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NCT Number: NCT07696286

Evaluation of Alexithymia in Chronic Pain Patients With Spinal Cord Stimulation

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Marmara University Pendik Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location status: Recruiting

Location contact

Osman Hakan Gunduz, Prof. MD

CONTACT

[email protected]

02166570606

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:

  • 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.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Psychometric Questionnaires and Retrospective Data Collection

Other

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

  1. Toronto Alexithymia Scale (TAS-20) Score

    Time frame: At a single time point (during the cross-sectional evaluation)

    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.

Secondary outcomes

  1. Visual Analog Scale (VAS) Score

    Time frame: At a single time point (during the cross-sectional evaluation)

    A 10 cm horizontal scale used to measure current pain intensity, where 0 represents no pain and 10 represents the most severe pain.

  2. Short Form Health Survey (SF-12) Score

    Time frame: At a single time point (during the cross-sectional evaluation)

    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.

  3. Hospital Anxiety and Depression Scale (HADS) Score

    Time frame: At a single time point (during the cross-sectional evaluation)

    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.

  4. Childhood Trauma Questionnaire (CTQ-33) Score

    Time frame: At a single time point (during the cross-sectional evaluation)

    A 33-item self-report scale evaluating retrospective childhood and adolescent adverse experiences. Higher scores indicate an increased level of trauma.

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jul 10, 2026
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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