Efficacy of Soft Active Back Exosuit to Reduce the Risk of Occupational Low Back Pain and Injuries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 97
- 试验地点
- 2
- 主要终点
- Level of work-interfering low back pain (changes over time and differences between groups)
研究概览
简要总结
The goal of this clinical trial is to determine if a wearable back exosuit can make it safer and easier for workers who bend, lift, and lower objects in an industrial setting.
Many studies have shown that wearable back exoskeletons or exosuits can provide helpful forces making a person's back muscles work less. It is believed that exosuits can lower a person's level of workplace effort and fatigue, making it less likely for them to have back pain at work. Back exosuits could be a solution to make a job easier, but how well they work in the real-world over a long period of time is unclear.
The investigators want to know if workers who wear a back exosuit during the workday will have lower rates of lower back pain or injury than those who are not wearing a back exosuit. The investigators also want to know how well exosuit technology integrates into the workplace (for example, how this technology improves or hinders job performance).
Participants will be randomized into an exosuit group or control group. Participants in the exosuit group will be given a back exosuit that they can use as much as they want at work. All participants will complete surveys monthly.
Researchers will compare the exosuit group to the control group to see if using a back exosuit in a workplace can reduce a person's risk and impact of low back injury or pain. The investigators also want to see if a back exosuit impacts job productivity and if participants find the exosuit becomes useful or bothersome over time.
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 (Outcomes Assessor)
盲法说明
Because of the transparency of a back exosuit, it is not feasible to blind participants and study team members. However, an independent blind statistician will perform our primary intention to treat analysis on our primary outcome measures. The statistician will perform analysis consistent with our statistical analysis plan, transforming data prior to knowledge of group assignment.
Additional secondary analysis will be performed on open labeled data.
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
- 是
入选标准
- •18-65 years old
- •Works as a full-time (>35 hours/ week) employee for our Industrial Partner
- •Regularly bends, lifts, or lowers objects below hip height >50% of their working day for multiple periods lasting more than 1 hour without sitting
- •Can read and speak in English
- •Has internet access
- •Has completed an Exosuit Shift Demonstration
- •Thigh circumference is > 19" and < 32"
- •Back length (Neck to Iliac Crest) is >18"
排除标准
- •Temporary workers not directly employed by our Industrial Partner
- •Diagnosed or self-reported sensory motor disorders (stroke, Parkinson's disease, ALS, multiple sclerosis, spinal cord injury, etc.)
- •Use of a pacemaker or other powered, implanted medical devices
- •Medical condition that would make the participant likely to break bones (i.e., osteoporosis or osteopenia)
- •Spinal fracture in the past 2 years
- •Spinal surgery at multiple vertebral levels in the participant's lifetime, including vertebroplasty but excluding injections, such as steroids, nerve blockers, etc.
- •Sought medical care for spinal surgery at a single vertebral level in the past 2 years, including vertebroplasty but excluding injections, such as steroids, nerve blockers, etc.
- •Current malignant cancer
- •Currently pregnant
- •Skin issues / sensitivity that an exosuit could exacerbate (e.g., thin skin, sensitive skin, easy rashing, easy bruising or skin conditions, Epidermolysis Bullosa, etc.)
- •A current episode of upper back or neck pain, requiring modified duties at work
- •A recent episode of LBP resulting in pain (sharp, shooting, burning), radiating below one or both legs (past mid-thigh) in the last 3 months (e.g., sciatica)
- •A recent episode of back pain resulting in time off work, modified duties, or seeking medical attention in the last 3 months
结局指标
主要结局
Level of work-interfering low back pain (changes over time and differences between groups)
时间窗: Baseline, Months (1-4)
The Cornell Musculoskeletal Discomfort Questionnaire (MDQ) is a composite score that considers the frequency, severity, and work interference of body aches and pains. The back pain score will be evaluated between the 2 groups at 5 time points.
Self-reported incidence of low back pain (changes over time and differences between groups)
时间窗: Baseline, Months (1-4)
The definition of low back pain highly influences incidence rates. Low back pain incidence will be identified as a meaningful change (answering in the affirmative with a previous negative response) to the following self-report measures: Reporting a Cornell MDQ low back pain score \>13.5 Answering yes to: "In the past month, have you felt low back pain that caused you to change your activities for at least 3 days (i.e., have you noticed avoiding certain movements or moving differently than you normally do)?" Answering yes to: "In the past month, have you seen a health care provider for low back pain (i.e., a doctor, nurse, physical therapist, chiropractor, or another health care provider)?" Answering yes to: "In the past month, have you taken time off work for low back pain?"
Workplace reported incidence of a low back injury (differences between groups)
时间窗: Continuously from randomization to 4 months
Our industrial partner will record if a participant reports a workplace low back injury. The rates of reported events will be measured in each group.
次要结局
- Self-reported intensity of global pain (changes over time and differences between groups)(Baseline, Months (1-4))
- Self-reported intensity of localized body discomfort (changes over time and differences between groups)(Baseline, Months (1-4))
- Self-reported perception of physical fatigue and effort (changes over time and differences between groups)(Baseline, Months (1-4))
- Self-reported severity of low back pain (changes over time and differences between groups)(Baseline, Months (1-4))
- Workplace reported severity of low back pain (differences between groups)(Continuously from randomization to 4 months)
研究者
David Adam Quirk
Principal Investigator
Harvard University