Soft Active Back Exosuit to Reduce Workplace Back Pain

Wyss Institute at Harvard University

Status: Completed

Conditions: Musculoskeletal Pain; Low Back Injury; Low Back Pain

Treatments: Device: Back Exosuit

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT05802914

IRB22-0308

4UH3AR076731-02 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 97 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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97 participants in 2 patient groups

Exosuit

Experimental group

Description:

Exosuit refers to a soft active back exosuit. Participants in the exosuit arm will be fitted to a personal back exosuit device. Participants will be trained on how to use the device (retrieval, donning, powering up, mode switching, and doffing). Participants will be instructed to use the device at work, emphasizing they wear it whenever it seems practical (e.g. lifting) for as long as it remains comfortable. Associates from Verve Motion will check in with exosuit participants to address comfort issues and help participants integrate the exosuit into their workday.

Treatment:

Device: Back Exosuit

Control

No Intervention group

Description:

Control participants will not be assigned a back exosuit. Participants in the control group will perform workplace tasks as normal, completing study surveys at baseline and monthly for 4 months that are identical to exosuit group.