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Evaluation of Alexithymia in Chronic Pain Patients With Spinal Cord Stimulation

ConditionChronic Pain
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMarmara University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

- 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

Disqualifiers

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)

Trial population

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

Trial design

Design model

Other

Time perspective

Cross-sectional

Treatments tested in this trial

  • Psychometric Questionnaires and Retrospective Data Collection

    Other intervention

    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.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: SCS Chronic Pain Patients1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Marmara University

Lead sponsor

Source ClinicalTrials.gov
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