Comparative Study Between Cervical Medial Branch Radiofrequency Ablation Versus Radiofrequency Plus Superficial Cervical Plexus Block in Treatment of the Cervical Facet and Cervical Spondylosis Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- pain releif
研究概览
简要总结
The goal of this clinical trial is to compare the effectiveness in the pain relief between doing radiofrequency ablation for the medial branch of the cervical facet pain alone vs using it combined with superficial cervical plexus block.in adults patients with cervical spondylosis pain
The main question it aims to answer is:
does adding superficial cervical plexus block to radiofrequency in patients with chronic neck pain provide better analgesia than radioprequency alone ?
详细描述
participants will be placed in prone position with neck preparation using an iodine-based product and drape in a sterile manner Then the ground pad of the radiofrequency machine will be placed on the back ( the Neurotherm NT1100 regenerator will be used) All the patients will be monitored by ECG, noninvasive blood pressure and pulse oximetry.
The entry sites will be detected under fluoroscopy then local anesthesia will be performed using lidocaine 2% followed by the insertion of the radiofrequency cannula (STRYKER 20 G, 9 cm with 1 cm active tip) targeting the medial branches supplying C4, C5, C6 & C7 bilateral.
the investigators will use 1 entry site for each side and then redirect the needles .
Confirmation of the appropriate location will be done on fluoroscopy in both A-P and lateral views Once targeted, sensory stimulation will be done and every patient is asked if he feels the same pain as that he used to suffer from. Once confirmed with absence of motor response; 1 more ml of lidocaine 20 % is injected and then start our ablation for 180 sec at 80 degrees
The procedure will be done bilateral the same. After 2 weeks , patient will be readmitted and then the investigators will choose to inject the superficial cervical plexus with 5 ml of lidocaine 20% plus 40 mg triamcinolone. injection was random in the right or left side using ultrasound to confirm success.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both genders.
- •Age between 30-70 years.
- •American society of anesthesiologist ASA 1,2 & 3 physical status.
- •MRI cervical spine diagnosing cervical facet arthropathy originating pain .
- •Failed full dose medical treatment and life style modification and physiotherapy for 3 months prior to intervention.
排除标准
- •Neurological disorders.(previous central and peripheral CNS affection ).
- •coagulopathy INR > 1.8 or platelets < 50,
- •Infection at or near the injection site.
- •Presence of pacemaker or defibrillator.
- •known allergy to used medications.
- •age >70 or <30 years.
- •patients with previous history of Radiotherapy , chemotherapy or metastasis
- •pregnant patients.
- •patients with rheumatological disorders ( rheumatoid arthritis, diffuse idiopathic skeletal hyerostosis, psoriatic arthritis, spondyloarthritis)
- •patients with antiphospholipid syndtrome.
结局指标
主要结局
pain releif
时间窗: 1 months
evaluating degree of pain releif after cervical medial branch radiofrequency ablation Monitoring pain score using numeric pain rating scale (NPRS) it is a 11 point scale scored from 0-10 * 0 represents no pain * 10 represents the worst pain imaginable . versus radiofrequency plus superficial cervical plexus block by using numeric pain rating scale after 1 month
次要结局
- global impression of change(6 months)
- improved life style(6 months)
研究者
Lydia edward aziz zakhary
lecturer
Ain Shams University