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).
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
- Conditions the study is for
- Coccydynia, Sagittal Balance, Morphological Analysis and Classification
- 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
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 group | Role | What they receive |
|---|---|---|
| Coccydynia | Coccydynia patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sacral Slope (SS)
Sacral slope will be measured on standardized lateral radiographs in both standing and sitting positions.
Measured: At baseline (single time point)
Pelvic Tilt (PT)
Pelvic tilt will be measured on sagittal radiographs in both standing and sitting positions.
Measured: At baseline (single time point)
Pelvic Incidence (PI)
Pelvic Incidence will be measured on sagittal radiographs in both standing and sitting positions.
Measured: At baseline (single time point)
Spinosacral Angle (SSA)
Spinosacral Angle will be measured on sagittal radiographs in both standing and sitting positions.
Measured: At baseline (single time point)
Sacral Kyphosis (SK)
Sacral Kyphosis will be measured on sagittal radiographs in both standing and sitting positions.
Measured: At baseline (single time point)
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)
Thoracic Kyphosis (TK)
Thoracic Kyphosis will be measured on sagittal radiographs in both standing and sitting positions.
Measured: At baseline (single time point)
Lumbar Lordosis (LL)
Lumbar Lordosis will be measured on sagittal radiographs in both standing and sitting positions.
Measured: At baseline (single time point)
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)
Thoracolumbar Angle (TPA-T1PA)
Thoracolumbar Angle will be measured on sagittal radiographs in both standing and sitting positions.
Measured: At baseline (single time point)
Coccygeal Morphology- Vertebral Segment Number
Coccygeal features will be evaluated
Measured: At baseline (single time point)
Coccygeal Morphology- sacrococcygeal joint fusion
Coccygeal features will be evaluated
Measured: At baseline (single time point)
Coccygeal Morphology- intercoccygeal joint fusion
Coccygeal features will be evaluated
Measured: At baseline (single time point)
Coccygeal Morphology- segmental angulation
Coccygeal features will be evaluated
Measured: At baseline (single time point)
Coccygeal Morphology- presence of coccygeal spicules
Coccygeal features will be evaluated
Measured: At baseline (single time point)
Coccygeal Morphometry Type
Classification (Type 1-5)
Measured: 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.
Measured: 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.
Measured: At baseline (single time point)
Intercoccygeal Angle (IKA)
IKA will be measured as the angle between coccygeal segments
Measured: 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.
Measured: 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.
Measured: At baseline (single time point)
Sacrococcygeal Height (SKY)
Combined vertical height from sacral promontory to coccyx.
Measured: At baseline (single time point)
Secondary outcomes (3)
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)
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)
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.
- First posted22 Jul 2025
- Study start1 Aug 2024
- Primary completion10 Jan 2025
- Study completion25 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoccydyniaStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Fatih Sultan Mehmet Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aslinur Keles Ercisli, MD, PhD, Fatih Sultan Mehmet Training and Research Hospital
- Investigators
- Aslinur Keles, MD., PhD, Principal investigator, Fatih Sultan Mehmet Training and Research Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sagittal Radiographic Analysis of Spinopelvic and Coccygeal Alignment in Sitting and Standing Positions in Patients With Coccydynia
- ClinicalTrials.gov ID
- NCT07076927
- Acronym / sponsor ID
- Coccydynia / 2024/4-4/6
- Keywords
- Coccygeal morphometry, spinopelvic morphometry, os coccygis, sagittal plane, coccydynia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Fatih Sultan Mehmet Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 10 Jan 2025 (actual)
- Study completion
- 25 May 2025 (actual)
- First posted
- 22 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.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Coccydynia | – | –Coccydynia patients |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (3 listed)
- Patients aged between 25 and 65 years
- Clinically diagnosed with coccydynia
- Provided informed consent to participate in the study
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sacral Slope (SS)
Time frame: At baseline (single time point)
Sacral slope will be measured on standardized lateral radiographs in both standing and sitting positions.
Pelvic Tilt (PT)
Time frame: At baseline (single time point)
Pelvic tilt will be measured on sagittal radiographs in both standing and sitting positions.
Pelvic Incidence (PI)
Time frame: At baseline (single time point)
Pelvic Incidence will be measured on sagittal radiographs in both standing and sitting positions.
Spinosacral Angle (SSA)
Time frame: At baseline (single time point)
Spinosacral Angle will be measured on sagittal radiographs in both standing and sitting positions.
Sacral Kyphosis (SK)
Time frame: At baseline (single time point)
Sacral Kyphosis will be measured on sagittal radiographs in both standing and sitting positions.
Sacral Table Angle (STA)
Time frame: At baseline (single time point)
Sacral Table Angle will be measured on sagittal radiographs in both standing and sitting positions.
Thoracic Kyphosis (TK)
Time frame: At baseline (single time point)
Thoracic Kyphosis will be measured on sagittal radiographs in both standing and sitting positions.
Lumbar Lordosis (LL)
Time frame: At baseline (single time point)
Lumbar Lordosis will be measured on sagittal radiographs in both standing and sitting positions.
Sagittal Vertical Axis (SVA)
Time frame: At baseline (single time point)
Sagittal Vertical Axis will be measured on sagittal radiographs in both standing and sitting positions.
Thoracolumbar Angle (TPA-T1PA)
Time frame: At baseline (single time point)
Thoracolumbar Angle will be measured on sagittal radiographs in both standing and sitting positions.
Coccygeal Morphology- Vertebral Segment Number
Time frame: At baseline (single time point)
Coccygeal features will be evaluated
Coccygeal Morphology- sacrococcygeal joint fusion
Time frame: At baseline (single time point)
Coccygeal features will be evaluated
Coccygeal Morphology- intercoccygeal joint fusion
Time frame: At baseline (single time point)
Coccygeal features will be evaluated
Coccygeal Morphology- segmental angulation
Time frame: At baseline (single time point)
Coccygeal features will be evaluated
Coccygeal Morphology- presence of coccygeal spicules
Time frame: At baseline (single time point)
Coccygeal features will be evaluated
Coccygeal Morphometry Type
Time frame: At baseline (single time point)
Classification (Type 1-5)
Coccygeal Mobility
Time frame: At baseline (single time point)
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.
Sacrococcygeal Angle (SKA)
Time frame: At baseline (single time point)
SKA will be measured using the angle between the sacral axis and first coccygeal segment on lateral radiographs.
Intercoccygeal Angle (IKA)
Time frame: At baseline (single time point)
IKA will be measured as the angle between coccygeal segments
Coccygeal Height (KY)
Time frame: At baseline (single time point)
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.
Sacral Height (SY)
Time frame: At baseline (single time point)
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.
Sacrococcygeal Height (SKY)
Time frame: At baseline (single time point)
Combined vertical height from sacral promontory to coccyx.
3 secondary outcomes
Clinical Assessment- Pain severity
Time frame: At baseline (single time point)
Clinical Assessment - Quality of Life (SF-12)
Time frame: At baseline (single time point)
Clinical Assessment - Disability - Oswestry Disability Index (ODI) Score
Time frame: At baseline (single time point)
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 22 Jul 2025.
- Individual participant dataSharing planned: Undecided. undecided
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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.
Aslinur Keles, MD., PhD principal investigator
Fatih Sultan Mehmet Training and Research Hospital
2 sites in 1 country: see every site and its status.
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.