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Clinical Trials/NCT05884684
NCT05884684CompletedNot Applicable

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

University of Michigan2 sites in 1 country141 target enrollmentStarted: August 1, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
141
Locations
2
Primary Endpoint
Modified Press Gainey Satisfaction (PGS) Questionnaire

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Sequential
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Modified Press Gainey Satisfaction (PGS) Questionnaire

Time Frame: 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 Outcomes

  • Patient Global Impression of Change (PGIC)(2 weeks following procedure)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

David Kohns

Principal Investigator

University of Michigan

Study Sites (2)

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