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CoccydyniaCoccydyniaNCT07076927

Sagittal Spinopelvic and Coccygeal Alignment in Sitting and Standing Positions in Coccydynia

An observational study of Coccydynia and Sagittal Balance, run by Fatih Sultan Mehmet Training and Research Hospital at 2 sites 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 observational cross-sectional study aims to investigate the differences in spinopelvic and coccygeal morphometric parameters in standing and sitting positions among patients diagnosed with coccydynia. Read more about this study

Who is it for?
Ages 25 to 65 years
How many people
50 participants
Where
2 sitesTurkey (Türkiye)
Study dates
1 Aug 2024to 25 May 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 25 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: patients aged 25 to 65 years who presented to the University of Health Sciences Fatih Sultan Mehmet Training and Research Hospital with a preliminary diagnosis of coccydynia and were clinically confirmed were consecutively enrolled. Patients with a history of spinal trauma, surgery, congenital deformities, malignancy, or rheumatological disease were excluded.

Who may be able to join

  • Patients aged between 25 and 65 years
  • Clinically diagnosed with coccydynia
  • Provided informed consent to participate in the study

Who cannot join

  • Presence of any disease that may cause spinal malalignment
  • Any hip- or knee-related condition that may lead to spinal malalignment
  • History of surgery involving the cervical, thoracic, lumbar, or coccygeal spine

Trial locations and contacts

2 sites in 1 country.

Turkey (Türkiye)2 sites
  • Fatih Sultan Mehmet Training and Research Hospital

    Istanbul, 34098

  • Fatih Sultan Mehmet Training and Research Hospital

    Istanbul, 34752

Other trials in Turkey (Türkiye)

About this study

Official title: Sagittal Radiographic Analysis of Spinopelvic and Coccygeal Alignment in Sitting and Standing Positions in Patients With Coccydynia

This observational cross-sectional study aims to investigate the differences in spinopelvic and coccygeal morphometric parameters in standing and sitting positions among patients diagnosed with coccydynia. A total of 50 adult patients (aged 25-65 years) diagnosed with coccydynia based on clinical evaluation and imaging findings were included. Lateral radiographs were obtained in both standing and sitting positions. Radiological assessments included spinopelvic parameters such as sacral slope (SS), pelvic tilt (PT), pelvic incidence (PI), sacral table angle (STA), and sacral kyphosis (SK), along with coccygeal morphology based on the Postacchini-Massobrio classification. The study further aimed to explore whether these morphometric differences are associated with the presence of low back pain and to assess variations across different coccygeal morphology types.

Read the detailed description

Coccydynia is a condition characterized by pain in the coccygeal region, often exacerbated by sitting and postural changes. While its etiology is multifactorial, anatomical variations in coccygeal and spinopelvic alignment may play a significant role in symptom development. Despite increasing attention to coccygeal mobility and morphology in radiological evaluations, the relationship between coccygeal type, spinopelvic alignment, and posture-specific morphometric changes has not been fully clarified.

This observational cross-sectional study was designed to evaluate morphometric parameters of the sacropelvic and coccygeal regions in both standing and sitting positions in patients diagnosed with coccydynia. The study included 50 adult patients (42 female, 8 male) aged between 25 and 65 years who were diagnosed with coccydynia based on clinical findings and radiological confirmation. Lateral radiographs were obtained in both weight-bearing and seated positions to allow for comparative measurement.

The following radiological parameters were assessed: thoracic kyphosis (TK), lumbar lordosis (LL), sagittal vertical axis (SVA), thoracopelvic angle and its modification (TPA-T1PA), sacral slope (SE), pelvic incidence (PI), pelvic tilt (PT), spinosacral angle (SSA), sacral table angle (STA), and sacral kyphosis (SK). Coccygeal features were evaluated based on vertebral segment number, sacrococcygeal and intercoccygeal joint fusion, segmental angulation, and mobility status. Morphological types were categorized using the modified Postacchini-Massobrio classification. The presence of coccygeal spicules and their frequency across types were recorded. Dynamic morphometric assessments included sacrococcygeal angle (SKA), intercoccygeal angle (IKA), coccygeal height (KY), sacral height (SY), and sacrococcygeal height (SKY). Mobility was determined by comparing the angular displacement between standing and sitting radiographs and classified as normal, hypermobile, hypomobile, or posterior luxation, depending on the flexion-extension response and translation under load.The study aimed to investigate the changes in these parameters between postures and explore whether these variations are associated with the presence of low back pain and functional impairment. Additionally, differences among coccygeal morphology subgroups in terms of spinopelvic parameters were analyzed.

Keywords
Coccygeal morphometry, spinopelvic morphometry, os coccygis, sagittal plane, coccydynia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07076927
Study groupRoleWhat they receive
CoccydyniaCoccydynia patients

What is being measured

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

  1. Sacral Slope (SS)

    Sacral slope will be measured on standardized lateral radiographs in both standing and sitting positions.

    Measured: At baseline (single time point)

  2. Pelvic Tilt (PT)

    Pelvic tilt will be measured on sagittal radiographs in both standing and sitting positions.

