Impact OF Cooled Versus Thermal Radiofrequency Denervation In Management Of Chronic Lumber Facet Joint Pain.Prospective Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in pain intensity
研究概览
简要总结
Chronic lumber facet joint pain is defined according to international association of study of pain (IASP)as multifactorial phenomenon of pain that persist more than 3 months after an injury and /or beyond the usual course of an acute lumber facet pain or a reasonable time for a comparable injury to heal .
lumber facet joint degeneration (LRFJ) is the 1st source of chronic low back pain with an incidence of 15% t o 45 % among patients with low back pain . the spinal facet joint has an abundant nerve supply ; therefore, pain can be caused by arthritic change, degenerative change, inflammation, and injury .
Degeneration of all LFJs (lumbar facet joints) was diagnosed using magnetic resonance image (MRI) , the most sensitive and diagnostic tool. Thus, hypertrophy, degeneration, and the accumulation of fluid within the joints are signs of LFJ degeneration it was found in all treated LFJs .
facet joint pain management can be achieved using medical therapy or facet joint therapeutic interventions, ultrasound guided injection,or fluoroscopically guided facet joint injection (FJI) , medial branch block (MBB) , or radiofrequency ablation .
Radiofrequency is a minimally invasive procedure and is operated under light
intravenous sedation or local anesthesia when necessary. Radiofrequency
energy is delivered to the target nerves through an insulated needle , and this
energy heats and denatures the nerve for the purpose of pain relief . The
radiofrequency techniques include, thermal, and cooled radiofrequency .
thermal radiofrequency (TRFA) uses more energy and higher temperature compared
with cooled radiofrequency , cooled radiofrequency ablation (CRFA) is a
newer technique, and may have some theoretical advantages over traditional
radiofrequency whereas , cooled radiofrequency adopts internally probes to
increase lesion size , and it can increase the chance of complete denervation .
based on heat neurotomy (60°C (celsius) vs. 80°C in TRFA) with the resulting ablative area twice as long and extending distally from the tip of the electrode.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •Patient's acceptance .
- •Both sexes (male and female).
- •Age between 30 and 70 years .
- •Physical status; ASA I , II. (American society of anesthesiologist)
- •BMI; 22-30 Kg/m
- •Presence of
- •Chronic Lumbar Facet Joint Pain (numerical rating scale (NRS) ≥ 6) lasting for 3 months or more without any response to noninvasive conservative treatment methods like NSAIDs and gabapentin therapy for pain control, or physiotherapy,
- •Patients have two to three levels of bilateral facet arthropathy with normal motor power of lower extremities
- •Local paraspinal tenderness with increased pain on hyperextension, rotation, or lateral bending of the lower lumbar spine.
- •More than or equal to 50% temporary pain relief following an ultrasound guided diagnostic medial branch block with local anesthetic corticosteroid injection.
排除标准
- •Those with spondylolisthesis or disc herniation or internal disc disruption (IDD).
- •Previous spinal surgery at the level to be treated , Spinal canal stenosis or spinal instability.
- •Patient with previous radiofrequency ablation.
- •Patients having radicular pain, neurogenic claudication, or neurological deficits.
- •Coagulopathy, bleeding disorders .
- •Allergy to medications or contrast to be used .
- •Rheumatic disorders.
- •Systemic infections, or local infections in the field of intervention .
- •Any uncontrolled medical or psychiatric condition .
- •Pregnancy, lactating women .
研究组 & 干预措施
thermal radio frequency denervation (T) group
The medial branch of the dorsal spinal ramus is the main target .The fluoroscopy will be then placed at slightly oblique view . An 22-gauge insulated RF needle with 1 cm active tip will be used .the parameters of Radiofrequency Denervation treatment are : the tip temperature being at 80 °C, 45V (volt), the frequency 2 Hz for 120 s, three cycles with rotation of the needle each time. At the end of the radiofrequency(RF)procedure, after the probe is removed , 20 mg methylprednisolone acetate will be given through the RF needle for each level
干预措施: thermal radio frequency denervation (Device)
Cooled Radiofrequency denervation (C) group
Patients will positioned prone with a C-arm fluoroscopy. 22-gauge spinal needles were placed in the appropriate location as lumbar medial branch blocks in Spinal Intervention Society Guidelines . 17-gauge 4 mm active tipped CRFA electrodes were used for the procedure . The CRFA (cooled radio frequency ablation) electrodes were also placed in the appropriate location similar to described as lumbar medial branch blocks procedure, instead of traditional placement of electrodes described as in Spinal Intervention Society Guidelines.The RFA generator temperature set to 60°C (intralesional temperature >80°) for 150 seconds for each
干预措施: Cooled Radiofrequency denervation (Device)
结局指标
主要结局
Change in pain intensity
时间窗: NRS will be detected and recorded immediately 2 hours post intervention and then at 1 week , 1 month , 3 months, and 6 months after intervention .
using a numerical rating scale (NRS) ranging from 0 to 10 (0: "no pain" to 10: "the worse pain")
次要结局
未报告次要终点
研究者
manal mohamed rashad
lecturer
Zagazig University