ISRCTN12101415进行中（未招募）未知
A pilot study to assess the diagnostic utility of lumbar facet medial branch blocks for identifying responders to stimulation of the medial branch of the dorsal ramus in chronic low back pain patients
eeds Teaching Hospitals NHS Trust0 个研究点目标入组 45 人开始时间: 2022年2月24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
- 45
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Age =18 years to =75 years
- •2. Chronic low back pain on the majority of days 12 weeks prior to enrolment
- •3. Continuing low back pain despite more than 90 days under medical management within last year
排除标准
- •Current exclusion criteria as of 31/05/2024:
- •1. BMI >35 kg/m²
- •2. Any current indication for back surgery
- •3. Leg pain worse than back pain or radiculopathy below the knee
- •Back pain exclusions:
- •4. Any diagnosis or correction of scoliosis
- •5. Neurological deficit (e.g., foot drop)
- •6. Sacroiliac joint pain
- •7. NRS of =5.0 and >9.0 at the Baseline Evaluation
- •8. ODI score <25% and >60% at enrolment
- •Drug use exclusions:
- •9. Baseline use >120 mg oral morphine equivalent per day of opioids
- •10. Medications not at stable dose in prior 30 days
- •Surgical exclusions:
- •11. Rhizotomy procedure of medial branch below T8 in <12 months
- •12. Anaesthetic block of medial branch or epidural steroids for back pain in prior 30 days
- •13. Previous back surgery below T8
- •14. Previous destructive thoracic or lumbar sympathectomy
- •Psycho-social exclusions:
- •15. Current/pending litigation, claim or monetary settlement
- •16. Closed claim in past five years, or financial incentive to remain impaired
- •17. Current active depression
- •Previous exclusion criteria:
- •1. BMI >35 kg/m²
- •2. Any current indication for back surgery
- •3. Leg pain worse than back pain or radiculopathy below the knee
- •4. Any diagnosis or correction of scoliosis
- •5. Neurological deficit (e.g. foot drop)
- •6. Sacroiliac joint pain
- •7. NRS =5.0 and >9.0 at baseline
- •8. ODI score <25% and >60% at enrolment
- •9. PainDETECT score >19 at enrolment
- •10. Baseline use >120 mg oral morphine equivalent per day of opioids
- •11. Medications not at stable dose in prior 30 days
- •12. Rhizotomy procedure of medial branch below T8 in < 12 months
- •13. Anaesthetic block of medial branch or epidural steroids for back pain in prior 30 days
- •14. Previous back surgery below T8
- •15. Previous destructive thoracic or lumbar sympathectomy
- •16. Current/pending litigation, claim or monetary settlement
- •17. Closed claim in past five years, or financial incentive to remain impaired
- •18. Current active depression
研究者
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