ClinicalTrials.gg
Not yet recruitingNCT07828145Updated Sep 18, 2026

Alexithymia, Pain Intensity, Quality of Life, and Psychological Symptoms in Chronic Coccydynia Patients Scheduled for Ganglion Impar Block

An observational study in Coccydynia, Chronic Pain and Alexithymia, sponsored by Marmara University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-18.

Sponsored by Marmara University · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
70
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.

Planned enrollment
72nd of 96
70 · median 100
Started
2026
with 33 others
Observational
96 of 203
34 open now
Primary completion
2027-03
later than 44 of 59 live
Registered
193rd 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 72nd largest by planned enrollment of the 96 observational ones, is one of 34 that started in 2026, is one of 96 observational ones, reaches primary completion later than 44 of the 59 other live ones, and was the 193rd 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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02

Study 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. 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:

  1. Sociodemographic and Clinical Questionnaire: Age, gender, duration and characteristics of pain, educational level, employment, analgesics, and psychiatric history.
  2. 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).
  3. Visual Analog Scale (VAS 0-10 cm): Evaluates subjective baseline pain intensity.
  4. Hospital Anxiety and Depression Scale (HADS): Assesses symptom severity for anxiety (HADS-A) and depression (HADS-D).
  5. 12-Item Short Form Health Survey (SF-12): Evaluates health-related quality of life summary components.
  6. 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.

03

Conditions studied

  • Coccydynia
  • Chronic Pain
  • Alexithymia

Keywords

  • Ganglion Impar Block
  • Coccydynia
  • Alexithymia
  • TAS-20
  • Quality of Life
  • Hospital Anxiety and Depression Scale
  • Childhood Trauma
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

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

  1. Age 18 years or older.
  2. Clinical diagnosis of chronic coccydynia persisting for at least 3 months.
  3. Clinical indication and scheduled for Ganglion Impar Block due to persistent pain to conservative treatments.
  4. Literate and possessing sufficient mental capacity to comprehend and complete self-report instruments.
  5. Provision of voluntary written .

Exclusion criteria

Exclusion Criteria:

  1. Significant cognitive impairment or communication barriers impairing capacity or questionnaire completion.
  2. Active psychotic disorder or current manic episode.
  3. Suspected acute self-harm or suicidal risk identified during clinical evaluation.
  4. Chronic coccygeal pain secondary to , acute fractures, or active infection.
  5. 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).

Terms in these criteria, in plain language(3)

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.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

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
Cohort
Time perspective
Cross-sectional
Enrollment
70 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

    Other: Psychometric and Clinical Survey Battery

Interventions

  • OtherPsychometric and Clinical Survey Battery

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline (immediately prior to the Ganglion Impar Block procedure)

Secondary outcomes

  1. 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.

    Time frame: Baseline (immediately prior to the Ganglion Impar Block procedure)

  2. 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).

    Time frame: Baseline (immediately prior to the Ganglion Impar Block procedure)

  3. 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.

    Time frame: Baseline (immediately prior to the Ganglion Impar Block procedure)

  4. 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.

    Time frame: Baseline (immediately prior to the Ganglion Impar Block procedure)

07

Study locations

1 site
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Sep 2026; primary completion for Mar 2027, 6 months later.

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

Registered
Sep 14, 2026
First posted
Sep 18, 2026
StartEst.
Sep 2026
Primary completionEst.
Mar 2027
CompletionEst.
Sep 2027
Last update
Sep 18, 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.
No changes since tracking began. The registry record was last updated on Sep 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07828145
Lead sponsor
Marmara University
Responsible party
Sponsor
First posted
Sep 18, 2026
Start date
Sep 2026 (estimated)
Primary completion
Mar 2027 (estimated)
Completion
Sep 2027 (estimated)
Last update
Sep 18, 2026

Study contacts

OSMAN H GÜNDÜZ, MD, Prof.
Contact
gunduzh@marmara.edu.tr
+90 216 657 06 06

Oversight

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

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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