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Surface Topography and Radiographic Spinal Damage in Radiographic Axial Spondyloarthritis

2026年9月28日 更新者：Seyma Alkan、Ankara Etlik City Hospital

Association Between Static Spinal Posture Assessed by Surface Topography (DIERS) and Radiographic Structural Damage (mSASSS) in Radiographic Axial Spondyloarthritis: A Cross-Sectional Study

Radiographic axial spondyloarthritis (r-axSpA) causes progressive structural damage of the spine, conventionally quantified on lateral cervical and lumbar radiographs using the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS). Repeated radiography entails cumulative radiation exposure, substantial inter-reader variability and low sensitivity in early disease. DIERS Formetric 4D surface topography provides radiation-free three-dimensional modelling of the spine and pelvis. The association between sagittal balance and structural damage has been demonstrated with a radiation-based system (EOS), but whether a radiation-free topographic method reflects the same association has not been investigated.

This single-centre, cross-sectional observational study will enrol 53 adults with r-axSpA fulfilling the ASAS criteria with radiographic sacroiliitis according to the modified New York criteria. At a single study visit, static DIERS Formetric 4D measurements, chest expansion, BASMI, BASDAI, BASFI and ASDAS-CRP are obtained. mSASSS is scored by two independent readers, blinded to clinical and topographic data, on existing lateral cervical and lumbar radiographs obtained within the preceding 12 months; no additional radiographs are performed for the study. The primary analysis is the correlation between total mSASSS and the DIERS fleche cervicale (cervical sagittal anterior displacement).

調査の概要

状態

募集

条件

介入・治療

詳細な説明

Design: single-centre, cross-sectional, non-interventional correlation study in a single patient group; no control group. All participant data are collected in one assessment session lasting approximately 45 to 60 minutes.

Measurements: (a) demographic and anthropometric data; (b) disease duration, age at symptom onset, comorbidities, extra-articular involvement (uveitis, inflammatory bowel disease, psoriasis), HLA-B27 status, current medication category; (c) radiographic sacroiliitis grade according to the modified New York criteria and mSASSS (range 0 to 72), scored independently by two blinded readers with inter-reader agreement reported as the intraclass correlation coefficient; (d) chest expansion; (e) BASDAI, BASFI and ASDAS-CRP, the latter using routine C-reactive protein values with no additional blood sampling; (f) BASMI total score and its five components; (g) DIERS Formetric 4D static parameters: fleche cervicale (cervical sagittal anterior displacement, mm), sagittal imbalance (mm and degrees), coronal imbalance (mm), pelvic obliquity (mm), pelvic torsion (degrees), cervical and lumbar depth distance (mm), kyphotic angle (degrees) and lordotic angle (degrees).

Statistical analysis: distribution is assessed with the Shapiro-Wilk test. The primary analysis is a Pearson or Spearman correlation between total mSASSS and fleche cervicale, reported with effect size and 95% confidence interval, followed by multiple linear regression adjusted for age and disease duration. Secondary analyses comprise correlations of DIERS parameters with clinical indices and an exploratory receiver operating characteristic analysis of the ability of DIERS sagittal parameters to predict prespecified mSASSS thresholds. The Benjamini-Hochberg procedure is applied to correct for multiple comparisons. Significance is set at p<0.05. Analyses are performed with IBM SPSS version 23 or later.

Sample size: calculated with G*Power 3.1.9 for a bivariate normal correlation model, two-tailed, rho H0 = 0, expected effect size r = 0.40, alpha = 0.05 and power = 0.85, giving a required sample of 53 participants (actual power 0.857). The effect size was set conservatively at r = 0.40 rather than the r = 0.61 reported by Wanders et al.

(2005) for occiput-to-wall distance versus mSASSS, because DIERS parameters are not identical to clinical mobility measures.

Reporting follows the STROBE statement.

