An observational study in Chronic Pain, sponsored by Marmara University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-12.
Sponsored by Marmara University · Observational
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.
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:
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.
Chronic pain patients aged 18 and older who have undergone permanent spinal cord stimulation (SCS) implantation due to clinical indications at the outpatient clinic.
Exclusion Criteria:
Chronic pain patients aged 18 and older who have undergone permanent spinal cord stimulation (SCS) implantation due to clinical indications.
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.
Toronto Alexithymia Scale (TAS-20) Score
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.
Time frame: Baseline
Visual Analog Scale (VAS) Score
A 10 cm horizontal scale used to measure current pain intensity, where 0 represents no pain and 10 represents the most severe pain.
Time frame: Baseline, 1 month, 3 months, and 6 months
Short Form Health Survey (SF-12) Score
A 12-item questionnaire used to assess health-related quality of life across 8 dimensions. Total scores range from 0 to 100, with higher scores indicating better quality of life.
Time frame: Baseline, 1 month, 3 months, and 6 months
Hospital Anxiety and Depression Scale (HADS) Score
A 14-item self-report scale with anxiety and depression subscales (7 items each). Scores for each subscale range from 0 to 21, with higher scores indicating higher symptom severity.
Time frame: Baseline
Childhood Trauma Questionnaire (CTQ-33) Score
A 33-item self-report scale evaluating retrospective childhood and adolescent adverse experiences. Higher scores indicate an increased level of trauma.
Time frame: Baseline
Plan to share: No
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Marmara University