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Musculoskeletal PainSCORENCT06525701

Surgeon Core-strengthening Program as a Modifier for Exertion Associated With Vaginal Surgery

A study testing Execise Group in people with Musculoskeletal Pain and Musculoskeletal Injury, run by Loyola University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Work-related musculoskeletal pain and injury is a growing concern in surgery. Vaginal surgery has unique ergonomic risks, but no studies have addressed the potential for an exercise regimen to reduce physical strain by vaginal surgeons Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Musculoskeletal Pain, Musculoskeletal Injury
What is being tested?
Execise Group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteUnited States
Study dates
12 Aug 2024to 1 Jul 2025
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

  • Participant: ob/gyn resident or urology resident or urogyn fellow or urogyn attending Case: vaginal prolapse surgery >2 hours in length

Who cannot join

  • Participant:
  • Actively in physical therapy
  • Joint surgery or joint injury within last 12 weeks
  • Pregnant
  • Less than 6 weeks postpartum
  • Case:
  • Vaginal surgery <2 hours in length
  • Non-prolapse vaginal surgery

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Loyola University Medical Center

    Maywood, Illinois, 60153

Other trials in United States

About this study

Official title: Surgeon Core-strengthening Program as a Modifier for Exertion Associated With Vaginal Surgery: the SCORE Randomized Controlled Trial

Work-related musculoskeletal pain and injury is a growing concern in surgery. Vaginal surgery has unique ergonomic risks, but no studies have addressed the potential for an exercise regimen to reduce physical strain by vaginal surgeons

Read the detailed description

Surgical ergonomics is a burgeoning field, spurred by the recognition of the high prevalence of work-related musculoskeletal pain and injury in practicing surgeons including obstetrician/gynecologists. Surgery is often a demanding physical task, and the muscles and joints that are stressed vary by the surgical approach. Vaginal surgery has unique ergonomic challenges, particularly for assistants who may need to laterally bend their torsos to visualize the surgical field while still holding retractors. This is often a compromising physical position for the back, the shoulders, and sometimes the neck which increases the risk of acute or chronic musculoskeletal injury. The risk of injury can be thought of as a discrepancy between the demands of the task and the individual's physical capabilities. Surgeons' injury risk may be decreased if their physical capabilities can be improved through exercise. Most existing publications on surgical ergonomics have focused on raising awareness and on environmental changes such as optimizing surgeon posture during the case or introducing micro-breaks and stretching. Few publications have assessed a structured exercise program with the goal of decreasing surgeon pain or fatigue during and after surgery. To our knowledge, no studies have addressed this in vaginal surgery.

Being tested
Execise Group, Control Group
Medical subject headings
Musculoskeletal Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Execise GroupOther

    SCORE workout: eight exercises done sequentially: bicycles, balancing dog, windshield wipers, three-point plank, kayaker, super push-ups, bridge, and side plank. These workouts are modified from the core regimen recommended by Steve House and Scott Johnston in their book Training for the New Alpinism: A Manual for the Climber as Athlete (House 2014). Each exercise is done until fatigue: when the individual is no longer able to complete the exercise with good form. The participant then rests for approximately thirty to sixty seconds before beginning the next exercise. Passive stretching can be performed during the rest periods. The workout is complete at twenty minutes. Those individuals who complete all eight exercises in less than twenty minutes begin again with the first exercise (bicycles) and continue until reaching twenty minutes. The workout is thus adaptive-seamlessly increasing in repetitions as an individual's strength and endurance increase.

  • Control GroupOther

    No additional exercises or tasks are requested of control participants. Control group participants will perform or not perform exercise as they otherwise would outside of the study.

Study groups in NCT06525701
Study groupRoleWhat they receive
Exercise GroupExperimentalParticipants randomized to the exercise group will be asked to perform the SCORE workout two times each week for 4 weeks prior to their urogynecology rotation and for 4 weeks during the rotation.
Receives: Other: Execise Group; Other: Control Group
Control GroupActive comparatorNo additional exercises or tasks are requested of control participants. Control group participants will perform or not perform exercise as they otherwise would outside of the study
Receives: Other: Execise Group; Other: Control Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The effect of a core-strengthening program on surgeons' physical exertion during and after vaginal prolapse surgery using the Borg rating of perceived exertion (Borg CR10). To determine the effect of a core-strengthening program on surgeon

    The effect of a core-strengthening program on surgeons' physical exertion during and after vaginal prolapse surgery as measured by the Borg Category Ratio (CR-10). The Borg Category Ratio scale is a self-reported tool that describes level of exertion and ranges from 0-10 where larger numbers represent greater exertion.