研究の種類

観察的

入学 (推定)

53

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

  • 名前：Seyma Alkan, MD
  • 電話番号：+90 538 337 97 91
  • メール：symalkan@gmail.com

研究連絡先のバックアップ

研究場所

  • トルコ（Türkiye）
    • Yenimahalle
      • Ankara、Yenimahalle、トルコ（Türkiye）、06560
        • 募集
        • Ankara Etlik City Hospital, Department of Physical Medicine and Rehabilitation
        • コンタクト：
          • Seyma Alkan, Medical Doctor
          • 電話番号：+90 5383379791
          • メール：symalkan@gmail.com

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年～65年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

サンプリング方法

非確率サンプル

調査対象母集団

Consecutive patients with radiographic axial spondyloarthritis attending the spondyloarthritis outpatient clinic of the Department of Physical Medicine and Rehabilitation, Ankara Etlik City Hospital.

説明

Inclusion Criteria:

  • Age 18 to 65 years
  • Diagnosis of radiographic axial spondyloarthritis fulfilling the ASAS criteria, confirmed by radiographic sacroiliitis according to the modified New York criteria
  • Able to provide written informed consent and to complete the assessments
  • Available lateral cervical and lumbar radiographs obtained within the 12 months preceding the DIERS measurement

Exclusion Criteria:

  • Neurological disease affecting balance, posture or gait (for example Parkinson disease, amyotrophic lateral sclerosis, cerebellar or vestibular disorders, history of stroke)
  • History of lower extremity joint arthroplasty (hip or knee)
  • Orthopaedic conditions affecting posture, balance or gait (ununited fracture, previous spinal or lower extremity surgery)
  • Advanced cardiopulmonary disease, active infection or malignancy
  • Pregnancy

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 観測モデル：COHORT
  • 時間の展望：CROSS_SECTIONAL

コホートと介入

グループ/コホート
介入・治療
Radiographic axial spondyloarthritis patients

Adults aged 18 to 65 years with radiographic axial spondyloarthritis fulfilling the ASAS classification criteria with radiographic sacroiliitis according to the modified New York criteria, attending the spondyloarthritis outpatient clinic. All participants undergo a single assessment session including static DIERS Formetric 4D surface topography, clinical indices (BASDAI, BASFI, BASMI, ASDAS-CRP) and chest expansion. mSASSS is scored on existing lateral cervical and lumbar radiographs obtained within the preceding 12 months; no additional radiographs are taken.
診断テスト：DIERS Formetric 4D surface topography

Radiation-free three-dimensional assessment of spinal and pelvic surface topography performed once in standing position. No radiation, no contact, no intervention on treatment.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Correlation between total mSASSS and DIERS fleche cervicale
時間枠：Single assessment session (Day 1); mSASSS scored on radiographs obtained within the 12 months preceding the assessment

Total modified Stoke Ankylosing Spondylitis Spine Score (mSASSS; range 0 to 72, higher scores indicate greater structural damage), calculated as the mean of two independent blinded readers, correlated with fleche cervicale (cervical sagittal anterior displacement, mm) measured by DIERS Formetric 4D surface topography. Reported as a correlation coefficient with magnitude, direction and 95% confidence interval.
Single assessment session (Day 1); mSASSS scored on radiographs obtained within the 12 months preceding the assessment

二次結果の測定

結果測定
メジャーの説明
時間枠
Correlation between total mSASSS and other DIERS Formetric static parameters
時間枠：Single assessment session (Day 1); mSASSS scored on radiographs obtained within the 12 months preceding the assessment

Total mSASSS (range 0 to 72, higher scores indicate greater structural damage) correlated with the remaining DIERS Formetric 4D static parameters: sagittal imbalance (mm and degrees), coronal imbalance (mm), pelvic obliquity (mm), pelvic torsion (degrees), cervical depth distance (mm), lumbar depth distance (mm), kyphotic angle (degrees) and lordotic angle (degrees). Reported as correlation coefficients with 95% confidence intervals.
Single assessment session (Day 1); mSASSS scored on radiographs obtained within the 12 months preceding the assessment
Correlation between DIERS sagittal parameters and BASDAI
時間枠：Single assessment session (Day 1)

