Back Exosuit for Back Pain

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Wyss Institute at Harvard University

No Placebo Group

Trial Summary

What is the purpose of this trial?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

This trial is for full-time workers aged 18-65 who regularly perform tasks involving bending, lifting, or lowering objects and have a back length of over 18 inches. They must speak English, have internet access, and not be pregnant or have certain medical conditions like osteoporosis or recent severe back pain.

Inclusion Criteria

I am between 18 and 65 years old.

Works as a full-time (>35 hours/ week) employee for our Industrial Partner

I frequently bend and lift objects at work for long periods.

+5 more

Exclusion Criteria

I have had a spinal fracture within the last 2 years.

I am experiencing upper back or neck pain that affects my work.

Temporary workers not directly employed by our Industrial Partner

+10 more

Participant Groups

The study tests if wearing a back exosuit at work reduces lower back pain or injury compared to those without it. Participants are randomly assigned to use the exosuit as desired during work hours while completing monthly surveys about their experience and any changes in job performance.

2Treatment groups

Experimental Treatment

Active Control

Group I: ExosuitExperimental Treatment1 Intervention

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.

Group II: ControlActive Control1 Intervention

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.