CoccydyniaCoccydyniaNCT06848062
Validation of the Paris (Functional Coccydynia Effect) Pain Questionnaire
An observational study of Coccydynia and Coccyx Disorder, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study aims to validate and assess the reliability of the Turkish version of the Paris Pain Questionnaire (PPQ) in patients with coccydynia. The PPQ was developed by Dr. Jean-Yves Maigne as a condition-specific tool to evaluate pain severity and functional limitations in individuals with coccydynia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Coccydynia, Coccyx Disorder, Coccyx Injury
- How many people
- 105 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Oct 2024to 21 Feb 2025
- How long will I take part?
- 2 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Diagnosed with coccydynia
Who may be able to join
- Age: 18 to 65 years
- Diagnosis of coccydynia confirmed through clinical and radiological evaluation
- Ability to read and understand Turkish
- Willingness to participate and provide informed consent
Who cannot join
- Presence of other conditions causing pelvic or rectal pain (e.g., endometriosis, ectopic pregnancy, hemorrhoids, rectal carcinoma)
- Severe psychiatric disorders (e.g., psychosis, major depression within the last 30 days)
- Neurological disorders affecting the pelvic region or lower back
- History of surgery or trauma to the coccygeal area within the past 90 days
- Primary complaints of low back pain rather than coccydynia
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Fatih Sultan Mehmet Training and Research Hospital
Istanbul, 34098
About this study
Official title: Validation of the Paris (Functional Coccydynia Effect) Pain Questionnaire for Coccydynia: A Study on Reliability and Validity in the Turkish Population
This study aims to validate and assess the reliability of the Turkish version of the Paris Pain Questionnaire (PPQ) in patients with coccydynia. The PPQ was developed by Dr. Jean-Yves Maigne as a condition-specific tool to evaluate pain severity and functional limitations in individuals with coccydynia. This study follows a cross-sectional observational design and includes 105 participants. The psychometric properties of the Turkish version will be assessed through internal consistency (Cronbach's alpha), test-retest reliability (intraclass correlation coefficient - ICC), and construct validity. The results will determine whether the PPQ is a valid and reliable tool for use in Turkish-speaking populations with coccydynia.
Read the detailed description
Coccydynia refers to pain localized in the coccyx and surrounding areas without radiation, significantly affecting quality of life. The condition was first described in 1588, and in 1950, Schapiro referred to it as "television disease." Rectal palpation revealing tenderness in the coccyx strongly supports the diagnosis of coccydynia. Symptoms typically worsen while sitting (especially on hard surfaces), transitioning from sitting to standing, and prolonged standing. Although its etiology remains uncertain, the most common risk factors include internal and external trauma, such as falls and childbirth. While idiopathic cases may also occur, the risk of developing coccydynia is higher in women and individuals with obesity. Coccyx morphology and hypermobility are closely associated with coccydynia, and degenerative changes in the intercoccygeal discs have been implicated as a cause in 41% of idiopathic cases and 44% of traumatic cases. Tumors such as chordoma, osteoid osteoma, and notochordal cell tumors, as well as infections, are other potential causes.
Anteroposterior (AP) and lateral radiographs are the primary imaging modalities used to rule out these conditions and investigate predisposing factors for coccydynia, such as bone spicules, retroverted coccyx, coccygeal subluxation, or scoliosis. Radiographs are also valuable for identifying fractures or dislocations resulting from trauma. Additionally, angular mobility evaluations are performed using dynamic imaging techniques.
Clinical decision-making relies on valid and reliable outcome measures. These measures assess disability levels, functional impairment, treatment effectiveness, and disease progression over time. To be clinically meaningful, an outcome measure must be easy to complete and score, valid, reliable, and responsive to changes. The Oswestry Disability Index (ODI) is a valid, reliable, and responsive assessment tool specifically designed for low back pain. Although it has been widely used in studies assessing disability in coccydynia, it does not include coccydynia-specific functional limitations, such as "pain while transitioning from sitting to standing." Furthermore, ODI includes questions that assess leg pain, which is not relevant to coccydynia.
Similarly, quality of life is commonly assessed using the Short Form-12 (SF-12) in coccydynia research. However, SF-12 is a general health-related quality-of-life measure, rather than a condition-specific tool. Additionally, the Numeric Rating Scale (NRS) has long been used for pain assessment, and despite some criticisms, its use alongside additional questions provides valuable insights.
Assessing coccydynia requires the evaluation of pain and its functional impact, along with condition-specific disability questionnaires. The Paris Pain Questionnaire (Functional Impact of Coccydynia Pain Questionnaire) was developed by Jean-Yves Maigne in 2006 as a condition-specific tool. However, its reliability and validity have not been formally established.[6] While it has not been widely used in subsequent studies, it was reintroduced in 2021 by Jean-Yves Maigne and his team in another study on coccydynia assessment. In this study, a modification was made to the original questionnaire by incorporating pain onset during sitting. Unlike other questionnaires, the Paris Pain Questionnaire assesses aspects of pain that impact daily life, including pain while sitting (beyond intensity alone, as measured by NRS), transitioning from sitting to standing (highly specific to coccydynia with radiological findings), walking, nighttime pain (which is common in severe coccydynia), and pain during travel (a key indicator of coccygeal pain sensitivity). However, a formal validation and reliability study for this questionnaire has not been conducted to date.
