An observational study in Chronic Low Back Pain, Radiculopathy and Alexithymia, sponsored by Marmara University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by Marmara University · Observational
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.
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:
Prospective follow-up evaluations are conducted post-procedure:
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.
483 studies on the registry are indexed under Radiculopathy; 145 are open to participants now.
This study's planned enrollment of 60 is below the median of 100 across 95 observational studies indexed under Radiculopathy.
Browse Radiculopathy studies →Marmara University is the lead sponsor of 599 studies on the registry; 138 are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
(Note: Depressive symptoms alone are not an exclusion criterion; they are systematically quantified via HADS and controlled for as covariates).
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Other: Psychometric Assessment and Clinical Follow-up Battery
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
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.
Time frame: Baseline (pre-injection) compared against clinical response status evaluated at 1 month post-TFESI
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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: Baseline (immediately prior to TFESI)
No study locations are listed for this record.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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