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

Sponsor

University of Michigan (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05884684

Collaborator

(none)

200

Enrollment

Location

Arms

Anticipated Duration (Months)

33.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Patient Satisfaction	Other: Reviewing Imaging with Participant	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Intervention Model Description:

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.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.

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

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."

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Michigan - Burlington Building	Ann Arbor	Michigan	United States	48108

Sponsors and Collaborators

University of Michigan

Investigators

Principal Investigator: Tahsin Choudhury, DO, University of Michigan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Tahsin Choudhury, Principal Investigator, University of Michigan

ClinicalTrials.gov Identifier:

NCT05884684

Other Study ID Numbers:

HUM00216837

First Posted:

Jun 1, 2023

Last Update Posted:

Jun 1, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Tahsin Choudhury, Principal Investigator, University of Michigan

Epidural

Spine procedure

Study Results

No Results Posted as of Jun 1, 2023