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

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.

Study Overview

• Status: Completed
• Conditions: Patient Satisfaction
• Intervention / Treatment: Other: Reviewing Imaging with Participant

• Study Type: Interventional
• Enrollment (Actual): 141
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48108
      • University of Michigan - Burlington Building

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Post-Procedural Images Not Discussed with Participants; 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.
Other: Post-Procedural Images Discussed with Participants; 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.	Other: Reviewing Imaging with Participant; Post-operatively, the images taken during the procedure will be reviewed with the participant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Press Gainey Satisfaction (PGS) Questionnaire	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.	Up to 2 hours following procedure in the post-op area

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Global Impression of Change (PGIC)	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."	2 weeks following procedure

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: David Kohns, DO, University of Michigan

Publications and helpful links

General Publications

• Choudhury T, Jung J, Barnes M, Chandran S, Eckner JT, Geisser M, Kohns DJ. The impact on fluoroscopic image review on perceived benefit, patient satisfaction, and short-term improvement following lumbosacral epidural steroid injections. Interv Pain Med. 2025 Aug 31;4(3):100640. doi: 10.1016/j.inpm.2025.100640. eCollection 2025 Sep.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Actual): April 30, 2025
• Study Completion (Actual): August 15, 2025

Study Registration Dates

• First Submitted: May 12, 2023
• First Submitted That Met QC Criteria: May 31, 2023
• First Posted (Actual): June 1, 2023

Study Record Updates

• Last Update Posted (Estimated): September 17, 2025
• Last Update Submitted That Met QC Criteria: September 10, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Epidural; Spine procedure
• Additional Relevant MeSH Terms: Behavior; Treatment Adherence and Compliance; Health Behavior; Patient Satisfaction
• Other Study ID Numbers: HUM00216837

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No