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

NCT05884684 | Completed

• 1 other identifier: HUM00216837
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 1

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.

Conditions

Patient Satisfaction

Keywords

Epidural; Spine procedure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Patient Global Impression of Change (PGIC)

  2 weeks following procedure

Study Arms (2)

Post-Procedural Images Not Discussed with Participants

NO 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.

Post-Procedural Images Discussed with Participants

OTHER

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

Interventions

Reviewing Imaging with Participant OTHER

Post-operatively, the images taken during the procedure will be reviewed with the participant.

Post-Procedural Images Discussed with Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Lumbosacral radiculopathy symptoms
• Received transforaminal epidural steroid injection

You may not qualify if:

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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan - Burlington Building

Ann Arbor, Michigan, 48108, United States

Location

Related Publications (1)

• 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.

  PMID: 40937359 DERIVED

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• David Kohns, DO

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A spine physician will not discuss images with the first group of participants immediately following their procedure. A spine physician will discuss images with the second group of participants immediately following their procedure.

Study Record Dates

• First Submitted: May 12, 2023
• First Posted: June 1, 2023
• Study Start: August 1, 2023
• Primary Completion: April 30, 2025
• Study Completion: August 15, 2025
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)