Effect of Post-Radiofrequency Corticosteroid Injection on the Incidence of Post-Neurotomy Neuritis: A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- The incidence of post-neurotomy neuritis (PNN) in patients undergoing radiofrequency neurotomy with and without post-RFN local corticosteroid injection
研究概览
简要总结
The purpose of this study is to compare the incidence of post-neurotomy neuritis (PNN) in adult patients undergoing radiofrequency neurotomy (RFN) for spine facet and sacroiliac joint pain, comparing those who receive a local corticosteroid injection after the procedure with those who do not. Participants are randomly assigned to receive either local anesthetic with dexamethasone or local anesthetic alone at the treatment sites. Pain scores, functional disability, and adverse events are evaluated before the procedure and at 4 weeks follow-up.
详细描述
Spine-related pain, including cervicalgia, dorsalgia, and lumbalgia, represents a major clinical challenge. Low back pain affects a substantial proportion of the global population and is associated with reduced physical activity and functional limitations in activities of daily living. Facet joint arthropathy is a frequent cause of axial spine pain resulting from repetitive biomechanical stress, local inflammation, and synovitis. Radiofrequency neurotomy (RFN) of the medial branch nerves is an established, minimally invasive interventional modality for managing recalcitrant facet pain.
Although RFN is generally safe, post-neurotomy neuritis (PNN)-a neuropathic condition characterized by burning, dysesthesia, or sunburn-like pain along the treated distribution-remains an important post-procedural complication. Reported incidence rates vary widely, and symptoms may persist for weeks to months. To mitigate PNN, clinicians frequently administer local corticosteroids through the cannula immediately following thermal lesioning; however, existing literature presents conflicting evidence regarding its efficacy, with reported outcomes ranging from significant risk reduction to no apparent protective effect.
This randomized, double-blind, parallel-group controlled trial evaluates whether local corticosteroid administration following RFN reduces the incidence of PNN in adult patients undergoing radiofrequency denervation for cervical, thoracic, lumbar facet, or sacroiliac joint pain at Siriraj Hospital.
Following confirmation of eligibility and written informed consent, enrolled participants are randomized into two parallel groups. All procedures are performed under fluoroscopic guidance by boarded-certified pain specialists using an 18-gauge, 100-mm RF cannula with a 10-mm active tip. Proper positioning is verified via multiplanar fluoroscopy, accompanied by motor and sensory electrical stimulation testing. Lesioning is conducted with a Boston G4 RF Generator, delivering two cycles per target site at 80°C for 3 minutes per cycle.
Following neurotomy, injectates are prepared by an unblinded independent physician to maintain allocation concealment :
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patient who aged equal and over 18 years old
- •Patient who scheduled for cervical, thoracic, and lumbar medial branch RFN and sacral lateral branch RFN
- •Patient who communicated effectively, demonstrated good understanding of questions and provided appropriate responses
排除标准
- •Contraindications to corticosteroids: Patients with a known allergy or hypersensitivity to dexamethasone or other glucocorticoids
- •Contraindications to local anesthetics: Patients with a history of severe allergic reactions to amide-type local anesthetics (e.g., bupivacaine)
- •Active Infection: Presence of localized infection at the planned injection site or systemic infection (sepsis) that may contraindicate the procedure
- •Coagulopathy: Patients with uncorrected bleeding disorders or those unable to safely discontinue anticoagulant/antiplatelet medications according to standard procedural guidelines
- •Pregnancy or Lactation: Pregnant or breastfeeding women, due to potential risks associated with radiation (fluoroscopy) and medication exposure
- •Recent Corticosteroid Exposure: Patients who have received systemic or local corticosteroid injections at the target site within the past 3 months, which may interfere with the study outcomes
- •Unstable Neurological Conditions: Patients with progressive neurological deficits or acute radiculopathy that requires urgent surgical intervention
研究组 & 干预措施
Non-steroid group
In the non-steroid group, same 0.5% bupivacaine volume was diluted with normal saline in same volume to dexamethasone of steroid group for injectate volume corresponding to the number of lesion sites after complete radiofrequency neurotomy
干预措施: Normal Saline (Drug)
Steroid group
In the steroid group, dexamethasone was mixed with 0.5% bupivacaine to achieve dexamethasone approximated 1.5 mg/ml/level for injectate volume corresponding to the number of lesion sites after complete radiofrequency neurotomy
干预措施: Dexamethasone (Drug)
结局指标
主要结局
The incidence of post-neurotomy neuritis (PNN) in patients undergoing radiofrequency neurotomy with and without post-RFN local corticosteroid injection
时间窗: 4 weeks post-procedure
The incidence of post-neurotomy neuritis (PNN) in patients undergoing radiofrequency neurotomy (RFN) at cervical, thoracic, lumbar facet and sacroiliac joint with and without post-RFN local corticosteroid injection (Post-neurotomy neuritis ; PNN is new-onset neuropathic-type pain which is tingling, numbness, burning, shooting, sunburn-like or confused signals from the degenerating nerve lasting ≥ 48 hours and occurring within 2 weeks after RFA)
次要结局
- Mean Pain Score Assessed by the Numerical Rating Scale (NRS-11)(Baseline and 4 weeks post-procedure)
- Functional Disability Score Assessed by ODI or NDI(Baseline and 4 weeks post-procedure)
- Incidence of Procedural Complications and Adverse Events(Up to 4 weeks post-procedure)
- Total Duration of Post-Neurotomy Neuritis (PNN) Symptoms(Up to 4 weeks post-procedure)
研究者
Kanuengthip Chuensurat
Anesthesiologist
Siriraj Hospital