Determining the Effects of Adding Exercise to Usual Care for Recent Onset Low Back Pain in the Emergency Department: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 2
- 主要终点
- Self-reported disability
研究概览
简要总结
Low back pain (LBP) is the leading contributor to years lived with disability and an important contributor to healthcare costs and time off work. Exercise is effective for chronic low back pain, but there is a lack of evidence to inform whether exercise in the emergency department is effective for people with acute low back pain. This randomized controlled trial will evaluate the effectiveness of a brief exercise intervention provided in the emergency department for people with recent onset low back pain. People with acute low back pain (<1 week) will be randomly assigned to either usual care or to usual care plus a brief exercise intervention delivered by trained physiotherapy students. The study will evaluate the impact of the added exercises on self-reported disability (primary outcome), pain intensity, global rating of change, patient satisfaction, and adverse events. In addition, we will pilot data collection related to return to work, healthcare utilization, and cost effectiveness outcomes to determine the feasibility of conducting a future trial with additional patient participants required to evaluate these outcomes. Outcomes will be evaluated at baseline, 48-72 hours, 1-week, 1-month, and 3-months from their initial emergency department visit. The results of this study have the potential to inform emergency department management of acute low back pain.
详细描述
Low back pain (LBP) is the leading contributor to years lived with disability and an important contributor to healthcare costs and time off work. Exercise is effective for chronic low back pain, but there is a lack of evidence to inform whether exercise in the emergency department is effective for people with acute (<1 week) low back pain.
The objectives of this randomized controlled trial are:
- To determine the effectiveness of an exercise intervention delivered in the ED in comparison to usual ED care on pain, function, global rating of change, patient satisfaction, and adverse effects in adults with recent onset LBP (< 1 week).
- To determine the feasibility of a future RCT to evaluate the effects of the ED exercise intervention on return to work outcomes, health care utilization, and cost-effectiveness in comparison to usual care.
The investigators hypothesize that an exercise intervention in the ED will improve pain, function, global rating of change, and patient satisfaction in comparison to usual ED care with no difference in adverse effects.
Design: A randomized controlled trial (RCT) with two parallel arms (exercise and usual care).
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •English speaking
- •Adults (18-65 years)
- •Recent onset low back pain (<1 week)
排除标准
- •Subacute/chronic LBP (> 1week)
- •Previous episode of low back pain in past 3 months
- •previous back surgery
- •urinary retention
- •saddle anaesthesia
- •bilateral or multilevel neurological impairment
- •traumatic mechanism of injury (fall >3m or 3 steps, MVC >100km/h).
研究组 & 干预措施
Exercise
Participants in the exercise intervention arm will receive the usual care protocol plus a standardized, evidence informed exercise intervention provided by trained physiotherapy students. The exercise intervention will begin with a brief assessment to rule out contraindications to exercise and to identify any directional preferences (e.g. pain with lumbar flexion and relief with extension). The PT will then be taught four standardized exercises: the pelvic tilt exercise, a rotational exercise, a tailored graded walking program taking into account the current abilities of the patient, and an exercise based on the directional preference of the individual. These will be re-enforced with a handout including the rationale, instructions and dosage recommendations for the exercises.
干预措施: Exercise (Behavioral)
Exercise
Participants in the exercise intervention arm will receive the usual care protocol plus a standardized, evidence informed exercise intervention provided by trained physiotherapy students. The exercise intervention will begin with a brief assessment to rule out contraindications to exercise and to identify any directional preferences (e.g. pain with lumbar flexion and relief with extension). The PT will then be taught four standardized exercises: the pelvic tilt exercise, a rotational exercise, a tailored graded walking program taking into account the current abilities of the patient, and an exercise based on the directional preference of the individual. These will be re-enforced with a handout including the rationale, instructions and dosage recommendations for the exercises.
干预措施: Advice to stay active and engaged in usual activities. (Behavioral)
Exercise
Participants in the exercise intervention arm will receive the usual care protocol plus a standardized, evidence informed exercise intervention provided by trained physiotherapy students. The exercise intervention will begin with a brief assessment to rule out contraindications to exercise and to identify any directional preferences (e.g. pain with lumbar flexion and relief with extension). The PT will then be taught four standardized exercises: the pelvic tilt exercise, a rotational exercise, a tailored graded walking program taking into account the current abilities of the patient, and an exercise based on the directional preference of the individual. These will be re-enforced with a handout including the rationale, instructions and dosage recommendations for the exercises.
干预措施: Advice on use of ice or heat (Behavioral)
Exercise
Participants in the exercise intervention arm will receive the usual care protocol plus a standardized, evidence informed exercise intervention provided by trained physiotherapy students. The exercise intervention will begin with a brief assessment to rule out contraindications to exercise and to identify any directional preferences (e.g. pain with lumbar flexion and relief with extension). The PT will then be taught four standardized exercises: the pelvic tilt exercise, a rotational exercise, a tailored graded walking program taking into account the current abilities of the patient, and an exercise based on the directional preference of the individual. These will be re-enforced with a handout including the rationale, instructions and dosage recommendations for the exercises.
干预措施: Advise regarding use of medications (Other)
Usual care
Our usual care protocol was developed based on 30 responses to an 18 item survey of Queen's Department of Emergency Medicine physicians. Three themes emerged as interventions most commonly used. Each of these strategies has evidence for small, but positive treatment effects and low risk of harms: 1) advice to stay active and engaged in usual activities, 2) use of ice or heat to manage pain, and 3) recommendation for analgesia using NSAIDs if needed and appropriate.
干预措施: Advice to stay active and engaged in usual activities. (Behavioral)
Usual care
Our usual care protocol was developed based on 30 responses to an 18 item survey of Queen's Department of Emergency Medicine physicians. Three themes emerged as interventions most commonly used. Each of these strategies has evidence for small, but positive treatment effects and low risk of harms: 1) advice to stay active and engaged in usual activities, 2) use of ice or heat to manage pain, and 3) recommendation for analgesia using NSAIDs if needed and appropriate.
干预措施: Advice on use of ice or heat (Behavioral)
Usual care
Our usual care protocol was developed based on 30 responses to an 18 item survey of Queen's Department of Emergency Medicine physicians. Three themes emerged as interventions most commonly used. Each of these strategies has evidence for small, but positive treatment effects and low risk of harms: 1) advice to stay active and engaged in usual activities, 2) use of ice or heat to manage pain, and 3) recommendation for analgesia using NSAIDs if needed and appropriate.
干预措施: Advise regarding use of medications (Other)
结局指标
主要结局
Self-reported disability
时间窗: Change from baseline to 3-months with repeated measures at baseline, 1-week, 1-month, 3-months and a primary comparison at 1-week
Roland Morris Questionnaire (0-24, higher represents greater disability)
次要结局
- Adverse effects(1-week, 1-month, 3-months with a primary comparison at 1-week)
- Pain intensity at its worst over the past 24-hours(Change from baseline to 3-months with repeated measures at baseline, 1-week, 1-month, 3-months and a primary comparison at 1-week)
- Recruitment rate (to determine feasibility for future trial on healthcare utilization, cost-effectiveness and return to work)(Recruitment rate over 4 month period)
- Pain Intensity currently(Change from baseline to 3-months with repeated measures at baseline, 1-week, 1-month, 3-months and a primary comparison at 1-week)
- Pain intensity on average over past 24-hours(Change from baseline to 3-months with repeated measures at baseline, 1-week, 1-month, 3-months and a primary comparison at 1-week)
- Work status - working or not working (piloted to determine the feasibility of conducting a future trial evaluating return to work outcomes)(Baseline, 1-week, 1-month, 3-months with a primary time-point of 1-week)
- Pain intensity at its least over the past 24-hours(Change from baseline to 3-months with repeated measures at baseline, 1-week, 1-month, 3-months and a primary comparison at 1-week)
- Global rating of change(1-week, 1-month, 3-months with a primary comparison at 1-week)
- Patient satisfaction(1-week, 1-month, 3-months with a primary comparison at 1-week)
- Treatment fidelity(At initial visit)
- Retention rate (to determine feasibility for future trial)(Baseline, 1-week, 1-month, 3-months with a primary time-point of 3-month follow-up)
- Work status - full or part time (piloted to determine the feasibility of conducting a future trial evaluating return to work outcomes)(Baseline, 1-week, 1-month, 3-months with a primary time-point of 1-week)
- Work status - full or modified duties/hours(piloted to determine the feasibility of conducting a future trial evaluating return to work outcomes)(Baseline, 1-week, 1-month, 3-months with a primary time-point of 1-week)
- Work status - hours worked (piloted to determine the feasibility of conducting a future trial evaluating return to work outcomes)(Baseline, 1-week, 1-month, 3-months with a primary time-point of 1-week)
- Healthcare utilization (piloted to determine the feasibility of conducting a future trial evaluating healthcare utilization)(1-week, 1-month, 3-months with a primary time-point of 3-months)
- Costs (piloted to determine the feasibility of conducting a cost-effectiveness analysis in a future trial)(All costs incurred between baseline and 3-month follow-up will be calculated)
- Quality of life (piloted to determine feasibility of performing cost-effectiveness analysis in a future trial)(Change from baseline to 3-months with repeated measures at baseline, 1-week, 1-month, 3-months and a primary time-point of 3-months)
研究者
Jordan Miller, PT, PhD
Assistant Professor
Queen's University