An Educational and Exercise Program as Secondary Prevention of Recurrent Lower Back Pain in Healthcare Workers: A Randomized, Controlled, 2-year Follow-up Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 351
- 试验地点
- 2
- 主要终点
- Percentage of patients with recurrence(s) of lower back pain (number of related days of sick leave) over 12 months and 24 months
研究概览
简要总结
At Lyon University Medical Center, back problems are the leading cause of sick leave. The course of lower back pain is usually relatively short (recovery occurs within 4 to 6 weeks in 90% of cases). However, about 5-10% develop chronic lower back pain. Although this is a relatively small group, the economic consequences are enormous (accounting for 70 to 80% of the total cost of lower back pain).
Nowadays, some very general training sessions are offered to workers at Lyon University Medical Center, irrespective of their lower back pain status. These very general training sessions are mostly preventive and primary in nature (like back school program) despite the fact that these people already have a history of lower back pain, the main risk factor of recurrence and chronic pain.
Since the 1980, some multidisciplinary functional restoration programs have been advised as a strategy for secondary and tertiary prevention of lower back pain.
The purpose of this randomized controlled trial is to assess the effectiveness of physical exercise combined with an educational program and self-led exercise for Lyon University Medical Center workers with lower back pain. We hope this intervention will reduce the risk of recurrence and chronic lower back pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
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
- •All healthcare workers in the 4 hospital sites
- •History of acute or subacute lower back pain in the 3 past years
排除标准
- •History of surgery for spinal fractures
- •History of lumbosacral arthrodesis
- •History of surgical intervention or discal hernia, more than 2 levels or more than twice
- •Radiculalgia with sign of motor deficit, or radiculalgia with a positive Lasègue sign
- •Eligible for enrollement in a functional restoration program for lower back pain
- •Ongoing low back pain (lumbago)
- •Psychosocial or behavioural impairment
- •Unstable cardiac disease
- •Inability to fill out the questionnaires and scales (inability to understand French)
- •Pregnancy
研究组 & 干预措施
1
Study intervention:
- A face/profile X-ray of their entire spine at baseline
- Educational program
- Exercise program
- Self-led exercises
- A follow-up at 12 and 24 months with their occupational therapist.
- A follow-up at 18 months with a physical therapist.
- Workers received also at the end of the educational program written standardized information about back pain ("the back book", an information booklet) 1.
- Coudeyre E., Tubach F., Rannou F. & all, Effect of simple information booklet on pain persistance after an acute episode of low back pain: a non- randomised trial in a primary care setting. PLoS ONE. 2007 ; 2 : e706
干预措施: educational program (Other)
1
Study intervention:
- A face/profile X-ray of their entire spine at baseline
- Educational program
- Exercise program
- Self-led exercises
- A follow-up at 12 and 24 months with their occupational therapist.
- A follow-up at 18 months with a physical therapist.
- Workers received also at the end of the educational program written standardized information about back pain ("the back book", an information booklet) 1.
- Coudeyre E., Tubach F., Rannou F. & all, Effect of simple information booklet on pain persistance after an acute episode of low back pain: a non- randomised trial in a primary care setting. PLoS ONE. 2007 ; 2 : e706
干预措施: exercise program (Other)
1
Study intervention:
- A face/profile X-ray of their entire spine at baseline
- Educational program
- Exercise program
- Self-led exercises
- A follow-up at 12 and 24 months with their occupational therapist.
- A follow-up at 18 months with a physical therapist.
- Workers received also at the end of the educational program written standardized information about back pain ("the back book", an information booklet) 1.
- Coudeyre E., Tubach F., Rannou F. & all, Effect of simple information booklet on pain persistance after an acute episode of low back pain: a non- randomised trial in a primary care setting. PLoS ONE. 2007 ; 2 : e706
干预措施: Self-led exercises (Other)
2
Control intervention :
- No intervention
- A face/profile X-ray of their entire spine at baseline
- A follow-up at 12 and 24 months with their occupational therapist,
- A follow-up at 18 months with a physical therapist.
结局指标
主要结局
Percentage of patients with recurrence(s) of lower back pain (number of related days of sick leave) over 12 months and 24 months
时间窗: 12 and 24 months
次要结局
- Recurrences of lower back pain(At baseline, 12 and 24 months after intervention)
- Percentage of patients with a chronic lower back pain (sick leave days>3 months)(At baseline, 12 and 24 months after intervention)
- Participant compliance with the global prevention program (self-led exercises)(At 6 and 12 months after intervention)
- Depression and anxiety (HAD scale)(At baseline, 12 and 24 months after intervention)
- Delay before a recurrence of lower back pain(At baseline, 12 and 24 months after intervention)
- Fear-avoidance beliefs(FABQ scale)(At baseline, 12 and 24 months after intervention)
- Quality of life (SF-12 scale)(At baseline, 12 and 24 months after intervention)
- Lower back function(At baseline, 12 and 24 months after intervention)
- Pain : characteristics, intensity (Quebec Back Pain Disability Scale)(At baseline, 12 and 24 months after intervention)
- sagittal alignement of the spine (X-ray)(At baseline)