Can light-bending glasses improve surgeons’ neck posture and reduce neck pain?

ISRCTN	ISRCTN34385943
DOI	https://doi.org/10.1186/ISRCTN34385943

Submission date: 19/01/2022
Registration date: 22/01/2022
Last edited: 28/02/2024

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Surgeons often suffer from work-related musculoskeletal disorders (MSDs) in the neck and shoulders. These MSDs impact surgical productivity and may shorten the work life of the surgeons. The occurrence of MSDs is partially due to high physical workload such as long-term neck bending, which is common among surgeons. The usage of traditional surgical loupes not only increase the bending angle of the surgeon’s neck, but also increase the load that the neck of the surgeon bears. This study aims to investigate whether prismatic loupes can reduce surgeons’ physical workload and improve their perceived discomfort without compromising performance.

Who can participate?
All experienced surgeons (experience of surgery over 2 years) from an academic university hospital who actively perform open surgeries

What does the study involve?
This study compares three types of surgical loupes: the surgeons’ own non-prismatic loupes (own), low-tilt prismatic loupes (LT), and high-tilt prismatic loupes (HT). Participants perform three surgical tasks with one of the three types of loupes at a time, and repeat with the other two types of loupes. Each participant is given a specific order of loupes from the following four options: 1) own, HT, LT; 2) own, LT, HT; 3) HT, LT, own; 4) LT, HT, own. Each time, participants perform the three surgical tasks in a fixed order: peg transfer (PT), basic suture (BS), and precision cutting (PC).
During the experiment, the researchers measure several outcomes for each participant in each task with each type of loupes, and compare the differences among the three types of loupes. These outcomes include the inclination angle and the velocity of the head, trunk and upper arm, muscle activity, as well as surgical errors and the completion time for each task. The researchers also ask participants how the visual quality of each type of loupes, if they experienced any discomfort in any body parts, and their comments, thoughts and preference of the three types of loupes.

What are the possible benefits and risks of participating?
The major possible benefits are reduced physical workload and a reduced risk of developing neck and shoulder pain by using prismatic loupes. All participants may keep one pair of prismatic loupes at the end of the study. There is no health risk of participating in the study, and during the laboratory study there is a minor, temporary risk of nausea, motion sickness, and double vision. The participants are free to end their participation at any time.

Where is the study run from?
Karolinska University Hospital at Solna (Sweden)

When is the study starting and how long is it expected to run for?
October 2019 to October 2021

Who is funding the study?
Afa Insurance (AFA)

Who is the main contact?
Prof. Mikael Forsman
mikael.forsman@ki.se

Contact information

Prof Mikael Forsman
Principal Investigator

Occupational Medicine
IMM Institute of Environmental Medicine
Karolinska Institutet
Stockholm
17177
Sweden

ORCID ID	0000-0001-5777-4232
Phone	+46 (0)704910196
Email	mikael.forsman@ki.se

Mr Xuelong Fan
Public

Occupational Medicine
IMM Institute of Environmental Medicine
Karolinska Institutet
Stockholm
17177
Sweden

ORCID ID	0000-0003-4145-5717
Phone	+46 (0)720328083
Email	xuelong.fan@ki.se

Prof Mikael Forsman
Scientific

Occupational Medicine
IMM Institute of Environmental Medicine
Karolinska Institutet
Stockholm
17177
Sweden

