CoccydyniaNCT07828145
Alexithymia, Pain Intensity, Quality of Life, and Psychological Symptoms in Chronic Coccydynia Patients Scheduled for Ganglion Impar Block
An observational study of Coccydynia and Chronic Pain, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
Chronic coccydynia is characterized by pain localized to the coccygeal region that typically worsens with sitting, leading to notable impairments in functional performance and health-related quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coccydynia, Chronic Pain, Alexithymia
- What is being tested?
- Psychometric and Clinical Survey Battery
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Sep 2026to Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Adult patients presenting to Marmara University Pendik Training and Research Hospital, Division of Algology outpatient clinic, who are diagnosed with chronic coccydynia and scheduled for clinically indicated Ganglion Impar Block.
Who may be able to join
- Age 18 years or older.
- Clinical diagnosis of chronic coccydynia persisting for at least 3 months.
- Clinical indication and scheduled for Ganglion Impar Block due to persistent pain refractory to conservative treatments.
- Literate and possessing sufficient mental capacity to comprehend and complete self-report instruments.
- Provision of voluntary written informed consent.
Who cannot join
- Significant cognitive impairment or communication barriers impairing informed consent capacity or questionnaire completion.
- Active psychotic disorder or current manic episode.
- Suspected acute self-harm or suicidal risk identified during clinical evaluation.
- Chronic coccygeal pain secondary to malignancy, acute fractures, or active infection.
- Severe active psychiatric disease currently under medical treatment (e.g., severe mental illness, schizophrenia, bipolar affective disorder).
- (Note: Depressive symptoms alone are not an exclusion criterion; they are assessed via HADS and controlled for as covariates in analytical models).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Marmara University Pendik Training and Research Hospital
Istanbul, 34899
Osman H Gündüz, MD, Prof., +902166570606, gunduzh@marmara.edu.tr
About this study
Official title: The Relationship Between Alexithymia Levels and Pain Intensity, Quality of Life, and Psychological Symptoms in Patients Scheduled for Ganglion Impar Block Due to Chronic Coccydynia: A Prospective Analytical Cross-Sectional Study
Chronic coccydynia is characterized by pain localized to the coccygeal region that typically worsens with sitting, leading to notable impairments in functional performance and health-related quality of life. In clinical practice, fluoroscopy-guided Ganglion Impar Block (GIB) is commonly performed as an interventional treatment in patients unresponsive to conservative medical therapies.
Alexithymia, defined as a multidimensional personality construct involving difficulty identifying and describing feelings alongside an externally oriented thinking style, has been shown to be prevalent in chronic pain conditions and associated with pain intensity, mood symptoms, and functional disability.
The primary objective of this prospective analytical cross-sectional study is to examine the relationship between alexithymia levels (evaluated via the 20-item Toronto Alexithymia Scale [TAS-20]) and pain intensity, health-related quality of life, anxiety, depression, and childhood trauma in patients with chronic coccydynia who are scheduled to undergo Ganglion Impar Block based on routine clinical indications.
Read the detailed description
This is a single-center, prospective analytical cross-sectional observational study conducted at Marmara University Pendik Training and Research Hospital, Division of Algology, in collaboration with the Department of Psychiatry.
Ganglion Impar Block (GIB) is performed strictly for routine therapeutic indication and standard clinical practice; it is not an experimental intervention designed for this trial. No additional experimental interventions or post-procedural longitudinal follow-up evaluations are administered as part of the research protocol.
Following written voluntary informed consent, all study data are collected prospectively at a single pre-procedural time point immediately prior to the injection procedure. Assessment instruments completed by participants (taking approximately 25 to 35 minutes) include:
- Sociodemographic and Clinical Questionnaire: Age, gender, duration and characteristics of pain, educational level, employment, analgesics, and psychiatric history.
- 20-Item Toronto Alexithymia Scale (TAS-20): Assesses total alexithymia severity and its three subdimensions (Difficulty Identifying Feelings, Difficulty Describing Feelings, and Externally Oriented Thinking).
