ClinicalTrials.gg
CompletedNCT07696286Updated Nov 2, 2026

Evaluation of Alexithymia in Chronic Pain Patients With Spinal Cord Stimulation

An observational study in Chronic Pain, sponsored by Marmara University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-02.

Sponsored by Marmara University · Observational

Updated Nov 2, 2026Now CompletedPrimary completion moved+3 moreGo to Updates ↓
Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
44
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 203 studies in Chronic Pain with a site in Turkey — 55 open to participants now, 60 under way, none of them phase 3. Chronic Pain · Turkey.

Enrollment
87th of 96
44 · median 100
Started
2026
with 33 others
Observational
96 of 203
34 open now
Registered
184th of 203
by date
Lead sponsor
6 of 203
Marmara University

Among the 203 studies in Chronic Pain with a site in Turkey, this one is the 87th largest by enrollment of the 96 observational ones, is one of 34 that started in 2026, is one of 96 observational ones, and was the 184th registered.

By phase

203 studies; the count open now beside each. This study's row is marked.

No phase101 · 21 open
Observationalthis study96 · 34 open
Phase 46 · 0 open

By the year they started

First in 2010; this study’s year is marked. 34 started in 2026.

Size and results

Median enrollment 60 across the 107 interventional studies, 100 across the 96 observational. Of the 121 that completed or were terminated, 0 (0%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 203 studies in Chronic Pain with a site in Turkey, or all of them as a file.
02

Study 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.

Read the detailed description

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.

03

Conditions studied

  • Chronic Pain

Keywords

  • CHRONIC PAIN
  • Spinal Cord Stimulation
  • Alexithymia
  • Quality of Life
  • Childhood Trauma
  • Anxiety and Depression
  • Neuromodulation
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • - Being 18 years of age or older
  • Having undergone permanent spinal cord stimulation (SCS) implantation due to clinical indications
  • Providing written 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

Exclusion Criteria:

  • Cognitive impairment or communication barriers that compromise the capacity to provide
  • 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 , active infection, acute fracture)
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
44 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • OtherPsychometric 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 (NRS) and clinical data are extracted retrospectively from medical records.

06

What researchers measure

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: At study enrollment (single cross-sectional assessment)

Secondary outcomes

  1. Numerical Rating Scale (NRS) for Pain Intensity

    Pain intensity was assessed using an 11-point Numerical Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). Historical NRS scores were retrospectively extracted from clinical records.

    Time frame: Pre-implantation baseline, 1, 3, and 6 months after SCS implantation and at study enrollment (single cross-sectional assessment)

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

    The 12-item Short Form Health Survey assesses health-related quality of life. Physical Component Summary (PCS) and Mental Component Summary (MCS) scores are calculated using norm-based scoring, with a reference population mean of 50 and standard deviation of 10. Higher scores indicate better physical or mental health-related quality of life.

    Time frame: Pre-implantation baseline, 1, 3, and 6 months after SCS implantation and at study enrollment (single cross-sectional assessment)

  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: At study enrollment (single cross-sectional assessment)

  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: At study enrollment (single cross-sectional assessment)

07

Study locations

1 site
  • Marmara University Pendik Training and Research Hospital
    Istanbul, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it moved

Ran from Jun 2026 to primary completion in Oct 2026, 4 months.

Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 2, 2026: primary completion Dec 2026 → Oct 2026 and completion Jun 2027 → Oct 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Jul 6, 2026
First posted
Jul 10, 2026
StartActual
Jun 1, 2026
Primary completionActual
Oct 1, 2026was Dec 2026
CompletionActual
Oct 15, 2026was Jun 2027
Last update
Nov 2, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Recruiting→Completed
changed Nov 2, 2026
Primary completion
Dec 1, 2026→Oct 1, 2026 (actual)
Nov 2, 2026
Study completion
Jun 1, 2027→Oct 15, 2026 (actual)
Nov 2, 2026
Enrollment
20 (estimated)→44 (actual)
Nov 2, 2026
Primary outcomes
1 time frame changed
What changed in the outcomes
  • Time frameToronto Alexithymia Scale (TAS-20) ScoreBaseline → At study enrollment (single cross-sectional assessment)
Nov 2, 2026
Secondary outcomes
1 edited, 3 time frame changed, 1 description edited
What changed in the outcomes
  • ChangedBefore Visual Analog Scale (VAS) ScoreNow Numerical Rating Scale (NRS) for Pain IntensityTime frame: Baseline, 1 month, 3 months, and 6 months → Pre-implantation baseline, 1, 3, and 6 months after SCS implantation and at study enrollment (single cross-sectional assessment)
  • Time frameShort Form Health Survey (SF-12) ScoreBaseline, 1 month, 3 months, and 6 months → Pre-implantation baseline, 1, 3, and 6 months after SCS implantation and at study enrollment (single cross-sectional assessment)
  • Time frameHospital Anxiety and Depression Scale (HADS) ScoreBaseline → At study enrollment (single cross-sectional assessment)
  • Time frameChildhood Trauma Questionnaire (CTQ-33) ScoreBaseline → At study enrollment (single cross-sectional assessment)
  • DescriptionShort Form Health Survey (SF-12) Score: how it is measured was reworded
Nov 2, 2026
Show all 1 update
  1. Nov 2, 2026
    Recruiting→Completed
    Primary completion Dec 1, 2026→Oct 1, 2026 (now actual)
    Study completion Jun 1, 2027→Oct 15, 2026 (now actual)
    Enrollment 20 (estimated)→44 (actual)
    Primary outcomes 1 time frame changed
    What changed in the outcomes
    • Time frameToronto Alexithymia Scale (TAS-20) ScoreBaseline → At study enrollment (single cross-sectional assessment)
    Secondary outcomes 1 edited, 3 time frame changed, 1 description edited
    What changed in the outcomes
    • ChangedBefore Visual Analog Scale (VAS) ScoreNow Numerical Rating Scale (NRS) for Pain IntensityTime frame: Baseline, 1 month, 3 months, and 6 months → Pre-implantation baseline, 1, 3, and 6 months after SCS implantation and at study enrollment (single cross-sectional assessment)
    • Time frameShort Form Health Survey (SF-12) ScoreBaseline, 1 month, 3 months, and 6 months → Pre-implantation baseline, 1, 3, and 6 months after SCS implantation and at study enrollment (single cross-sectional assessment)
    • Time frameHospital Anxiety and Depression Scale (HADS) ScoreBaseline → At study enrollment (single cross-sectional assessment)
    • Time frameChildhood Trauma Questionnaire (CTQ-33) ScoreBaseline → At study enrollment (single cross-sectional assessment)
    • DescriptionShort Form Health Survey (SF-12) Score: how it is measured was reworded
    + 4 other changes: verification date, arm descriptions, site details and contact details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07696286
Lead sponsor
Marmara University
Responsible party
Haner Direskeneli (Professor, MD, Marmara University) — Principal investigator
First posted
Jul 10, 2026
Start date
Jun 1, 2026
Primary completion
Oct 1, 2026
Completion
Oct 15, 2026
Last update
Nov 2, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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