Chronic Low Back PainNCT07828132
Effect of Alexithymia on Treatment Response to Transforaminal Epidural Steroid Injections in Chronic Low Back Pain
An observational study of Chronic Low Back Pain and Radiculopathy, run by Marmara University.
Trial summary
Low back pain and lumbosakral radiculopathy represent common clinical challenges substantially diminishing health-related quality of life and work productivity. Transforaminal Epidural Steroid Injection (TFESI) is widely performed in routine practice to reduce radicular pain, enhance functional capacity, and mitigate… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Low Back Pain, Radiculopathy, Alexithymia
- What is being tested?
- Psychometric Assessment and Clinical Follow-up Battery
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Oct 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting to the Algology outpatient clinic at Marmara University Pendik Training and Research Hospital with chronic low back pain who are clinically indicated and scheduled for Transforaminal Epidural Steroid Injection.
Who may be able to join
- Adults aged 18 years or older.
- Clinical diagnosis of chronic low back pain persisting for at least 3 months.
- Clinical indication and scheduled for Transforaminal Epidural Steroid Injection (TFESI) due to failure of conservative management.
- Literate and possessing sufficient cognitive capacity to understand and complete self-report instruments.
- Voluntary written informed consent.
Who cannot join
- Significant cognitive impairment or communication barriers impairing informed consent capacity or questionnaire completion.
- Active psychotic disorder or current manic episode.
- Suspected acute self-harm or suicidal risk identified during clinical examination.
- Chronic back pain secondary to malignancy, acute fracture, or active local/systemic infection.
- Severe active psychiatric illness currently undergoing medical treatment (e.g., severe mental illness, schizophrenia, bipolar affective disorder).
- (Note: Depressive symptoms alone are not an exclusion criterion; they are systematically quantified via HADS and controlled for as covariates).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effectiveness of Transforaminal Epidural Steroid Injection in Patients With Chronic Low Back Pain and the Impact of Alexithymia on Treatment Response: A Prospective Observational Cohort Study
Low back pain and lumbosakral radiculopathy represent common clinical challenges substantially diminishing health-related quality of life and work productivity. Transforaminal Epidural Steroid Injection (TFESI) is widely performed in routine practice to reduce radicular pain, enhance functional capacity, and mitigate the need for surgery. However, clinical response to TFESI remains notably heterogeneous, indicating that biomedical parameters alone may not fully account for treatment efficacy and that psychosocial variables play a critical role.
Alexithymia, defined as difficulty in identifying and describing emotions coupled with an externally oriented cognitive style, is prevalent among individuals with chronic spinal pain and linked to heightened pain perception and affective distress.
This prospective observational cohort study aims to investigate the influence of baseline alexithymia levels (measured by the 20-item Toronto Alexithymia Scale [TAS-20]) on treatment response (defined as pain relief and functional improvement) following routine clinically indicated TFESI in patients with chronic low back pain and radiculopathy.
Read the detailed description
This single-center, prospective observational cohort study is conducted at Marmara University Pendik Training and Research Hospital, Division of Algology, in collaboration with the Department of Psychiatry.
Transforaminal Epidural Steroid Injection (TFESI) is performed strictly based on routine clinical indications under fluoroscopic guidance (using 3 ml bupivacaine, 1 ml saline, and 1 ml betamethasone); no experimental intervention or additional procedural risk is introduced by this research protocol.
Eligible adult patients providing written voluntary informed consent undergo comprehensive baseline evaluations prior to injection, including:
- Sociodemographic and Clinical Questionnaire
- 20-Item Toronto Alexithymia Scale (TAS-20)
- Visual Analog Scale (VAS 0-10 cm) for pain severity
- Hospital Anxiety and Depression Scale (HADS)
- 12-Item Short Form Health Survey (SF-12)
- Childhood Trauma Questionnaire (CTQ-33)
Prospective follow-up evaluations are conducted post-procedure:
- Week 1: Pain intensity via VAS
- Month 1: Pain intensity via VAS and quality of life via SF-12
- Month 3: Pain intensity via VAS and quality of life via SF-12
Treatment response is primarily categorized at Month 1 post-injection (responder: ≥30% or ≥2-point reduction in VAS; non-responder: <30% or <2-point reduction). The primary analysis will compare baseline TAS-20 scores between responders and non-responders, evaluate correlations between alexithymia subdimensions and clinical changes, and identify independent predictors of treatment success through multivariable regression models adjusted for depression, anxiety, and baseline pain duration.
