What is the Potential Impact of Reviewing Post-procedure Images With Patients Following Interventional Spine Procedures.

Not Applicable

Recruiting

• Conditions: Patient Satisfaction
• Interventions: Other: Reviewing Imaging with Participant

• Registration Number: NCT05884684
• Lead Sponsor: University of Michigan

Brief Summary

The purpose of this study is to explore the impact of spine physicians reviewing post-procedural fluoroscopic images with patients. The outcome measure to be assessed will be the potential impact the patient satisfaction and the patient's global impression of change (PGIC) 2 weeks after the spine procedure.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-12
• Study First Submitted QC: 2023-05-31
• Study First Posted: 2023-06-01
• Study Start: 2023-09-11
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-04
• Last Update Posted: 2024-10-08
• Primary Completion: 2025-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Lumbosacral radiculopathy symptoms
• Received transforaminal epidural steroid injection

Exclusion Criteria

• Patients who will be sedated for transforaminal epidural steroid injection
• Unable to read or understand English-language survey

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Post-Procedural Images Discussed with Participants	Reviewing Imaging with Participant	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.

Primary Outcome Measures

Name	Time	Method
Modified Press Gainey Satisfaction (PGS) Questionnaire	Up to 2 hours following procedure in the post-op area	Patient satisfaction as measured by a modified version of the PGS Questionnaire. The questionnaire is comprised of 9 questions measuring general patient satisfaction with the care experience. Each question is on a scale of 1 (very poor) to 5 (very good). The lowest possible score of the PGS is 9, and the highest possible score is 45. The lower the total score, the poorer the patient's satisfaction, while the higher the score, the higher the patient's satisfaction.

Secondary Outcome Measures

Name	Time	Method
Patient Global Impression of Change (PGIC)	2 weeks following procedure	The PGIC is a scale participants use to rate the level of change they have experienced following treatment. The PGIC is a 7-point scale from 1 (very much better) to 7 (very much worse). After making this selection, participants then rate the percentage of how their condition is following the transforaminal epidural steroid injection compared to before, with 10% being "a little better" and 100% being "very much better."

Trial Locations

Locations (1)

University of Michigan - Burlington Building; 🇺🇸 Ann Arbor, Michigan, United States