The Relationship of Alexithymia With Pain and Quality of Life Scales in Chronic Pain Patients Who Underwent Spinal Cord Stimulation: A Cross-Sectional Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Toronto Alexithymia Scale (TAS-20) Score
研究概览
简要总结
The purpose of this study is to investigate the relationship between alexithymia levels and clinical parameters, including pain intensity and quality of life, in chronic pain patients treated with spinal cord stimulation (SCS). Chronic neuropathic pain can lead to psychological distress and decreased quality of life. While SCS is an effective neuromodulation therapy for managing refractory pain, patient outcomes vary significantly, suggesting that biomedically similar patients experience different levels of relief due to psychosocial factors.
Alexithymia, characterized by difficulties in identifying and describing emotions, may significantly influence the individual pain experience and treatment outcomes. In this cross-sectional observational study, patients who underwent SCS implantation for clinical indications will be evaluated. Clinical data regarding pain history will be collected retrospectively from patient files, while psychosocial profiles will be assessed at a single time point using validated psychometric questionnaires. The study aims to contribute to a better understanding of psychosocial variables in neuromodulation outcomes, potentially aiding in improved patient selection and expectation management.
详细描述
Chronic pain is a multidimensional clinical syndrome that can lead to decreased functionality, sleep and mood disorders, loss of social and occupational roles, and a significant reduction in quality of life. In chronic neuropathic pain cases, spinal cord stimulation (SCS) is increasingly used as a neuromodulation-based, reversible, and minimally invasive treatment option. However, responses to SCS in clinical practice are heterogeneous, and functional gains vary among patients with similar biomedical characteristics, suggesting that outcomes are influenced by psychosocial factors.
This single-center, non-interventional, cross-sectional observational analytical study aims to investigate the relationship between alexithymia levels and clinical parameters in chronic pain patients who underwent SCS implantation at the Marmara University Pendik Training and Research Hospital Algology Clinic between January 2023 and May 2026.
Clinical data (Visual Analog Scale/Numeric Rating Scale for pain intensity and SF-12 data) will be collected retrospectively from patient files. Psychometric evaluations will be performed at a single time point using validated self-report questionnaires during a single session lasting approximately 25-35 minutes. No repetitive measurements or follow-up visits are planned for research purposes.
The evaluation tools include:
- Sociodemographic Data Form: Captures clinical and demographic characteristics.
- Toronto Alexithymia Scale (TAS-20): Assesses difficulties identifying emotions, difficulties describing emotions, and externally-oriented thinking.
- Hospital Anxiety and Depression Scale (HADS): Measures anxiety and depression levels to control for mood symptoms as potential confounding factors.
- Short Form Health Survey (SF-12): Evaluates health-related quality of life.
- Childhood Trauma Questionnaire (CTQ-33): Assesses retrospective childhood and adolescent adverse experiences (emotional, physical, and sexual abuse; emotional and physical neglect; overprotection-control).
- Visual Analog Scale (VAS): Measures current pain intensity on a 0-10 cm horizontal line.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
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
- •- Being 18 years of age or older
- •Having undergone permanent spinal cord stimulation (SCS) implantation due to clinical indications
- •Providing written informed consent for study participation
- •Being literate
- •Having the cognitive capacity to complete the psychometric scales
- •No active, severe psychiatric disorders requiring immediate treatment (e.g., schizophrenia, bipolar affective disorder, severe psychotic disorders)
排除标准
- •Cognitive impairment or communication barriers that compromise the capacity to provide informed consent
- •Presence of active psychotic disorders or manic episodes
- •Suspected self-harm or suicide risk during the clinical interview
- •Presence of specific secondary causes that could explain the pain (e.g., active malignancy, active infection, acute fracture)
研究组 & 干预措施
SCS Chronic Pain Patients
Chronic pain patients aged 18 and older who have undergone permanent spinal cord stimulation (SCS) implantation due to clinical indications.
干预措施: Psychometric Questionnaires and Retrospective Data Collection (Other)
结局指标
主要结局
Toronto Alexithymia Scale (TAS-20) Score
时间窗: Baseline
A 20-item self-report questionnaire used to assess alexithymia levels. It evaluates three subscales: difficulty identifying feelings, difficulty describing feelings, and externally-oriented thinking. Total scores range from 20 to 100, with higher scores indicating higher levels of alexithymia.
次要结局
- Visual Analog Scale (VAS) Score(Baseline, 1 month, 3 months, and 6 months)
- Short Form Health Survey (SF-12) Score(Baseline, 1 month, 3 months, and 6 months)
- Hospital Anxiety and Depression Scale (HADS) Score(Baseline)
- Childhood Trauma Questionnaire (CTQ-33) Score(Baseline)
研究者
Haner Direskeneli
Professor, MD
Marmara University