Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

Evaluation of Alexithymia in Chronic Pain Patients With Spinal Cord Stimulation

6 luglio 2026 aggiornato da: Haner Direskeneli, Marmara University

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

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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Stimato)

20

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Turchia (Türkiye)
      • Istanbul, Turchia (Türkiye)
        • Reclutamento
        • Marmara University Pendik Training and Research Hospital
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

Chronic pain patients aged 18 and older who have undergone permanent spinal cord stimulation (SCS) implantation due to clinical indications at the outpatient clinic.

Descrizione

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)

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
SCS Chronic Pain Patients
Chronic pain patients aged 18 and older who have undergone permanent spinal cord stimulation (SCS) implantation due to clinical indications.
Altro: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Toronto Alexithymia Scale (TAS-20) Score
Lasso di tempo: 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.
At a single time point (during the cross-sectional evaluation)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Visual Analog Scale (VAS) Score
Lasso di tempo: 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.
At a single time point (during the cross-sectional evaluation)
Short Form Health Survey (SF-12) Score
Lasso di tempo: 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.
At a single time point (during the cross-sectional evaluation)
Hospital Anxiety and Depression Scale (HADS) Score
Lasso di tempo: 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.
At a single time point (during the cross-sectional evaluation)
Childhood Trauma Questionnaire (CTQ-33) Score
Lasso di tempo: 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.
At a single time point (during the cross-sectional evaluation)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Marmara University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 giugno 2026

Completamento primario (Stimato)

1 dicembre 2026

Completamento dello studio (Stimato)

1 giugno 2027

Date di iscrizione allo studio

Primo inviato

6 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

6 luglio 2026

Primo Inserito (Effettivo)

10 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

10 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

6 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 09.2026.26-0497

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Dolore cronico

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Mauritius

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

3
Sottoscrivi