The Identification of Prognostic Indicators for Exercise Therapy in Patients With Nonspecific Chronic Low Back Pain: A Multicenter Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Measurement of functional disability
研究概览
简要总结
There is a consensus that exercise therapy should be used as a therapy approach in CLBP but little consensus has been reached about the preferential type of therapy. There occurs to be a wash out effect because of the heterogeneous character of CLBP patients. As a result, no effect can be demonstrated for the entire sample. This is why one should consider creating subgroups based on prognostic indicators.
Objectives for this trial is to possibly identify prognostic indicators for treatment response to three forms of exercise therapy for patients with nonspecific chronic low back pain (CLBP).
The study design is a multicenter cohort design. Patients with nonspecific low back pain of more than three months duration are recruited in two different hospitals (Antwerp University Hospital and Sint Vincentius Hospital). After examination patients are assigned to one of three intervention groups: motor control therapy, isometric training therapy and a combination therapy. All patients will undergo eighteen treatment sessions during nine weeks. Measurements will be taken at baseline and after nine weeks of treatment.
The primary outcome used is the Modified Oswestry Disability Questionnaire (MDQ). For each type of exercise therapy prognostic indicators will be investigated.
Never before a multi-arm design was performed for the identification of prognostic indicators for exercise therapy in patients with nonspecific CLBP.
详细描述
Methods/ Design
Ethical approval (B300201215600) was obtained from the local ethics committees of the Antwerp University Hospital.
Study design In the identification of prognostic indicators is derived from a number of variables that have predictive potential for therapy outcome. These variables are obtained from baseline measurements and have a multidimensional character (impairments, activities/participation and contextual factors).
Patient recruitment Patients will be recruited by doctors at the service of two settings located in Antwerp namely the Antwerp University Hospital (UZA) and the Sint-Vincentius Hospital. Treatment and measurements will be performed at the site where the patient has been recruited.
Inclusion criteria: Current nonspecific LBP persisting at least three months, consulted a medical doctor during the last month because of the persistent low back pain, age between 18 and 60, sufficient fluency in Dutch to follow treatment instructions and answer survey questions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •at least 3 months low back pain
- •consulted a medical doctor during last month because of persistent low back pain
- •age between 18 - 60
排除标准
- •vestibular dysfunction
- •a history of known spinal fractures
- •spondylolysis and spondylolisthesis
- •radiating pain below the knee
- •muscle, nerve, skin, joint diseases
- •pregnancy
研究组 & 干预措施
Motor control therapy
physiotherapy
干预措施: physiotherapy (Other)
Isometric training therapy
physiotherapy
干预措施: physiotherapy (Other)
Combination therapy
physiotherapy
干预措施: physiotherapy (Other)
结局指标
主要结局
Measurement of functional disability
时间窗: 2 years
Modified Oswestry Low Back Pain Disability Questionnaire (MDQ): the patient questionnaire contains topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. Each topic category is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. Zero is equated with no disability and 100 being maximum disability.
次要结局
- patient characteristics(2 years)
- clinical testing(2 years)
- patient reported outcome measures(2 years)
研究者
Denteneer Lenie
Dra. Denteneer Lenie
Universiteit Antwerpen