跳至主要内容
临床试验/NCT05719948
NCT05719948已完成不适用

Combined Continuous and Pulsed Radiofrequency Ablation for Pain Relief and Their Safety in Cervical Facet Pain

Fayoum University Hospital2 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2020年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
43
试验地点
2
主要终点
neck disability index pre and post-intervention between comparison groups

研究概览

简要总结

Continuous radiofrequency ablation (CRF) is the effective management for cervical facet joint pain but related with neuropathic symptoms in post-radiofrequency period. Additionally, pulse radiofrequency ablation (PRF) provides relief of neuropathic symptoms. However, the effect of CRF followed by PRF has yet to be validated

详细描述

Diagnostic procedure symptomatic facet joint was designated according to pain referral. Also, medial branches were injected with 2% lidocaine 0.3 ml per site.

Treatment procedure The posterior technique was first described in 1995 . All interventions assessed the intravenous saline lock on arrival at the outpatient department using pulse oximetry and noninvasive blood pressure monitoring and intravenous sedation as required. Patients were assigned in a prone position under C-ARM fluoroscopic guidance with a Neurotherm NT 2000 Lesion Generator the (USA manufactured) . The electrode pad of the radiofrequency equipment was attached to the ipsilateral side of the posterior thigh. After the skin was then anesthetized with 1% lidocaine, a 20-gauge, 10-cm cannula with 10-mm curved active tip (Diros RF Cannula, Diros Technology Inc., Canada) was inserted along a 15 to 30 degree angle to the sagittal plane (slightly posterior oblique approach) . The cannula was applied until reaching the lateral part of the articular pillar . Then the depth of the cannula was checked using a lateral view. A probe was inserted through the cannula and linked to a radiofrequency generator (Diros Technology OWL, Canada). After impedance were accomplished at below 500 Ohm, sensory stimulation was performed at 50 Hz and the patient reported not feeling any tingling sensation along the distribution of dermatome. Consequently, a motor stimulation (2 Hz) was executed until multifidus twitching was presented at stimulation less than 1 volts and no motor twitching was observed along the myotome. A non-ionic contrast medium was injected to ensure the intravascular injection before 1% lidocaine 0.5 ml was injected after the needle reached the desired location. The study investigated two lesions due to the anatomical variation of the medial branches. Patients in the CRF group (n = 16) underwent CRF at 80°C for 90 seconds for 2 cycles. Patients in the CPRF group underwent CRF at 80°C for 90 seconds for 1 cycle followed by PRF at 42°C for 120 seconds for 1 cycle. 0.125% bupivacaine plus 2 mg of dexamethasone in a total volume of 1 mL were injected after lesioning had performed.

Measurement The demographic data including age, sex, comorbidities, body mass index (BMI), level of procedure, visual analog scale (VAS;1-100) Neck Pain Disability Index and complications were reviewed. It contains ten sectors: seven sectors related to everyday existing behaviors, two sectors correlated to pain, and one sector correlated to concentration. All items are marked from 0 to 5. A mark of 0 denotes the maximum level of function, while a mark of 5 indicates the bottom level of function. The maximum mark is 50, and a greater mark relates to an increased level of disability. The NDI scores were recorded before intervention and first month, third month, sixth month, ninth months and 12 months after intervention. The follow-up was performed either face to face or by phone, and patients were not permitted to use over-the counter analgesic medication. The primary outcome was number of patients who had successful treatment, expressed as at least 80% pain relief from baseline and NDI score less than 15 for at least 3 months . The secondary outcomes comprised the duration of pain relief defined as the time of pain relief until VAS had restored to at least 50% from baseline and side effects including numbness, ataxia, dysesthesia, hypersensitivity, itching and muscular weakness (dropped head syndrome) between group comparisons. A research assistant, who was uninvolved in the intervention or post-operative follow-up, collected all data in prospective medical records.

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 (Investigator, Outcomes Assessor)

盲法说明

None of the investigator or outcomees assessor know the intervention used

入排标准

年龄范围
30 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients age from (30-75) years old.
  • ASA ( I, II).
  • Patients presenting positive diagnostic cervical medial branche block defined as pain relief more than 50% from baseline.

排除标准

  • Repeated cervical radiofrequency ablation.
  • Patients presenting neck pain with radicular symptoms.
  • Previous cervical discectomy or fixation surgery.
  • Malignancy.
  • local infection
  • Psychological problem.
  • language barrier.
  • History of allergy to radio-opaque contrast solution,lidocaine or bupivacaine. - Inadequate medical proplem (hepatic, renal, cardiac) patients.

结局指标

主要结局

neck disability index pre and post-intervention between comparison groups

时间窗: 12 months

Neck disability index : It contains ten sectors: seven sectors related to everyday existing behaviors, two sectors correlated to pain, and one sector correlated to concentration. All items are marked from 0 to 5. A mark of 0 denotes the maximum level of function, while a mark of 5 indicates the bottom level of function. The maximum mark is 50, and a greater mark relates to an increased level of disability.

VAS SCORE

时间窗: 12 months

of procedure, visual analog scale (VAS;1-100)

次要结局

  • Complications(One month, 3 months, 6months, 12 months)
  • Duration of pain relief(One month, 3months,6 months, 12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Atef Mohamed Sayed mahmoud

Associate professor

Fayoum University Hospital

研究点 (2)

Loading locations...

相似试验