Association of Subcutaneous Fat Index, Paraspinal Muscle Characteristics, and Facet Morphology With Lumbar Facet Joint Degeneration
Subkutan Yağ İndeksi, Paraspinal Kas Özellikleri ve Faset Morfolojisinin Lomber Faset Eklem Dejenerasyonu Ile İlişkisi: Disk Dejenerasyonunun Olası Aracılık Rolü
This prospective observational study aims to investigate the association between subcutaneous fat index, paraspinal muscle characteristics, facet morphology, and lumbar facet joint degeneration in adults with chronic low back pain. The study will use lumbar magnetic resonance imaging (MRI) obtained as part of routine clinical care. The study will evaluate whether subcutaneous fat index is associated with moderate-to-severe lumbar facet joint degeneration and will also examine the relationships of disc degeneration, facet morphology, paraspinal muscle characteristics, and pain severity with facet joint degeneration.
調査の概要
詳細な説明
This is a prospective, non-interventional observational clinical study conducted in patients with chronic low back pain. Participants will be adults aged 18 to 75 years who present to the Algology outpatient clinic of Marmara University Pendik Training and Research Hospital and who have a clinical indication for lumbar MRI as part of routine patient care, independent of study participation.
No additional MRI examinations, radiation exposure, medication administration, injections, or invasive procedures will be performed for research purposes. Participation in the study will not alter the patients' routine diagnostic, treatment, or follow-up procedures.
Demographic and clinical characteristics, including age, sex, height, weight, body mass index, smoking status, diabetes mellitus, hypertension, duration and severity of low back pain, and the presence of leg or radicular pain, will be recorded. Pain severity will be assessed using the Numeric Rating Scale.
Lumbar MRI images obtained during routine clinical care will be evaluated for subcutaneous fat index, intervertebral disc degeneration, facet joint degeneration, facet joint angle and tropism, paraspinal muscle cross-sectional area and fat infiltration, and Modic changes. Subcutaneous fat index will be measured at the L1-L2 level. Intervertebral disc degeneration will be assessed using the Pfirrmann classification, while facet joint degeneration will be assessed using the Weishaupt classification. Facet tropism will be calculated as the absolute difference between the right and left facet joint angles. Paraspinal muscle measurements will be performed at the L3-L4, L4-L5, and L5-S1 levels for the multifidus and erector spinae muscles.
The primary objective is to evaluate the association between subcutaneous fat index and moderate-to-severe lumbar facet joint degeneration. Secondary objectives include evaluating the relationships between subcutaneous fat index and total disc degeneration, disc degeneration and facet joint degeneration, facet morphology and facet joint degeneration, paraspinal muscle characteristics and disc or facet joint degeneration, and subcutaneous fat index and pain severity. An exploratory mediation analysis will also assess the potential mediating role of disc degeneration in the relationship between subcutaneous fat index and facet joint degeneration.
Imaging assessments will be performed by an evaluator blinded to pain severity, body mass index, and other clinical findings. Inter-rater or intra-rater reliability will be assessed in a randomly selected subset of approximately 20% of the study sample.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前:Serhat Köse
- 電話番号:05350150460
- メール:serhatkose03@gmail.com
研究場所
-
-
Istanbul
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Istanbul、Istanbul、トルコ(Türkiye)、34890
- 募集
- Marmara University Pendik Training and Research Hospital
-
コンタクト:
- Serhat Köse
- 電話番号:05350150460
- メール:serhatkose03@gmail.com
-
主任研究者:
- Osman Hakan Gündüz, Prof.Dr.
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
Adults aged 18-75 years with chronic low back pain lasting at least 3 months who present to the Algology outpatient clinic of Marmara University Faculty of Medicine Pendik Training and Research Hospital and have a lumbar MRI clinically indicated as part of routine patient management independently of the study. Routine lumbar MRI images and demographic and clinical characteristics will be evaluated for associations between subcutaneous fat index, intervertebral disc degeneration, facet joint degeneration, facet morphology, and paraspinal muscle characteristics.
説明
Inclusion Criteria:
-
Inclusion Criteria:
- Age 18-75 years.
- Low back pain lasting for at least 3 months.
- Evaluation at the Algology outpatient clinic.
