- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07076927
- Original Trial
Sagittal Spinopelvic and Coccygeal Alignment in Sitting and Standing Positions in Coccydynia (Coccydynia)
Sagittal Radiographic Analysis of Spinopelvic and Coccygeal Alignment in Sitting and Standing Positions in Patients With Coccydynia
Study Overview
Status
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Istanbul, Turkey, 34752
- Fatih Sultan Mehmet Training and Research Hospital
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İstanbul, Turkey, 34098
- Fatih Sultan Mehmet Training and Research Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
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.
Description
Inclusion Criteria:
Patients aged between 25 and 65 years
Clinically diagnosed with coccydynia
Provided informed consent to participate in the study
Exclusion Criteria:
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Coccydynia
Coccydynia patients
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Sacral Slope (SS)
Time Frame: At baseline (single time point)
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Sacral slope will be measured on standardized lateral radiographs in both standing and sitting positions.
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At baseline (single time point)
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Pelvic Tilt (PT)
Time Frame: At baseline (single time point)
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Pelvic tilt will be measured on sagittal radiographs in both standing and sitting positions.
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At baseline (single time point)
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Pelvic Incidence (PI)
Time Frame: At baseline (single time point)
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Pelvic Incidence will be measured on sagittal radiographs in both standing and sitting positions.
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At baseline (single time point)
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Spinosacral Angle (SSA)
Time Frame: At baseline (single time point)
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Spinosacral Angle will be measured on sagittal radiographs in both standing and sitting positions.
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At baseline (single time point)
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Sacral Kyphosis (SK)
Time Frame: At baseline (single time point)
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Sacral Kyphosis will be measured on sagittal radiographs in both standing and sitting positions.
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At baseline (single time point)
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Sacral Table Angle (STA)
Time Frame: At baseline (single time point)
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Sacral Table Angle will be measured on sagittal radiographs in both standing and sitting positions.
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At baseline (single time point)
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Thoracic Kyphosis (TK)
Time Frame: At baseline (single time point)
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Thoracic Kyphosis will be measured on sagittal radiographs in both standing and sitting positions.
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At baseline (single time point)
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Lumbar Lordosis (LL)
Time Frame: At baseline (single time point)
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Lumbar Lordosis will be measured on sagittal radiographs in both standing and sitting positions.
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At baseline (single time point)
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Sagittal Vertical Axis (SVA)
Time Frame: At baseline (single time point)
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Sagittal Vertical Axis will be measured on sagittal radiographs in both standing and sitting positions.
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At baseline (single time point)
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Thoracolumbar Angle (TPA-T1PA)
Time Frame: At baseline (single time point)
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Thoracolumbar Angle will be measured on sagittal radiographs in both standing and sitting positions.
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At baseline (single time point)
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Coccygeal Morphology- Vertebral Segment Number
Time Frame: At baseline (single time point)
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Coccygeal features will be evaluated
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At baseline (single time point)
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Coccygeal Morphology- sacrococcygeal joint fusion
Time Frame: At baseline (single time point)
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Coccygeal features will be evaluated
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At baseline (single time point)
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Coccygeal Morphology- intercoccygeal joint fusion
Time Frame: At baseline (single time point)
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Coccygeal features will be evaluated
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At baseline (single time point)
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Coccygeal Morphology- segmental angulation
Time Frame: At baseline (single time point)
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Coccygeal features will be evaluated
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At baseline (single time point)
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Coccygeal Morphology- presence of coccygeal spicules
Time Frame: At baseline (single time point)
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Coccygeal features will be evaluated
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At baseline (single time point)
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Coccygeal Morphometry Type
Time Frame: At baseline (single time point)
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Classification (Type 1-5)
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At baseline (single time point)
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Coccygeal Mobility
Time Frame: At baseline (single time point)
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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.
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At baseline (single time point)
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Sacrococcygeal Angle (SKA)
Time Frame: At baseline (single time point)
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SKA will be measured using the angle between the sacral axis and first coccygeal segment on lateral radiographs.
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At baseline (single time point)
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Intercoccygeal Angle (IKA)
Time Frame: At baseline (single time point)
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IKA will be measured as the angle between coccygeal segments
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At baseline (single time point)
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Coccygeal Height (KY)
Time Frame: At baseline (single time point)
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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)
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Sacral Height (SY)
Time Frame: At baseline (single time point)
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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)
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Sacrococcygeal Height (SKY)
Time Frame: At baseline (single time point)
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Combined vertical height from sacral promontory to coccyx.
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At baseline (single time point)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Clinical Assessment- Pain severity
Time Frame: At baseline (single time point)
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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.
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At baseline (single time point)
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Clinical Assessment - Quality of Life (SF-12)
Time Frame: At baseline (single time point)
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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).
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At baseline (single time point)
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Clinical Assessment - Disability - Oswestry Disability Index (ODI) Score
Time Frame: At baseline (single time point)
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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. |
At baseline (single time point)
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Collaborators and Investigators
Investigators
- Principal Investigator: Aslinur Keles, MD., PhD, Fatih Sultan Mehmet Training and Research Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2024/4-4/6
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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