Lumbar Disc DiseaseNCT07495501
Patient Satisfaction During Lomber Transforaminal Epidural Steroid Injection: The Role of Sedation, Anxiety, and Pain
An observational study of Lumbar Disc Disease and Radiculopathy Lumbar, run by Mersin University at 1 site in Turkey (Türkiye).
Trial summary
Transforaminal epidural steroid injection (TFESI) is a minimally invasive procedure commonly used for the management of lumbar radicular pain. It is intended to reduce inflammation around the affected nerve root, limit edema, and modulate nociceptive transmission, with the aim of relieving pain, improving physical… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lumbar Disc Disease, Radiculopathy Lumbar, Radicular Pain
- What is being tested?
- Fluoroscopy-guided lumbar transforaminal epidural steroid injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2026to 15 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will include adult patients presenting to the pain medicine outpatient clinic of Mersin University Faculty of Medicine Hospital who provide written informed consent, meet the eligibility criteria, and undergo lumbar transforaminal epidural steroid injection during the study period.
Who may be able to join
- Adults aged 18 to 80 years
- No prior history of any interventional pain procedure
- Ability to read and write in Turkish and to complete the study questionnaires
- Written informed consent provided.
- Planned lumbar transforaminal epidural steroid injection for radicular pain
Who cannot join
- Refusal to provide written informed consent.
- Inability to complete the satisfaction questionnaires reliably due to lack of Turkish literacy, significant cognitive impairment or severe visual or hearing impairment
- Presence of major comorbidities such as decompensated cardiac or respiratory failure, uncontrolled arrhythmia or angina, myocardial infarction or stroke within the past 3 months, advanced liver or kidney failure, uncontrolled obstructive sleep apnea associated with morbid obesity, or severe pulmonary hypertension.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Mersin University Faculty of Medicine, Pain Clinic
Mersin
Mesut Bakır, Assoc. Prof., +90 545 745 06 55, mesutbakir@mersin.edu.tr
About this study
Official title: Patient Satisfaction During Lomber Transforaminal Epidural Steroid Injection: The Role of Sedation, Anxiety, and Pain: A Prospective Observational Study
Transforaminal epidural steroid injection (TFESI) is a minimally invasive procedure commonly used for the management of lumbar radicular pain. It is intended to reduce inflammation around the affected nerve root, limit edema, and modulate nociceptive transmission, with the aim of relieving pain, improving physical function, and potentially reducing the need for surgery. Although TFESI may improve function and quality of life, treatment benefit is not uniform, and the degree of pain relief and patient satisfaction may differ across individuals.
This prospective observational study aims to evaluate postprocedural pain intensity and patient satisfaction in individuals undergoing lumbar TFESI and to identify clinical and demographic factors associated with satisfaction. Demographic and clinical characteristics, medical and surgical history, procedural pain scores, anxiety level, postprocedural pain scores, sedation status, fluoroscopy-related metrics, and intraprocedural events will be recorded. Patient satisfaction will be assessed 1 hour after the procedure using a Likert-based questionnaire, and operator satisfaction will also be documented.
By examining patient-reported outcomes together with procedural and clinical variables, this study seeks to provide a more standardized assessment of real-world TFESI outcomes and to support better patient selection and follow-up strategies.
Read the detailed description
Lumbar radicular pain is a common clinical problem that can substantially impair daily functioning and quality of life. Transforaminal epidural steroid injection (TFESI) is a minimally invasive procedure frequently used in the management of this condition.
In clinical practice, TFESI may provide pain relief, improve physical function, and in some patients reduce or delay the need for surgical intervention. However, its effectiveness is not uniform, and the magnitude and duration of benefit may vary across individuals. In some patients, symptom relief may be temporary, and recurrent pain may lead to repeat injection or surgical treatment. Published studies have also shown a wide range of treatment success rates, suggesting that patient-related and procedure-related factors may influence outcomes.
In this context, a more standardized evaluation of patient-reported outcomes after TFESI is needed. Pain intensity, anxiety level, and patient satisfaction are clinically relevant outcomes that may provide a more comprehensive understanding of the patient experience during and after the procedure. In particular, patient satisfaction may be influenced not only by postprocedural pain relief, but also by anxiety before or during the procedure, sedation status, procedural discomfort, and other clinical or demographic characteristics.
