Skip to main content
OpenTrials
Not yet recruiting

NCT Number: NCT07828132

Effect of Alexithymia on Treatment Response to Transforaminal Epidural Steroid Injections in Chronic Low Back Pain

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.

Not yet recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Chronic Low Back Pain Affective Symptoms Alexithymia Behavior Behavioral Symptoms Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Radiculopathy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

Psychometric Assessment and Clinical Follow-up Battery

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change in Pain Intensity via Visual Analog Scale (VAS)

    Time frame: Baseline, 1 week, 1 month, and 3 months post-procedure

    Measured on a 10-cm horizontal line ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores reflect greater pain severity.

  2. Change in Health-Related Quality of Life via SF-12

    Time frame: Baseline, 1 month, and 3 months post-procedure

    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

  3. Baseline Psychological Symptoms via Hospital Anxiety and Depression Scale (HADS)

    Time frame: Baseline (immediately prior to TFESI)

    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

  4. Baseline Childhood Trauma Questionnaire (CTQ-33) Total Score

    Time frame: Baseline (immediately prior to TFESI)

    Assesses retrospective childhood maltreatment across subscales. Total scores range from 25 to 150, where higher scores reflect greater childhood trauma severity.

Study contacts

Contact information is provided by the study sponsor or research team.

Konuralp Karbeyaz, MD

CONTACT

[email protected]

+905326209392

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 18, 2026
Registry last updated
Sep 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.