Bath Ankylosing Spondylitis Disease Activity Index (range 0 to 10, higher scores indicate greater disease activity) correlated with DIERS sagittal parameters.
Single assessment session (Day 1)
Correlation between DIERS sagittal parameters and BASFI
時間枠：Single assessment session (Day 1)

Bath Ankylosing Spondylitis Functional Index (range 0 to 10, higher scores indicate worse physical function) correlated with DIERS Formetric 4D static parameters: fleche cervicale (mm), sagittal imbalance (mm and degrees), coronal imbalance (mm), pelvic obliquity (mm), pelvic torsion (degrees), cervical and lumbar depth distance (mm), kyphotic angle (degrees) and lordotic angle (degrees).
Single assessment session (Day 1)
Correlation between DIERS sagittal parameters and BASMI
時間枠：Single assessment session (Day 1)

Bath Ankylosing Spondylitis Metrology Index (range 0 to 10, higher scores indicate worse spinal mobility) correlated with DIERS Formetric 4D static parameters: fleche cervicale (mm), sagittal imbalance (mm and degrees), coronal imbalance (mm), pelvic obliquity (mm), pelvic torsion (degrees), cervical and lumbar depth distance (mm), kyphotic angle (degrees) and lordotic angle (degrees).
Single assessment session (Day 1)
Correlation between DIERS sagittal parameters and ASDAS-CRP
時間枠：Single assessment session (Day 1)

Ankylosing Spondylitis Disease Activity Score with C-reactive protein (higher scores indicate greater disease activity) correlated with DIERS Formetric 4D static parameters: fleche cervicale (mm), sagittal imbalance (mm and degrees), coronal imbalance (mm), pelvic obliquity (mm), pelvic torsion (degrees), cervical and lumbar depth distance (mm), kyphotic angle (degrees) and lordotic angle (degrees).
Single assessment session (Day 1)
Correlation between DIERS sagittal parameters and chest expansion
時間枠：Single assessment session (Day 1)

Chest expansion measured in centimetres correlated with DIERS Formetric 4D static parameters: fleche cervicale (mm), sagittal imbalance (mm and degrees), coronal imbalance (mm), pelvic obliquity (mm), pelvic torsion (degrees), cervical and lumbar depth distance (mm), kyphotic angle (degrees) and lordotic angle (degrees).
Single assessment session (Day 1)
Discriminative performance of DIERS sagittal parameters for mSASSS thresholds
時間枠：Single assessment session (Day 1); mSASSS scored on radiographs obtained within the 12 months preceding the assessment

Exploratory receiver operating characteristic analysis of DIERS Formetric 4D sagittal parameters for discriminating prespecified total mSASSS thresholds. Reported as area under the curve with 95% confidence interval, sensitivity and specificity.
Single assessment session (Day 1); mSASSS scored on radiographs obtained within the 12 months preceding the assessment

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Ankara Etlik City Hospital

捜査官

  • 主任研究者：Ajda Bal、Professor of Physical Medicine and Rehabilitation

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

便利なリンク

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年9月19日

一次修了 (推定)

2027年6月20日

研究の完了 (推定)

2027年8月20日

試験登録日

最初に提出

2026年9月28日

QC基準を満たした最初の提出物

2026年9月28日

最初の投稿 (実際)

2026年10月2日

学習記録の更新

投稿された最後の更新 (実際)

2026年10月2日

QC基準を満たした最後の更新が送信されました

2026年9月28日

最終確認日

2026年9月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • AEŞH-BADEK1-2026-048

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

Individual participant data will not be shared. According to the approved protocol, research data are accessible only to the investigators. Aggregate results will be published.

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米国FDA規制機器製品の研究

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