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CompletedNCT06848062CoccydyniaUpdated Mar 5, 2025

Validation of the Paris (Functional Coccydynia Effect) Pain Questionnaire

An observational study in Coccydynia, Coccyx Disorder and Coccyx Injury, sponsored by Fatih Sultan Mehmet Training and Research Hospital. Completed at 1 site in Turkey. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-03-05.

Sponsored by Fatih Sultan Mehmet Training and Research Hospital · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
105
Ages
18 Years to 65 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Coccydynia
  • Coccyx Disorder
  • Coccyx Injury

Keywords

  • coccyx
  • coccydynia
  • Paris Pain Questionnaire
  • validation
03

In context

Lead sponsor

Fatih Sultan Mehmet Training and Research Hospital is the lead sponsor of 118 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Diagnosed with coccydynia

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
105 participants (actual)
Target follow-up
2 Days
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. Internal Consistency (Cronbach's Alpha)

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

    Time frame: Baseline

  2. Test-Retest Reliability (ICC)

    Intraclass correlation coefficient (ICC) will be calculated to assess reliability over time.

    Time frame: Baseline and 3-day follow-up

Secondary outcomes

  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).

    Time frame: Baseline

  2. Factor Analysis

    Exploratory factor analysis will be conducted to evaluate the structural validity of the Turkish PPQ

    Time frame: Baseline

07

Study locations

1 site
  • Fatih Sultan Mehmet Training and Research Hospital
    İstanbul, 34098, Turkey
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06848062
Lead sponsor
Fatih Sultan Mehmet Training and Research Hospital
Responsible party
Aslinur Keles Ercisli, MD (Principal investigator, Fatih Sultan Mehmet Training and Research Hospital) — Principal investigator
First posted
Feb 26, 2025
Start date
Oct 30, 2024
Primary completion
Feb 21, 2025
Completion
Feb 21, 2025
Last update
Mar 5, 2025

Study contacts

Aslinur Keles Ercisli, M. D.
principal investigator · Fatih Sultan Mehmet Training and Research Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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