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Sarcopenia and Interlaminar Epidural Steroid Injection Outcomes in Lumbar Spinal Stenosis

2026年10月3日更新者：Marmara University

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.

研究概览

地位

招聘中

条件

研究类型

观察性的

注册 (估计的)

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

姓名：Konuralp Karbeyaz
电话号码：+90 216 625 45 45
邮箱：nurbanuhindioglu@gmail.com

学习地点

土耳其（türkiye）
- Istanbul
  - Istanbul、Istanbul、土耳其（türkiye）、34899
    - 招聘中
    - Marmara University Pendik Training and Research Hospital
    - 接触：
      
      Konuralp Karbeyaz
      
      电话号码：+90 216 625 45 45
      
      邮箱：nurbanuhindioglu@gmail.com

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

50年至 75年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

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.

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

观测模型：COHORT
时间观点：PROSPECTIVE

团体/队列数

队列和干预

团体/队列
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.
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.

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Change in Leg Pain Following Interlaminar Epidural Steroid Injection by Sarcopenia Status 大体时间：Baseline, 3 weeks, and 3 months	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

次要结果测量

结果测量	措施说明	大体时间
Change in Low Back Pain Following Interlaminar Epidural Steroid Injection by Sarcopenia Status 大体时间：Baseline, 3 weeks, and 3 months	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
Change in Functional Disability Following Interlaminar Epidural Steroid Injection by Sarcopenia Status 大体时间：Baseline, 3 weeks, and 3 months	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
Change in Health-Related Quality of Life Following Interlaminar Epidural Steroid Injection by Sarcopenia Status 大体时间：Baseline, 3 weeks, and 3 months	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
Correlation Between Erector Spinae Cross-Sectional Area and Leg Pain Outcome 大体时间：Baseline Magnetic Resonance Imaging; leg pain at baseline, 3 weeks and 3 months	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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Marmara University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年10月2日

初级完成 (估计的)

2027年3月1日

研究完成 (估计的)

2027年4月1日

研究注册日期

首次提交

2026年9月28日

首先提交符合 QC 标准的

2026年9月28日

首次发布 (实际的)

2026年10月2日

研究记录更新

最后更新发布 (实际的)

2026年10月7日

上次提交的符合 QC 标准的更新

2026年10月3日

最后验证

2026年10月1日