- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05946018
Physiatrist Ergonomic Intervention on Work Related Musculoskeletal Pain in Surgeons
Physiatrist Ergonomic Intervention on Work Related Musculoskeletal Pain in Surgeons: A Randomized Control Trial
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:
- To evaluate pain in surgeons before and after surgical cases.
- To evaluate work-load related stress in surgeons after surgical cases.
- To evaluate surgeons' quality of life.
- 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.
Study Overview
Status
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Texas
-
Dallas, Texas, United States, 75390
- UT Southwestern Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Education only
This arm only includes a 6-8 minute 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.
|
|
Other: Education and coaching sessions
This arm includes a 6-8 minute education video on ergonomics and 1:1 15 minute coach sessions at 0, 2, 4, and 6 weeks.
|
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.
Physical therapy coaching sessions include a standard assessment with individualized instruction on range of motion, strength, endurance, and flexibility.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To evaluate pain in surgeons after operating.
Time Frame: 6 months
|
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
|
Collaborators and Investigators
Investigators
- Principal Investigator: Kimberly Kho, MD, UTSW
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STU-2023-0516
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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