Validation of the Paris (Functional Coccydynia Effect) Pain Questionnaire

NCT06848062 | Completed

• 1 other identifier: 2024/12-12/39
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coccydynia; Coccyx Disorder; Coccyx Injury

Keywords

coccyx; coccydynia; Paris Pain Questionnaire; validation

Outcome Measures

Primary Outcomes (2)

• Internal Consistency (Cronbach's Alpha)

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

  Baseline

• Test-Retest Reliability (ICC)

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

  Baseline and 3-day follow-up

Secondary Outcomes (2)

• Construct Validity (Pearson Correlation)

  Baseline

• Factor Analysis

  Baseline

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Diagnosed with coccydynia

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fatih Sultan Mehmet Training and Research Hospital: lead

Study Sites (1)

Fatih Sultan Mehmet Training and Research Hospital

Istanbul, 34098, Turkey (Türkiye)

Location

Study Officials

• Aslinur Keles Ercisli, M. D.

  Fatih Sultan Mehmet Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 2 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 21, 2025
• First Posted: February 26, 2025
• Study Start: October 30, 2024
• Primary Completion: February 21, 2025
• Study Completion: February 21, 2025
• Last Updated: March 5, 2025

Record last verified: 2025-03

Locations

TU (1)