Chronic PainNCT07696286
Evaluation of Alexithymia in Chronic Pain Patients With Spinal Cord Stimulation
An observational study of Chronic Pain, run by Marmara University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Psychometric Questionnaires and Retrospective Data Collection
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2026to 15 Oct 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- - 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University Pendik Training and Research Hospital
Istanbul
About this study
Official 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
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:
- 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.
- Conditions
- Chronic Pain
- Being tested
- Psychometric Questionnaires and Retrospective Data Collection
- Keywords
- CHRONIC PAIN, Spinal Cord Stimulation, Alexithymia, Quality of Life, Childhood Trauma, Anxiety and Depression, Neuromodulation
- Medical subject headings
- Chronic Pain, Affective Symptoms, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychometric Questionnaires and Retrospective Data CollectionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| SCS Chronic Pain Patients | Chronic pain patients aged 18 and older who have undergone permanent spinal cord stimulation (SCS) implantation due to clinical indications. Receives: Other: Psychometric Questionnaires and Retrospective Data Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At study enrollment (single cross-sectional assessment)
Secondary outcomes (4)
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.
Measured: Pre-implantation baseline, 1, 3, and 6 months after SCS implantation and at study enrollment (single cross-sectional assessment)
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.
Measured: Pre-implantation baseline, 1, 3, and 6 months after SCS implantation and at study enrollment (single cross-sectional assessment)
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.
Measured: At study enrollment (single cross-sectional assessment)
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.
Measured: At study enrollment (single cross-sectional assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study start1 Jun 2026
- Primary completion1 Oct 2026
- Study completion15 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haner Direskeneli, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07696286
- Sponsor's protocol ID
- 09.2026.26-0497
- Status last verified
- Oct 2026
- First submitted
- 6 Jul 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07696286
- Acronym / sponsor ID
- 09.2026.26-0497
- Conditions
- Chronic Pain
- Keywords
- CHRONIC PAIN, Spinal Cord Stimulation, Alexithymia, Quality of Life, Childhood Trauma, Anxiety and Depression, Neuromodulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 1 Oct 2026 (actual)
- Study completion
- 15 Oct 2026 (actual)
- First posted
- 10 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SCS Chronic Pain Patients | – | Other: Psychometric Questionnaires and Retrospective Data CollectionChronic pain patients aged 18 and older who have undergone permanent spinal cord stimulation (SCS) implantation due to clinical indications. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- - 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychometric Questionnaires and Retrospective Data CollectionParticipants 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. | Other | SCS Chronic Pain Patients |
Primary outcome
Toronto Alexithymia Scale (TAS-20) Score
Time frame: At study enrollment (single cross-sectional assessment)
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.
4 secondary outcomes
Numerical Rating Scale (NRS) for Pain Intensity
Time frame: Pre-implantation baseline, 1, 3, and 6 months after SCS implantation and at study enrollment (single cross-sectional assessment)
Short Form Health Survey (SF-12) Score
Time frame: Pre-implantation baseline, 1, 3, and 6 months after SCS implantation and at study enrollment (single cross-sectional assessment)
Hospital Anxiety and Depression Scale (HADS) Score
Time frame: At study enrollment (single cross-sectional assessment)
Childhood Trauma Questionnaire (CTQ-33) Score
Time frame: At study enrollment (single cross-sectional assessment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain, run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Toronto Alexithymia Scale (TAS-20) Score (time frame: At study enrollment (single cross-sectional assessment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.