Effect of Alexithymia on Treatment Response to Transforaminal Epidural Steroid Injections in Chronic Low Back Pain
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMarmara University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Psychometric Assessment and Clinical Follow-up Battery
Other interventionPre-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
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Chronic Low Back Pain Patients Receiving TFESI1 intervention
Trial outcomes
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.
Time frame
Baseline (pre-injection) compared against clinical response status evaluated at 1 month post-TFESISecondary outcomes
1
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-procedure2
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-procedure3
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)4
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)Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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