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NCT05884684 Clinical Trial

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

Patient Satisfaction Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05884684
Other study ID # HUM00216837
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 11, 2023
Est. completion date July 2024

Study information
Verified date April 2024
Source University of Michigan
Contact Tahsin Choudhury, DO
Phone 734-615-6722
Email ctahsin@med.umich.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date July 2024
Est. primary completion date July 2024
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• Reviewing Imaging with Participant
Post-operatively, the images taken during the procedure will be reviewed with the participant.

Locations
Country Name City State
United States University of Michigan - Burlington Building Ann Arbor Michigan

Sponsors (1)
Lead Sponsor Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
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