Clinical trial NCT05802914: Soft Active Back Exosuit to Reduce Workplace Back Pain
Official title: Efficacy of Soft Active Back Exosuit to Reduce the Risk of Occupational Low Back Pain and Injuries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Musculoskeletal Pain
Low Back Injury
Keywords: Exoskeleton
Ergonomics
Wearable Robotics
Exosuit
Occupational Injury
Lead sponsor: Wyss Institute at Harvard University
Sponsor class: OTHER
Collaborators: name: Boston University
name: Liberty Mutual
name: Verve Motion
name: University of Delaware
name: Industrial Partner
name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2023-04-07
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized into an exosuit or a control group using a 2:1 stratified ratio. Strata will be developed based on workplace, lifetime back pain history, and job tenure (\>90 days). Participants in each group will complete regular workplace tasks while wearing or not wearing a back exosuit respectively.
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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"

Exclusion Criteria:

* 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

Primary outcomes:
measure: Level of work-interfering low back pain (changes over time and differences between groups)
timeFrame: Baseline, Months (1-4)
measure: Self-reported incidence of low back pain (changes over time and differences between groups)
timeFrame: Baseline, Months (1-4)
measure: Workplace reported incidence of a low back injury (differences between groups)
timeFrame: Continuously from randomization to 4 months
Secondary outcomes:
measure: Self-reported severity of low back pain (changes over time and differences between groups)
timeFrame: Baseline, Months (1-4)
measure: Workplace reported severity of low back pain (differences between groups)
timeFrame: Continuously from randomization to 4 months
measure: Self-reported intensity of global pain (changes over time and differences between groups)
timeFrame: Baseline, Months (1-4)
measure: Self-reported intensity of localized body discomfort (changes over time and differences between groups)
timeFrame: Baseline, Months (1-4)
measure: Self-reported perception of physical fatigue and effort (changes over time and differences between groups)
timeFrame: Baseline, Months (1-4)
Other outcomes:
measure: Perceived intervention satisfaction, job productivity, device usability, and device adverse events (changes over time and differences between groups)
timeFrame: Baseline, Months (1-4)
Locations:
city: Louisville
country: United States
facility: Undisclosed Location
state: Kentucky
Study officials:
References:
citation: Quirk DA, Chung J, Schiller G, Cherin JM, Arens P, Sherman DA, Zeligson ER, Dalton DM, Awad LN, Walsh CJ. Reducing Back Exertion and Improving Confidence of Individuals with Low Back Pain with a Back Exosuit: A Feasibility Study for Use in BACPAC. Pain Med. 2023 Aug 4;24(Suppl 1):S175-S186. doi: 10.1093/pm/pnad003.
citation: Zelik KE, Nurse CA, Schall MC Jr, Sesek RF, Marino MC, Gallagher S. An ergonomic assessment tool for evaluating the effect of back exoskeletons on injury risk. Appl Ergon. 2022 Feb;99:103619. doi: 10.1016/j.apergo.2021.103619. Epub 2021 Nov 2.
citation: Hedge A, Morimoto S, McCrobie D. Effects of keyboard tray geometry on upper body posture and comfort. Ergonomics. 1999 Oct;42(10):1333-49. doi: 10.1080/001401399184983.
citation: Baldassarre A, Lulli LG, Cavallo F, Fiorini L, Mariniello A, Mucci N, Arcangeli G. Industrial exoskeletons from bench to field: Human-machine interface and user experience in occupational settings and tasks. Front Public Health. 2022 Nov 21;10:1039680. doi: 10.3389/fpubh.2022.1039680. eCollection 2022.