    Measured: 8-12 weeks

Secondary outcomes (4)
  1. To describe the baseline core strength in a population of vaginal surgeons using the validated Core Score

    • Core Score: The Core Score ranges from 0-12 where higher scores indicate better performance on core-related exercises.

    Measured: 8-12 weeks

  2. To describe the execise habits and activity level in a populationa of vaginal surgeons using activity tracker data and the International Physical Activity Questionnaire.

    • International Physical Activity Questionnaire-Short Form (IPAQ-SF): Participant responses on time spent walking, doing moderate exercise, and doing vigorous exercise are first compared to a rubric for the categorical score. The categorical score ranges 1-3 where 1 is "inactive" and 3 is "health-enhancing physical activity". Participant responses are also used to calculate the weekly metabolic equivalent (MET) minutes where a higher number indicates more time spent being physically active.

    Measured: 8-12 weeks

  3. To measure the effect of a core-strengthening program on surgeons' pain during and after vaginal prolapse surgery using the PROMIS Pain Intensity-Short Form (PI-SF) and body diagrams.

    • PROMIS Pain Intensity-Short Form (PI-SF): The raw score ranges from 3-15 where higher scores indicate more pain. Raw scores are converted to t-scores where a t-score of 50 represents the average in the United States population.

    Measured: 8-12 weeks

  4. To measure objective and subjective change in core strength after completion of the core-strengthening program using the Core Score and Patient Global Impression of Improvement (PGI-I).

    • Patient Global Impression of Improvement (PGI-I): Lower Patient Global Impression of Improvement scores indicate more improvement. PGI-I ranges from 1 ("very much better") to 7 ("very much worse").

    Measured: 8-12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2024
  2. Study start12 Aug 2024
  3. Primary completion1 Jul 2025
  4. Study completion1 Jul 2025

Resources

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
Randomised
Intervention model
Parallel groups
Model description
The intervention group will complete a core workout lasting 20 minutes twice a week for 4 weeks
Masking
Single blind
Who is masked
Investigator
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06525701
Sponsor's protocol ID
218292
Acronym
SCORE
Status last verified
Sep 2025
First submitted
24 Jul 2024
Last updated
9 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Giagio S, Volpe G, Pillastrini P, Gasparre G, Frizziero A, Squizzato F. A Preventive Program for Work-related Musculoskeletal Disorders Among Surgeons: Outcomes of a Randomized Controlled Clinical Trial. Ann Surg. 2019 Dec;270(6):969-975. doi: 10.1097/SLA.0000000000003199.

    PubMed 30672801
  • Allespach H, Sussman M, Bolanos J, Atri E, Schulman CI. Practice Longer and Stronger: Maximizing the Physical Well-Being of Surgical Residents with Targeted Ergonomics Training. J Surg Educ. 2020 Sep-Oct;77(5):1024-1027. doi: 10.1016/j.jsurg.2020.04.001. Epub 2020 Aug 4.

    PubMed 32763097
  • Al Reshidi FS. Level of Physical Activity of Physicians Among Residency Training Program At Prince Sultan Military Medical City, Riyadh, KSA 2014. Int J Health Sci (Qassim). 2016 Jan;10(1):39-47. doi: 10.12816/0031215.

    PubMed 27004056
  • Bertolaccini L, Viti A, Terzi A. Ergon-trial: ergonomic evaluation of single-port access versus three-port access video-assisted thoracic surgery. Surg Endosc. 2015 Oct;29(10):2934-40. doi: 10.1007/s00464-014-4024-6. Epub 2014 Dec 17.

    PubMed 25515979
  • Cruz-Montecinos C, Bustamante A, Candia-Gonzalez M, Gonzalez-Bravo C, Gallardo-Molina P, Andersen LL, Calatayud J. Perceived physical exertion is a good indicator of neuromuscular fatigue for the core muscles. J Electromyogr Kinesiol. 2019 Dec;49:102360. doi: 10.1016/j.jelekin.2019.102360. Epub 2019 Sep 28.

