Effect of Alexithymia on Treatment Response to Transforaminal Epidural Steroid Injections in Chronic Low Back Pain
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
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Konuralp Karbeyaz, MD
- Número de telefone: +905326209392
- E-mail: karbeyazkonuralp@gmail.com
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Descrição
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).
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
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
|
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
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Difference in Baseline TAS-20 Scores Between Responders and Non-Responders
Prazo: 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.
|
Baseline (pre-injection) compared against clinical response status evaluated at 1 month post-TFESI
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Pain Intensity via Visual Analog Scale (VAS)
Prazo: 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.
|
Baseline, 1 week, 1 month, and 3 months post-procedure
|
|
Change in Health-Related Quality of Life via SF-12
Prazo: 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
|
Baseline, 1 month, and 3 months post-procedure
|
|
Baseline Psychological Symptoms via Hospital Anxiety and Depression Scale (HADS)
Prazo: 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
|
Baseline (immediately prior to TFESI)
|
|
Baseline Childhood Trauma Questionnaire (CTQ-33) Total Score
Prazo: 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.
|
Baseline (immediately prior to TFESI)
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 09.2026.877
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .