Patient SatisfactionNCT05884684
What is the Potential Impact of Reviewing Post-procedure Images With Patients Following Interventional Spine Procedures.
A study testing Reviewing Imaging with Participant in people with Patient Satisfaction, run by University of Michigan at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient Satisfaction
- What is being tested?
- Reviewing Imaging with Participant
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2023to 15 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Lumbosacral radiculopathy symptoms
- Received transforaminal epidural steroid injection
Who cannot join
- Patients who will be sedated for transforaminal epidural steroid injection
- Unable to read or understand English-language survey
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan - Burlington Building
Ann Arbor, Michigan, 48108
About this study
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
- Being tested
- Reviewing Imaging with Participant
- Keywords
- Epidural, Spine procedure
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reviewing Imaging with ParticipantOther
Post-operatively, the images taken during the procedure will be reviewed with the participant.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Reviewing Imaging with Participant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 2 hours following procedure in the post-op area
Secondary outcomes (1)
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."
Measured: 2 weeks following procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2023
- Study start1 Aug 2023
- Primary completion30 Apr 2025
- Study completion15 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patient SatisfactionStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- 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.
- Masking
- None (open label)
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Kohns, University of Michigan
- Investigators
- David Kohns, DO, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05884684
- Sponsor's protocol ID
- HUM00216837
- Status last verified
- Sep 2025
- First submitted
- 12 May 2023
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40937359
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What is the Potential Impact of Reviewing Post-procedure Images With Patients Following Interventional Spine Procedures.
- ClinicalTrials.gov ID
- NCT05884684
- Acronym / sponsor ID
- HUM00216837
- Conditions
- Patient Satisfaction
- Keywords
- Epidural, Spine procedure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 15 Aug 2025 (actual)
- First posted
- 1 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Reviewing Imaging with ParticipantDuring 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Lumbosacral radiculopathy symptoms
- Received transforaminal epidural steroid injection
Key exclusion criteria (2 listed)
- Patients who will be sedated for transforaminal epidural steroid injection
- Unable to read or understand English-language survey
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reviewing Imaging with ParticipantPost-operatively, the images taken during the procedure will be reviewed with the participant. | Other | Post-Procedural Images Discussed with Participants |
Primary outcome
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.
1 secondary outcome
Patient Global Impression of Change (PGIC)
Time frame: 2 weeks following procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
- Derived from this study: PubMed 40937359Choudhury 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.
- Individual participant dataSharing planned: No
Related trials for Patient Satisfaction
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Hybrid mHealth and Telerehabilitation vs Conventional Physiotherapy for Subacromial Pain Syndrome
Subacromial Pain Syndrome
RecruitingObservational study
A Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Atezolizumab in Participants Treated in Routine Clinical Practice
Lung Cancer, Hepatocellular Carcinoma
Recruiting
Effect of Mandala Coloring on Anxiety, Pain, Vital Signs, and Patient Satisfaction in Patients Undergoing Transurethral Resection of the Prostate
Mandala Coloring
Not yet recruiting
Feasibility of a Web-based Single-session Intervention Combined With Ecological Momentary Assessment and Intervention for Patients With Complex Posttraumatic Stress Disorder Awaiting Inpatient Treatment
PTSD - Post Traumatic Stress Disorder, Depression
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Kohns, DO principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reviewing Imaging with Participant in people with Patient Satisfaction, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Press Gainey Satisfaction (PGS) Questionnaire (time frame: Up to 2 hours following procedure in the post-op area). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05884684, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2025.