    PubMed 31580987
  • Choi SH, Kuchta K, Rojas A, Mehdi SA, Ramirez Barriga M, Hays S, Talamonti MS, Hogg ME. Residents perform better technically, have less stress and workload, and prefer robotic to laparoscopic technique during inanimate simulation. Surg Endosc. 2023 Sep;37(9):7230-7237. doi: 10.1007/s00464-023-10216-5. Epub 2023 Jul 3.

    PubMed 37395804
  • Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.

    PubMed 12900694
  • Dairywala MI, Gupta S, Salna M, Nguyen TC. Surgeon Strength: Ergonomics and Strength Training in Cardiothoracic Surgery. Semin Thorac Cardiovasc Surg. 2022 Winter;34(4):1220-1229. doi: 10.1053/j.semtcvs.2021.09.015. Epub 2021 Sep 29.

    PubMed 34597795
  • Friedrich J, Brakke R, Akuthota V, Sullivan W. Reliability and Practicality of the Core Score: Four Dynamic Core Stability Tests Performed in a Physician Office Setting. Clin J Sport Med. 2017 Jul;27(4):409-414. doi: 10.1097/JSM.0000000000000366.

    PubMed 28653966
  • Henriksen A, Haugen Mikalsen M, Woldaregay AZ, Muzny M, Hartvigsen G, Hopstock LA, Grimsgaard S. Using Fitness Trackers and Smartwatches to Measure Physical Activity in Research: Analysis of Consumer Wrist-Worn Wearables. J Med Internet Res. 2018 Mar 22;20(3):e110. doi: 10.2196/jmir.9157.

    PubMed 29567635
  • Jo D, Bilodeau M. Rating of perceived exertion (RPE) in studies of fatigue-induced postural control alterations in healthy adults: Scoping review of quantitative evidence. Gait Posture. 2021 Oct;90:167-178. doi: 10.1016/j.gaitpost.2021.08.015. Epub 2021 Aug 25.

    PubMed 34492503
  • Keohane DM, McGillivary NA, Daly B. Physical activity levels and perceived barriers to exercise participation in Irish General Practitioners and General Practice trainees. Ir Med J. 2018 Feb 9;111(2):690.

    PubMed 29952439
  • Kopkash K, Novak K, Murphy R, Deliere A, Kuchta K, Rabbitt S, Pesce C, Winchester D, Yao K. Improving the Breast Surgeon's Ergonomic Workload for Nipple-Sparing Mastectomies Using Exercise and Operating Room Positioning Protocol. Ann Surg Oncol. 2021 Oct;28(10):5698-5706. doi: 10.1245/s10434-021-10447-7. Epub 2021 Jul 27.

    PubMed 34318384
  • Kromberg LS, Kildebro NV, Mortensen LQ, Amirian I, Rosenberg J. Microbreaks in Laparoscopic Appendectomy have No Effect on Surgeons' Performance and Well-being. J Surg Res. 2020 Jul;251:1-5. doi: 10.1016/j.jss.2020.01.007. Epub 2020 Feb 21.

    PubMed 32092608
  • Lentz TA, Rhon DI, George SZ. Predicting Opioid Use, Increased Health Care Utilization and High Costs for Musculoskeletal Pain: What Factors Mediate Pain Intensity and Disability? J Pain. 2020 Jan-Feb;21(1-2):135-145. doi: 10.1016/j.jpain.2019.06.004. Epub 2019 Jun 13.

    PubMed 31201989

Questions about this trial

What is this clinical trial studying?

A study testing Execise Group in people with Musculoskeletal Pain and Musculoskeletal Injury, run by Loyola University at 1 site 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 8 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: finished, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

The effect of a core-strengthening program on surgeons' physical exertion during and after vaginal prolapse surgery using the Borg rating of perceived exertion (Borg CR10). To determine the effect of a core-strengthening program on surgeon (time frame: 8-12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06525701, which also lists 26 linked publications.

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 9 Sep 2025; AzTrials last refreshed its copy on 27 Oct 2026.

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