Ignite Creation Date:
2024-05-06 @ 7:14 PM
Last Modification Date:
2024-10-26 @ 3:03 PM
Study NCT ID:
NCT05946018
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-10-03
First Post:
2023-07-06
Brief Title:
Physiatrist Ergonomic Intervention on Work Related Musculoskeletal Pain in Surgeons
Sponsor:
University of Texas Southwestern Medical Center
Organization:
University of Texas Southwestern Medical Center
Study Overview
Official Title:
Physiatrist Ergonomic Intervention on Work Related Musculoskeletal Pain in Surgeons A Randomized Control Trial
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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 demographicgeneral questionnaire WHO GPAQ SURG-TLX BPI and 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 demographicgeneral questionnaire WHO GPAQ SURG-TLX BPI and Surgery Day Questionnaire
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None