- Visual Analog Scale (VAS 0-10 cm): Evaluates subjective baseline pain intensity.
- Hospital Anxiety and Depression Scale (HADS): Assesses symptom severity for anxiety (HADS-A) and depression (HADS-D).
- 12-Item Short Form Health Survey (SF-12): Evaluates health-related quality of life summary components.
- Childhood Trauma Questionnaire (CTQ-33): Assesses retrospective self-reports of childhood maltreatment and neglect.
The study aims to analyze bivariate correlations among TAS-20 scores, pain intensity, quality of life, and affective symptoms, compare clinical profiles between alexithymic and non-alexithymic cohorts, and determine independent predictors of alexithymia severity using multivariable linear regression models.
- Conditions
- Coccydynia, Chronic Pain, Alexithymia
- Being tested
- Psychometric and Clinical Survey Battery
- Keywords
- Ganglion Impar Block, Coccydynia, Alexithymia, TAS-20, Quality of Life, Hospital Anxiety and Depression Scale, Childhood Trauma
- Medical subject headings
- Chronic Pain, Affective Symptoms, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychometric and Clinical Survey BatteryOther
Cross-sectional pre-procedural assessment consisting of self-report questionnaires administered immediately prior to the Ganglion Impar Block procedure. The battery includes the 20-Item Toronto Alexithymia Scale (TAS-20), Visual Analog Scale (VAS 0-10 cm), Hospital Anxiety and Depression Scale (HADS), 12-Item Short Form Health Survey (SF-12), and Childhood Trauma Questionnaire (CTQ-33), alongside a structured sociodemographic data form.
| Study group | Role | What they receive |
|---|---|---|
| Chronic Coccydynia Patients | Adult patients aged 18 years or older diagnosed with chronic coccydynia for at least 3 months, who are scheduled to undergo fluoroscopy-guided Ganglion Impar Block due to persistent pain despite conservative treatments. Receives: Other: Psychometric and Clinical Survey Battery |
What is being measured
The primary outcome is the main question the study is designed to answer.
20-Item Toronto Alexithymia Scale (TAS-20) Total Score
The TAS-20 is a self-report questionnaire used to assess the severity of alexithymia. It contains 20 items scored on a 5-point Likert scale ranging from 1 to 5. The total score ranges from 20 to 100, where higher scores indicate greater alexithymia severity. Established cut-off scores: ≤51 indicates non-alexithymia, 52 to 60 indicates possible alexithymia, and ≥61 indicates alexithymia.
Measured: Baseline (immediately prior to the Ganglion Impar Block procedure)
Secondary outcomes (4)
Pain Intensity Measured by Visual Analog Scale (VAS)
Pain intensity is evaluated using a standard 10-cm horizontal Visual Analog Scale ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores reflect greater subjective pain severity.
Measured: Baseline (immediately prior to the Ganglion Impar Block procedure)
Hospital Anxiety and Depression Scale (HADS) Scores
The HADS evaluates psychological distress using 14 items categorized into two 7-item subscales: Anxiety (HADS-A) and Depression (HADS-D). Each item is scored from 0 to 3, yielding subscale scores between 0 and 21. Higher scores reflect higher severity of symptoms (cut-off scores: ≥10 for anxiety, ≥7 for depression).
Measured: Baseline (immediately prior to the Ganglion Impar Block procedure)
Health-Related Quality of Life Measured by 12-Item Short Form Survey (SF-12)
A 12-item self-administered generic health questionnaire used to evaluate health-related quality of life across Physical Component Summary (PCS) and Mental Component Summary (MCS). Scores range from 0 to 100, with higher scores reflecting better functional status and quality of life.