The aim of this prospective observational study is to quantitatively assess postprocedural pain, preprocedural anxiety, and patient satisfaction in patients undergoing lumbar TFESI, and to identify the clinical and demographic factors associated with patient satisfaction. The study is designed to reflect real-world clinical practice rather than protocol-driven intervention assignment.
A total of 120 participants who present to the pain medicine outpatient clinic of Mersin University Faculty of Medicine Hospital, who undergo lumbar TFESI, and who meet the inclusion and exclusion criteria will be enrolled after providing written informed consent. Demographic and baseline clinical data, including age, body mass index, primary diagnosis, comorbidities, pain intensity, and medical and surgical history, will be collected using a standardized data collection form.
Procedure-related assessments will also be documented in a standardized manner. Peak pain intensity during the procedure, measured using the Numeric Rating Scale (NRS), and pain intensity at 1 hour after the procedure will be recorded. Anxiety level will also be assessed and documented. Sedation status, fluoroscopy-related metrics, and intraprocedural events will be recorded. Patient satisfaction will be evaluated at 1 hour after the procedure using a Likert-based satisfaction questionnaire.
By analyzing patient-reported and procedure-related outcomes together, this study aims to provide a clearer understanding of the factors associated with patient satisfaction after lumbar TFESI. The findings may help support more individualized patient selection, improve periprocedural assessment, and contribute to better follow-up strategies in routine clinical practice.
- Conditions
- Lumbar Disc Disease, Radiculopathy Lumbar, Radicular Pain
- Being tested
- Fluoroscopy-guided lumbar transforaminal epidural steroid injection
- Keywords
- Patient satisfaction, Sedation, Anxiety, Epidural steroid injection, Pain intensity
- Medical subject headings
- Intervertebral disc disease, Patient Satisfaction, Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluoroscopy-guided lumbar transforaminal epidural steroid injectionProcedure or surgery
Routine fluoroscopy-guided lumbar transforaminal epidural steroid injection performed at the L2-3, L3-4, L4-5, or L5-S1 level(s) for the treatment of lumbar radicular pain.
| Study group | Role | What they receive |
|---|---|---|
| Patients Treated With Lumbar Transforaminal Epidural Steroid Injection | Adult patients with lumbar radicular pain undergoing routine fluoroscopy-guided lumbar transforaminal epidural steroid injection and followed with periprocedural and early postprocedural assessments of pain, anxiety, sedation status, and patient satisfaction. Receives: Procedure: Fluoroscopy-guided lumbar transforaminal epidural steroid injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction
Patient satisfaction will be assessed at 1 hour after lumbar transforaminal epidural steroid injection using a Likert-based satisfaction questionnaire.
Measured: 1 hour after the procedure
Secondary outcomes (2)
Preprocedural anxiety level
Preprocedural anxiety level will be assessed using the Spielberger State-Trait Anxiety Inventory (STAI).
Measured: Before the procedure
Operator satisfaction
Operator satisfaction with the procedure will be assessed using the study-specific satisfaction assessment.
Measured: Immediately after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion15 Aug 2026 (estimated)
- Study completion15 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lumbar Disc DiseaseStudies of the same condition, open and under way.
- More trials run by Mersin UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mesut Bakır, Mersin University
- Investigators
- Mesut Bakır, Principal investigator, Mersin University Faculty of Medicine, Pain Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07495501
- Sponsor's protocol ID
- TFESI-PSAP-2026
- Status last verified
- Mar 2026
- First submitted
- 21 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to patient privacy concerns and institutional data protection policies. Data will be used solely for the purposes of this study and reported in aggregate form
Publications
Verheijen EJA, van Haagen OBHAM, Bartels EC, van der Sloot K, van den Akker-van Marle ME, Steyerberg EW, Vleggeert-Lankamp CLA. Prediction of transforaminal epidural injection success in sciatica (POTEISS): a protocol for the development of a multivariable prediction model for outcome after transforaminal epidural steroid injection in patients with lumbar radicular pain due to disc herniation or stenosis. BMC Neurol. 2024 Aug 20;24(1):290. doi: 10.1186/s12883-024-03801-1.
PubMed 39164613Bahar-Ozdemir Y, Sencan S, Ercalik T, Kokar S, Gunduz OH. The Effect of Pre-Treatment Depression, Anxiety and Somatization Levels on Transforaminal Epidural Steroid Injection: A Prospective Observational Study. Pain Physician. 2020 Jun;23(3):E273-E280.
