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Evaluation of Alexithymia in Chronic Pain Patients With Spinal Cord Stimulation

ClinicalTrials.gov IDNCT07696286

PhaseNot Applicable

Enrollment20

SponsorMarmara University

Age18 Years

SexALL

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Conditions studied

Chronic Pain

About this study

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.

Interventions

Other: Psychometric Questionnaires and Retrospective Data Collection — Participants are evaluated at a single time point using self-report questionnaires including the Toronto Alexithymia Scale (TAS-20), Hospital Anxiety and Depression Scale (HADS), Short Form Health Survey (SF-12), and Childhood Trauma Questionnaire (CTQ-33). Pain intensity (VAS/NRS) and clinical data are extracted retrospectively from medical records.

Primary outcomes

Toronto Alexithymia Scale (TAS-20) Score (Baseline)

Eligibility information

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 locations

Marmara University Pendik Training and Research Hospital, Istanbul, Turkey (Türkiye)

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.