Evaluation of Alexithymia in Chronic Pain Patients With Spinal Cord Stimulation

NCT07696286 | Recruiting

• 1 other identifier: 09.2026.26-0497
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Pain

Keywords

CHRONIC PAIN; Spinal Cord Stimulation; Alexithymia; Quality of Life; Childhood Trauma; Anxiety and Depression; Neuromodulation

Outcome Measures

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.

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

Secondary Outcomes (4)

• Visual Analog Scale (VAS) Score

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

• Short Form Health Survey (SF-12) Score

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

• Hospital Anxiety and Depression Scale (HADS) Score

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

• Childhood Trauma Questionnaire (CTQ-33) Score

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

Study Arms (1)

SCS Chronic Pain Patients

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

Interventions

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.

SCS Chronic Pain Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• \- 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University Pendik Training and Research Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Chronic Pain; Affective Symptoms; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD

Study Record Dates

• First Submitted: July 6, 2026
• First Posted: July 10, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: July 10, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)