aged 18 to 55 years old
- •Suffering from common-looking low back pain. Low back pain is defined as pain or localized discomfort under the 12th dorsal vertebrae and above the inner fold buttock, with possible irradiation to the lower limb but not exceeding the knee.
- •Evolving for 4 to 12 weeks (subacute period).
- •Period preceded by a period of 30 days without low back pain (in order to avoid recurrent low back pain, rather similar to the chronic phase).
排除标准
- •Signs of specific low back pain (confirmed or highly suspected diagnosis): fracture, infection, osteoporosis, inflammatory disease, tumor
- •Irradiation below the knee
- •Patient knowing she is pregnant
- •Protected adults
- •Patient with proven cognitive impairment
- •Patient with a decompensated psychiatric pathology
- •Incapacity to consent
- •Refusal to participate in the study
结局指标
主要结局
Evolution over time of patients' pain
时间窗: 3 months
The main outcome will be the evolution over time of patients' pain as assessed by a visual analogue scale completed daily by the patient himself.
次要结局
- Evolution of the pain localization will be done on a body chart filled daily by the patient(3 months)
- Evolution of drug consumption through a completed questionnaire daily by the patient(3 months)
- Evolution of functional disability through the EIFEL questionnaire(3 months)
- Evolution of psychosocial factors by STarT Back(3 months)
- Evolution of beliefs and fears through the FABQ (Fear Avoidance Belief) questionnaire(3 months)