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Набор скоро начнётся NCT07002918

The Impact of Paraspinal Muscle Atrophy in Spine Surgeries

Наблюдательное Paraspinal Muscles Degenerative Lumbar Diseases

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Paraspinal Muscles, Degenerative Lumbar Diseases. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Египет
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

The Impact of Paraspinal Muscle Atrophy in Lumbar Spinal Fusion Outcomes

Обзор

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.

Подробное описание

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%.

\- Study tools (in detail, e.g., lab methods, instruments, steps, chemicals, …):

A. Preoperative:

* Magnetic resonance imaging (MRI) of lumbar spine will be used to measure the total cross-sectional area (TCSA), functional cross-sectional area (FCSA) and fatty infiltration (FI) of erector spinae (ES), multifidus (MF) and psoas major (PM) at the level of diseased segment together with one level above \& below using ImageJ software v1.54p. * plain X-rays will be used to measure local kyphotic angle and lumbar lordosis using Surgimap software v2.3.2.1. * Oswerty disability index Arabic version (ODI) * EuroQol-5-dimension 5-level Arabic version (EQ-5D-5L) * Visual analogue scale (VAS) B. Day one postoperative: Postoperative X-ray. C. Two weeks postoperative: Wound check. ODI, EQ-5D-5L, Visual Analogue Score. D. Six weeks postoperative: Wound check. ODI, EQ-5D-5L, Visual Analogue Score. E. Three months postoperative: ODI, EQ-5D-5L, Visual Analogue Score. F. Six months Postoperative: ODI, EQ-5D-5L, Visual Analogue Score, X-ray. G. One year Postoperative: ODI, EQ-5D-5L, Visual Analogue Score, X-ray, MRI if the patient is still complaining.

Первичные конечные точки

  • Oswerty disability index Arabic version (ODI) [Срок оценки: Baseline, 2 weeks postoperative, 6 weeks postoperative, 3 months postoperative, 6 months postoperative and 1 year postoperative.]
Вторичные конечные точки (4)
  • Visual analogue scale (VAS) [Срок оценки: Baseline, 2 weeks postoperative, 6 weeks postoperative, 3 months postoperative, 6 months postoperative and 1 year postoperative.]
  • Local kyphotic angle [Срок оценки: Baseline, 1 day postoperative, 6 months postoperative and 1 year postoperative.]
  • Lumbar lordosis [Срок оценки: Baseline, 1 day postoperative, 6 months postoperative and 1 year postoperative.]
  • EuroQol-5-dimension 5-level Arabic version (EQ-5D-5L) [Срок оценки: Baseline, 2 weeks postoperative, 6 weeks postoperative, 3 months postoperative, 6 months postoperative and 1 year postoperative.]

Критерии участия

Критерии включения

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

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Египет · 1 центр
  • Assiut University — Asyut

Публикации

  • Shawky Abdelgawaad A, El-Sharkawi M, Sarhan AM, Hassanien MA, Aziz M. Validation of the arabic version of the EuroQol-5-dimension 5-level (EQ-5D-5 L) in patients with spinal degenerative diseases. BMC Public Health. 2024 Apr 23;24(1):1119. doi: 10.1186/s12889-024-18367-3. PMID 38654180
  • Algarni AS, Ghorbel S, Jones JG, Guermazi M. Validation of an Arabic version of the Oswestry index in Saudi Arabia. Ann Phys Rehabil Med. 2014 Dec;57(9-10):653-63. doi: 10.1016/j.rehab.2014.06.006. Epub 2014 Aug 4. PMID 25262247
  • Waschke A, Hartmann C, Walter J, Dunisch P, Wahnschaff F, Kalff R, Ewald C. Denervation and atrophy of paraspinal muscles after open lumbar interbody fusion is associated with clinical outcome--electromyographic and CT-volumetric investigation of 30 patients. Acta Neurochir (Wien). 2014 Feb;156(2):235-44. doi: 10.1007/s00701-013-1981-9. Epub 2014 Jan 3. PMID 24384989
  • Mayer TG, Vanharanta H, Gatchel RJ, Mooney V, Barnes D, Judge L, Smith S, Terry A. Comparison of CT scan muscle measurements and isokinetic trunk strength in postoperative patients. Spine (Phila Pa 1976). 1989 Jan;14(1):33-6. doi: 10.1097/00007632-198901000-00006. PMID 2913665
  • Cooper RG, St Clair Forbes W, Jayson MI. Radiographic demonstration of paraspinal muscle wasting in patients with chronic low back pain. Br J Rheumatol. 1992 Jun;31(6):389-94. doi: 10.1093/rheumatology/31.6.389. PMID 1534505
  • You KH, Cho M, Lee JH. Effect of Muscularity and Fatty Infiltration of Paraspinal Muscles on Outcome of Lumbar Interbody Fusion. J Korean Med Sci. 2023 May 22;38(20):e151. doi: 10.3346/jkms.2023.38.e151. PMID 37218352
  • Alhaug OK, Dolatowski FC, Solberg TK, Lonne G. Predictors for failure after surgery for lumbar spinal stenosis: a prospective observational study. Spine J. 2023 Feb;23(2):261-270. doi: 10.1016/j.spinee.2022.10.010. Epub 2022 Nov 5. PMID 36343913
  • Sihvonen T, Herno A, Paljarvi L, Airaksinen O, Partanen J, Tapaninaho A. Local denervation atrophy of paraspinal muscles in postoperative failed back syndrome. Spine (Phila Pa 1976). 1993 Apr;18(5):575-81. doi: 10.1097/00007632-199304000-00009. PMID 8484148

Идентификаторы

NCT: NCT07002918 · Paraspinal muscle atrophy

Первоисточники (государственные реестры)

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