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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMarmara University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

  • Psychometric and Clinical Survey Battery

    Other intervention

    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.

Treatment groups

70 Participants
are divided into 1 treatment group
Group A: Chronic Coccydynia Patients1 intervention

Trial outcomes

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)

Other outcomes

Sponsors and contacts

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