Neck Posturing in Surgeons During Microsurgery Procedures Using Upright Go 2 Device

NCT06167525 | Unknown DMC

• 1 other identifier: RCSI sponsorship ref: 23-161
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief Summary

Consultant and senior registrars performing microsurgery will be invited to participate in this Study. The study will take place at single site (Beaumont Hospital). A questionnaire to collect demographic information (age, height, sex, year of training, prior neck trauma or know neck issues) will be given to the consented surgeons. Additionally, surgery characteristics will be recorded (procedure, surgeon role (i.e lead or assisting), table height, frequency of adjustment of table height, and use of sitting or step stool, headlight, and/or loupes for \>50% of the procedure). A postural training device, Upright Go 2 will be positioned at the spinous process of the cervical vertebrae of each surgeon and used to measure neck positions during microsurgical procedures. The device will be calibrated to an ideal neutral cervical spine position, so that excessive flexion and extension of the neck can be recorded. The device contains built-in sensors that provide bio-feedback in the form of gentle vibrations if posture has deviated from neutral position. During the first stage of the study the device will be set to record cervical spine positioning without bio-feedback signals. This will be used to record duration of time surgeons held maladaptation postures. The second stage will involve real-time feedback through the device. For surgeons who consent, bio-feedback signals will be given once deviated from a neutral posture for \>1 minute. Response of surgeons to bio-feedback signals will also be recorded. The Neck Disability index score will be used to assess for neck pain and the functional implications in relation to reported neck pain. This will be completed following study completion.

Conditions

Neck Pain Musculoskeletal

Outcome Measures

Primary Outcomes (2)

• Measuring neck positioning using upright go 2 device during microsurgery procedures and adjustments in neck positioning after receiving bio-feedback signals.

  1. The Upright go 2 device has sensors that are used to detect neck posture in real-time. This device will be used to measure surgeon's postural maladaptation. This measure will be degree angle of cervical spine flexion (\>30 degrees is considered maladaptive) 2. Neck Disability Index to assess neck pain and condition-specific functional status which will be compared to neck posture data obtained from neck measuring device. Score of 10-28% (i.e., 5-14 points) is considered by the authors to constitute mild disability; 30-48% is moderate; 50-68% is severe; 72% or more is complete. Measure of change will be baseline (i.e no bio-feeback) and bio-feeback through device. Time between baseline and bio-feedback will depend on when each participant has a microsurgical case.

  3 months

• Time and rate spent in maladaptive neck positions in surgeons during as measured by the upright go 2 device.

  1\. Feedback from device will be recorded (amount of times feedback is required and whether surgeons react to biofeedback). Again measure in degree angles of cervical flexion and adjustment angle. This information will indicate the amount of times adjustments are made in neck positioning by the participants and if responses to bio-feeback are continuous and sustained.

  3 months

Study Arms (1)

Neck posture monitoring device without feedback option

OTHER

Real-time feedback through the device. For surgeons who consent, bio-feedback signals will be given once deviated from a neutral posture for \>1 minute.

Device: Real-time feedback through the device. Bio-feedback signals will be given once deviated from a neutral posture for >1 minute. Response of surgeons to bio-feedback signals will be recorded

Interventions

Real-time feedback through the device. Bio-feedback signals will be given once deviated from a neutral posture for >1 minute. Response of surgeons to bio-feedback signals will be recorded DEVICE

During the first stage of the study the device will be set to record cervical spine positioning without bio-feedback signals. This will be used to record duration of time surgeons held maladaptation postures. The second stage will involve real-time feedback through the device. For surgeons who consent, bio-feedback signals will be given once deviated from a neutral posture for \>1 minute. Response of surgeons to bio-feedback signals will also be recorded. The Neck Disability index score will be used to assess for neck pain and the functional implications in relation to reported neck pain. This will be completed following study completion.

Neck posture monitoring device without feedback option

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Plastic and reconstructive surgeons performing microsurgery
• Consultants, Registrars, and Senior House Officers with no prior cervical spine surgery or cervical degeneration

You may not qualify if:

• Surgeons not performing microsurgery on a regular basis (at least once a month)
• Plastic and reconstructive surgery trainees with \<1 years experience in microsurgery.

Sponsors & Collaborators

• Royal College of Surgeons, Ireland: lead

Central Study Contacts

Kasie O' Reilly, BMBS

CONTACT

00353872057741; kasie.oreilly08@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2023
• First Posted: December 12, 2023
• Study Start: January 18, 2024
• Primary Completion: April 10, 2024
• Study Completion: May 31, 2024
• Last Updated: December 20, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share