    Measured: At baseline (single time point)

  3. Pelvic Incidence (PI)

    Pelvic Incidence will be measured on sagittal radiographs in both standing and sitting positions.

    Measured: At baseline (single time point)

  4. Spinosacral Angle (SSA)

    Spinosacral Angle will be measured on sagittal radiographs in both standing and sitting positions.

    Measured: At baseline (single time point)

  5. Sacral Kyphosis (SK)

    Sacral Kyphosis will be measured on sagittal radiographs in both standing and sitting positions.

    Measured: At baseline (single time point)

  6. Sacral Table Angle (STA)

    Sacral Table Angle will be measured on sagittal radiographs in both standing and sitting positions.

    Measured: At baseline (single time point)

  7. Thoracic Kyphosis (TK)

    Thoracic Kyphosis will be measured on sagittal radiographs in both standing and sitting positions.

    Measured: At baseline (single time point)

  8. Lumbar Lordosis (LL)

    Lumbar Lordosis will be measured on sagittal radiographs in both standing and sitting positions.

    Measured: At baseline (single time point)

  9. Sagittal Vertical Axis (SVA)

    Sagittal Vertical Axis will be measured on sagittal radiographs in both standing and sitting positions.

    Measured: At baseline (single time point)

  10. Thoracolumbar Angle (TPA-T1PA)

    Thoracolumbar Angle will be measured on sagittal radiographs in both standing and sitting positions.

    Measured: At baseline (single time point)

  11. Coccygeal Morphology- Vertebral Segment Number

    Coccygeal features will be evaluated

    Measured: At baseline (single time point)

  12. Coccygeal Morphology- sacrococcygeal joint fusion

    Coccygeal features will be evaluated

    Measured: At baseline (single time point)

  13. Coccygeal Morphology- intercoccygeal joint fusion

    Coccygeal features will be evaluated

    Measured: At baseline (single time point)

  14. Coccygeal Morphology- segmental angulation

    Coccygeal features will be evaluated

    Measured: At baseline (single time point)

  15. Coccygeal Morphology- presence of coccygeal spicules

    Coccygeal features will be evaluated

    Measured: At baseline (single time point)

  16. Coccygeal Morphometry Type

    Classification (Type 1-5)

    Measured: At baseline (single time point)

  17. Coccygeal Mobility

    Coccygeal mobility will be assessed by measuring the angular difference of the coccyx between the standing and sitting positions on lateral radiographs. The change in coccygeal angle reflects the degree of coccygeal movement during postural transition.

    Measured: At baseline (single time point)

  18. Sacrococcygeal Angle (SKA)

    SKA will be measured using the angle between the sacral axis and first coccygeal segment on lateral radiographs.

    Measured: At baseline (single time point)

  19. Intercoccygeal Angle (IKA)

    IKA will be measured as the angle between coccygeal segments

    Measured: At baseline (single time point)

  20. Coccygeal Height (KY)

    The vertical height of the coccyx from the tip to the base will be measured in the sagittal plane.

    ertical height of the coccyx from the tip to the base will be measured in the sagittal plane.

    Vertical height of the coccyx from the tip to the base will be measured in the sagittal plane.

    Measured: At baseline (single time point)

  21. Sacral Height (SY)

    Vertical sacral height will be assessed from the superior to the inferior sacral end on the lateral radiograph.

    ertical height of the coccyx from the tip to the base will be measured in the sagittal plane.

    Vertical height of the coccyx from the tip to the base will be measured in the sagittal plane.

    Measured: At baseline (single time point)

  22. Sacrococcygeal Height (SKY)

    Combined vertical height from sacral promontory to coccyx.

    Measured: At baseline (single time point)

Secondary outcomes (3)
  1. Clinical Assessment- Pain severity

    Unit of Measure: Units on a Numeric Rating Scale (0-10) Description: Pain severity will be assessed using the Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst imaginable pain.

    Measured: At baseline (single time point)

  2. Clinical Assessment - Quality of Life (SF-12)

    Unit of Measure: SF-12 Score (0-100) Description: General health-related quality of life will be evaluated using the 12-Item Short Form Survey (SF-12).

    Measured: At baseline (single time point)

  3. Clinical Assessment - Disability - Oswestry Disability Index (ODI) Score

    Unit of Measure: Score (0-100)

    Description:

    Functional disability related to low back pain will be assessed using the Oswestry Disability Index (ODI). The ODI is a validated questionnaire consisting of 10 sections, each scored from 0 to 5. The total score is converted to a percentage, with higher scores indicating greater disability.

    Measured: At baseline (single time point)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2025
  2. Study start1 Aug 2024
  3. Primary completion10 Jan 2025
  4. Study completion25 May 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
Cohort
Time perspective
Cross-sectional
Enrolment
50 participants (actual)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT07076927
Sponsor's protocol ID
2024/4-4/6
Acronym
Coccydynia
Status last verified
Jul 2025
First submitted
3 Jun 2025
Last updated
22 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Coccydynia and Sagittal Balance, run by Fatih Sultan Mehmet Training and Research Hospital at 2 sites 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 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Sacral Slope (SS) (time frame: At baseline (single time point)). The study lists 22 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 22 Jul 2025.

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