Effect of Alexithymia on Treatment Response to Transforaminal Epidural Steroid Injections in Chronic Low Back Pain
Not yet recruitingNCT07828132
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- 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
- Conditions
- Chronic Low Back Pain
- Radiculopathy
- Alexithymia
- Interventions
- Other: Psychometric Assessment and Clinical Follow-up Battery
- Sponsor
- Marmara University
- Start date
- 2026-09
- Primary completion
- 2027-09
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Total sites listed
- 0
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. Adults aged 18 years or older. 2. Clinical diagnosis of chronic low back pain persisting for at least 3 months. 3. Clinical indication and scheduled for Transforaminal Epidural Steroid Injection (TFESI) due to failure of conservative management. 4. Literate and possessing sufficient cognitive capacity to understand and complete self-report instruments. 5. Voluntary written informed consent. Exclusion Criteria: 1. Significant cognitive impairment or communication barriers impairing informed consent capacity or questionnaire completion. 2. Active psychotic disorder or current manic episode. 3. Suspected acute self-harm or suicidal risk identified during clinical examination. 4. Chronic back pain secondary to malignancy, acute fracture, or active local/systemic infection. 5. 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).
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07828132