NCT07076927

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2024

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2025

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

June 3, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 22, 2025

Completed
Last Updated

July 22, 2025

Status Verified

July 1, 2025

Enrollment Period

5 months

First QC Date

June 3, 2025

Last Update Submit

July 19, 2025

Conditions

Keywords

Coccygeal morphometryspinopelvic morphometryos coccygissagittal planecoccydynia

Outcome Measures

Primary Outcomes (22)

  • Sacral Slope (SS)

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

    At baseline (single time point)

  • Pelvic Tilt (PT)

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

    At baseline (single time point)

  • Pelvic Incidence (PI)

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

    At baseline (single time point)

  • Spinosacral Angle (SSA)

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

    At baseline (single time point)

  • Sacral Kyphosis (SK)

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

    At baseline (single time point)

  • Sacral Table Angle (STA)

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

    At baseline (single time point)

  • Thoracic Kyphosis (TK)

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

    At baseline (single time point)

  • Lumbar Lordosis (LL)

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

    At baseline (single time point)

  • Sagittal Vertical Axis (SVA)

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

    At baseline (single time point)

  • Thoracolumbar Angle (TPA-T1PA)

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

    At baseline (single time point)

  • Coccygeal Morphology- Vertebral Segment Number

    Coccygeal features will be evaluated

    At baseline (single time point)

  • Coccygeal Morphology- sacrococcygeal joint fusion

    Coccygeal features will be evaluated

    At baseline (single time point)

  • Coccygeal Morphology- intercoccygeal joint fusion

    Coccygeal features will be evaluated

    At baseline (single time point)

  • Coccygeal Morphology- segmental angulation

    Coccygeal features will be evaluated

    At baseline (single time point)

  • Coccygeal Morphology- presence of coccygeal spicules

    Coccygeal features will be evaluated

    At baseline (single time point)

  • Coccygeal Morphometry Type

    Classification (Type 1-5)

    At baseline (single time point)

  • 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.

    At baseline (single time point)

  • Sacrococcygeal Angle (SKA)

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

    At baseline (single time point)

  • Intercoccygeal Angle (IKA)

    IKA will be measured as the angle between coccygeal segments

    At baseline (single time point)

  • 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.

    At baseline (single time point)

  • 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.

    At baseline (single time point)

  • Sacrococcygeal Height (SKY)

    Combined vertical height from sacral promontory to coccyx.

    At baseline (single time point)

Secondary Outcomes (3)

  • Clinical Assessment- Pain severity

    At baseline (single time point)

  • Clinical Assessment - Quality of Life (SF-12)

    At baseline (single time point)

  • Clinical Assessment - Disability - Oswestry Disability Index (ODI) Score

    At baseline (single time point)

Study Arms (1)

Coccydynia

Coccydynia patients

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Fatih Sultan Mehmet Training and Research Hospital

Istanbul, 34098, Turkey (Türkiye)

Location

Fatih Sultan Mehmet Training and Research Hospital

Istanbul, 34752, Turkey (Türkiye)

Location

Study Officials

  • Aslinur Keles, MD., PhD

    Fatih Sultan Mehmet Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 3, 2025

First Posted

July 22, 2025

Study Start

August 1, 2024

Primary Completion

January 10, 2025

Study Completion

May 25, 2025

Last Updated

July 22, 2025

Record last verified: 2025-07

Locations