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临床试验/NCT05231759
NCT05231759Unknown不适用

Efficacy of Navigable Percutaneous Plasma Disc Decompression Device (L'DISQ) in Patients With Severe Lumbar Disc Herniation

Korea University Anam Hospital0 个研究点目标入组 30 人开始时间: 2009年3月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
主要终点
Visual analogue scale (VAS)

研究概览

简要总结

This study aims to assess the clinical outcome of percutaneous disc decompression using the L'DISQ in patients with severe lumbar disc herniation (LDH).

详细描述

Low back pain (LBP) is one of the most leading cause of chronic pain worldwide and 70-85% of adults have experienced LBP during their lifetime. The one of most common symptom of lumbar disc herniation (LDH) is sciatica, affecting about 1-5% of people worldwide. Almost two thirds of patients suffer from continuous pain even after 12 months of the first episode of LBP. Moreover, such persistent pain reduces the patient's quality of life and increases the social and economic burden due to increased hospital stay and surgical treatment. Traditionally, the primary treatment of LDH is non-surgical treatment including pain medication, rehabilitation exercise, and spinal injection, and about 70% of the patients show improvement of pain within 4 weeks. Surgical treatment is considered if there are neurological symptoms such as bladder dysfunction or progressive muscle weakness, or if symptoms persist for more than 6 weeks despite conservative treatment.

The patients with LDH usually experience sudden onset of LBP with radiating pain to lower extremity. Sensory symptoms such as focal paresis or motor weakness of specific myotome can also occur in the LDH patients. The symptoms and area of pain can vary due to the herniation level and severity. Michigan State University (MSU) classification was often used to evaluate and select for surgical treatment of LDH patients. In this classification, the herniated disc is evaluated using T2 axial magnetic resonance imaging (MRI) scan and classified by its size and location. The size of disc herniation is classified into 1 (*<50% of the distance to the intra-facet line), 2 (intra-facet line>*≥50% of the distance to the intra-facet line), or 3 (beyond intra-facet line). Then the position is classified in to A (central), B (lateral), or C (far lateral). The disc herniations size 3 (beyond intra-facet line) and zone B (lateral) or C (far lateral) are known to have greater impact on nerve compression, which tend to cause worse sciatica and neurologic symptoms and require surgical treatment. Moreover, the patients with larger lumbar disc herniation areas tend to show better outcomes with surgical treatment than conservative treatments and high-grade spinal canal stenosis patients had higher need for surgical treatment.

Over the past few years, various minimally invasive disc decompression procedures, were developed and used in LDH patients. These minimally invasive disc decompression techniques include intradiscal electrothermal therapy, radiofrequency annuloplasy, percutaneous disc decompression, nucleoplasty, and percutaneous laser disc decompression, which caused less damage to spinal structures and reduced tissue destructions than conventional surgical treatments. In particular, nucleoplasty was proven as effective as open discectomy in the treatment of single level lumbar disc herniation. The L'DISQ (U&I Co., Uijeongbu, Korea) is one of the safe and effective minimally invasive disc decompression procedures which introduced in 2011. In contrast to most percutaneous nucleotomy procedures that used rigid tip, the L'DISQ used a navigable tip and flexible handle allowing resection of the posterolateral or posterior median disc tissue without thermal damage.

The L'DISQ can be mainly performed in patients with less severe LDH while surgical treatment was mainly indicated in patients with severe LDH with neurologic symptoms. However, surgical treatment such as lumbar discectomy or spinal fusion increase hospitalization time and may increase financial burden of patients. And spinal fusion surgery might lead to delayed complications such as back muscle weakness or adjacent segment disease. Moreover, patients with severe LDH might refuse or not be able to perform surgery due to medical, financial, or other personal reasons. Recently, studies on the efficacy of L'DISQ or plasma decompression in disc patients are being conducted, and shows similar outcome when compared to surgical treatment in mild to moderate disc herniation patients. However, no studies have been conducted on the efficacy of L'DISQ in patients with severe LDH requiring surgical treatment. Purpose of this study is to report the efficacy of the L'DISQ procedure in patients with severe LDH corresponding to MSU classification 3.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • single-level LDH of MSU classification of grade 3 and refusal of spine surgery
  • LBP or lower extremity pain symptoms that persisted for 3 months or more
  • unresponsiveness to sufficient conservative treatments, including oral analgesics, physical modalities, or spinal injections (such as selective nerve root blocks)
  • limited activities of daily living due to pain.

排除标准

  • patients lost during the 1-year follow-up
  • evidence of peripheral neuropathy on electromyography, which might cause lower extremity pain
  • evidence of vertebral fracture in the X-ray analysis
  • history of tumor or myelopathy
  • history of spinal surgery
  • history of coagulopathy

结局指标

主要结局

Visual analogue scale (VAS)

时间窗: Change from baseline data, evaluated during the hospitalization prior to the L'DISQ procedure, to 4, 12, 24, and 48 weeks after the procedure.

VAS (Visual Analogue Scale) is a measuring tool that can quickly and easily measure the level of pain through the patient's expression or attitude.

次要结局

  • Roland-Morris Disability Questionnaire (RMDQ)(Change from baseline data, evaluated during the hospitalization prior to the L'DISQ procedure, to 4, 12, 24, and 48 weeks after the procedure)
  • Bodily Pain Score (BPS) of Short Form-36 version 2 (SF-36v2)(Change from baseline data, evaluated during the hospitalization prior to the L'DISQ procedure, to 4, 12, 24, and 48 weeks after the procedure)
  • Straight Leg Raise Test (SLRT)(Change from baseline data, evaluated during the hospitalization prior to the L'DISQ procedure, to 4, 12, 24, and 48 weeks after the procedure)
  • Oswestry Disability Index (ODI)(Change from baseline data, evaluated during the hospitalization prior to the L'DISQ procedure, to 4, 12, 24, and 48 weeks after the procedure)
  • Physical Component Score (PCS) of Short Form-36 version 2 (SF-36v2)(Change from baseline data, evaluated during the hospitalization prior to the L'DISQ procedure, to 4, 12, 24, and 48 weeks after the procedure)

研究者

申办方类型
Other
责任方
Sponsor

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