PubMed 32517403Sencan S, Edipoglu IS, Bilim S, Gunduz OH. Does Coadministration of Transforaminal Epidural Steroid Injection with Sedation Improve Patient Satisfaction? A Prospective Randomized Clinical Study. Pain Physician. 2019 Jul;22(4):E287-E294.
PubMed 31337170
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Satisfaction During Lomber Transforaminal Epidural Steroid Injection: The Role of Sedation, Anxiety, and Pain: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07495501
- Acronym / sponsor ID
- TFESI-PSAP-2026
- Conditions
- Lumbar Disc Disease, Radiculopathy Lumbar, Radicular Pain
- Keywords
- Patient satisfaction, Sedation, Anxiety, Epidural steroid injection, Pain intensity
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 15 Aug 2026 (estimated)
- Study completion
- 15 Sep 2026 (estimated)
- First posted
- 27 Mar 2026 (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.
Transforaminal epidural steroid injection (TFESI) is a minimally invasive procedure commonly used for the management of lumbar radicular pain. It is intended to reduce inflammation around the affected nerve root, limit edema, and modulate nociceptive transmission, with the aim of relieving pain, improving physical function, and potentially reducing the need for surgery. Although TFESI may improve function and quality of life, treatment benefit is not uniform, and the degree of pain relief and patient satisfaction may differ across individuals.
This prospective observational study aims to evaluate postprocedural pain intensity and patient satisfaction in individuals undergoing lumbar TFESI and to identify clinical and demographic factors associated with satisfaction. Demographic and clinical characteristics, medical and surgical history, procedural pain scores, anxiety level, postprocedural pain scores, sedation status, fluoroscopy-related metrics, and intraprocedural events will be recorded. Patient satisfaction will be assessed 1 hour after the procedure using a Likert-based questionnaire, and operator satisfaction will also be documented.
By examining patient-reported outcomes together with procedural and clinical variables, this study seeks to provide a more standardized assessment of real-world TFESI outcomes and to support better patient selection and follow-up strategies.
Detailed description
Lumbar radicular pain is a common clinical problem that can substantially impair daily functioning and quality of life. Transforaminal epidural steroid injection (TFESI) is a minimally invasive procedure frequently used in the management of this condition.
In clinical practice, TFESI may provide pain relief, improve physical function, and in some patients reduce or delay the need for surgical intervention. However, its effectiveness is not uniform, and the magnitude and duration of benefit may vary across individuals. In some patients, symptom relief may be temporary, and recurrent pain may lead to repeat injection or surgical treatment. Published studies have also shown a wide range of treatment success rates, suggesting that patient-related and procedure-related factors may influence outcomes.
In this context, a more standardized evaluation of patient-reported outcomes after TFESI is needed. Pain intensity, anxiety level, and patient satisfaction are clinically relevant outcomes that may provide a more comprehensive understanding of the patient experience during and after the procedure. In particular, patient satisfaction may be influenced not only by postprocedural pain relief, but also by anxiety before or during the procedure, sedation status, procedural discomfort, and other clinical or demographic characteristics.
The aim of this prospective observational study is to quantitatively assess postprocedural pain, preprocedural anxiety, and patient satisfaction in patients undergoing lumbar TFESI, and to identify the clinical and demographic factors associated with patient satisfaction. The study is designed to reflect real-world clinical practice rather than protocol-driven intervention assignment.
A total of 120 participants who present to the pain medicine outpatient clinic of Mersin University Faculty of Medicine Hospital, who undergo lumbar TFESI, and who meet the inclusion and exclusion criteria will be enrolled after providing written informed consent. Demographic and baseline clinical data, including age, body mass index, primary diagnosis, comorbidities, pain intensity, and medical and surgical history, will be collected using a standardized data collection form.
Procedure-related assessments will also be documented in a standardized manner. Peak pain intensity during the procedure, measured using the Numeric Rating Scale (NRS), and pain intensity at 1 hour after the procedure will be recorded. Anxiety level will also be assessed and documented. Sedation status, fluoroscopy-related metrics, and intraprocedural events will be recorded. Patient satisfaction will be evaluated at 1 hour after the procedure using a Likert-based satisfaction questionnaire.
