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Набира участници Не е приложимо NCT03829631

Lumbar Brace Deployment in the Emergency Department for Benign Low Back Pain

Не е приложима фаза (напр. обсервационно)
Заболявания: Low Back Pain Brace Emergencies Pain Health Care Resources

Спонсор: University of Alberta

Налично на: БГ
Обобщение
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.
Описание
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 1. Wearing a semi-rigid lumbar brace for 4 weeks following emergency department presentation will reduce participant pain and discomfort; 2. The same bracing protocol will improve spine function; 3. The same bracing protocol will decrease analgesic consumption including opioids; 4. The same bracing protocol will decrease future use of healthcare resources. SPECIFIC AIMS 1. PRIMARY: To determine if lumbar bracing for 30 days after the emergency department presentation will reduce low back pain; 2. SECONDARY: To determine if this same bracing protocol will improve spinal function and quality of life; 3. SECONDARY: To establish if this same bracing protocol will reduce prescription and/or consumption of analgesics; 4. EXPLORATORY: To establish if this same bracing protocol will reduce back pain-related use of health resources (e.g., emergency department, primary care, imaging, and non-prescription management). RESEARCH PLAN Study Design This project is a prospective, superiority, 1:1 allocation, randomised controlled trial with
Кой може да участва
Inclusion Criteria: * Aged between 18 and 65 years * Ambulatory * Able to read and understand English * Living in Edmonton * Presenting to an emergency department Exclusion Criteria: * 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
Места на провеждане 1
Австралия (1)
Royal Perth Hospital
Perth
Технически детайли
Статус
Набира участници
Фаза
Не е приложимо
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Максимална възраст
65 Years
Здрави доброволци
Не
Начална дата
12.06.2019
Крайна дата
31.12.2026
Регистрационен номер
NCT03829631
Източник
anzctr
Запитване за медицински туризъм

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