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

NCT07828132 | Not Yet Recruiting

• 1 other identifier: 09.2026.877
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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 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.

Conditions

Chronic Low Back Pain; Alexithymia; Radiculopathy

Keywords

Transforaminal Epidural Steroid Injection; TFESI; Chronic Low Back Pain; Radicular Pain; Alexithymia; TAS-20; Treatment Outcome; Quality of Life

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

  Baseline, 1 week, 1 month, and 3 months post-procedure

• Change in Health-Related Quality of Life via SF-12

  Baseline, 1 month, and 3 months post-procedure

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

  Baseline (immediately prior to TFESI)

• Baseline Childhood Trauma Questionnaire (CTQ-33) Total Score

  Baseline (immediately prior to TFESI)

Study Arms (1)

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

Other: Psychometric Assessment and Clinical Follow-up Battery

Interventions

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

Chronic Low Back Pain Patients Receiving TFESI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Marmara University: lead

MeSH Terms

Conditions

Radiculopathy; Affective Symptoms

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Behavioral Symptoms; Behavior

Central Study Contacts

Konuralp Karbeyaz, MD

CONTACT

+905326209392; karbeyazkonuralp@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2026
• First Posted: September 18, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: September 18, 2026

Record last verified: 2026-09