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NOT YET RECRUITING
NCT07828132

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

Sponsor: Marmara University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

60

Start Date

2026-09

Completion Date

2027-10

Last Updated

2026-09-18

Healthy Volunteers

No

Interventions

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