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Evaluation of Alexithymia in Chronic Pain Patients With Spinal Cord Stimulation

NCT07696286 · Marmara University
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Official title
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
About this study
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: 1. Sociodemographic Data Form: Captures clinical and demographic characteristics. 2. Toronto Alexithymia Scale (TAS-20): Assesses difficulties identifying emotions, difficulties describing emotions, and externally-oriented thinking. 3. Hospital Anxiety and Depression Scale (HADS): Measures anxiety and depression levels to control for mood symptoms as potential confounding factors. 4. Short Form Health Survey (SF-12): Evaluates health-related quality of life. 5. Childhood Trauma Questionnaire (CTQ-33): Assesses retrospective childhood and adolescent adverse experiences (emotional, physical, and sexual abuse; emotional and physical neglect; overprotection-control). 6. Visual Analog Scale (VAS): Measures current pain intensity on a 0-10 cm horizontal line. The primary objective is to evaluate the relationship between alexithymia levels, pain intensity, and quality of life scales. Secondary objectives include analyzing the relationship between alexithymia and patient-reported outcomes (functionality, pain, and life quality), evaluating the potential confounding effects of childhood trauma and anxiety/depression symptoms on this relationship, and providing insights into how psychosocial factors influence clinical measurement tools.
Eligibility criteria
Inclusion Criteria: * \- 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) Exclusion Criteria: * 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)
Study design
Enrollment target: 20 participants
Age groups: adult, older_adult
Timeline
Starts: 2026-06-01
Estimated completion: 2027-06-01
Last updated: 2026-08-12
Interventions
Other: Psychometric Questionnaires and Retrospective Data Collection
Primary outcomes
  • Toronto Alexithymia Scale (TAS-20) Score (Baseline)
Sponsor
Marmara University · other
All locations (1)
Marmara University Pendik Training and Research HospitalRecruiting
Istanbul, Turkey (Türkiye)