跳至主要内容
临床试验/NCT00300898
NCT00300898撤回不适用

Radiofrequency Nucleoplasty vs Percutaneous Nucleotomy (Dekompressor) vs Decompression Catheter for the Treatment of Painful Contained Lumbar Disc Herniation: A Prospective Randomized Controlled Study

The Cleveland Clinic0 个研究点开始时间: 2006年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
主要终点
VAS pain evaluation score at baseline, 1, 3, 6, 9, 12 months

研究概览

简要总结

The purpose of this study is to learn which of three minimally invasive procedures is the most effective for treatment of contained lumbar disc herniation.

详细描述

Contained herniation of the lumbar intervertebral disc is a frequent cause of leg and back pain. Over the last decade, there is a tendency to shift from surgical treatment of the intervertebral disc including laminectomy/discectomy to an excess of nonoperative management. Three techniques introduced recently are used as minimally invasive treatments for decompression of contained herniation of the nucleus pulposus. Nucleoplasty uses Coblation® radiofrequency vaporization of nuclear tissue to decompress the intervertebral disc. Catheter disc decompression uses heat from a resistive coil positioned in the area of disc herniation while Dekompressor® uses volume reduction to decrease an intradiscal pressure.

This is a comparison study which investigates if intervertebral electrothermal disc decompression produces better pain relief measured on VAS scale, improvement in functional capacity, return to work and opioid use, than nucleoplasty or percutaneous disc decompression (Dekompressor) of the lumbar intervertebral disc in a prospective randomized controlled study. Patients will be randomized into four treatment groups in equal numbers. The first group will be treated using nucleoplasty, the second will receive Dekompressor® lumbar disc decompression, the third will receive thermal treatment using decompression catheter (Achutherm TM) and the forth will be the control group. The control group will be treated conservatively using medications including gabapentin, a breakthrough opioid (oxycodone 5 mg 1-2 tablets q 4-6 hours as needed), NSAID, epidural steroid injections and physical therapy.

Patients will be followed and assessed at one, three, six, nine and twelve months following the procedure using VAS scores, Oswestry and SF-36 Short Form questionnaires, opioid use and return to work evaluation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 54 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •History of concordant radicular leg pain unresponsive to conservative treatment for longer than 3 months
  • •Leg pain must be greater than back pain
  • •Contained disc herniation as evidenced by MRI
  • •No evidence of psychological issues by exam or history

排除标准

  • •A score of greater than 10 on Beck Depression Inventory (BDI)
  • •Patients with pending workers compensation claim or litigation
  • •Pregnancy
  • •Systemic infection or localized infection at the anticipated entry needle site
  • •Traumatic spinal fracture
  • •History of coagulopathy
  • •Unexplained bleeding
  • •Progressive neurological deficits
  • •History of opioid abuse or patients currently on long acting opioids
  • •Patients presenting with moderate or severe lumbar central or lateral canal stenosis, free disc fragments or degenerative disc disease as described on MRI

研究组 & 干预措施

Electrothermal disc decompression (IDET)

Active Comparator

Procedure/Surgery: Intervertebral electrothermal disc decompression (IDET)

干预措施: Intervertebral electrothermal disc decompression (IDET) (Procedure)

Behavioral:Conservative treatment

Experimental

Conservative treatment with oral medications, physical therapy, epidural steroid injections

干预措施: Conservative treatment (Behavioral)

Nucleoplasty

Active Comparator

Procedure/Surgery: Nucleoplasty

干预措施: Nucleoplasty (Procedure)

Percutaneous decompression

Active Comparator

Procedure/Surgery: Percutaneous decompression

干预措施: Percutaneous decompression (Procedure)

结局指标

主要结局

VAS pain evaluation score at baseline, 1, 3, 6, 9, 12 months

时间窗: baseline 1, 3, 6, 9, 12 months

次要结局

  • Return to work evaluation(1 month)
  • Depression score(BASELINE)
  • Opioid use(1, 3, 6, 9, 12 months)
  • Oswestry results(baseline 1, 3, 6, 9, 12 months)
  • Quality of Life SF-36(baseline 1, 3, 6, 9, 12 months)

研究者

申办方类型
Other
责任方
Sponsor

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