ISRCTN04820368已完成未知
Multi-centre randomised control trial comparing the clinical and cost effectiveness of trans-foraminal epidural steroid injection to surgical microdiscectomy for the treatment of chronic radicular pain secondary to prolapsed intervertebral disc herniation: Nerve rootblock versus surgery (NERVES)
The Walton Centre NHS Foundation Trust (UK)0 个研究点目标入组 163 人开始时间: 2014年6月5日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 163
研究概览
简要总结
2018 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/30185221 2021 results in https://pubmed.ncbi.nlm.nih.gov/33845941/ (added 14/04/2021) (published 01/04/2021) 2021 results in https://pubmed.ncbi.nlm.nih.gov/33969319/ (added 11/05/2021)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •As of 19/05/2016:
- •1. Diagnosed lower extremity radiculopathy (sciatica)
- •2. Sciatica secondary to prolapsed intervertebral disc (PID) (proven on MRI)
- •3. Duration of symptoms between 6 weeks and 12 months
- •4. Leg pain non-responsive to conservative, non-invasive management
- •5. Age 16 – 65 years
- •6. Patient has attempted at least one form of conservative (non-operative) treatment* but this has not provided adequate relief of patient’s pain/symptoms
- •7. Patient willing and able to give consent
- •*including but not limited to; medication, physiotherapy, modification of daily activities
- •Previous inclusion criteria:
- •1. Newly diagnosed disabling sciatica secondary to prolapsed intervertebral disc (proven on MRI)
- •2. Duration of symptoms between 6 weeks and 6 months
- •3. Failed conservative, non-invasive management
- •4. Age over 16 years
- •5. Diagnosed with lower extremity radiculopathy (sciatica) secondary to a lumbar disc herniation
- •6. Medication has not been helpful in treating the patient's pain/symptoms
- •7. Modification of daily activities has not been helpful in treating the patient's pain/symptoms
- •8. Physiotherapy has not been helpful in treating the patient's pain/symptoms
- •9. Patient willing to give consent
排除标准
- •As of 19/05/2016:
- •1. Serious neurological deficit (e.g. foot-drop/possible cauda-equina compression)
- •2. Previous spinal surgery at the same intervertebral disc (level)
- •3. Sciatica presentation for longer than 12 months
- •4. Age < 16
- •5. Age > 65
- •6. Patient has not attempted any form of conservative treatment
- •7. Any patient who has a contraindication for surgery and/or injection
- •8. Patient known to be pregnant
- •Previous exclusion criteria:
- •1. Neurological deficit (foot-drop/possible cauda-equina compression)
- •2. Previous surgery at that level
- •3. Age: < 16
- •4. Any patient who has not attempted conservative non-operative treatment for a minimum of 6 weeks
- •5. Any patient who has a contraindication for surgery
- •6. Any patient who is pregnant
研究者
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