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

December 14, 2023 updated by: Royal College of Surgeons, Ireland

Assessment of the Effects of Maladaptive Neck Posturing in Surgeons During Microsurgery Procedures Using Upright Go 2 Device

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Neck posture monitoring device without feedback option
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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measuring neck positioning using upright go 2 device during microsurgery procedures and adjustments in neck positioning after receiving bio-feedback signals.
Time Frame: 3 months
  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.
Time Frame: 3 months

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal College of Surgeons, Ireland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 18, 2024

Primary Completion (Estimated)

April 10, 2024

Study Completion (Estimated)

May 31, 2024

Study Registration Dates

First Submitted

November 15, 2023

First Submitted That Met QC Criteria

December 11, 2023

First Posted (Actual)

December 12, 2023

Study Record Updates

Last Update Posted (Estimated)

December 20, 2023

Last Update Submitted That Met QC Criteria

December 14, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RCSI sponsorship ref: 23-161

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Study aims have been described so that data relevant to the aims of the study is collected by researchers. Data for all questionnaires will be stored in numerical value without context to their significance in the database.

Paper versions of the questionnaires will be used to collect the scores during in-person meeting with one of the project investigators. These paper sheets will be discarded in the hospital confidentiality bins in Beaumont Outpatients after the data is transferred to the database

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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