NCT07696260

Brief Summary

This study aims to investigate the prevalence and levels of alexithymia in patients diagnosed with chronic coccydynia (tailbone pain lasting for 3 months or longer) and to explore its relationship with various clinical and psychological parameters. Chronic coccydynia can significantly impair daily activities, functionality, and reduce quality of life. Participants in this prospective, observational study will be evaluated during their routine visits to the pain management clinic. Evaluation of the participants will be performed using validated self-report questionnaires, including the Toronto Alexithymia Scale (TAS-20) for alexithymia, the Hospital Anxiety and Depression Scale (HADS) for mood symptoms, the Childhood Trauma Questionnaire (CTQ-33) for early life adverse experiences, the Visual Analog Scale (VAS) for pain intensity, and the SF-12 Health Survey for quality of life. The primary objective of the study is to determine how alexithymia relates to pain severity, duration, emotional symptoms, childhood trauma history, and overall quality of life in this specific population. The results of this pilot study may help strengthen the biopsychosocial approach in the evaluation of chronic coccydynia and optimize future multidisciplinary treatment strategies.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
8mo left

Started Mar 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress39%
Mar 2026Mar 2027

Study Start

First participant enrolled

March 20, 2026

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 6, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 10, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

July 10, 2026

Status Verified

July 1, 2026

Enrollment Period

12 months

First QC Date

July 6, 2026

Last Update Submit

July 6, 2026

Conditions

Keywords

Chronic coccydyniaAlexithymiaChildhood TraumaChronic PainQuality of Life

Outcome Measures

Primary Outcomes (1)

  • Toronto Alexithymia Scale (TAS-20) Score

    A 20-item self-report questionnaire used to evaluate the presence and severity of alexithymia. It assesses three subscales: difficulty identifying feelings, difficulty describing feelings, and externally-oriented thinking. Total scores range from 20 to 100, where higher scores indicate a higher level of alexithymia.

    Baseline (Single-time assessment during the clinical interview)

Secondary Outcomes (4)

  • Visual Analog Scale (VAS) for Pain

    Baseline (Single-time assessment)

  • Hospital Anxiety and Depression Scale (HADS) Score

    Baseline (Single-time assessment)

  • Childhood Trauma Questionnaire (CTQ-33) Score

    Baseline (Single-time assessment)

  • Short Form Health Survey (SF-12) Score

    Baseline (Single-time assessment)

Study Arms (1)

Chronic Coccydynia Patients

Patients aged 18 and older who present to the algology outpatient clinic with a diagnosis of chronic coccydynia lasting for 3 months or longer. Participants will undergo a single-time biopsychosocial assessment using validated psychometric scales including TAS-20, HADS, CTQ-33, VAS, and SF-12 during their routine evaluation.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients aged 18 and older who present to the algology outpatient clinic and meet the diagnostic criteria for chronic coccydynia lasting for 3 months or longer.

You may qualify if:

  • Being older than 18 years of age
  • Volunteering to participate in the study and providing written informed consent
  • Being literate and having the mental capacity to comprehend the questionnaires
  • Having no active, treated severe psychiatric disorder (such as schizophrenia or bipolar affective disorder)

You may not qualify if:

  • \- Cognitive impairment or communication barriers that compromise the capacity to consent
  • Active psychotic disorder or manic episode
  • Suspected self-harm or suicide risk during the clinical interview
  • Distinct secondary causes of pain such as malignancy, active infection, or acute fracture

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University Pendik Training and Research Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Affective SymptomsChronic Pain

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, MD

Study Record Dates

First Submitted

July 6, 2026

First Posted

July 10, 2026

Study Start

March 20, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

July 10, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations