PostpartumNCT07089147
Postpartum Coccydynia and the Paris Questionnaire
An observational study of Postpartum and Coccydynia, run by KTO Karatay University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum, Coccydynia
- What is being tested?
- questionnaire
- How many people
- 292 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2025to 1 Oct 2025
- How long will I take part?
- 1 Day
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Those who have undergone surgical intervention on their spine
- Those with a history of malignancy
- Those with rectal or gynecological diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of the Paris Questionnaire in the Assessment of Postpartum Coccydynia: Associations With Quality of Life and Functional Outcomes
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.
Read the detailed description
Females aged between 18 and 65 years who have given birth will be included in the study. The postpartum duration of eligible participants will range from a minimum of 6 weeks to a maximum of 2 years. At the beginning of the survey, participants will be informed about the study and asked to provide their informed consent.
Sociodemographic and clinical data including age, height, body weight, educational level, income status, family type, smoking status, engagement in regular physical activity, presence of chronic diseases, and obstetric history (i.e., most recent mode of delivery, number of pregnancies, number of births) will be recorded. Following this, participants will be asked to complete the Paris Questionnaire, the General Quality of Life Scale, and the Low Back Outcome Score. The relationships among the relevant questionnaires will be analyzed, and the association of the Paris Questionnaire with the other scales will be interpreted.
- Conditions
- Postpartum, Coccydynia
- Being tested
- questionnaire
- Keywords
- postpartum, coccydynia, paris questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaireOther
Paris questionnaire, EuroQool (EQ-5D-3L) Questionnaire, Low Back Outcome Score
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline
Secondary outcomes (2)
EuroQool (EQ-5D-3L)
The General Quality of Life Scale is a tool developed to assess health-related quality of life. It consists of two parts. The first part defines the health profile across five dimensions: mobility, self-care, social life, pain, and psychological status. Each dimension includes three statements reflecting the severity of problems (1 = slight problems, 2 = moderate problems, 3 = severe problems). The second part includes a visual analogue scale, similar to a thermometer, on which respondents rate their current health or pain status on a scale from 0 to 100
Measured: baseline
Low Back Outcome Score
The Low Back Outcome Score is a questionnaire used to evaluate the functional status and outcomes in individuals with low back pain. The Low Back Outcome Score (LBOS) consists of 13 items, each with a different scoring system. Pain is assessed separately. While all other items are scored on a four-point scale, their contributions to the total score vary based on item weightings. Three distinct scoring categories can be identified: items scored on a 9-point scale (pain, employment, domestic and sports activities) can receive 0, 3, 6, or 9 points; items scored on a 6-point scale (rest, treatment or consultation, analgesia, and sexual life) can receive 0, 2, 4, or 6 points; and items scored on a 3-point scale (sleep, walking, sitting, traveling, dressing) can receive 0, 1, 2, or 3 points. The total score is calculated by summing the points of all items and ranges from 0 to 75. Lower scores indicate greater disability.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start1 Aug 2025
- Primary completion1 Sep 2025
- Study completion1 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PostpartumStudies 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
- Prospective
- Enrolment
- 292 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- KTO Karatay University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Özlem Akkoyun Sert, PhD, Study director, KTO Karatay University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07089147
- Sponsor's protocol ID
- 2024/044
- Status last verified
- Jul 2025
- First submitted
- 17 Jul 2025
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Peyton FW. Coccygodynia in women. Indiana Med. 1988 Aug;81(8):697-8. No abstract available.
PubMed 3171154Maigne 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.
PubMed 22820826
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of the Paris Questionnaire in the Assessment of Postpartum Coccydynia: Associations With Quality of Life and Functional Outcomes
- ClinicalTrials.gov ID
- NCT07089147
- Acronym / sponsor ID
- 2024/044
- Conditions
- Postpartum, Coccydynia
- Keywords
- postpartum, coccydynia, paris questionnaire
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 292 participants (actual)
- Lead sponsor
- KTO Karatay UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 1 Oct 2025 (actual)
- First posted
- 28 Jul 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.
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.
Detailed description
Females aged between 18 and 65 years who have given birth will be included in the study. The postpartum duration of eligible participants will range from a minimum of 6 weeks to a maximum of 2 years. At the beginning of the survey, participants will be informed about the study and asked to provide their informed consent.
Sociodemographic and clinical data including age, height, body weight, educational level, income status, family type, smoking status, engagement in regular physical activity, presence of chronic diseases, and obstetric history (i.e., most recent mode of delivery, number of pregnancies, number of births) will be recorded. Following this, participants will be asked to complete the Paris Questionnaire, the General Quality of Life Scale, and the Low Back Outcome Score. The relationships among the relevant questionnaires will be analyzed, and the association of the Paris Questionnaire with the other scales will be interpreted.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| females in the postpartum period | – | Other: questionnaireThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Those who have undergone surgical intervention on their spine
- Those with a history of malignancy
- Those with rectal or gynecological diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnaireParis questionnaire, EuroQool (EQ-5D-3L) Questionnaire, Low Back Outcome Score | Other | females in the postpartum period |
Primary outcome
Paris Questionnaire
Time frame: baseline
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.
2 secondary outcomes
EuroQool (EQ-5D-3L)
Time frame: baseline
Low Back Outcome Score
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 23 Dec 2025.
- Results publication: PubMed 3171154Peyton FW. Coccygodynia in women. Indiana Med. 1988 Aug;81(8):697-8. No abstract available.
- Results publication: PubMed 22820826Maigne 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.
- Individual participant dataSharing planned: No
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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.
Özlem Akkoyun Sert, PhD study director
KTO Karatay University
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 Postpartum and Coccydynia, run by KTO Karatay University 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 3 inclusion and 3 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 23 Dec 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?
Paris Questionnaire (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07089147, which also lists 2 linked publications.
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 23 Dec 2025.