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临床试验/NCT05392933
NCT05392933已完成不适用

Investigation of the Presence of Piriformis Syndrome Accompanying Lumbar Radiculopathy

Istanbul University - Cerrahpasa2 个研究点 分布在 2 个国家目标入组 39 人开始时间: 2023年1月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
39
试验地点
2
主要终点
Change from baseline pain at 30 minutes after piriformis muscle injection

研究概览

简要总结

Piriformis syndrome is a neuromuscular disorder that is characterized by piriformis muscle tenderness, hip, and leg pain, and may be accompanied by compression or irritation of the sciatic nerve under the piriformis muscle. There are many studies in the literature to establish diagnostic criteria for piriformis syndrome, and there is still no clear consensus on these criteria. However, cases with lumbar radiculopathy were accepted as exclusion criteria in all these studies. The aim of our study is to investigate whether lumbar radiculopathy and piriformis syndrome can coexist. For this reason, a diagnostic piriformis muscle injection under ultrasonography guidance is planned for patients with lumbar radiculopathy who also have a prediagnosis of piriformis syndrome clinically.

详细描述

Lumbar radiculopathy is a condition in which lumbar spinal nerve roots are affected due to various pathologies. The diagnosis is made clinically by the symptoms and physical examination findings. Most of the time, the diagnosis is supported by imaging methods and electrodiagnostic tests.

Piriformis syndrome is a neuromuscular disorder that is characterized by piriformis muscle tenderness, hip, and leg pain, and may be accompanied by compression or irritation of the sciatic nerve under the piriformis muscle. Similarly, the diagnosis of piriformis syndrome is made clinically based on the patients' history and physical examination. In addition, piriformis muscle injections are an accepted method for the diagnosis of piriformis syndrome. However, the diagnosis of piriformis syndrome is still a controversial issue due to the absence of universally accepted diagnostic criteria, pathognomonic findings, or a gold standard diagnostic method. In this context, many authors have reported that piriformis syndrome is mostly a diagnosis of exclusion. For this reason, the diagnosis of piriformis syndrome is missed in patients with lumbar radiculopathy and these patients may apply to multiple physicians due to their ongoing pain. This can lead to loss of time, financial losses, sensitization and chronic pain in patients and even unnecessary lumbar surgery. Our aim is to investigate whether these two clinical conditions coexist by performing a diagnostic piriformis muscle injection test under ultrasonographic guidance to patients with a diagnosis of lumbar radiculopathy and also with symptoms and signs of piriformis syndrome.

The diagnostic injection test into the piriformis muscle has also been reported to have therapeutic effects. Therefore, the second goal of our study is to investigate the therapeutic effect of piriformis muscle injection in patients diagnosed with lumbar radiculopathy and also piriformis syndrome.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

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

  • Aged over 18 years
  • Having clinical symptoms and signs of L4/L5/S1 radiculopathy which may be supported by imaging and/or electrodiagnostic evaluation
  • Having tenderness at the piriformis muscle

排除标准

  • Injection history at the lumbar, hip, gluteal region in the last 6 months
  • Operation history at the lumbar and/ or hip region
  • History of inflammatory rheumatic disease
  • History of infectious disease
  • History of bleeding disorder
  • History of anticoagulation use
  • Uncontrolled diabetes mellitus or hypertension
  • History of neurological disease
  • Being in gestational or lactational period
  • Noncompensated chronic heart/liver/renal deficiency, or vascular/tumoral disease
  • Active psychiatric disease
  • History of allergic reaction to the substance to be applied as local anesthetic

结局指标

主要结局

Change from baseline pain at 30 minutes after piriformis muscle injection

时间窗: Baseline, 30 minutes after piriformis muscle injection

After the piriformis muscle injection, the percentage of relief in patient's symptoms will be questioned. It has been reported that 50% or more reduction in the patient's complaints after injecting the local anesthetic agent into the piriformis muscle, with or without steroids, is diagnostic for piriformis syndrome. Therefore, patients with at least 50% reduction in post-injection complaints will be diagnosed with piriformis syndrome.

次要结局

  • Change in patient's pain level via Numeric Rating Scale at 1 week and 1 month after injection(Baseline, one week after piriformis muscle injection, one month after piriformis muscle injection)

研究者

发起方
Istanbul University - Cerrahpasa
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yasar Burak Topcu

Principal Investigator

Istanbul University - Cerrahpasa

研究点 (2)

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