Phone	+46 (0)704910196
Email	mikael.forsman@ki.se

Study information

Study design	Randomized cross over study
Primary study design	Interventional
Secondary study design	Randomised cross over trial
Study setting(s)	Hospital
Study type	Prevention
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet
Scientific title	Non-prismatic and prismatic loupes in simulated surgical tasks among surgeons – a controlled, randomized cross-over laboratory trial
Study acronym	PrismSurg1
Study objectives	Can prismatic loupes reduce surgeons’ physical workload and reduce surgeons’ perceived discomfort without compromising performance?
Ethics approval(s)	Approved 06/07/2020, Swedish Ethical Review Authority (Etikprövningsmyndigheten, Box 2110, 750 02 Uppsala, Sweden; +46 (0)10 4750800; registrator@etikprovning.se), ref: Dnr 2020-02161, an extension of Dnr 2014/1120-31
Health condition(s) or problem(s) studied	Work-related musculoskeletal disorders
Intervention	This randomized cross-over study enrolled eligible surgeons in an academic hospital in Sweden from September to December 2021, to compare two prismatic loupes (new) and one non-prismatic loupes (conventional) in three simulated surgical tasks, i.e., peg transfer (PT), basic suture (BS) and precision cutting (PC), in a surgical training room. Each participant performs three simulated surgical tasks, peg transfer (PT), basic suture (BS) and precision cutting (PC), in a fixed order with one of three types surgical loupes, i.e., their own non-prismatic loupes (own), low-tilt prismatic loupes (LT) with an angulation angle of 15° in the prism, and high-tilt prismatic loupes (HT) with an angulation angle of 48° in the prism. Each participant is randomized, balanced, and assigned to one of the following four orders of loupes: own->LT->HT, own->HT->LT, LT->HT->own, and HT->LT-> own. The assignment of order is calculated in Excel with a randomization function and announced on site.
Intervention type	Procedure/Surgery
Primary outcome measure	1. Physical workload including: 1.1. Inclination angle and velocity of head, trunk and both upper arms measured using inertial measurement units during each task with each type of surgical loupes 1.2. Muscle activity of cervical erector spinae, trapezius and lumbar erector spinae measured using electromyography during each task with each type of surgical loupes
Secondary outcome measures	1. Perceived visual quality measured using 5-point Likert-type scale or 4-point scale depending on questions with each type of surgical loupes at the end of each task 2. Perceived body-part discomfort measured using a Borg CR-10 scale with each type of surgical loupes at the end of each task 3. Surgical performance, including task completion duration measured using a timer, and number of errors evaluated by two independent surgeons with each type of surgical loupes at the end of each task 4. Subjective evaluations and preferences of loupes measured using a semi-structured interview on the same day at the end of the study
Overall study start date	01/10/2019
Completion date	21/10/2021

Eligibility

Participant type(s)	Health professional
Age group	Adult
Sex	Both
Target number of participants	30
Total final enrolment	19
Key inclusion criteria	1. Currently actively working as surgeons 2. Work experience as surgeons ≥2 years 3. Work actively with open surgeries in vascular surgery or in otorhinolaryngology (endocrine surgery) 4. Never used prismatic surgical loupes 5. No age limitations (due to sufficiency of other criteria)
Key exclusion criteria	1. Experienced severe discomfort when using any surgical loupes during the experiment 2. Experienced severe discomfort due to the technical measurement of ergonomic exposure
Date of first enrolment	03/04/2020
Date of final enrolment	15/01/2021

Locations

Countries of recruitment

Sweden

Study participating centre

Karolinska Universitetssjukhuset, Solna

Karolinska vägen, Solna
Stockholm
17176
Sweden

Sponsor information

Karolinska Institute
University/education

Institutet för Miljömedicin (IMM)
Nobels väg 13
Solna
17165
Sweden

Phone	+46 (0)8 524 875 88
Email	irene.tjernberg@ki.se
Website	http://ki.se/en/startpage
"ROR"	https://ror.org/056d84691

Funders

Funder type

Industry

AFA Försäkring
Private sector organisation / For-profit companies (industry)

Alternative name(s): AFA Insurance
Location: Sweden

Results and Publications

Intention to publish date	01/10/2022
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Planned publication in a high-impact peer-reviewed surgery journal.
IPD sharing plan	All the raw data are available on request from Xuelong Fan (Xuelong.fan@ki.se) and Mikael Forsman (Mikael.forsman@ki.se). Primary analysed data will be available after the publication of the manuscript for 10 years for research groups in relevant fields in worldwide-recognized universities and/or hospitals for meta-analyses and musculoskeletal disorder research.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		09/01/2024	28/02/2024	Yes	No

Editorial Notes

28/02/2024: Publication reference added.
21/01/2022: Trial's existence confirmed by the Swedish Ethical Review Authority.