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Image Reviews for Patient Satisfaction After Spine Procedures
N/A
Recruiting
Led By Tahsin Choudhury, DO
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks following procedure
Awards & highlights
Study Summary
This trial will explore how patient satisfaction and opinion are affected when spine physicians review post-procedure images with patients.
Who is the study for?
This trial is for individuals with lumbosacral radiculopathy symptoms who have received a transforaminal epidural steroid injection. It's designed to see if showing patients their post-procedure images affects how satisfied they feel and their overall impression of the treatment's change.Check my eligibility
What is being tested?
The study is testing whether reviewing fluoroscopic images (a type of X-ray) with patients after spine procedures can improve patient satisfaction and perception of improvement, measured two weeks following the procedure.See study design
What are the potential side effects?
Since this trial involves only the review of imaging with participants and not a medical intervention, there are no direct side effects associated with it.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 weeks following procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks following procedure
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Modified Press Gainey Satisfaction (PGS) Questionnaire
Secondary outcome measures
Patient Global Impression of Change (PGIC)
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Post-Procedural Images Discussed with ParticipantsExperimental Treatment1 Intervention
During a lumbar epidural steroid injection under fluoroscopic guidance, images are taken as part of the procedure. Following the procedure, the surgeon who performed it will discuss the images with the participants in this arm.
Group II: Post-Procedural Images Not Discussed with ParticipantsActive Control1 Intervention
During a lumbar epidural steroid injection under fluoroscopic guidance, images are taken as part of the procedure. Following the procedure, the surgeon who performed it will not discuss the images with the participants in this arm.
If participants request an explanation of the images, they will not be included in the analysis.
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Who is running the clinical trial?
University of MichiganLead Sponsor
1,798 Previous Clinical Trials
6,377,938 Total Patients Enrolled
Tahsin Choudhury, DOPrincipal InvestigatorUniversity of Michigan
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I will be sedated for a spine injection to reduce pain.I have received a steroid injection in my spine.I have pain that extends from my lower back down through my leg.
Research Study Groups:
This trial has the following groups:- Group 1: Post-Procedural Images Not Discussed with Participants
- Group 2: Post-Procedural Images Discussed with Participants
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are individuals able to enroll in this investigation at present?
"This clinical trial is not presently recruiting; the original posting was on June 1st, 2023 with the most recent edit being May 31st of that same year. Unfortunately, this study cannot accept participants at present but there are 46 different trials where enrollment is ongoing."
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