- Lumbar MRI has been clinically indicated as part of routine patient management independently of the study.
- Lumbar MRI images including sagittal T1-weighted, sagittal T2-weighted, and axial T2-weighted images covering the L1-L2 through L5-S1 levels.
- Height and body weight can be measured.
- Low back pain severity can be assessed using the Numeric Rating Scale (NRS).
- Sufficient cognitive and linguistic capacity to complete the Oswestry Disability Index.
- Ability to understand the study and provide informed consent.
- Written informed consent to participate in the study.
Exclusion Criteria:
- Previous lumbar spine surgery or lumbar fusion.
- Acute vertebral fracture or significant lumbar trauma.
- Spinal malignancy or vertebral metastasis.
- Spondylodiscitis or other spinal infections.
- Inflammatory spondyloarthritis.
- Advanced lumbar scoliosis.
- Severe congenital lumbar vertebral anomaly.
- Anatomic variation preventing reliable identification of vertebral levels.
- Pregnancy.
- Inability to complete the MRI examination.
- MRI images inadequate for assessment of subcutaneous fat, intervertebral discs, facet joints, or paraspinal muscles.
- Missing clinical data or required outcome measures.
- Failure to provide written informed consent.
Exclusion Criteria:
-
研究計画
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:PROSPECTIVE
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Chronic Low Back Pain Cohort
Participants with chronic low back pain who meet the eligibility criteria and undergo lumbar MRI as part of routine clinical care will be included in this observational cohort. MRI findings and demographic and clinical characteristics will be evaluated to investigate the associations between subcutaneous fat index, paraspinal muscle characteristics, facet morphology, intervertebral disc degeneration, and lumbar facet joint degeneration. |
Lumbar MRI images obtained as part of routine clinical care will be evaluated for study purposes. No additional MRI examination or radiation exposure will be performed because of study participation. MRI findings will be assessed for subcutaneous fat index, intervertebral disc degeneration, facet joint degeneration, facet morphology, and paraspinal muscle characteristics. |
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 |
|---|---|---|
|
Association between subcutaneous fat index and moderate-to-severe lumbar facet joint degeneration
時間枠:At baseline
|
Moderate-to-severe lumbar facet joint degeneration will be defined as Weishaupt Grade ≥2 in the right or left facet joint at any lumbar level from L1-L2 to L5-S1. The association with subcutaneous fat index measured on lumbar MRI will be evaluated. |
At baseline
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Association between subcutaneous fat index and total Pfirrmann score
時間枠:At baseline
|
The association between subcutaneous fat index and total Pfirrmann score for lumbar intervertebral disc degeneration will be evaluated. |
At baseline
|
|
Association between intervertebral disc degeneration and facet joint degeneration
時間枠:At baseline
|
The association between intervertebral disc degeneration and lumbar facet joint degeneration will be evaluated using Pfirrmann and Weishaupt classifications. |
At baseline
|
|
Association between facet angle, facet tropism, and facet joint degeneration
時間枠:At baseline
|
The associations between facet angle, facet tropism, and lumbar facet joint degeneration will be evaluated. |
At baseline
|
|
Association between paraspinal muscle characteristics and intervertebral disc and facet joint degeneration
時間枠:At baseline
|
The associations between paraspinal muscle characteristics, including total cross-sectional area, functional cross-sectional area, and fat infiltration, and intervertebral disc and lumbar facet joint degeneration will be evaluated. |
At baseline
|
|
Association between subcutaneous fat index and low back pain severity
時間枠:At baseline
|
The association between subcutaneous fat index and low back pain severity will be evaluated using the Numeric Rating Scale (NRS). |
At baseline
|
|
Exploratory mediation analysis of intervertebral disc degeneration in the association between subcutaneous fat index and facet joint degeneration
時間枠:At baseline
|
The potential statistical mediation role of intervertebral disc degeneration in the association between subcutaneous fat index and lumbar facet joint degeneration will be evaluated as an exploratory analysis. |
At baseline
|
協力者と研究者
スポンサー
捜査官
- 主任研究者:OSMAN H GÜNDÜZ、Marmara University
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 09.2026.26-0770
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?
IPD プランの説明
Individual participant data will not be shared with other researchers because no plan for individual participant data sharing has been established for this study.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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