This study aims to:
Translate the Paris Pain Questionnaire (Functional Impact of Coccydynia Pain Questionnaire) from English to Turkish.
Assess its validity and test-retest reliability (intra-rater reliability) in the Turkish-speaking population.
The Paris Pain Questionnaire was developed by Jean-Yves Maigne and his team and has been used in their clinical research; however, a formal reliability study has never been conducted. Currently, there is no standardized assessment tool specifically designed for coccydynia, and most studies rely on general low back pain measures.
Validating the Paris Pain Questionnaire is crucial for future research on coccydynia, as it provides a condition-specific measure of functional impact and pain severity. This study represents the first attempt to validate and establish the reliability of the Paris Pain Questionnaire, making it a valuable tool for clinicians and researchers. The Turkish validity and reliability study of this questionnaire will allow healthcare providers to use this unique assessment tool in Turkish-speaking patients with coccydynia.
- Conditions
- Coccydynia, Coccyx Disorder, Coccyx Injury
- Keywords
- coccyx, coccydynia, Paris Pain Questionnaire, validation
What is being measured
The primary outcome is the main question the study is designed to answer.
Internal Consistency (Cronbach's Alpha)
Internal consistency of the Turkish PPQ will be assessed using Cronbach's alpha.
Measured: Baseline
Test-Retest Reliability (ICC)
Intraclass correlation coefficient (ICC) will be calculated to assess reliability over time.
Measured: Baseline and 3-day follow-up
Secondary outcomes (2)
Construct Validity (Pearson Correlation)
PPQ scores will be correlated with the Oswestry Disability Index (ODI), Numeric Rating Scale (NRS), and Short Form-12 (SF-12).
Measured: Baseline
Factor Analysis
Exploratory factor analysis will be conducted to evaluate the structural validity of the Turkish PPQ
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2025
- Study start30 Oct 2024
- Primary completion21 Feb 2025
- Study completion21 Feb 2025
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.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 105 participants (actual)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Fatih Sultan Mehmet Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aslinur Keles Ercisli, MD, Fatih Sultan Mehmet Training and Research Hospital
- Investigators
- Aslinur Keles Ercisli, M. D., Principal investigator, Fatih Sultan Mehmet Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06848062
- Sponsor's protocol ID
- 2024/12-12/39
- Acronym
- Coccydynia
- Status last verified
- Mar 2025
- First submitted
- 21 Feb 2025
- Last updated
- 5 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Paris (Functional Coccydynia Effect) Pain Questionnaire for Coccydynia: A Study on Reliability and Validity in the Turkish Population
- ClinicalTrials.gov ID
- NCT06848062
- Acronym / sponsor ID
- Coccydynia / 2024/12-12/39
- Conditions
- Coccydynia, Coccyx Disorder, Coccyx Injury
- Keywords
- coccyx, coccydynia, Paris Pain Questionnaire, validation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Fatih Sultan Mehmet Training and Research HospitalUniversity, hospital or other
- Study start
- 30 Oct 2024 (actual)
- Primary completion
- 21 Feb 2025 (actual)
- Study completion
- 21 Feb 2025 (actual)
- First posted
- 26 Feb 2025 (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 validate and assess the reliability of the Turkish version of the Paris Pain Questionnaire (PPQ) in patients with coccydynia. The PPQ was developed by Dr. Jean-Yves Maigne as a condition-specific tool to evaluate pain severity and functional limitations in individuals with coccydynia. This study follows a cross-sectional observational design and includes 105 participants. The psychometric properties of the Turkish version will be assessed through internal consistency (Cronbach's alpha), test-retest reliability (intraclass correlation coefficient - ICC), and construct validity. The results will determine whether the PPQ is a valid and reliable tool for use in Turkish-speaking populations with coccydynia.
Detailed description
Coccydynia refers to pain localized in the coccyx and surrounding areas without radiation, significantly affecting quality of life. The condition was first described in 1588, and in 1950, Schapiro referred to it as "television disease." Rectal palpation revealing tenderness in the coccyx strongly supports the diagnosis of coccydynia. Symptoms typically worsen while sitting (especially on hard surfaces), transitioning from sitting to standing, and prolonged standing. Although its etiology remains uncertain, the most common risk factors include internal and external trauma, such as falls and childbirth. While idiopathic cases may also occur, the risk of developing coccydynia is higher in women and individuals with obesity. Coccyx morphology and hypermobility are closely associated with coccydynia, and degenerative changes in the intercoccygeal discs have been implicated as a cause in 41% of idiopathic cases and 44% of traumatic cases. Tumors such as chordoma, osteoid osteoma, and notochordal cell tumors, as well as infections, are other potential causes.
