NCT07089147

Brief Summary

The aim of this study is to investigate the presence of coccydynia (tailbone pain) in women who have given birth and to examine the relationship between the Paris Questionnaire and other relevant assessment tools. The relationship between the Paris questionnaire, the Low Back Outcome Score, and Quality of Life will also be evaluated.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
292

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 28, 2025

Completed
4 days until next milestone

Study Start

First participant enrolled

August 1, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

December 23, 2025

Status Verified

July 1, 2025

Enrollment Period

1 month

First QC Date

July 17, 2025

Last Update Submit

December 22, 2025

Conditions

Keywords

postpartumcoccydyniaparis questionnaire

Outcome Measures

Primary Outcomes (1)

  • Paris Questionnaire

    The Paris questionnaire assesses patients' pain in different positions and consists of five items.This questionnaire exclusively assesses functional aspects and has a maximum score of 10. An increase in the total score indicates greater pain intensity.

    baseline

Secondary Outcomes (2)

  • EuroQool (EQ-5D-3L)

    baseline

  • Low Back Outcome Score

    baseline

Study Arms (1)

females in the postpartum period

The study will include females aged between 18 and 65 years who have not previously received any treatment for coccydynia and who are within a maximum of 2 years postpartum. The study does not involve any intervention. Only a questionnaire will be administered to the females.

Other: questionnaire

Interventions

Paris questionnaire, EuroQool (EQ-5D-3L) Questionnaire, Low Back Outcome Score

females in the postpartum period

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Females who have not previously received any treatment for coccydynia, who are within a maximum of 2 years postpartum, and who voluntarily agree to participate in the study will be included.

You may qualify if:

  • Being between 18 and 65 years of age
  • Having not received any previous treatment for coccydynia
  • Having given birth within the last 2 years at most

You may not qualify if:

  • Those who have undergone surgical intervention on their spine
  • Those with a history of malignancy
  • Those with rectal or gynecological diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kto Karatay University

Konya, Karatay, 42030, Turkey (Türkiye)

Location

Related Publications (2)

  • Peyton FW. Coccygodynia in women. Indiana Med. 1988 Aug;81(8):697-8. No abstract available.

  • Maigne JY, Rusakiewicz F, Diouf M. Postpartum coccydynia: a case series study of 57 women. Eur J Phys Rehabil Med. 2012 Sep;48(3):387-92. Epub 2012 Jul 23.

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Özlem Akkoyun Sert, PhD

    KTO Karatay University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2025

First Posted

July 28, 2025

Study Start

August 1, 2025

Primary Completion

September 1, 2025

Study Completion

October 1, 2025

Last Updated

December 23, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations