Comparison of positive predictive value of diagnostic single vs dual median branch block for Radio-Frequency neurotomy in lumbar facet joint syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Numerical rating score (NRS):0-10
研究概览
简要总结
This study will determine the correlation between Median branch block responses and radiofrequency Neurotomy outcomes, specifically whether patients with concordant analgesic responses to dual controlled MBB have superior radiofrequency Neurotomy outcomes as compared to those with concordant single MBB.
30 patients with facet syndrome will be randomly selected and divided into two groups, namely Group I and Group II. Patients in Group I will be given diagnostic median branch block using 1%, 0.2-0.4 ml lidocaine. Patients in Group II will be given diagnostic median branch block using 1%, 0.2-0.4 ml lidocaine. Patients having atleast 80% pain relief for more than 2 hours will be subjected to second block using 0.25%, 0.2-0.3 ml bupivacaine after an interval of 2-3 weeks after first block. RF Neurotomy will be performed in all the patients having positive response two to three days following MBB in both the groups. Patients in both the groups will be assessed using Numerical Rating Score (NRS) on a scale of 0-10 and Roland Morris Disability Questionnaire (RDQ) on a scale of 0-24 before every MBB and 1 month after the RF Neurotomy. All the data collected will be analysed using appropriate statistical test
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Chronic low back pain with or without proximal non-radicular extremity pain of greater than 3- month duration.
- •2.Pain unresponsive to conservative treatment including medical management, physical therapy, and previous interventions.
排除标准
- •1.Pain for less than 3 months 2.Neurological deficits 3.Pregnancy and lactating mother 4.Prior low back surgery 5.Concurrent cervical or thoracic pain or pain in these regions lasting longer than 2 weeks during the previous 6 months 6.Primary or metastatic spine tumour or spinal cord injury.
- •7.Allergy to medications used in procedure, blood coagulation disorder.
结局指标
主要结局
Numerical rating score (NRS):0-10
时间窗: NRS before & after every median branch block and 1 month after neurotomy | RDQ before first median branch block and one moth after neurotomy
Roland Morris Disability Questionnaire (RDQ) :0-24
时间窗: NRS before & after every median branch block and 1 month after neurotomy | RDQ before first median branch block and one moth after neurotomy
次要结局
- Roland Morris Disability Questionnaire (RDQ) :0-24(RDQ after first median branch block and after second median branch block and before radiofrequency neurotomy)