Measured: Baseline (immediately prior to the Ganglion Impar Block procedure)
Childhood Trauma Questionnaire (CTQ-33) Total Score
The CTQ-33 is a self-report instrument assessing retrospective childhood traumatic experiences across subscales of emotional, physical, and sexual abuse, emotional and physical neglect, and overprotection/control. Total scores range from 25 to 150, where higher scores indicate higher severity of childhood trauma.
Measured: Baseline (immediately prior to the Ganglion Impar Block procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoccydyniaStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07828145
- Sponsor's protocol ID
- 09.2026.880
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Alexithymia Levels and Pain Intensity, Quality of Life, and Psychological Symptoms in Patients Scheduled for Ganglion Impar Block Due to Chronic Coccydynia: A Prospective Analytical Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT07828145
- Acronym / sponsor ID
- 09.2026.880
- Conditions
- Coccydynia, Chronic Pain, Alexithymia
- Keywords
- Ganglion Impar Block, Coccydynia, Alexithymia, TAS-20, Quality of Life, Hospital Anxiety and Depression Scale, Childhood Trauma
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 18 Sep 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.
Chronic coccydynia is characterized by pain localized to the coccygeal region that typically worsens with sitting, leading to notable impairments in functional performance and health-related quality of life. In clinical practice, fluoroscopy-guided Ganglion Impar Block (GIB) is commonly performed as an interventional treatment in patients unresponsive to conservative medical therapies.
Alexithymia, defined as a multidimensional personality construct involving difficulty identifying and describing feelings alongside an externally oriented thinking style, has been shown to be prevalent in chronic pain conditions and associated with pain intensity, mood symptoms, and functional disability.
The primary objective of this prospective analytical cross-sectional study is to examine the relationship between alexithymia levels (evaluated via the 20-item Toronto Alexithymia Scale [TAS-20]) and pain intensity, health-related quality of life, anxiety, depression, and childhood trauma in patients with chronic coccydynia who are scheduled to undergo Ganglion Impar Block based on routine clinical indications.
Detailed description
This is a single-center, prospective analytical cross-sectional observational study conducted at Marmara University Pendik Training and Research Hospital, Division of Algology, in collaboration with the Department of Psychiatry.
Ganglion Impar Block (GIB) is performed strictly for routine therapeutic indication and standard clinical practice; it is not an experimental intervention designed for this trial. No additional experimental interventions or post-procedural longitudinal follow-up evaluations are administered as part of the research protocol.
Following written voluntary informed consent, all study data are collected prospectively at a single pre-procedural time point immediately prior to the injection procedure. Assessment instruments completed by participants (taking approximately 25 to 35 minutes) include:
- Sociodemographic and Clinical Questionnaire: Age, gender, duration and characteristics of pain, educational level, employment, analgesics, and psychiatric history.
- 20-Item Toronto Alexithymia Scale (TAS-20): Assesses total alexithymia severity and its three subdimensions (Difficulty Identifying Feelings, Difficulty Describing Feelings, and Externally Oriented Thinking).
- Visual Analog Scale (VAS 0-10 cm): Evaluates subjective baseline pain intensity.
- Hospital Anxiety and Depression Scale (HADS): Assesses symptom severity for anxiety (HADS-A) and depression (HADS-D).
- 12-Item Short Form Health Survey (SF-12): Evaluates health-related quality of life summary components.
- Childhood Trauma Questionnaire (CTQ-33): Assesses retrospective self-reports of childhood maltreatment and neglect.
The study aims to analyze bivariate correlations among TAS-20 scores, pain intensity, quality of life, and affective symptoms, compare clinical profiles between alexithymic and non-alexithymic cohorts, and determine independent predictors of alexithymia severity using multivariable linear regression models.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic Coccydynia Patients | – | Other: Psychometric and Clinical Survey BatteryAdult patients aged 18 years or older diagnosed with chronic coccydynia for at least 3 months, who are scheduled to undergo fluoroscopy-guided Ganglion Impar Block due to persistent pain despite conservative treatments. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients presenting to Marmara University Pendik Training and Research Hospital, Division of Algology outpatient clinic, who are diagnosed with chronic coccydynia and scheduled for clinically indicated Ganglion Impar Block.