By analyzing patient-reported and procedure-related outcomes together, this study aims to provide a clearer understanding of the factors associated with patient satisfaction after lumbar TFESI. The findings may help support more individualized patient selection, improve periprocedural assessment, and contribute to better follow-up strategies in routine clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients Treated With Lumbar Transforaminal Epidural Steroid Injection | – | Procedure: Fluoroscopy-guided lumbar transforaminal epidural steroid injectionAdult patients with lumbar radicular pain undergoing routine fluoroscopy-guided lumbar transforaminal epidural steroid injection and followed with periprocedural and early postprocedural assessments of pain, anxiety, sedation status, and patient satisfaction. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include adult patients presenting to the pain medicine outpatient clinic of Mersin University Faculty of Medicine Hospital who provide written informed consent, meet the eligibility criteria, and undergo lumbar transforaminal epidural steroid injection during the study period.
Key inclusion criteria (5 listed)
- Adults aged 18 to 80 years
- No prior history of any interventional pain procedure
- Ability to read and write in Turkish and to complete the study questionnaires
- Written informed consent provided.
- Planned lumbar transforaminal epidural steroid injection for radicular pain
Key exclusion criteria (3 listed)
- Refusal to provide written informed consent.
- Inability to complete the satisfaction questionnaires reliably due to lack of Turkish literacy, significant cognitive impairment or severe visual or hearing impairment
- Presence of major comorbidities such as decompensated cardiac or respiratory failure, uncontrolled arrhythmia or angina, myocardial infarction or stroke within the past 3 months, advanced liver or kidney failure, uncontrolled obstructive sleep apnea associated with morbid obesity, or severe pulmonary hypertension.
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 |
|---|---|---|
| Fluoroscopy-guided lumbar transforaminal epidural steroid injectionRoutine fluoroscopy-guided lumbar transforaminal epidural steroid injection performed at the L2-3, L3-4, L4-5, or L5-S1 level(s) for the treatment of lumbar radicular pain. | Procedure or surgery | Patients Treated With Lumbar Transforaminal Epidural Steroid Injection |
Primary outcome
Patient satisfaction
Time frame: 1 hour after the procedure
Patient satisfaction will be assessed at 1 hour after lumbar transforaminal epidural steroid injection using a Likert-based satisfaction questionnaire.
2 secondary outcomes
Preprocedural anxiety level
Time frame: Before the procedure
Operator satisfaction
Time frame: Immediately after the procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Background: PubMed 39164613Verheijen EJA, van Haagen OBHAM, Bartels EC, van der Sloot K, van den Akker-van Marle ME, Steyerberg EW, Vleggeert-Lankamp CLA. Prediction of transforaminal epidural injection success in sciatica (POTEISS): a protocol for the development of a multivariable prediction model for outcome after transforaminal epidural steroid injection in patients with lumbar radicular pain due to disc herniation or stenosis. BMC Neurol. 2024 Aug 20;24(1):290. doi: 10.1186/s12883-024-03801-1.
- Background: PubMed 32517403Bahar-Ozdemir Y, Sencan S, Ercalik T, Kokar S, Gunduz OH. The Effect of Pre-Treatment Depression, Anxiety and Somatization Levels on Transforaminal Epidural Steroid Injection: A Prospective Observational Study. Pain Physician. 2020 Jun;23(3):E273-E280.
- Background: PubMed 31337170Sencan S, Edipoglu IS, Bilim S, Gunduz OH. Does Coadministration of Transforaminal Epidural Steroid Injection with Sedation Improve Patient Satisfaction? A Prospective Randomized Clinical Study. Pain Physician. 2019 Jul;22(4):E287-E294.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to patient privacy concerns and institutional data protection policies. Data will be used solely for the purposes of this study and reported in aggregate form
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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.
Mesut Bakır principal investigator
Mersin University Faculty of Medicine, Pain Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Disc Disease and Radiculopathy Lumbar, run by Mersin University at 1 site in Turkey (Türkiye).
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 5 inclusion and 3 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: opening soon, as of the sponsor's last update on 27 Mar 2026. 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mesut Bakır, Assoc.Prof (+905457450655, mesutbakir@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient satisfaction (time frame: 1 hour after the procedure). 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 NCT07495501, which also lists 3 linked publications.
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 27 Mar 2026.