Chronic CoccydyniaNCT07696260
Evaluation of Alexithymia and Its Relationship With Clinical Parameters in Patients With Chronic Coccydynia
An observational study of Chronic Coccydynia and Alexithymia, run by Marmara University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Coccydynia, Alexithymia
- How many people
- 15 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Mar 2026to Mar 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: 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.
Who may be able to join
- 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)
Who cannot join
- - 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
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, 1 recruiting
- Recruiting
Marmara University Pendik Training and Research Hospital
Istanbul
Osman Hakan Gunduz, Prof. MD, 02166570606, ipek98uyanik@gmail.com
About this study
Official title: Evaluation of the Presence of Alexithymia and Its Relationship With Clinical Parameters in Patients With Chronic Coccydynia (>=3 Months)
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 12-Item Short Form Health Survey (SF-12) 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.
Read the detailed description
Chronic coccydynia is a persistent pain condition localized to the coccygeal region, often exacerbated by sitting and significantly impairing daily activities, functionality, and health-related quality of life. While biomechanical and structural variables play a substantial role in its etiology, the pain can become chronic, making it difficult to explain solely through structural changes. Chronic pain is a complex phenomenon that interacts bidirectionally with cognitive-emotional processes and stress response systems. Within this framework, alexithymia-characterized by difficulty identifying and describing emotions-has been recognized as a psychological trait associated with higher pain intensity and functional interference in chronic pain populations.
The relationship between chronic pain, anxiety, depressive symptoms, and early adverse life events such as childhood trauma is also clinically critical, as these factors can amplify pain perception and restriction of activities. Despite these known associations in general chronic pain conditions, studies comprehensively evaluating alexithymia levels alongside pain duration, mood symptoms, childhood trauma history, and quality of life specifically within the coccydynia population remain limited. This gap in the literature underscores the importance of systematically examining the biopsychosocial components of chronic coccydynia to help optimize multidisciplinary treatment planning.
This prospective, observational cohort study aims to investigate the presence and levels of alexithymia in patients with chronic coccydynia (≥3 months) and to analyze its relationship with clinical and psychological variables. Patients presenting with tailbone pain will be evaluated at the multidisciplinary clinics. Following written informed consent, data collection will be completed in a single session utilizing a comprehensive battery of validated psychometric instruments. These include the Visual Analog Scale (VAS) for pain intensity, the 20-item Toronto Alexithymia Scale (TAS-20), the Hospital Anxiety and Depression Scale (HADS), the 33-item Childhood Trauma Questionnaire (CTQ-33), and the 12-item Short-Form Health Survey (SF-12). The findings are expected to contribute to the early identification of high-risk patient subgroups and strengthen the integration of supportive psychosocial interventions into future chronic pain management protocols.
- Conditions
- Chronic Coccydynia, Alexithymia
- Keywords
- Chronic coccydynia, Alexithymia, Childhood Trauma, Chronic Pain, Quality of Life
- Medical subject headings
- Affective Symptoms, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
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 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.
Measured: Baseline (Single-time assessment during the clinical interview)
Secondary outcomes (4)
Visual Analog Scale (VAS) for Pain
A 10-cm horizontal scale used to measure pain intensity. Scores range from 0 (no pain) to 10 (worst possible pain). Participants indicate their current tailbone pain level on this line.
Measured: Baseline (Single-time assessment)
Hospital Anxiety and Depression Scale (HADS) Score
A 14-item self-report questionnaire consisting of two subscales: anxiety (7 items) and depression (7 items). Each subscale is scored from 0 to 21, where higher scores reflect greater severity of anxiety or depression. Cut-off scores are 10 for anxiety and 7 for depression.
Measured: Baseline (Single-time assessment)
Childhood Trauma Questionnaire (CTQ-33) Score
A 33-item scale evaluating retrospective childhood and adolescent adverse experiences. It assesses emotional abuse, physical abuse, sexual abuse, emotional neglect, physical neglect, and overprotection-control. Total scores range from 25 to 150, with higher scores representing more severe childhood trauma.
Measured: Baseline (Single-time assessment)
Short Form Health Survey (SF-12) Score
A 12-item health-related quality of life survey consisting of 8 domains. Total and component scores range from 0 to 100, where higher scores indicate better health-related quality of life.
