Effect of Physiotherapy in Patients Presenting to the Emergency Department With Nonspecific Lower Back Pain. A Brief Intervention Focusing on Patient Reported Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 126
- 试验地点
- 2
- 主要终点
- Oswestry Disability Index (ODI)
研究概览
简要总结
Physiotherapy is a long established therapy in lower back pain. It is unknown if physiotherapeutic interventions in patients presenting to the Emergency Department (ED) with nonspecific lower back pain are beneficial. The aim of this study is to assess whether patients presenting to the emergency department with non-specific low risk low back pain would benefit from a physiotherapy intervention, as compared to patients without physiotherapy intervention at time of ED presentation.
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
- •Written informed consent
- •Experiencing nonspecific lower back pain
- •Presentation to the Emergency Department (ED) of the University Hospital Basel
排除标准
- •Inpatient disposition after ED work-up
- •"Red Flags" at time of ED-presentation:
- •Major trauma in all patients
- •Fractures leading to immobilization
- •Severe or progressive sensory alteration or weakness
- •Bladder or bowel dysfunction
- •Evidence of neurological deficit on physical examination
- •Severe chronic disease, such as metastasized cancer, palliative care
- •Epidural steroid injections in the last 3 months
- •Inability or contraindications to undergo the investigated intervention or to follow the study procedures, e.g. due to certain neurological disorders, language problems, psychological disorders, cognitive impairment, physical inability etc.
- •Prior enrolment in this trial
结局指标
主要结局
Oswestry Disability Index (ODI)
时间窗: At Day 0 and at Day 7 ± 7 days
This self-completed questionnaire contains ten topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. Each topic category is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. The patient then checks the statement which most closely resembles their situation. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.
次要结局
- Oswestry Disability Index (ODI)(Day 21 ± 3 days, Day 42 ± 3 days)
- Pain Numeric Rating Scale (NRS)(At Day 0, Day 7 ± 7 days, Day 21 ± 3 days, Day 42 ± 3 days)
- Adherence to therapy recommendations(At Day 7 ± 7 days)
- StarT Back Screening Tool (SBST)(Day 0, Day 7 ± 7 days, Day 42 ± 3 days)
- Feasibility of the intervention(At Day 0)
- Utilization of medical resources(At Day 7 ± 7 days, Day 21 ± 3 days, Day 42 ± 3 days)
- Ability to work(At Day 7 ± 7 days, Day 21 ± 3 days, Day 42 ± 3 days)
- Patient satisfaction(At Day 7 ± 7 days)
- Pain medication use(At Day 0, Day 7 ± 7 days, Day 21 ± 3 days, Day 42 ± 3 days)