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临床试验/CTRI/2022/11/047558
CTRI/2022/11/047558尚未招募不适用

The effectiveness of radiofrequency denervation of medial branch nerve in the treatment of facet mediated low back pain in adults. A prospective interventional study.

Ragul D1 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2022年11月30日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
17
试验地点
1
主要终点
pain relief

研究概览

简要总结

Athorough pre anaesthetic evaluation will be done 24 hours prior to theprocedure. All patients will be assigned to LFJ intraarticular PRP injection orRFA of medial branch nerve. The evaluation of the enrolled patients will bedone by experienced Orthopedician and the diagnosis will be based on physicalexamination, radio imaging (MRI) and diagnostic block of L3/L4-L5/S1 LFJ with 0.5%Bupivacaine.  Standard monitoring with electrocardiography(ECG), automated NIBP (noninvasive blood pressure), and pulse oximetry (SpO2) will be done for intraoperative monitoring.

Randomization of the participants into two groups iddone by using sealed shuffled opaque envelope technique.

 Participants will be divided into two groups:-

GROUP 1:-Those who are receiving intraarticular PRPinjections

GROUP 2:- Those who are receiving RFA of medial branchnerve

 This will be a double blindedstudy. In both groups, all procedures will be performed by the same experiencedpain physician. The only unblinded personnel in this study is the primary painphysician. Patients will be unblinded after the 6 months follow up or ifrequested before that time.

 Intraarticular Diagnostic blocks:

Patients in prone position, underfluoroscopy and under strict aseptic conditions, a 22G needle is inserted untilit is contacted at the edge of the LFJ. Adequate needle positioning isconfirmed by injecting 0.3 to 0.5ml of contrast. Once position is confirmed, 1mlof 0.5% bupivacaine is injected into LFJ.

 Radiofrequency Denervation:

All RFA procedures areperformed under fluoroscopic guidance. Patients in prone position, underaseptic conditions, 20G curved 100mm RF needles with active tips are placed atthe site of the dorsal ramus medial branch of the relevant L3/L4-L5/S1 LFJ’s.Correct placement is confirmed using electrostimulation at 50 HZ for sensoryand 2HZ for motor functions. Then 0.5% bupivacaine is injected through cannulato decrease procedure related pain. The RF probe is then reinserted into thecannula and lesioning at a temperature of 80℃ for 90 seconds using RFgenerator. Then, inj.dexamethasone 4mg is injected to prevent post operativeneuritis.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • 1 LFJ related low back pain >3months 2 Ability to understand study protocol and able to provide voluntary written consent 3 Benefit in pain reduction atleast 50% after intraarticular diagnostic block 4 MRI proven LFJ osteoarthritis.

排除标准

  • 1 A lack of positive response after diagnostic block 2 History of osteoporosis, malignancy and trauma.
  • 3 Allergic reaction to local anaesthetics.
  • 4 Pregnancy or lactating 5 Lumbar spinal stenosis, vertebral fractures.

结局指标

主要结局

pain relief

时间窗: at Baseline,1 month and at 6 months

次要结局

  • quality of life(at baseline, 1 month and 6 months)

研究者

发起方
Ragul D
申办方类型
Other [self]

研究点 (1)

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