ISRCTN16473239进行中（未招募）未知
Radiofrequency denervation for chronic and moderate to severe low back pain (RADICAL)
orth Bristol NHS Trust0 个研究点目标入组 250 人开始时间: 2021年11月9日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 250
研究概览
简要总结
2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/39067879/ (added 29/07/2024)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 22/05/2023:
- •1. 18 years of age or older
- •2. LBP is the primary source of pain
- •3. Positive response to a single diagnostic MBB with no steroids administered
- •4. Chronic LBP (>3 months duration), assumed due to the fact patient was listed for MBB
- •5. Moderate to severe LBP (pain NRS score =5 on Baseline Questionnaire)
- •6. Listed for RFD by their clinical care team
- •Previous inclusion criteria:
- •1. 18 years of age or older
- •2. Chronic moderate to severe LBP (>3 months duration, pain NRS score =5 for usual pain over the past week at the time of screening)
- •3. LBP is the primary source of pain
- •4. Referred to a pain or spinal clinic
- •5. Listed for MBB by their clinical care team (due to clinical suspicion or clinical features suggesting that the main source of LBP is from a facet joint)
- •6. Positive response to a single diagnostic MBB with 1 ml or less of local anaesthetic at each level (no steroids)
- •7. Listed for RFD by their clinical care team
排除标准
- •Current exclusion criteria as of 22/05/2023:
- •1. Known pregnancy
- •2. Severe depression (Hospital Anxiety and Depression Scale (HADS) depression score >= 15)
- •3. Known previous RFD
- •4. Known previous back surgery where metal-work has been used in the lumbar spine
- •5. Pacemaker or implantable cardioverter-defibrillator
- •6. Clinical suspicion that an alternative diagnosis is the reason for low back pain (as defined by NICE, including, but not limited to: metastatic spinal cord compression, spinal injury, spondyloarthritis, or cancer)
- •7. Prisoner
- •8. Patient lacks capacity to consent
- •9. Existing co-enrolment in another clinical study if: i) the intervention in the other study is expected to influence the primary outcome (this will be considered by a senior clinician on a case-by-case basis); ii) it is considered too burdensome for the patient; or iii) it is not permitted by the other study
- •Previous exclusion criteria:
- •1. Known pregnancy
- •2. Unwilling or unable to tolerate procedure
- •3. Severe depression (Hospital Anxiety and Depression Scale (HADS) depression score >= 15)
- •4. Known previous RFD
- •5. Known previous back surgery where metal-work has been used in the lumbar spine
- •6. Pacemaker or implantable cardioverter-defibrillator
- •7. Clinical suspicion that an alternative diagnosis is the reason for low back pain (as defined by NICE, including, but not limited to: metastatic spinal cord compression, spinal injury, spondyloarthritis, or cancer)
- •8. Prisoner
- •9. Patient lacks capacity to consent
- •10. Existing co-enrolment in another clinical study if: i) the intervention in the other study is expected to influence the primary outcome (this will be considered by a senior clinician on a case-by-case basis); ii) it is considered too burdensome for the patient; or iii) it is not permitted by the other study
研究者
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