Neck Pain MusculoskeletalNCT06167525
Neck Posturing in Surgeons During Microsurgery Procedures Using Upright Go 2 Device
A study testing 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 in people with Neck Pain Musculoskeletal, run by Royal College of Surgeons, Ireland.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Neck Pain Musculoskeletal
- What is being tested?
- 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
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 18 Jan 2024to 31 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Plastic and reconstructive surgeons performing microsurgery
- Consultants, Registrars, and Senior House Officers with no prior cervical spine surgery or cervical degeneration
Who cannot join
- Surgeons not performing microsurgery on a regular basis (at least once a month)
- Plastic and reconstructive surgery trainees with <1 years experience in microsurgery.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read more
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
- Being tested
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 recordedDevice
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring neck positioning using upright go 2 device during microsurgery procedures and adjustments in neck positioning after receiving bio-feedback signals.
- 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)
- 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.
Measured: 3 months
Time and rate spent in maladaptive neck positions in surgeons during as measured by the upright go 2 device.
- 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2023
- Study start18 Jan 2024 (estimated)
- Primary completion10 Apr 2024 (estimated)
- Study completion31 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck Pain MusculoskeletalStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal College of Surgeons, Ireland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06167525
- Sponsor's protocol ID
- RCSI sponsorship ref: 23-161
- Status last verified
- Dec 2023
- First submitted
- 15 Nov 2023
- Last updated
- 20 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Effects of Maladaptive Neck Posturing in Surgeons During Microsurgery Procedures Using Upright Go 2 Device
- ClinicalTrials.gov ID
- NCT06167525
- Acronym / sponsor ID
- RCSI sponsorship ref: 23-161
- Conditions
- Neck Pain Musculoskeletal
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Royal College of Surgeons, IrelandUniversity, hospital or other
- Study start
- 18 Jan 2024 (estimated)
- Primary completion
- 10 Apr 2024 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 12 Dec 2023 (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.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neck posture monitoring device without feedback option | Other | 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 recordedReal-time feedback through the device. For surgeons who consent, bio-feedback signals will be given once deviated from a neutral posture for >1 minute. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Plastic and reconstructive surgeons performing microsurgery
- Consultants, Registrars, and Senior House Officers with no prior cervical spine surgery or cervical degeneration
Key exclusion criteria (2 listed)
- Surgeons not performing microsurgery on a regular basis (at least once a month)
- Plastic and reconstructive surgery trainees with <1 years experience in microsurgery.
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 |
|---|---|---|
| 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 recordedDuring 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. | Device | Neck posture monitoring device without feedback option |
Primary outcome
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
- Individual participant dataSharing planned: No. 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
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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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing 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 in people with Neck Pain Musculoskeletal, run by Royal College of Surgeons, Ireland.
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 2 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: status not confirmed, as of the sponsor's last update on 20 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kasie O' Reilly, BMBS (00353872057741, kasie.oreilly08@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. 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 Dec 2023.