Key inclusion criteria (5 listed)
- Age 18 years or older.
- Clinical diagnosis of chronic coccydynia persisting for at least 3 months.
- Clinical indication and scheduled for Ganglion Impar Block due to persistent pain refractory to conservative treatments.
- Literate and possessing sufficient mental capacity to comprehend and complete self-report instruments.
- Provision of voluntary written informed consent.
Key exclusion criteria (6 listed)
- Significant cognitive impairment or communication barriers impairing informed consent capacity or questionnaire completion.
- Active psychotic disorder or current manic episode.
- Suspected acute self-harm or suicidal risk identified during clinical evaluation.
- Chronic coccygeal pain secondary to malignancy, acute fractures, or active infection.
- Severe active psychiatric disease currently under medical treatment (e.g., severe mental illness, schizophrenia, bipolar affective disorder).
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 and Clinical Survey BatteryCross-sectional pre-procedural assessment consisting of self-report questionnaires administered immediately prior to the Ganglion Impar Block procedure. The battery includes the 20-Item Toronto Alexithymia Scale (TAS-20), Visual Analog Scale (VAS 0-10 cm), Hospital Anxiety and Depression Scale (HADS), 12-Item Short Form Health Survey (SF-12), and Childhood Trauma Questionnaire (CTQ-33), alongside a structured sociodemographic data form. | Other | Chronic Coccydynia Patients |
Primary outcome
20-Item Toronto Alexithymia Scale (TAS-20) Total Score
Time frame: Baseline (immediately prior to the Ganglion Impar Block procedure)
The TAS-20 is a self-report questionnaire used to assess the severity of alexithymia. It contains 20 items scored on a 5-point Likert scale ranging from 1 to 5. The total score ranges from 20 to 100, where higher scores indicate greater alexithymia severity. Established cut-off scores: ≤51 indicates non-alexithymia, 52 to 60 indicates possible alexithymia, and ≥61 indicates alexithymia.
4 secondary outcomes
Pain Intensity Measured by Visual Analog Scale (VAS)
Time frame: Baseline (immediately prior to the Ganglion Impar Block procedure)
Hospital Anxiety and Depression Scale (HADS) Scores
Time frame: Baseline (immediately prior to the Ganglion Impar Block procedure)
Health-Related Quality of Life Measured by 12-Item Short Form Survey (SF-12)
Time frame: Baseline (immediately prior to the Ganglion Impar Block procedure)
Childhood Trauma Questionnaire (CTQ-33) Total Score
Time frame: Baseline (immediately prior to the Ganglion Impar Block procedure)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
Related trials for Coccydynia
Recruiting
Shock Wave Therapy Versus High-Intensity Laser Therapy for Coccydynia (Tailbone Pain)
Coccydynia, Coccygodynia
Recruiting
Conventional vs Pulsed RF in Coccydynia
Back Pain
RecruitingPhase 3
Study Evaluating the Analgesic Efficacy of Capsaicin 8% Patches in Chronic Coccygodynia.
Coccyx Disorder, Neuropathic Pain
RecruitingObservational study
Evaluation of Alexithymia and Its Relationship With Clinical Parameters in Patients With Chronic Coccydynia
Chronic Coccydynia, Alexithymia
Recruiting
Comparison of Single- and Double-Level Radiofrequency Ablation for Chronic Coccydynia
Chronic Coccydynia
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.
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 Coccydynia and 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 5 inclusion and 6 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: opening soon, as of the sponsor's last update on 18 Sep 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact OSMAN H GÜNDÜZ, MD, Prof. (+90 216 657 06 06, gunduzh@marmara.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
20-Item Toronto Alexithymia Scale (TAS-20) Total Score (time frame: Baseline (immediately prior to the Ganglion Impar Block procedure)). 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 18 Sep 2026.