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

NCT ID: NCT05884684

Last Updated: 2025-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

141 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-01

Study Completion Date

2025-08-15

Brief Summary

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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

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Conditions

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Patient Satisfaction

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

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.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type OTHER

Reviewing Imaging with Participant

Intervention Type OTHER

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

Interventions

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Reviewing Imaging with Participant

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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David Kohns

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David Kohns, DO

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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University of Michigan - Burlington Building

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 40937359 (View on PubMed)

Other Identifiers

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HUM00216837

Identifier Type: -

Identifier Source: org_study_id

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