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NCT05802914 · ClinicalTrials.gov registry record · NA
Soft Active Back Exosuit to Reduce Workplace Back Pain
A NA study of Low Back Pain and Musculoskeletal Pain, sponsored by Wyss Institute at Harvard University.
- Completed
- Registry status
- NA
- Development phase
- 97
- Enrollment target
- 1
- Study location
NCT05802914: Completed NA study of Low Back Pain and Musculoskeletal Pain, sponsored by Wyss Institute at Harvard University.
NCT05802914 is a NA study of Low Back Pain and Musculoskeletal Pain that has completed, run by Wyss Institute at Harvard University. The registered enrollment target is 97 participants, below the 503-participant average among 122 other Low Back Pain trials with a reported enrollment target (81% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05802914, a NA study of Low Back Pain and Musculoskeletal Pain, has completed, sponsored by Wyss Institute at Harvard University.
- COMPLETED
- Registry status
- NA
- Development phase
- 97 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DEVICE Back Exosuit
Study Locations (1)
Kentucky
- Undisclosed Location - Louisville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 97 participants |
| Start Date | 2023-02-08 |
| Est. Completion | 2025-04-26 |
| Phase | NA |
What the finished NCT05802914 record still lists
NCT05802914 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 97 participants, a relatively small participant target, below the 503-participant average among 122 other Low Back Pain trials with a reported enrollment target (81% lower).
The record links to 3 conditions, with Low Back Pain appearing as the primary indexed condition, and to 1 intervention - of which Back Exosuit is the first listed.
NCT05802914 reports a single indexed study location in Kentucky.
Frequently Asked Questions
What is clinical trial NCT05802914 about?
NCT05802914 is a clinical study titled "Soft Active Back Exosuit to Reduce Workplace Back Pain". 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 muscl...
What is the current status of trial NCT05802914?
This trial is currently completed. It is a NA study. The enrollment target is 97 participants. The study started on 2023-02-08. Estimated completion is 2025-04-26.
What conditions does trial NCT05802914 study?
This clinical trial studies the following conditions: Low Back Pain, Musculoskeletal Pain, Low Back Injury.
What interventions are being tested in trial NCT05802914?
The interventions under investigation include: Back Exosuit (DEVICE).
Who is sponsoring clinical trial NCT05802914?
This trial is sponsored by Wyss Institute at Harvard University, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05802914 being conducted?
This trial has 1 study location across Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05802914's enrollment target sits among peer trials
97 62nd of 122 higher than 61 of 122 other Low Back Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Low Back Pain trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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