Low Back PainNCT05802914
Soft Active Back Exosuit to Reduce Workplace Back Pain
A study testing Back Exosuit in people with Low Back Pain and Musculoskeletal Pain, run by Wyss Institute at Harvard University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain, Musculoskeletal Pain, Low Back Injury
- What is being tested?
- Back Exosuit
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Feb 2023to 26 Apr 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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"
Who cannot join
- 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.
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- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Soft Active Back Exosuit to Reduce the Risk of Occupational Low Back Pain and Injuries
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.
Read more
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.
- Conditions
- Low Back Pain, Musculoskeletal Pain, Low Back Injury
- Being tested
- Back Exosuit
- Keywords
- Exoskeleton, Ergonomics, Wearable Robotics, Exosuit, Occupational Injury
- Medical subject headings
- Low Back Pain, Musculoskeletal Pain, Occupational Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Back ExosuitDevice
Also called Verve SafeLift Suit
The back exosuit is a soft wearable robotic suit designed to improve a wearer physiology, kinetics, kinematics to reduce the possibility of injury. The back exosuit is primarily composed of textiles that wrap around an individual's shoulder (backpack) and thighs (thigh wrap) to serve as anchor points. An actuating element attaches to those anchor elements to provide assistive forces while the user performs a physical activity. The soft wearable robot integrates sensing components to be able to detect user biomechanics and device function and actuating elements via algorithms that command the actuation based on users' intent. To encourage usability, the device is easy to don and intuitive to use. This back exosuit has demonstrated significant reductions in back (18%), hip (11%) and knee (22%) extensor muscle activity during a 1-hour workplace simulation task when compared to lifting without a suit.
| Study group | Role | What they receive |
|---|---|---|
| Exosuit | Experimental | 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. Receives: Device: Back Exosuit |
| Control | No 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of Work-interfering Low Back Pain (Changes Over Time and Differences Between Groups)
The Cornell Musculoskeletal Discomfort Questionnaire (MDQ) is a composite score that ranges from 0-90. The score is calculated by multiplying a perceived rating frequency, severity, and work interference of body discomfort with higher scores corresponding to higher overall discomfort. The back discomfort score will be evaluated between the 2 groups at 5 time points.
Measured: Baseline, Months (1-4)
Self-reported Incidence of Low Back Pain (Changes Over Time and Differences Between Groups)
The incidence of a workplace low back discomfort event was defined as a > 6-point increase in a participant's lower back MDQ (reference in outcome 1) relative to their last recorded survey. If an incidence of low back discomfort is recorded the affirmative status is carried forward into subsequent completed surveys.
Measured: Months (1-4)
Secondary outcomes (5)
Self-reported Severity of Low Back Pain (Changes Over Time and Differences Between Groups)
Back pain severity refers to the level of intensity and the occupational or medical consequence of back pain. The following self-report measures will determine these values.
Numerical rating scale of back pain, which ranges from 0-10 where the highest score 10 represents a participants worst pain imaginable.
Measured: Baseline, Months (1-4)
Self-reported Intensity of Global Pain (Changes Over Time and Differences Between Groups)
Beyond low back pain, participants will report on total body discomfort and the intensity of discomfort at various joints:
Total body discomfort and interference will be evaluated using the Pain, Enjoyment of Lift and General Activity (PEG) 3 Scale, which ranges from 0-10. A higher score indicates greater pain intensity and greater interference with enjoyment of life and everyday activity.
Measured: Baseline, Months (1-4)
Self-reported Intensity of Localized Body Discomfort (Changes Over Time and Differences Between Groups)
The Cornell MSD scale (reference in outcome 1) will also be evaluated at every other body part (for example, ankles, knees, hip, upper back, neck, shoulders, elbows, and wrists). The composite score represents the sum (total) of all scores across 9 body parts, and ranges from 0-810. A higher score indicates higher intensity, and frequency of work interfering discomfort for multiple body parts.
Measured: Baseline, Months (1-4)
Self-reported Perception of Effort (Changes Over Time and Differences Between Groups)
A modified BORG scale has been developed with questions focusing on perceived level of back exertion. The scale ranges from 0-100, where a higher score indicates higher perceived back effort (maximal effort).
Measured: Baseline, Months (1-4)
Self-reported Perception of Physical Fatigue (Changes Over Time and Differences Between Groups)
A modified BORG scale has been developed with questions focusing on perceived level of workplace fatigue. The scale ranges from 0-100, where a higher score indicates higher perceived physical fatigue (absolutely exhausted).
Measured: Baseline, Months 1-4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study start8 Feb 2023
- Primary completion26 Apr 2025
- Study completion26 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wyss Institute at Harvard University
- Sponsor type
- University, hospital or other
- Collaborators
- Boston University, Liberty Mutual, Verve Motion, University of Delaware, Industrial Partner, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Principal investigator, David Adam Quirk, Harvard University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05802914
- Sponsor's protocol ID
- IRB22-0308
- Other IDs
- 4UH3AR076731-02
- Status last verified
- Sep 2026
- First submitted
- 2 Mar 2023
- Last updated
- 14 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Data collected in this study are part of the National Institutes of Health (NIH) Helping to End Addiction Long-term (HEAL) Initiative. As part of the Back Pain Consortium (BACPAC) data form this study will be submitted to the Data Integration, Algorithm Development and Operations Management Center (DAC) following study completion. Researchers will have the possibility to request data from the DAC.
Publications
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.
PubMed 36794907Zelik 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.
PubMed 34740072Hedge 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.
PubMed 10582503Baldassarre 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.
PubMed 36478728Quirk DA, Hess A, Taylor S, Williams DOR, Pohlig R, Dalton D, Awad L, Jacobs JV, Walsh C. Moderate exosuit use reduces the incidence of back discomfort in logistic warehouse workers: a randomised controlled trial with an exploratory dose-stratified analysis. Ergonomics. 2026 Oct 15:1-20. doi: 10.1080/00140139.2026.2742501. Online ahead of print.
PubMed 42878865