ACTRN12618001041246撤回未知
A Single-Blind, Prospective, Randomised Control Trial Comparing Anatomical Thermal Radiofrequency Neurotomy (RFN) of Lumbar Medial Branch Derived Facet Pain to the Generic Radiofrequency Neurotomy Technique.
Monash Clinical Research0 个研究点目标入组 98 人开始时间: 2018年6月22日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 撤回
- 发起方
- 入组人数
- 98
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 40 Years 至 70 Years（—）
- 性别
- All
入选标准
- •To participate in this study, subjects must meet all of the following inclusion criteria:
- •1.Have been diagnosed with lumbar medial branch derived facet pain via positive medial branch blocks
- •2.Have received pain relief from a prior RFN procedure.
- •3.Have agreed to undergo another RFN treatment.
- •4.Have an average pain intensity of 5 or more out of 10 on the NPRS.
- •5.Aged 40 to 70 years of age.
- •6.Be capable of subjective evaluation, able to read and understand ethics committee approved written questionnaires, and are able to read, understand and sign the EC-approved written informed consent, all of which will be in Australian English.
- •7.Be willing and able to comply with study-related requirements, procedures and visits.
排除标准
- •To participate in this study, subjects must not meet any of the following exclusion criteria:
- •8.Have a body mass index (BMI) >40.
- •9.Unable to give informed consent.
- •10.Have a medical condition or pain in other area(s) not intended to be treated with RFN, that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the Investigator
- •11.Have evidence of an active disruptive psychological disorder or other known condition significant enough to impact perception of pain and/or the ability to evaluate treatment outcome as determined by the investigator and the subject’s medical history.
- •12.Have a co-existing major illness which may interfere with the treatment, as determined by the investigator.
- •13.Are currently taking > 10 morphine milligram equivalents (MME) per day.
- •14.Are suffering pain that is different to the previously treated pain from RFN treatment.
- •15.Are on workcover, TAC or similar.
- •16.Need treatment for 4 or more spine levels on one side.
- •17.Have a life expectancy of less than 1 year.
- •18.Be pregnant or planning to become pregnant during the course of the study (if female and sexually active, subject must be using a reliable form of birth control, be surgically sterile or be at least 2 years post-menopausal).
- •19.Have within 6 months of enrolment a significant untreated addiction to dependency producing medications or have been a substance abuser (including alcohol and illicit drugs).
- •20.Be concomitantly participating or planning to participate in another clinical study overlapping in time with the present clinical study.
- •21.Have a condition currently requiring or likely to require surgery during the study period.
- •22.Be concomitantly undertaking a physical therapy regimen.
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