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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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 50
Est. completion date December 1, 2024
Est. primary completion date August 1, 2024
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Attending/faculty surgeon or surgical trainee (PGY2 or above) in any surgical specialty - Operates at least one day per week Exclusion Criteria: - Currently under active treatment for a musculoskeletal injury (example: physical therapy) - Plans to decrease operating time to less than one day per week in the next 6 months

Study Design


Intervention

Other:
Educational video on ergonomics
A 6-8 minute education video that includes information on why ergonomics is important and recommendations for how to arrange the operating room to reduce the risk of injury.
Verbal physical therapy coaching sessions
Physical therapy coaching sessions include a standard assessment with individualized instruction on range of motion, strength, endurance, and flexibility.

Locations

Country Name City State
United States UT Southwestern Medical Center Dallas Texas

Sponsors (1)

Lead Sponsor Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary To evaluate pain in surgeons after operating. Surgeons receiving personalized education and a physical activity plan will report less pain (as assessed by the Brief Pain Index). The BPI measures pain on a 0-10 scale with higher scores meaning worse outcomes. 6 months
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