- Conditions
- Chronic Low Back Pain, Radiculopathy, Alexithymia
- Being tested
- Psychometric Assessment and Clinical Follow-up Battery
- Keywords
- Transforaminal Epidural Steroid Injection, TFESI, Chronic Low Back Pain, Radicular Pain, Alexithymia, TAS-20, Treatment Outcome, Quality of Life
- Medical subject headings
- Radiculopathy, Affective Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychometric Assessment and Clinical Follow-up BatteryOther
Pre-procedural assessment (VAS, TAS-20, HADS, SF-12, CTQ-33, sociodemographic form) followed by longitudinal clinical evaluations at Week 1 (VAS), Month 1 (VAS, SF-12), and Month 3 (VAS, SF-12) post-TFESI
| Study group | Role | What they receive |
|---|---|---|
| Chronic Low Back Pain Patients Receiving TFESI | Adult patients aged 18 years or older with chronic low back pain with or without radiculopathy scheduled to receive clinically indicated fluoroscopy-guided Transforaminal Epidural Steroid Injection due to failure of conservative therapies Receives: Other: Psychometric Assessment and Clinical Follow-up Battery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Baseline TAS-20 Scores Between Responders and Non-Responders
Evaluates whether baseline total alexithymia severity differs significantly between patients achieving clinical treatment response versus non-responders. Treatment response is defined as a reduction of ≥30% or ≥2 points in the 10-cm Visual Analog Scale (VAS) from baseline to 1 month post-TFESI. TAS-20 total score ranges from 20 to 100, where higher scores reflect greater alexithymia severity.
Measured: Baseline (pre-injection) compared against clinical response status evaluated at 1 month post-TFESI
Secondary outcomes (4)
Change in Pain Intensity via Visual Analog Scale (VAS)
Measured on a 10-cm horizontal line ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores reflect greater pain severity.
Measured: Baseline, 1 week, 1 month, and 3 months post-procedure
Change in Health-Related Quality of Life via SF-12
12-item health survey evaluating Physical and Mental Component Summary scores. Scores range from 0 to 100, with higher scores reflecting better health-related quality of life
Measured: Baseline, 1 month, and 3 months post-procedure
Baseline Psychological Symptoms via Hospital Anxiety and Depression Scale (HADS)
Assesses anxiety (HADS-A) and depression (HADS-D) subscale scores (each scored 0 to 21, higher scores indicate greater symptom severity). Used to control for confounding effects on treatment response
Measured: Baseline (immediately prior to TFESI)
Baseline Childhood Trauma Questionnaire (CTQ-33) Total Score
Assesses retrospective childhood maltreatment across subscales. Total scores range from 25 to 150, where higher scores reflect greater childhood trauma severity.
Measured: Baseline (immediately prior to TFESI)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- More trials run by Marmara 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07828132
- Sponsor's protocol ID
- 09.2026.877
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Transforaminal Epidural Steroid Injection in Patients With Chronic Low Back Pain and the Impact of Alexithymia on Treatment Response: A Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT07828132
- Acronym / sponsor ID
- 09.2026.877
- Conditions
- Chronic Low Back Pain, Radiculopathy, Alexithymia
- Keywords
- Transforaminal Epidural Steroid Injection, TFESI, Chronic Low Back Pain, Radicular Pain, Alexithymia, TAS-20, Treatment Outcome, Quality of Life
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 18 Sep 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.
Low back pain and lumbosakral radiculopathy represent common clinical challenges substantially diminishing health-related quality of life and work productivity. Transforaminal Epidural Steroid Injection (TFESI) is widely performed in routine practice to reduce radicular pain, enhance functional capacity, and mitigate the need for surgery. However, clinical response to TFESI remains notably heterogeneous, indicating that biomedical parameters alone may not fully account for treatment efficacy and that psychosocial variables play a critical role.
Alexithymia, defined as difficulty in identifying and describing emotions coupled with an externally oriented cognitive style, is prevalent among individuals with chronic spinal pain and linked to heightened pain perception and affective distress.
This prospective observational cohort study aims to investigate the influence of baseline alexithymia levels (measured by the 20-item Toronto Alexithymia Scale [TAS-20]) on treatment response (defined as pain relief and functional improvement) following routine clinically indicated TFESI in patients with chronic low back pain and radiculopathy.
Detailed description
This single-center, prospective observational cohort study is conducted at Marmara University Pendik Training and Research Hospital, Division of Algology, in collaboration with the Department of Psychiatry.
