Work Related Upper Limb DisorderNCT06576570
Evaluation and Modification of Surgeon Ergonomics in the Operation Room Using Artificial Intelligence Analytics
A study testing Education presentation of surgical ergonomics and Summary of Ergonomic Measurement System in people with Work Related Upper Limb Disorder and Musculoskeletal Pain, run by University of Florida at 2 sites in United States.
Trial summary
The study is working to identify actions of surgeons in the operating room that can contribute to work-related musculoskeletal disorders. This includes poor positioning and time spent in poor positioning while working in the operating room. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Work Related Upper Limb Disorder, Musculoskeletal Pain
- What is being tested?
- Education presentation of surgical ergonomics and Summary of Ergonomic Measurement System
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Oct 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any general surgery operative case by a surgeon from the Division of Acute Care Surgery. These cases will be conducted in what has been designated as the "Acute Care Surgery OR" for the day.
Who cannot join
- Any operative case in which the surgical attending or resident has not signed informed consent to record this individual during the case.
- Any operative case that the surgical attending feels is inappropriate for video recording or when filming could interfere with surgical procedures
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
UF Health at Shands Hospital
Gainesville, Florida, 32610
UF Health Shands Hospital at the University of Florida
Gainesville, Florida, 32610
About this study
The study is working to identify actions of surgeons in the operating room that can contribute to work-related musculoskeletal disorders. This includes poor positioning and time spent in poor positioning while working in the operating room. The study is also looking to determine if fatigue plays a role in work-related musculoskeletal disorders and whether an education intervention will change ergonomic risk.
Read the detailed description
The study is working to identify actions of surgeons in the operating room that can contribute to work-related musculoskeletal disorders. This includes poor positioning and time spent in poor positioning while working in the operating room. The study is also looking to determine if fatigue plays a role in work-related musculoskeletal disorders.
Employing within-subject pre-post design to assess 1) patterns of aggregate risk data from video analysis in the OR for resident and attending surgeons over time and for different types of surgical tasks, 2) concurrent reliability assessment of the Rapid Upper Limb Assessment and Rapid Entire Body Assessment scores calculated from the software and visual analysis, 3) changes in pain data after review of the SOTER Task ergonomic outputs. The feasibility of using the system in the OR will also be assessed for open and laparoscopic surgery.
The study team will collect data, perform assessments, collect information from self-proctored surveys, and video record surgeon activities in the operating room on 20 surgeons. The video recordings will take measurements to assess risk factors for work-related musculoskeletal disorders. Following the fifth surgical case, the study team complete an education intervention by reviewing measurements established in the video recordings and supply a brief presentation on Ergonomics for Surgeons. A summary of observed body positioning for each subject is provided. Post intervention, five additional surgical cases will be observed in the manner of the previous cases to identify change in ergonomic risk.
- Being tested
- Education presentation of surgical ergonomics, Summary of Ergonomic Measurement System
- Medical subject headings
- Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education presentation of surgical ergonomicsBehavioural
During an individual meeting with participant, a brief presentation will be supplied for review.
Summary of Ergonomic Measurement SystemBehavioural
Participant will view a video of their movements with a visual guideline highlighting high-risk angles and movements.
| Study group | Role | What they receive |
|---|---|---|
| Acute Care Surgery Attending and Resident Surgeons | Other | Participants will be asked to perform their normal operative work for 5 cases while being filmed. Data will be collected using the SoterTask™ software which calculates momentary data on risk and an aggregate risk level. Two standard ergonomic risk assessments: Rapid Upper Limb Assessment (RULA) or the Rapid Entire Body Assessment (REBA) are also calculated. Both assessments are current best practice standard for determining the level of ergonomic risk. The RULA and REBA data calculated by SoterTask will be compared to scores assessed by the research team from the same video recordings of the work tasks.
Following the fifth operative case, participants will view an educational presentation of surgical ergonomics and review the data summarized from the ergonomic measurement system with video of their movement with a visual guideline highlighting high-risk angles and movements including legs, arms, neck and back. Receives: Behavioral: Education presentation of surgical ergonomics; Behavioral: Summary of Ergonomic Measurement System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine Ergonomic Risk Through Video-based Analysis calculated by an artificial intelligence software and evaluator assessment of Rapid Upper Limb Assessment (RULA) and Rapid Entire Body Assessment (REBA)
determine the ergonomic risk experienced by surgical attendings and residents during open and laparoscopic surgery measured through video-based analysis of
Measured: 1 year
Secondary outcomes (1)
Change in Ergonomic Risk After Reviewing Video Capture and Risk Data
determine if there is any change in ergonomic risk after reviewing video capture and risk data collated through artificial intelligence algorithms
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2024
- Study start21 Oct 2024
- Primary completion15 Oct 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Work Related Upper Limb DisorderStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Within-subject pre-post design
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philip Efron, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06576570
- Sponsor's protocol ID
- IRB202301655
- Status last verified
- Nov 2025
- First submitted
- 21 Aug 2024
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation and Modification of Surgeon Ergonomics in the Operation Room Using Artificial Intelligence Analytics
- ClinicalTrials.gov ID
- NCT06576570
- Acronym / sponsor ID
- IRB202301655
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 21 Oct 2024 (actual)
- Primary completion
- 15 Oct 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 28 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is working to identify actions of surgeons in the operating room that can contribute to work-related musculoskeletal disorders. This includes poor positioning and time spent in poor positioning while working in the operating room. The study is also looking to determine if fatigue plays a role in work-related musculoskeletal disorders and whether an education intervention will change ergonomic risk.
