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临床试验/NCT07002918
NCT07002918尚未招募不适用

The Impact of Paraspinal Muscle Atrophy in Lumbar Spinal Fusion Outcomes

Assiut University1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2025年6月最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
55
试验地点
1
主要终点
Oswerty disability index Arabic version (ODI)

研究概览

简要总结

The goal of this observational study is to learn about the role of pre-operative paraspinal muscle atrophy in outcomes of lumbar spine fusion surgeries in patients with degenerative lumbar spine diseases. The main question it aims to answer is:

Does paraspinal muscle atrophy worsen lumbar spine fusion surgeries outcomes? Participants undergoing lumbar spine fusion surgeries as part of their treatment for degenerative lumbar spine diseases will answer survey questions about their low back pain and daily activities for 1 year.

详细描述

Lumbar spine fusion surgery is a widely performed intervention worldwide with the rate steadily increasing. This trend reflects the growing burden of degenerative spinal disorders (DSD) and low back pain (LBP), which globally affect an estimated 266 million individuals (3.63% of the global population) each year. Socioeconomic factors are important risk aspects for lumbar pain and disability both directly and indirectly. Despite the widespread use of lumbar fusion surgery, outcomes are not uniformly successful. A significant proportion of patients experience poor postoperative results, with studies indicating that 33% of patients report treatment failure, including a 22% worsening rate after surgery for lumbar spinal stenosis. Factors associated with these poor outcomes include prolonged back pain duration (>12 months), prior spinal surgery, and advanced age (>70 years). One critical yet often overlooked factor contributing to poor outcomes is paraspinal muscle atrophy. The paraspinal muscles and vertebrae are interdependent tissues, and the health of these muscles plays a vital role in spinal stability and function. The multifidi, erector spinae, psoas, and quadratus lumborum muscles provide support for the lower back. Numerous studies have explored the degeneration or atrophy of back muscles and the reduction in back extensor muscle strength in patients with lower back pain. Patients with high lumbar muscularity and mild fatty infiltration ratio observed on preoperative MRI demonstrated more promising clinical and radiographic outcomes after lumbar interbody fusion. As the prevalence of degenerative spinal conditions continues to rise globally, understanding the role of paraspinal muscle health in surgical success is critical. By prioritizing patient selection based on modifiable risk factors, clinicians can enhance postoperative outcomes and mitigate the economic and clinical burdens associated with lumbar fusion surgery.

  • Sample Size Calculation:

Based on determining the main outcome variable, The estimated minimum required sample size is 55 patients.

The sample size was calculated using Epi-info version 7 software, based on the following assumptions:

Main outcome variable is to determine the impact of paraspinal muscle atrophy on lumbar spine fusion outcomes. Previous studies indicate a significant decrease in paraspinal muscle volume one year after surgery, dropping from 67.8% to 60.4%. This reduction correlates significantly with physical and mental outcomes, as well as pain levels. With 80% confidence, the margin of error for these findings is estimated to be within 3%.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with degenerative lumbar spine diseases undergoing lumbar spinal fusion.

排除标准

  • Long-level fusion ≥ 3 levels.
  • History of previous lumbar surgery.
  • Patients diagnosed with spondylolysis.
  • Other pathological conditions such as fractures, infections or tumors.
  • Uncontrolled comorbidities.

结局指标

主要结局

Oswerty disability index Arabic version (ODI)

时间窗: Baseline, 2 weeks postoperative, 6 weeks postoperative, 3 months postoperative, 6 months postoperative and 1 year postoperative.

The Oswestry Disability Index (ODI) translates low back pain disability into a numerical score for better understanding and communication. It's a questionnaire used to assess the impact of low back pain on a person's daily life, work, and ability to perform specific tasks. The ODI translates into a score from 0-100, with higher scores indicating greater disability. This score helps clinicians and researchers quantify the functional disability caused by low back pain.

次要结局

  • Visual analogue scale (VAS)(Baseline, 2 weeks postoperative, 6 weeks postoperative, 3 months postoperative, 6 months postoperative and 1 year postoperative.)
  • Local kyphotic angle(Baseline, 1 day postoperative, 6 months postoperative and 1 year postoperative.)
  • Lumbar lordosis(Baseline, 1 day postoperative, 6 months postoperative and 1 year postoperative.)
  • EuroQol-5-dimension 5-level Arabic version (EQ-5D-5L)(Baseline, 2 weeks postoperative, 6 weeks postoperative, 3 months postoperative, 6 months postoperative and 1 year postoperative.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Adnan Ahmad Elkamel

Resident Doctor

Assiut University

研究点 (1)

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