Evaluating the Effects of Six-Week of Lumbar Bracing on Type I Modic Changes: A Pilot Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Change in the size of the bone marrow lesions
研究概览
简要总结
Despite the high prevalence of low back pain, little is still known about its underlying pathology. Only a small proportion of people (~1%) have a diagnosable pathoanatomical entity causing low back pain. The other types of back pain are classified as non-specific low back pain. Thus, current back pain management typically focuses on relieving symptoms. This is largely ineffective without understanding the cause. Yet, there are some pathologies which are thought to be associated with low back pain.
Vertebral bone marrow oedemas are now known to be a hallmark feature for low back pain. There are three types of vertebral bone marrow oedemas. Type I oedemas are dynamic lesions that may progress to a higher grade, stop, or even return to normal. Although the precise cause of type I oedemas is not well understood, loading on the spine plays a key role in its development. Lumbar braces are known to reduce loads on the spine. Thus, they may reduce the size of oedema by modifying loads on the spine. The investigators already know that wearing a lumbar brace reduces pain in people with back pain and type I vertebral bone marrow oedemas. Unfortunately, there is no study showing that pain reduction with bracing is associated with a reduction of oedema. The goal of this study is to determine if wearing a lumbar brace for six weeks will reduce the dimensions of type I vertebral bone marrow oedema.
详细描述
Purpose
Modic changes are now known to have a high specificity for low back pain. Modic changes represent bone oedema and are dynamic lesions that may progress to a higher grade, stop, or even reverse to a lower grade. Although the precise aetiology of Modic changes is not well understood currently, abnormal mechanical loading plays a key role in their development and progression. Biomechanical studies have demonstrated that abnormal shear forces acting on the vertebral endplate could lead to endplate microtrauma and marrow oedema correlating with type I Modic changes. This suggests that Modic changes may be ideal structural targets for treatment designed to alter vertebral loading. The main goal of this project is, therefore, to mitigate, stop, or reverse Modic lesion progression and their associated pain through the use of lumbar orthoses that can modify loads acting on the lumbar spine by limiting both fine and gross trunk movements, and thus decreasing demands for muscular activities. As this effect of bracing likely reduces biomechanical stress on the vertebral endplate as well, lumbar orthoses should, in theory, be able to impact bone marrow lesions by normalizing lumbar loading.
Hypothesis
I) Modification of the mechanical load in the lumbar spine using a semi-rigid lumbosacral orthosis for six weeks will reduce the dimensions of Modic changes
II) The same bracing protocol will help mitigate, stop, or reverse the progression of 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)
盲法说明
Due to the nature of each intervention, blinding will not be feasible for participants. However, the MR technician, outcomes assessor, outcome adjudicators, and the statistician will be blinded to the actual allocation. The actual allocation will not be disclosed to the research assistant responsible for image processing, data entry, and the statistician.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pain between the 12th rib and buttocks with or without symptoms into one or both legs, which, in the opinion of the examiner, originate from the lumbar region
- •Have MRI evidence of type I Modic changes
- •Have a baseline Oswestry Disability Index >25%
- •Aged between 18 and 65 years
- •Are ambulatory
- •Can read and understand English
- •Living in Edmonton, Alberta, Canada
排除标准
- •Back pain due to a systemic or specific disease such as known cancer, spinal infection, fracture, or ankylosing spondylitis
- •Severe pain in the hip and knee joints
- •Claustrophobia
- •Any contraindications for MRI, such as pacemakers, orthopaedic prosthesis, device or implants at the spine or pelvic girdle
- •Pregnancy
- •Implanted with an intrauterine contraceptive device
- •Significant compression of the spinal cord/nerves
- •Previous back surgery
- •Waist circumference greater than 70 inches
- •Have received back injections within the last 4 weeks
- •On-going workers' compensation or litigation cases
结局指标
主要结局
Change in the size of the bone marrow lesions
时间窗: Week 6
Change in the size of the bone marrow lesion (Modic Changes) between the baseline and six-week follow-up will be evaluated by measuring the area of the lesion.
Change in the pain level
时间窗: Month 12
Change in the pain level between the baseline and 12-month follow-up will be evaluated using the Numeric Pain Rating Scale \[0-10\].
Change in the size of the texture of marrow lesions
时间窗: Weeks 0 and 6
Change in the texture of the bone marrow lesion (Modic Changes) between the baseline and six weeks will be evaluated using grey level co-occurrence matrix (Contrast, correlation, homogeneity, and the entropy).
次要结局
- Change in the self-reported Disability Level - Questionnaire A(12 Months)
- Change in the self-reported Disability Level - Questionnaire B(12 months)