Continuous Versus Combined Continuous and Pulsed Radiofrequency Ablation for Pain Relief and Safety in Cervical Facet-Mediated Pain: A Prospective Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 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
One prevalent and incapacitating problem seen in pain treatment therapy is chronic neck pain originating from the cervical facet joints. (1). Cervical facet joint pain was shown to be 49% common in a recent study (2). Depending on the level of the cervical facet joint, a facet referral pattern is characteristic of cervical facet joint discomfort (3,4). Radiofrequency (RF) ablation of the medial branch nerves is a proven, minimally invasive therapeutic option for long-lasting pain alleviation once a good response to diagnostic cervical medial branch blocks validates the diagnosis. Cervical facet joint pain has been successfully treated with traditional continuous radiofrequency ablation (RFA) of the cervical medial branches (5). Regretfully, even with sufficient analgesia, over 40% of patients undergoing RFA experience negative side effects, including post-procedural sensory side effects like numbness, dysesthesia, and hypersensitivity. 6,7). As a result, Continuous radiofrequency ablation (CRF) is the established minimally invasive treatment for chronic facet-mediated spinal pain once diagnostic medial branch blocks confirm the pain source, producing a thermal lesion at the target nerve to interrupt nociceptive transmission. Manchikanti et al. rated continuous RFA as Level II evidence for managing chronic spinal pain from the facet joints, reflecting its established role in clinical practice (6). However, despite its efficacy, more than 40% of patients undergoing CRF of the cervical medial branches experience post-procedural sensory side effects such as numbness, dysesthesia, and hypersensitivity (7,8) prompting interest in alternative radiofrequency strategies that preserve analgesic benefit while reducing these neuropathic effects. Combining continuous and pulsed radiofrequency (CPRF) has been proposed as a strategy to preserve the analgesic effect achieved with thermal ablation while reducing the incidence of post-procedural neuropathic side effects through the added neuromodulatory pulsed phase (9). However, there are no studies comparing the effectiveness and safety of pulse versus combined radiofrequency ablation in the cervical facet joint. This study was designed to compare the effectiveness and safety of continuous radiofrequency (CRF) alone versus combined continuous and pulsed radiofrequency (CPRF) in patients with chronic cervical facet joint pain.
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
- 否
入选标准
- •Patients age from (30-75) years.
- •American Society of Anesthesiologists (ASA) physical status class I or II
- •≥ 4 points on the verbal numeric rating scale (VNRS) (scored from 0 = no pain to 100 = worst pain imaginable)) before RF stimulation of the cervical medial branches;
- •Patients presenting with a 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.
研究组 & 干预措施
Flouroscopic guidance cervical medial branch continous RF ablation
After the patient lying prone we obtaining the posterior approach with PA view then lateral 15 degrees the C shaped edge of the cervical vertebrae were appeared and then we advance the needle till reaching this C shaped till hitting the bone then slipping the active tip slightly therafter we obtaining lateral view to determine the depth of the needle over the cervical pedicle.
patients in the continous radiofrequency group will be underwent continous radiofrequency at 80°C for 90 seconds for 2 cycles
干预措施: Flouroscopic guidance cervical medial branch radiofrequency ablation (Procedure)
Flouroscopic guidance cervical medial branch combined pulsed and continous RF ablation
After the patient lying prone we obtaining the posterior approach with PA view then lateral 15 degrees the C shaped edge of the cervical vertebrae were appeared and then we advance the needle till reaching this C shaped till hitting the bone then slipping the active tip slightly therafter we obtaining lateral view to determine the depth of the needle over the cervical pedicle.
patients in the continous and pulsed group will be underwent continous and pulsed radiofrequency at 80°C for 90 seconds for 1 cycle followed by pulsed radiofrequency at 42°C for 120 seconds for 1 cycle
干预措施: Flouroscopic guidance cervical medial branch radiofrequency ablation (Procedure)
结局指标
主要结局
neck disability index pre and post-intervention between comparison groups
时间窗: 6 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.
次要结局
- neck disability index pre and post-intervention between comparison groups(One month)
- neck disability index pre and post-intervention between comparison groups(3 months)
- neck disability index pre and post-intervention between comparison groups(12 months)
- VAS SCORE(One month)
- VAS SCORE(3 months)
- VAS SCORE(12 months)
- VAS SCORE(6 months)
- Duration of pain relief(One month, 3months,6 months, 12 months)
- Complications(One month, 3 months, 6months, 12 months)
研究者
Atef Mohamed mahmoud
Associate professor
Fayoum University Hospital