Detailed description
The study is working to identify actions of surgeons in the operating room that can contribute to work-related musculoskeletal disorders. This includes poor positioning and time spent in poor positioning while working in the operating room. The study is also looking to determine if fatigue plays a role in work-related musculoskeletal disorders.
Employing within-subject pre-post design to assess 1) patterns of aggregate risk data from video analysis in the OR for resident and attending surgeons over time and for different types of surgical tasks, 2) concurrent reliability assessment of the Rapid Upper Limb Assessment and Rapid Entire Body Assessment scores calculated from the software and visual analysis, 3) changes in pain data after review of the SOTER Task ergonomic outputs. The feasibility of using the system in the OR will also be assessed for open and laparoscopic surgery.
The study team will collect data, perform assessments, collect information from self-proctored surveys, and video record surgeon activities in the operating room on 20 surgeons. The video recordings will take measurements to assess risk factors for work-related musculoskeletal disorders. Following the fifth surgical case, the study team complete an education intervention by reviewing measurements established in the video recordings and supply a brief presentation on Ergonomics for Surgeons. A summary of observed body positioning for each subject is provided. Post intervention, five additional surgical cases will be observed in the manner of the previous cases to identify change in ergonomic risk.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Within-subject pre-post design
| Arm | Type | Receives |
|---|---|---|
| Acute Care Surgery Attending and Resident Surgeons | Other | Behavioral: Education presentation of surgical ergonomics, Behavioral: Summary of Ergonomic Measurement SystemParticipants will be asked to perform their normal operative work for 5 cases while being filmed. Data will be collected using the SoterTask™ software which calculates momentary data on risk and an aggregate risk level. Two standard ergonomic risk assessments: Rapid Upper Limb Assessment (RULA) or the Rapid Entire Body Assessment (REBA) are also calculated. Both assessments are current best practice standard for determining the level of ergonomic risk. The RULA and REBA data calculated by SoterTask will be compared to scores assessed by the research team from the same video recordings of the work tasks. Following the fifth operative case, participants will view an educational presentation of surgical ergonomics and review the data summarized from the ergonomic measurement system with video of their movement with a visual guideline highlighting high-risk angles and movements including legs, arms, neck and back. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any general surgery operative case by a surgeon from the Division of Acute Care Surgery. These cases will be conducted in what has been designated as the "Acute Care Surgery OR" for the day.
Key exclusion criteria (2 listed)
- Any operative case in which the surgical attending or resident has not signed informed consent to record this individual during the case.
- Any operative case that the surgical attending feels is inappropriate for video recording or when filming could interfere with surgical procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education presentation of surgical ergonomicsDuring an individual meeting with participant, a brief presentation will be supplied for review. | Behavioural | Acute Care Surgery Attending and Resident Surgeons |
| Summary of Ergonomic Measurement SystemParticipant will view a video of their movements with a visual guideline highlighting high-risk angles and movements. | Behavioural | Acute Care Surgery Attending and Resident Surgeons |
Primary outcome
Determine Ergonomic Risk Through Video-based Analysis calculated by an artificial intelligence software and evaluator assessment of Rapid Upper Limb Assessment (RULA) and Rapid Entire Body Assessment (REBA)
Time frame: 1 year
determine the ergonomic risk experienced by surgical attendings and residents during open and laparoscopic surgery measured through video-based analysis of
1 secondary outcome
Change in Ergonomic Risk After Reviewing Video Capture and Risk Data
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Individual participant dataSharing planned: No
Related trials for Work Related Upper Limb Disorder
Not yet recruiting
ARPE Training for Manual Handling Workers: A Quasi-Experimental Study on Ergonomic Knowledge and Practice
Occupational Diseases, Work Related Upper Limb Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Philip Efron, MD principal investigator
University of Florida
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education presentation of surgical ergonomics and Summary of Ergonomic Measurement System in people with Work Related Upper Limb Disorder and Musculoskeletal Pain, run by University of Florida at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine Ergonomic Risk Through Video-based Analysis calculated by an artificial intelligence software and evaluator assessment of Rapid Upper Limb Assessment (RULA) and Rapid Entire Body Assessment (REBA) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.