Transforaminal Epidural Steroid Injection (TFESI) is performed strictly based on routine clinical indications under fluoroscopic guidance (using 3 ml bupivacaine, 1 ml saline, and 1 ml betamethasone); no experimental intervention or additional procedural risk is introduced by this research protocol.
Eligible adult patients providing written voluntary informed consent undergo comprehensive baseline evaluations prior to injection, including:
- Sociodemographic and Clinical Questionnaire
- 20-Item Toronto Alexithymia Scale (TAS-20)
- Visual Analog Scale (VAS 0-10 cm) for pain severity
- Hospital Anxiety and Depression Scale (HADS)
- 12-Item Short Form Health Survey (SF-12)
- Childhood Trauma Questionnaire (CTQ-33)
Prospective follow-up evaluations are conducted post-procedure:
- Week 1: Pain intensity via VAS
- Month 1: Pain intensity via VAS and quality of life via SF-12
- Month 3: Pain intensity via VAS and quality of life via SF-12
Treatment response is primarily categorized at Month 1 post-injection (responder: ≥30% or ≥2-point reduction in VAS; non-responder: <30% or <2-point reduction). The primary analysis will compare baseline TAS-20 scores between responders and non-responders, evaluate correlations between alexithymia subdimensions and clinical changes, and identify independent predictors of treatment success through multivariable regression models adjusted for depression, anxiety, and baseline pain duration.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic Low Back Pain Patients Receiving TFESI | – | Other: Psychometric Assessment and Clinical Follow-up BatteryAdult patients aged 18 years or older with chronic low back pain with or without radiculopathy scheduled to receive clinically indicated fluoroscopy-guided Transforaminal Epidural Steroid Injection due to failure of conservative therapies |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting to the Algology outpatient clinic at Marmara University Pendik Training and Research Hospital with chronic low back pain who are clinically indicated and scheduled for Transforaminal Epidural Steroid Injection.
Key inclusion criteria (5 listed)
- Adults aged 18 years or older.
- Clinical diagnosis of chronic low back pain persisting for at least 3 months.
- Clinical indication and scheduled for Transforaminal Epidural Steroid Injection (TFESI) due to failure of conservative management.
- Literate and possessing sufficient cognitive capacity to understand and complete self-report instruments.
- Voluntary written informed consent.
Key exclusion criteria (6 listed)
- Significant cognitive impairment or communication barriers impairing informed consent capacity or questionnaire completion.
- Active psychotic disorder or current manic episode.
- Suspected acute self-harm or suicidal risk identified during clinical examination.
- Chronic back pain secondary to malignancy, acute fracture, or active local/systemic infection.
- Severe active psychiatric illness currently undergoing medical treatment (e.g., severe mental illness, schizophrenia, bipolar affective disorder).
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 |
|---|---|---|
| Psychometric Assessment and Clinical Follow-up BatteryPre-procedural assessment (VAS, TAS-20, HADS, SF-12, CTQ-33, sociodemographic form) followed by longitudinal clinical evaluations at Week 1 (VAS), Month 1 (VAS, SF-12), and Month 3 (VAS, SF-12) post-TFESI | Other | Chronic Low Back Pain Patients Receiving TFESI |
Primary outcome
Difference in Baseline TAS-20 Scores Between Responders and Non-Responders
Time frame: Baseline (pre-injection) compared against clinical response status evaluated at 1 month post-TFESI
Evaluates whether baseline total alexithymia severity differs significantly between patients achieving clinical treatment response versus non-responders. Treatment response is defined as a reduction of ≥30% or ≥2 points in the 10-cm Visual Analog Scale (VAS) from baseline to 1 month post-TFESI. TAS-20 total score ranges from 20 to 100, where higher scores reflect greater alexithymia severity.
4 secondary outcomes
Change in Pain Intensity via Visual Analog Scale (VAS)
Time frame: Baseline, 1 week, 1 month, and 3 months post-procedure
Change in Health-Related Quality of Life via SF-12
Time frame: Baseline, 1 month, and 3 months post-procedure
Baseline Psychological Symptoms via Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline (immediately prior to TFESI)
Baseline Childhood Trauma Questionnaire (CTQ-33) Total Score
Time frame: Baseline (immediately prior to TFESI)
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 18 Sep 2026.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Low Back Pain and Radiculopathy, run by Marmara University.
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 6 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 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Konuralp Karbeyaz, MD (+905326209392, karbeyazkonuralp@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in Baseline TAS-20 Scores Between Responders and Non-Responders (time frame: Baseline (pre-injection) compared against clinical response status evaluated at 1 month post-TFESI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Sep 2026.