Sarcopenia and Interlaminar Epidural Steroid Injection Outcomes in Lumbar Spinal Stenosis
Association Between Sarcopenia and Outcomes of Interlaminar Epidural Steroid Injection in Patients With Lumbar Spinal Stenosis: A Prospective Observational Study
This prospective observational study aims to investigate the association between sarcopenia and clinical outcomes following interlaminar epidural steroid injection in patients with lumbar spinal stenosis.
Patients who are scheduled to undergo interlaminar epidural steroid injection as part of routine clinical care will be enrolled. Before the procedure, sarcopenia-related assessments, including the SARC-F questionnaire, handgrip strength, and the five-times sit-to-stand test, will be performed. Lumbar magnetic resonance imaging (MRI) will also be evaluated for paraspinal muscle characteristics and the severity of lumbar spinal stenosis.
Pain intensity, functional status, walking capacity, and health-related quality of life will be assessed at baseline. Pain intensity, functional status, and health-related quality of life will be reassessed at 3 weeks and 3 months after the procedure. The study will evaluate whether sarcopenia and MRI-based paraspinal muscle characteristics are associated with clinical outcomes following interlaminar epidural steroid injection.
調査の概要
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Konuralp Karbeyaz
- 電話番号：+90 216 625 45 45
- メール：nurbanuhindioglu@gmail.com
研究場所
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Istanbul
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Istanbul、Istanbul、トルコ（Türkiye）、34899
- 募集
- Marmara University Pendik Training and Research Hospital
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コンタクト：
- Konuralp Karbeyaz
- 電話番号：+90 216 625 45 45
- メール：nurbanuhindioglu@gmail.com
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-
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
The study population will consist of patients aged 50-75 years with clinically and radiologically diagnosed lumbar spinal stenosis who are scheduled to undergo interlaminar epidural steroid injection as part of routine clinical care due to persistent symptoms despite conservative treatment. Participants will be classified according to sarcopenia status based on baseline assessments and followed for 3 months.
説明
Inclusion Criteria:
- Clinical and radiological diagnosis of lumbar spinal stenosis
- Persistent symptoms despite conservative treatment and scheduled to undergo interlaminar epidural steroid injection as part of routine clinical care
- Age between 50 and 75 years
- Low back and/or leg pain for at least 3 months
- Availability of lumbar magnetic resonance imaging (MRI)
Exclusion Criteria:
- History of lumbar fusion surgery
- Lumbar epidural steroid injection within the previous 3 months
- Prominent radiculopathy due to lumbar disc herniation
- Severe motor deficit or an indication for surgical treatment
- Polyneuropathy, neuromuscular disease, or neurological disease that may significantly affect muscle mass
- Active malignancy or systemic inflammatory disease
- Significant mobility limitation due to advanced hip or knee osteoarthritis
- Cognitive impairment or communication problems that may prevent completion of study assessments
- Coagulopathy or active infection constituting a contraindication to epidural injection
- Inflammatory rheumatic disease requiring chronic corticosteroid therapy
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 |
|---|
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Patients with Sarcopenia
Patients with lumbar spinal stenosis who meet the European Working Group on Sarcopenia in Older People 2 (EWGSOP2) criteria for probable sarcopenia based on reduced muscle strength at baseline and who are scheduled to undergo interlaminar epidural steroid injection as part of routine clinical care. |
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Patients without Sarcopenia
Patients with lumbar spinal stenosis who do not meet the European Working Group on Sarcopenia in Older People 2 (EWGSOP2) criteria for probable sarcopenia based on muscle strength assessment at baseline and who are scheduled to undergo interlaminar epidural steroid injection as part of routine clinical care. |
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 |
|---|---|---|
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Change in Leg Pain Following Interlaminar Epidural Steroid Injection by Sarcopenia Status
時間枠：Baseline, 3 weeks, and 3 months
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Leg pain intensity will be assessed using the Numeric Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. NRS scores will be recorded at baseline, 3 weeks, and 3 months. Changes in leg pain intensity from baseline will be compared between patients with and without sarcopenia. |
Baseline, 3 weeks, and 3 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Low Back Pain Following Interlaminar Epidural Steroid Injection by Sarcopenia Status
時間枠：Baseline, 3 weeks, and 3 months
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Low back pain intensity will be assessed using the Numeric Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. NRS scores will be recorded at baseline, 3 weeks, and 3 months. Changes in low back pain intensity from baseline will be compared between patients with and without sarcopenia. |
Baseline, 3 weeks, and 3 months
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Change in Functional Disability Following Interlaminar Epidural Steroid Injection by Sarcopenia Status
時間枠：Baseline, 3 weeks, and 3 months
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Functional disability will be assessed using the Istanbul Low Back Pain Disability Index (ILBPDI). The ILBPDI consists of 18 items and has a total score ranging from 0 to 90, with higher scores indicating greater disability. ILBPDI scores will be recorded at baseline, 3 weeks, and 3 months. Changes from baseline will be compared between patients with and without sarcopenia. |
Baseline, 3 weeks, and 3 months
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Change in Health-Related Quality of Life Following Interlaminar Epidural Steroid Injection by Sarcopenia Status
時間枠：Baseline, 3 weeks, and 3 months
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Health-related quality of life will be assessed using the 12-Item Short Form Health Survey (SF-12), which provides Physical Component Summary (PCS) and Mental Component Summary (MCS) scores. Both scores range from 0 to 100, with higher scores indicating better health-related quality of life. Scores will be recorded at baseline, 3 weeks, and 3 months. Changes from baseline will be compared between patients with and without sarcopenia. |
Baseline, 3 weeks, and 3 months
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Correlation Between Erector Spinae Cross-Sectional Area and Leg Pain Outcome
時間枠：Baseline Magnetic Resonance Imaging; leg pain at baseline, 3 weeks and 3 months
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Erector spinae cross-sectional area (CSA) will be measured on baseline lumbar magnetic resonance imaging (MRI) in square centimeters (cm²). Leg pain intensity will be assessed using the Numeric Rating Scale (NRS), ranging from 0 to 10, with higher scores indicating greater pain intensity. The correlation between baseline erector spinae CSA and change in leg pain NRS from baseline will be evaluated. |
Baseline Magnetic Resonance Imaging; leg pain at baseline, 3 weeks and 3 months
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協力者と研究者
スポンサー
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
追加の関連 MeSH 用語
その他の研究ID番号
- 09.2026.878
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 are not planned to be shared publicly due to participant confidentiality and data protection considerations.
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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