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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05175443
Other study ID # 72626
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 8, 2022
Est. completion date December 31, 2022

Study information

Verified date January 2023
Source University of Kentucky
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The physical demands of surgery are in many ways similar to those of high-performance athletes. No professional athlete would consider performing without careful attention to strengthening and physical preparedness, yet surgeons routinely place rigorous demands on their bodies without any training plan specific to their work demands. A series of exercises were developed to help stretch and strengthen the key core muscles to support surgeons during operating to prevent neck pain. This study hypothesizes that Neck pain discomfort will decrease following an 8-week intervention program compared to baseline reported scores.


Description:

Participant will be asked to fill out a series 5 questionnaires at beginning of the study, end of the 8-week intervention and 1 month later to determine how the exercise program affected their general health, neck pain, and function. 1. Demographic information about their age, height, weight, sex, surgical experience, surgical frequency, level of pain, and exercise frequency and types. (21 items) 2. A questionnaire about neck pain (10 items) 3. A questionnaire about how pain interferes with their life (8 items) 4. A questionnaire about general health (10 items) 5. A questionnaire about how much the participant typically exercise. (4 items) All these questionnaires can be completed on a computer or tablet and the data will be stored on a secure site (RedCap). This should be completed in approximately 20 minutes at each assessment. Next participants will be instructed how to perform a series of 4 exercises described in the intervention Every week the participant will be sent a 3-item questionnaire to report their level of pain, surgical burden, and exercise compliance for the week. There are only 3 multiple choice questions which should take approximately 1 minute to complete per week.


Recruitment information / eligibility

Status Completed
Enrollment 41
Est. completion date December 31, 2022
Est. primary completion date December 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria: - must be an actively operating surgeon either faculty, fellow, or resident. - Must report at least 4 out of 10 with pain at worst over the previous week at intake that is attributed to operating. Exclusion Criteria: - Participants will be excluded if they have prior neck or upper back surgery within the last year. - If the participant has any other medical condition that would prevent the participant from performing shoulder and neck strengthening and stretching exercises.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Exercise
Participants will be trained, by a physical therapist, to perform a set of four daily exercises requiring 1 sets of 2 minutes for each exercise totaling 8 minutes of targeted exercise per day for 8 weeks of the intervention. These exercises will be progressed or modified every 2-4 weeks to assure the participant is receiving maximal benefit for their exercise intervention.

Locations

Country Name City State
United States University of Kentucky Lexington Kentucky

Sponsors (1)

Lead Sponsor Collaborator
Timothy Uhl

Country where clinical trial is conducted

United States, 

References & Publications (5)

Alhusuny A, Cook M, Khalil A, Xie Y, Johnston V. Neck/Shoulder Problems and Visual Disturbances Among Surgeons: A Scoping Review. J Surg Res. 2020 Mar;247:413-428. doi: 10.1016/j.jss.2019.09.064. Epub 2019 Oct 31. — View Citation

Cleland JA, Childs JD, Whitman JM. Psychometric properties of the Neck Disability Index and Numeric Pain Rating Scale in patients with mechanical neck pain. Arch Phys Med Rehabil. 2008 Jan;89(1):69-74. doi: 10.1016/j.apmr.2007.08.126. — View Citation

Daher A, Carel RS, Tzipi K, Esther H, Dar G. The effectiveness of an aerobic exercise training on patients with neck pain during a short- and long-term follow-up: a prospective double-blind randomized controlled trial. Clin Rehabil. 2020 May;34(5):617-629. doi: 10.1177/0269215520912000. Epub 2020 Mar 17. — View Citation

Lee PH, Macfarlane DJ, Lam TH, Stewart SM. Validity of the International Physical Activity Questionnaire Short Form (IPAQ-SF): a systematic review. Int J Behav Nutr Phys Act. 2011 Oct 21;8:115. doi: 10.1186/1479-5868-8-115. — View Citation

Vernon H, Mior S. The Neck Disability Index: a study of reliability and validity. J Manipulative Physiol Ther. 1991 Sep;14(7):409-15. Erratum In: J Manipulative Physiol Ther 1992 Jan;15(1):followi. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Neck Disability Index The Neck Disability Index is 10 items, with each item consisting of likert type scale ranging from 0-4 with a lower score indicating less disability. The 10 items are summed for a total of potential 50 points which is then normalized to 100% scale by multiplying by 2. Baseline, at end of 8 weeks of intervention
Secondary Worse Neck Pain Numeric pain rating scale of worse pain for the week in the neck. Scale ranges from 0=no pain to 10=worst pain imaginable Baseline, at end of 8 weeks of intervention
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