Measured: Baseline (Single-time 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 start20 Mar 2026
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Prospective
- Enrolment
- 15 participants (estimated)
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
- NCT07696260
- Sponsor's protocol ID
- 09.2026.26-0189
- Status last verified
- Jul 2026
- First submitted
- 6 Jul 2026
- Last updated
- 12 Aug 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 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Presence of Alexithymia and Its Relationship With Clinical Parameters in Patients With Chronic Coccydynia (>=3 Months)
- ClinicalTrials.gov ID
- NCT07696260
- Acronym / sponsor ID
- 09.2026.26-0189
- Conditions
- Chronic Coccydynia, Alexithymia
- Keywords
- Chronic coccydynia, Alexithymia, Childhood Trauma, Chronic Pain, Quality of Life
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 20 Mar 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- 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.
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 12-Item Short Form Health Survey (SF-12) 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.
Detailed description
Chronic coccydynia is a persistent pain condition localized to the coccygeal region, often exacerbated by sitting and significantly impairing daily activities, functionality, and health-related quality of life. While biomechanical and structural variables play a substantial role in its etiology, the pain can become chronic, making it difficult to explain solely through structural changes. Chronic pain is a complex phenomenon that interacts bidirectionally with cognitive-emotional processes and stress response systems. Within this framework, alexithymia-characterized by difficulty identifying and describing emotions-has been recognized as a psychological trait associated with higher pain intensity and functional interference in chronic pain populations.
The relationship between chronic pain, anxiety, depressive symptoms, and early adverse life events such as childhood trauma is also clinically critical, as these factors can amplify pain perception and restriction of activities. Despite these known associations in general chronic pain conditions, studies comprehensively evaluating alexithymia levels alongside pain duration, mood symptoms, childhood trauma history, and quality of life specifically within the coccydynia population remain limited. This gap in the literature underscores the importance of systematically examining the biopsychosocial components of chronic coccydynia to help optimize multidisciplinary treatment planning.
This prospective, observational cohort study aims to investigate the presence and levels of alexithymia in patients with chronic coccydynia (≥3 months) and to analyze its relationship with clinical and psychological variables. Patients presenting with tailbone pain will be evaluated at the multidisciplinary clinics. Following written informed consent, data collection will be completed in a single session utilizing a comprehensive battery of validated psychometric instruments. These include the Visual Analog Scale (VAS) for pain intensity, the 20-item Toronto Alexithymia Scale (TAS-20), the Hospital Anxiety and Depression Scale (HADS), the 33-item Childhood Trauma Questionnaire (CTQ-33), and the 12-item Short-Form Health Survey (SF-12). The findings are expected to contribute to the early identification of high-risk patient subgroups and strengthen the integration of supportive psychosocial interventions into future chronic pain management protocols.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (4 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Toronto Alexithymia Scale (TAS-20) Score
Time frame: Baseline (Single-time assessment during the clinical interview)
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.
4 secondary outcomes
Visual Analog Scale (VAS) for Pain
Time frame: Baseline (Single-time assessment)
Hospital Anxiety and Depression Scale (HADS) Score
Time frame: Baseline (Single-time assessment)
Childhood Trauma Questionnaire (CTQ-33) Score
Time frame: Baseline (Single-time assessment)
Short Form Health Survey (SF-12) Score
Time frame: Baseline (Single-time assessment)
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 12 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Chronic Coccydynia
RecruitingPhase 3
Study Evaluating the Analgesic Efficacy of Capsaicin 8% Patches in Chronic Coccygodynia.
Coccyx Disorder, Neuropathic Pain
Not yet recruitingObservational study
Alexithymia, Pain Intensity, Quality of Life, and Psychological Symptoms in Chronic Coccydynia Patients Scheduled for Ganglion Impar Block
Coccydynia, Chronic Pain
Recruiting
Comparison of Single- and Double-Level Radiofrequency Ablation for Chronic Coccydynia
Chronic Coccydynia
RecruitingObservational study
Analgesic Efficacy of Capsaicin 8% Patch (QUTENZA®) in Coccygodygnia
Coccyx Disorder
Active, not recruiting
Comparative Study Between Conventional Radiofrequency Ablation vs Chemical Neurolysis of Ganglion Impar for Treatment of Chronic Non Cancer Related Coccydynia
Pain Management
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.
Marmara University Pendik Training and Research Hospital
Istanbul, Turkey (Türkiye)
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 Coccydynia and Alexithymia, 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 4 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: looking for participants now, as of the sponsor's last update on 12 Aug 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Toronto Alexithymia Scale (TAS-20) Score (time frame: Baseline (Single-time assessment during the clinical interview)). 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 12 Aug 2026.