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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Difference in Baseline TAS-20 Scores Between Responders and Non-Responders
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
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
干预措施: Psychometric Assessment and Clinical Follow-up Battery (Other)
结局指标
主要结局
Difference in Baseline TAS-20 Scores Between Responders and Non-Responders
时间窗: 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.
次要结局
- 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))