Cervical Transforaminal Injection of Steroids Guided by Ultrasound
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 主要终点
- change of pain severity rated on a Visual Analog Scale (VAS)
研究概览
简要总结
Cervical transforaminal epidural steroid injections (TFESI) are indicated in cervical radicular pain resistant to conservation therapy, by which steroids can be delivered into anterior epidural space surrounding target spinal nerve roots to help alleviate pain in the upper limb or neck. Cervical TFESI is traditionally commended to perform with guidance of fluoroscopy or CT. As fluoroscopy can not monitor the injection route whether it pass vessel or not, many serious neurological complications caused by inadvertent intra-arterial injection have been reported2. Here, the investigators will introduce a novel cervical TFESI guided by ultrasound, which incidence of inadvertent vessel injury or injection might be lower than those guided by fluoroscopy.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •evidence of a cervical radiculopathy involving 1 spinal nerve of at least 1 month's duration refractory to medical treatment
- •symptoms of cervical pain radiating to the upper limb
- •and signs of altered sensations, ab- normal reflexes, or motor weakness caused by degenerative spondylosis and/or disk herniation as documented at CT or MR imaging and a current mean pain VAS score of six.
- •Exclusion criteria:
- •evidence of vertebral fracture, tumor, or infection of the cervical spine
- •treatment with cervical corticosteroid injections within the past 3 months
- •coagulopathy
- •allergy to iodinated contrast media.
排除标准
- 未提供
研究组 & 干预措施
USNR steroid injection
the patient who are treated with steroid (dexamethasone) injection through selected cervical spinal nerve block approach guided by ultrasound and C arm.
干预措施: SNR steroid (dexamethasone) injection (Procedure)
USNR steroid injection
the patient who are treated with steroid (dexamethasone) injection through selected cervical spinal nerve block approach guided by ultrasound and C arm.
干预措施: Dexamethasone (Drug)
USNR steroid injection
the patient who are treated with steroid (dexamethasone) injection through selected cervical spinal nerve block approach guided by ultrasound and C arm.
干预措施: Ultrasound (Device)
USNR steroid injection
the patient who are treated with steroid (dexamethasone) injection through selected cervical spinal nerve block approach guided by ultrasound and C arm.
干预措施: C arm (Radiation)
UCTF steroid injection
the patients who are treated with steroid (dexamethasone) injection through cervical transforaminal approach guided by ultrasound and C arm.
干预措施: CTF steroid (dexamethasone) injection (Procedure)
UCTF steroid injection
the patients who are treated with steroid (dexamethasone) injection through cervical transforaminal approach guided by ultrasound and C arm.
干预措施: Dexamethasone (Drug)
UCTF steroid injection
the patients who are treated with steroid (dexamethasone) injection through cervical transforaminal approach guided by ultrasound and C arm.
干预措施: Ultrasound (Device)
UCTF steroid injection
the patients who are treated with steroid (dexamethasone) injection through cervical transforaminal approach guided by ultrasound and C arm.
干预措施: C arm (Radiation)
XCTF steroid injection
the patients who are treated with steroid (dexamethasone) injection through cervical transforaminal approach guided only by C arm.
干预措施: CTF steroid (dexamethasone) injection (Procedure)
XCTF steroid injection
the patients who are treated with steroid (dexamethasone) injection through cervical transforaminal approach guided only by C arm.
干预措施: Dexamethasone (Drug)
XCTF steroid injection
the patients who are treated with steroid (dexamethasone) injection through cervical transforaminal approach guided only by C arm.
干预措施: C arm (Radiation)
结局指标
主要结局
change of pain severity rated on a Visual Analog Scale (VAS)
时间窗: 1 day before, 1day after, 1week after and 4 weeks after the intervention
次要结局
- change of medication use rated on Medication Quantitative Scale (MQS)(1 day before, 1day after, 1week after and 4 weeks after the intervention)
- change of neck actives rated on Neck Disability Index (NDI)(1 day before, 1day after, 1week after and 4 weeks after the intervention)
研究者
Dongping Du
Pain Management Center
Shanghai Jiao Tong University Affiliated Sixth People's Hospital