Lumbar Brace Deployment in The Emergency Department for Benign Low Back Pain: Effectiveness and Impact on Pain, Spine Function, Analgesic Use and Community Resources
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 152
- 试验地点
- 1
- 主要终点
- Change in the pain level
研究概览
简要总结
Low back pain accounts for billions of dollars in health care expenditures. Most cases of back pain do not have a clear cause. Thus, low back pain management methods usually rely on targeting people' pain and discomfort. Painkillers, including opioids, are usually prescribed in the emergency departments for people with low back pain. But, like all medications, painkillers can have side effects, and some of those can be serious. There are also serious concerns about the overuse of painkillers. Thus, newer pain management methods are needed to reduce the use of painkillers in people with low back pain. Lumbar braces are one of the underutilized low back pain management methods in the emergency departments. Like crutches for leg and ankle injuries, they can minimise movements of the spine. This may decrease people pain and improve their function. This may also reduce the use of painkillers. In support of this approach, two recent studies conducted in a primary-care setting observed a reduction in the use of painkillers in people with low back pain who wore lumbar braces. The investigators are conducting this study to determine if wearing a lumbar brace for 4 weeks following emergency department presentation will reduce people's pain and discomfort and increase spine function. This may decrease the use of painkiller and future use of healthcare resources. This research study may also assist emergency-department staff with offering new recommendations to improve the quality of clinical decisions.
详细描述
BACKGROUND/SIGNIFICANCE
The global point prevalence of activity-limiting low back pain was 7.3% in 2015, implying that 540 million people were affected at one time. Although people with acute or chronic low back pain usually improve in the first six weeks, they usually suffer from low to moderate levels of pain and disability in the first year. Low back pain is an urgent global public health concern, accounting for billions of dollars in health care expenditures. Much of this spending is for high-cost, low-value care such as evaluating low back pain in the emergency department; only 3% of persons with low back pain attending the emergency department are admitted to the hospital while those who are discharged leave without effective pain control. This low-value approach is thought to increase use of additional health-related resources including repeat use of the emergency department for future low back pain complaints and use of opioids. This reduces limited available resources that should more appropriately be used for other health care needs.
While emergency departments routinely recommend analgesics for low back pain (paracetamol, nonsteroidal anti-inflammatory drugs, opioids, etc.), current guidelines do not support this approach; only nonsteroidal anti-inflammatory drugs are recommended as second-line/adjunctive treatment. As such, there is a critical need to provide emergency-department staff with better short-term pain control solutions. One underutilized pain-control solution in emergency departments is lumbar orthoses. Like crutches for leg or ankle injuries, lumbar orthoses can minimise lumbar spine movements, which can reduce pain and discomfort while preserving important aspects of daily function. In support of this approach, two recent randomised controlled trials conducted in a primary-care setting observed a reduced analgesic consumption in low back pain patients who received lumbar orthoses.
HYPOTHESES
- Wearing a semi-rigid lumbar brace for 4 weeks following emergency department presentation will reduce participant pain and discomfort;
- The same bracing protocol will improve spine function;
- The same bracing protocol will decrease analgesic consumption including opioids;
- The same bracing protocol will decrease future use of healthcare resources.
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, outcomes assessor and adjudicators, as well as the statistician, will be blinded to the actual allocation. The investigators will develop two interpretations of our results based on a blinded review of the primary outcome data (intervention A vs. intervention B). One scenario will assume intervention A was brace and the other will assume intervention A was routine recommendations. Only after our team has agreed that there will be no further changes in the interpretation of the scenarios will the randomisation code be broken, and the correct interpretation used in manuscript preparation.
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
- •Aged between 18 and 65 years
- •Ambulatory
- •Able to read and understand English
- •Living in Edmonton
- •Presenting to an emergency department
排除标准
- •Back pain due to systemic or specific disease such as known cancer, spinal infection, fracture, or ankylosing spondylitis
- •Pregnancy
- •Significant compression of the spinal cord/nerves
- •Previous back surgery
- •On-going workers' compensation or litigation cases
研究组 & 干预措施
Intervention
Participants will be instructed to follow their current low back pain management program, in addition, they will be instructed to wear a lumbar brace (Horizon 627 Lumbar Brace) during the day for four weeks only when they are in pain in addition to their current management program.
干预措施: Horizon 627 Lumbar Brace, Aspen Medical Company, Oak Canyon, Irvine, CA 92618 (Device)
Control
Participants will be instructed to follow their current low back pain management program.
结局指标
主要结局
Change in the pain level
时间窗: Month 12
The change in the pain level between the baseline and 12-month follow-up will be evaluated using the Numeric Pain Rating Scale \[0-10\]. The 11-point numeric scale ranges from '0' representing "no pain" to '10' representing the "worst pain imaginable".
Change in the pain level
时间窗: Week 6
The change in the pain level between the baseline and 6-week follow-up will be evaluated using the Numeric Pain Rating Scale \[0-10\]. The 11-point numeric scale ranges from '0' representing "no pain" to '10' representing the "worst pain imaginable".
Change in the pain level
时间窗: Month 4
The change in the pain level between the baseline and 4-month follow-up will be evaluated using the Numeric Pain Rating Scale \[0-10\]. The 11-point numeric scale ranges from '0' representing "no pain" to '10' representing the "worst pain imaginable".
Change in the pain level
时间窗: Month 8
The change in the pain level between the baseline and 8-month follow-up will be evaluated using the Numeric Pain Rating Scale \[0-10\]. The 11-point numeric scale ranges from '0' representing "no pain" to '10' representing the "worst pain imaginable".
次要结局
- Change in the self-reported disability level - Questionnaire A(Month 12)
- Change in the self-reported disability level - Questionnaire B(Month 12)
- Change in the self-reported disability level - Questionnaire A(Week 6)
- Change in the self-reported disability level - Questionnaire A(Month 4)
- Change in the self-reported disability level - Questionnaire A(Month 8)
- Change in the self-reported disability level - Questionnaire B(Week 6)
- Change in the self-reported disability level - Questionnaire B(Month 4)
- Change in the self-reported disability level - Questionnaire B(Month 8)