Rehabilitation of Patients With Modic Changes in the Lumbar Spine - 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
- 100
- 试验地点
- 2
- 主要终点
- The primary outcome measure is actual LBP, as measured with an "11 point box scale".
研究概览
简要总结
The purpose of this study is to compare patients with low back pain (LBP) and Modic Changes from The Backcenter Funen, Ringe:
- To compare the effect of two types of non-operative treatments:
A. exercise and advice to be physically active
B. restitution and advice not to overload the spine 2. To investigate if the results of the treatment are influenced by gender, age, smoking, and physical load.
详细描述
The clinical experience is that many patients with Modic changes have relatively severe and persistent LBP, which typically appears to be resistant to treatment. Furthermore, a retrospective study at The Backcenter Funen, Ringe, shows that patients with MC fail to improve engaging physical activity. This is unfortunate, because the typical rehabilitation for patients with persistent LBP is back exercises and information about keeping physically active. This means that this relatively large subgroup of patients with Modic changes probably does not improve with the rehabilitation tools used today.
A randomised controlled trial has therefore been designed to study the specific subgroup of patients with Modic changes. In this study we will compare the present "state-of-the art" rehabilitation approach to persistent LBP (namely to exercise and keep active) with a new concept (restitution). The justification for this is that restitution reduces mechanical stress on the vertebrae and therefore would allow heeling of the possible micro fractures in Modic changes.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary inclusion criteria for receiving MRI
- •The patient must have LBP with a current duration of 3 - 12 month.
- •The patient must have an actual pain intensity ≥4 on numerical pain rating scale from 0-
- •Secondary inclusion criteria for receiving MRI
- •The patient must speak and understand Danish.
- •The patient must be between 18-60 years of age.
- •The patient must be willing to participate in the project. Inclusions criterium for the project
- •There must be an MRI showing MC in the lumbar spine.
排除标准
- •The patient is unable to go through with the project because of other physical or mental disorder.
- •The patient is pregnant.
- •The patient is referred to operation.
结局指标
主要结局
The primary outcome measure is actual LBP, as measured with an "11 point box scale".
时间窗: 10 weeks and 12 months
次要结局
- General Health, as measured with the EQ-5D (EuroQol)(10 weeks and 12 months)
- General improvement, as measured with two global instruments a 7-point transition question and an assessment score consisting of a "bothersomeness index"(10 weeks and 12 months)
- Physical functions measured with "Roland Morris Disability Questionnaire"(10 weeks and 12 months)
研究者
Rikke Krüger Jensen
MSc
The Back Research Center, Denmark