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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in Turkey (Türkiye)

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.

Keywords
coccyx, coccydynia, Paris Pain Questionnaire, validation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Internal Consistency (Cronbach's Alpha)

    Internal consistency of the Turkish PPQ will be assessed using Cronbach's alpha.

    Measured: Baseline

  2. 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)
  1. 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

  2. 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.

  1. First posted26 Feb 2025
  2. Study start30 Oct 2024
  3. Primary completion21 Feb 2025
  4. Study completion21 Feb 2025

Resources

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
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

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.

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