Effect of Lumbar Bracing on Spinal Function
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 主要终点
- Oswestry Disability Index
研究概览
简要总结
A recent province-wide survey (Alberta, Canada) suggests that clinicians' beliefs about soft lumbar bracing for low back pain (LBP) vary substantially. Approximately 50% of clinicians (MDs, DCs, PTs) find back braces "useful" for acute back pain while the remaining half report that bracing causes muscle atrophy. While previous studies suggest bracing for acute low back conditions can reduce pain and does not cause atrophy, no prior study has assessed back function after bracing using self-reported and objective measures within the same cohort.
PURPOSE:
To assess both self-reported and objective measures of spine function before, and after, use of an inelastic lumbar brace over a two week period.
STUDY DESIGN:
Before-After Design
OUTCOME MEASURES:
Self-reported spine function, spinal stiffness and muscle endurance.
METHODS:
Three groups were studied: asymptomatics who did not wear a brace (-LBP/-Brace), asymptomatics who were braced (-LBP/+Brace) and acute LBP subjects who were braced (+LBP/+Brace). Both groups of braced subjects (-LBP/+Brace; +LBP/+Brace) were instructed to wear the brace continually for 2 weeks with the exception of bedroom & bathroom activities. Before and after the 2 week period, 3 measures of spine function were performed: spinal stiffness via motorized indentation of the L3 spinous process, a modified Sorensen test (timed lumbar extension against gravity), and the Oswestry Disability Index (ODI). Unbraced (-LBP/-Brace) subjects were studied over the same time with the same measures. Repeated measures analyses of variance were conducted for all three outcomes with a significance level of 0.05.
详细描述
Background: While various treatments for low back pain (LBP) are prescribed, one in particular appears to be frequently self-prescribed: external lumbar bracing (i.e. elastic corsets and other similar devices). Given that the mechanical function of the back is to bear static and dynamic loads and that most LBP is thought to be mechanical in nature, there is a biological plausibility that underlies bracing as a treatment for LBP Indeed, several reports suggest lumbar bracing may be effective for some LBP patients.
The high frequency of self-prescribed bracing may be the result of the clinical community's reluctance to prescribe these devices. Approximately half of Alberta spine clinicians believe that spine bracing results in muscle atrophy and/or future dependency on braces. Conversely, recent work from our laboratory has shown that after two weeks of brace wearing, the volume of spinal muscles remains unchanged in asymptomatic subjects (i.e. no brace-induced atrophy was caused)
Objective and hypothesis: While bracing for 14 days does not result in decreased muscle volume in asymptomatic subjects, there is a need to understand if bracing preserves muscle volume while muscle function declines. This information would allow us to understand the effects of bracing on spinal function independent of changes in muscle volume. Therefore, we hypothesize that that brace-wearing will result in an insignificant alteration in spinal function.
Future Relevance: Results from this pilot study will allow us to construct future investigations to reveal the underlying mechanisms of bracing with respect to the alleviation of LBP.
Subjects: Subjects of both genders between the ages of 18 and 65 will be recruited from the University of Alberta and surrounding area. The target recruitment populations are 1) asymptomatic subjects and 2) those with low back pain. Subjects excluded from the study will have a history of back pain with red flags, those who are pregnant (or believe they may be pregnant) or other contraindications described in the full protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
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
- 是
入选标准
- •Subjects enrolled in the study will be between the ages of 18 and 65 and include both genders.
- •Asymptomatic subjects will be asymptomatic for low back pain for a period of 3 months or more.
- •Symptomatic subjects will have non-specific low back pain that is of an acute or chronic nature. Recruiting those with non-specific low back pain ensures that we are not enrolling subjects with a specific cause for back pain (eg, spinal fracture) for which spinal function testing is contraindicated.
排除标准
- •Specific to the spinal function tests used here, excluded subjects will include those with suspected or confirmed malignancy as the cause for back pain, spinal fracture (current or within the last 5 years), previous non-day surgery to the abdomen, spine pelvis or hips, presence of nerve root involvement (presence of at least 2 of the 3: myotomal weakness, altered sensation in dermatomal patterns, and/or altered knee/ankle reflexes), ankylosing spondylitis and current skin conditions that may be aggravated by bracing, These exclusion criteria relate to back conditions for which spinal function testing is contraindicated (eg, malignancy) or in which there is a greater chance of causing discomfort (eg, nerve root involvement).
- •General exclusion criteria include: osteoporosis, rheumatoid arthritis (or taking any disease modifying anti-rheumatic drugs), pregnancy or suspected pregnancy, known severe spondylolisthesis, severe scoliosis, Type I diabetes mellitus, hyperparathyroidism, hyperthyroidism, inability to lie prone for at least 40 minutes, inability to tolerate back extension or spinal indentation (eg, indentations cause discomfort), inability to speak or read English (to ensure that participants understand what is happening and can reliably relay any discomfort). People currently taking muscle relaxants will also be excluded. In addition, subjects who are hypertensive, or are prone to hypertension (smokers), will be excluded from this study as will subjects who have a history of aortic aneurysm. Although hypertension and aortic aneurysm are not contraindications to lumbar bracing, we will exclude them from this trial. Finally, some persons with low or high body mass indexes may not be eligible to participate if they are unable to be fitted properly with a brace. Subjects will also be excluded if they feel they would be unable to lie prone (i.e. face-down) for up to 1 hour during spinal stiffness and RUSI testing.
研究组 & 干预措施
-LBP/-Brace
Subjects in this arm did not have back pain nor did they wear brace (asymptomatic controls). Subjects had their spine function measured before and after a two week period.
-LBP/+Brace
Intervention = Lumbar corset (Quickdraw, Aspen Medical Products) Subjects in this arm did not have back pain but wore a brace for a two week period (asymptomatic intervention). Subjects had their spine function measured before and after a two week period.
干预措施: Lumbar corset (Quickdraw, Aspen Medical Products) (Device)
+LBP/+Brace
Intervention = Lumbar corset (Quickdraw, Aspen Medical Products) Subjects in this arm had back pain and wore a brace for a two week period (symptomatic intervention). Subjects had their spine function measured before and after a two week period.
干预措施: Lumbar corset (Quickdraw, Aspen Medical Products) (Device)
结局指标
主要结局
Oswestry Disability Index
时间窗: 2 weeks
The Oswestry Disability Index (ODI) questionnaire is a self-reported measure of function that examines the perceived level of disability. The ODI is made up of 10 questions. Each question is scored from 0-5 (minimum to maximum) The point total from each section is summed and then divided by the total number of questions answered and multiplied by 100 to create a percentage disability. The scores range from 0-100% with lower scores meaning less disability. If one section is missed (or not applicable) the score is calculated: (Total scored) / (total possible score with section removed) x 100 = __%
次要结局
- Modified Sorensen Test(2 weeks)
- Bulk Spinal Stiffness(2 weeks)
- Rehabilitation Ultrasound Imaging(2 weeks)