Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT05946018 |
| Other study ID # |
STU-2023-0516 |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 25, 2023 |
| Est. completion date |
December 1, 2024 |
Study information
| Verified date |
September 2023 |
| Source |
University of Texas Southwestern Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The goal of this randomized control trial is to learn if physical therapy coaching and
education improves work-related muscle pain in surgeons more than education alone. The main
focuses of this study are to:
1. To evaluate pain in surgeons before and after surgical cases.
2. To evaluate work-load related stress in surgeons after surgical cases.
3. To evaluate surgeons' quality of life.
4. To evaluate surgeons' grip strength.
Participants will be put into two groups at random. One group will watch an educational video
only. The other group will watch an educational video and get a coaching session from a
physical therapist.
Description:
All participants will undergo the same baseline, pre-intervention assessments.
Pre-intervention assessments will include several questionnaires: general demographic
questionnaire, baseline questionnaire, WHO GPAQ for assessment of physical activity, and AROM
assessment. Additionally, following one day operating they will complete a SURG-TLX
questionnaire, Brief Pain Index (BPI), and a questionnaire regarding how many hours they
operated that day and what type of surgeries they performed (Surgery Day Questionnaire).
For participants randomized to the education only group, they will watch a short (5-7 minute)
educational video. The video content includes information on why ergonomics is important
(preventing work-related musculoskeletal disorders, types of injuries, physician longevity)
and recommendations for how to ergonomically arrange the operating room to reduce the risk of
injury.
For participants randomized to the education plus personal coaching group, they will first
watch the same video as described previously. Then they will have four 15 to 20-minute
sessions with a physiatrist. These sessions will include a standard assessment with
individualized instruction on range of motion, strength, endurance, and flexibility. These
sessions will include verbal coaching, instructor demonstration, however no hands-on
treatment or intervention will be provided. The sessions will occur at 0 weeks (same day as
participant views video), 2 weeks, 4 weeks, and 6 weeks after viewing of the educational
video. The first session will be in person, the remainder of the sessions will be virtual.
Post-intervention follow up will begin after the video is viewed by those in the
education-only group and after the video is viewed and the first personal coaching session is
complete by the education plus coaching group. The first timepoint of post-intervention
assessment will be the first operating day after the intervention. Assessments will include
SURG-TLX, BPI, and Surgery Day Questionnaire. Two additional post-intervention assessments
will be at 2 weeks after initial intervention and 6 weeks after initial intervention. The 6
week timepoint reflects the completion of the personal coaching series for those in that
group.
Long-term follow-up assessments will be performed at 3 and 6 months after the initial
intervention (week 0). The assessments that will be administered then will include a
demographic/general questionnaire, WHO GPAQ, SURG-TLX, BPI, and Surgery Day Questionnaire.