Anteroposterior (AP) and lateral radiographs are the primary imaging modalities used to rule out these conditions and investigate predisposing factors for coccydynia, such as bone spicules, retroverted coccyx, coccygeal subluxation, or scoliosis. Radiographs are also valuable for identifying fractures or dislocations resulting from trauma. Additionally, angular mobility evaluations are performed using dynamic imaging techniques.
Clinical decision-making relies on valid and reliable outcome measures. These measures assess disability levels, functional impairment, treatment effectiveness, and disease progression over time. To be clinically meaningful, an outcome measure must be easy to complete and score, valid, reliable, and responsive to changes. The Oswestry Disability Index (ODI) is a valid, reliable, and responsive assessment tool specifically designed for low back pain. Although it has been widely used in studies assessing disability in coccydynia, it does not include coccydynia-specific functional limitations, such as "pain while transitioning from sitting to standing." Furthermore, ODI includes questions that assess leg pain, which is not relevant to coccydynia.
Similarly, quality of life is commonly assessed using the Short Form-12 (SF-12) in coccydynia research. However, SF-12 is a general health-related quality-of-life measure, rather than a condition-specific tool. Additionally, the Numeric Rating Scale (NRS) has long been used for pain assessment, and despite some criticisms, its use alongside additional questions provides valuable insights.
Assessing coccydynia requires the evaluation of pain and its functional impact, along with condition-specific disability questionnaires. The Paris Pain Questionnaire (Functional Impact of Coccydynia Pain Questionnaire) was developed by Jean-Yves Maigne in 2006 as a condition-specific tool. However, its reliability and validity have not been formally established.[6] While it has not been widely used in subsequent studies, it was reintroduced in 2021 by Jean-Yves Maigne and his team in another study on coccydynia assessment. In this study, a modification was made to the original questionnaire by incorporating pain onset during sitting. Unlike other questionnaires, the Paris Pain Questionnaire assesses aspects of pain that impact daily life, including pain while sitting (beyond intensity alone, as measured by NRS), transitioning from sitting to standing (highly specific to coccydynia with radiological findings), walking, nighttime pain (which is common in severe coccydynia), and pain during travel (a key indicator of coccygeal pain sensitivity). However, a formal validation and reliability study for this questionnaire has not been conducted to date.
This study aims to:
Translate the Paris Pain Questionnaire (Functional Impact of Coccydynia Pain Questionnaire) from English to Turkish.
Assess its validity and test-retest reliability (intra-rater reliability) in the Turkish-speaking population.
The Paris Pain Questionnaire was developed by Jean-Yves Maigne and his team and has been used in their clinical research; however, a formal reliability study has never been conducted. Currently, there is no standardized assessment tool specifically designed for coccydynia, and most studies rely on general low back pain measures.
Validating the Paris Pain Questionnaire is crucial for future research on coccydynia, as it provides a condition-specific measure of functional impact and pain severity. This study represents the first attempt to validate and establish the reliability of the Paris Pain Questionnaire, making it a valuable tool for clinicians and researchers. The Turkish validity and reliability study of this questionnaire will allow healthcare providers to use this unique assessment tool in Turkish-speaking patients with coccydynia.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Days
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diagnosed with coccydynia
Key inclusion criteria (4 listed)
- Age: 18 to 65 years
- Diagnosis of coccydynia confirmed through clinical and radiological evaluation
- Ability to read and understand Turkish
- Willingness to participate and provide informed consent
Key exclusion criteria (5 listed)
- Presence of other conditions causing pelvic or rectal pain (e.g., endometriosis, ectopic pregnancy, hemorrhoids, rectal carcinoma)
- Severe psychiatric disorders (e.g., psychosis, major depression within the last 30 days)
- Neurological disorders affecting the pelvic region or lower back
- History of surgery or trauma to the coccygeal area within the past 90 days
- Primary complaints of low back pain rather than coccydynia
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
Internal Consistency (Cronbach's Alpha)
Time frame: Baseline
Internal consistency of the Turkish PPQ will be assessed using Cronbach's alpha.
Test-Retest Reliability (ICC)
Time frame: Baseline and 3-day follow-up
Intraclass correlation coefficient (ICC) will be calculated to assess reliability over time.
2 secondary outcomes
Construct Validity (Pearson Correlation)
Time frame: Baseline
Factor Analysis
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
- Individual participant dataSharing planned: Undecided
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Study Evaluating the Analgesic Efficacy of Capsaicin 8% Patches in Chronic Coccygodynia.
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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. This study is not recruiting at the moment.
Aslinur Keles Ercisli, M. D. principal investigator
Fatih Sultan Mehmet Training and Research Hospital
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 Coccyx Disorder, run by Fatih Sultan Mehmet Training and Research Hospital 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 5 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: finished, as of the sponsor's last update on 5 Mar 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Internal Consistency (Cronbach's Alpha) (time frame: Baseline). The study lists 2 primary outcomes in all. 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 5 Mar 2025.