Pulsed Epidural Radiofrequency Versus Epidural Steroid Injection in Patients With Failed Back Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 131
- 试验地点
- 4
- 主要终点
- Change in pain intensity measured by Visual Analogue Scale (VAS)
研究概览
简要总结
This study is for people who continue to have low back pain after spinal surgery, a condition called persistent spinal pain syndrome type II. Current treatments, such as epidural injections, often provide only limited relief. Doctors are testing a procedure called pulsed radiofrequency (PRF), given through a small catheter in the epidural space, with or without the addition of corticosteroids. The goal is to see if this treatment can reduce pain and improve daily function better than standard injections. About 130 patients took part, and their pain and quality of life were followed for several months after the procedure.
详细描述
Persistent spinal pain syndrome type II (PSPS II) is a frequent and disabling condition encountered in Pain Units after lumbar surgery. Conventional therapeutic options such as epidural corticosteroid injections and epidurolysis often provide only partial or temporary benefit. Pulsed radiofrequency (PRF) delivered through a catheter into the epidural space has shown promising results compared to transforaminal approaches, offering a potential alternative for managing this challenging pain condition.
The purpose of this randomized, controlled, multicenter clinical trial is to evaluate the efficacy and safety of epidural PRF with or without the addition of corticosteroids in patients with PSPS II. A total of 131 patients were enrolled and assigned to receive either epidural corticosteroids alone or PRF combined with corticosteroids. Pain intensity, functional status, neuropathic pain features, and global impression of improvement were assessed at multiple follow-up visits. The findings of this study aim to provide evidence-based guidance for interventional pain management in PSPS II.
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
- Single (Participant)
盲法说明
Participants were blinded to treatment assignment. Care providers and investigators were aware of group allocation in order to perform the procedures. No additional parties were masked.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women over 18 years old.
- •Written informed consent obtained according to ICH/GCP and Spanish legislation prior to any study procedure.
- •Pain VAS score of at least 5 points.
- •Duration of pain lasting at least 3 months after back surgery despite conservative treatment.
- •Leg-dominant radicular pain deemed neuropathic based on clinical history and examination.
- •Responsiveness to selective radicular nerve block with bupivacaine 0.125%.
- •Previous epidural steroid injection.
排除标准
- •1. Pregnancy or lactation.
- •Participation in a study involving medicines or other clinical devices
- •Inability to follow instructions or collaborate during the study.
- •Findings in physical examination, clinical analysis abnormalities, or other medical, social, or psychosocial factors that, in the researcher's opinion, could negatively influence study outcomes
- •Presence of myelopathy, systemic diseases, infection (systemic or local), cancer, indication for immediate surgery, coagulation disorders, anticoagulants use, diabetes mellitus or multiple sclerosis.
- •7. Life expectancy of less than one year.
- •Current diagnosis of a progressive neurological disease.
研究组 & 干预措施
Experimental Arm
Participants received epidural pulsed radiofrequency with corticosteroid injection.
干预措施: Epidural Pulsed Radiofrequency (Procedure)
Experimental Arm
Participants received epidural pulsed radiofrequency with corticosteroid injection.
干预措施: Betamethasone (Epidural Corticosteroid Injection) (Drug)
Control Arm: Epidural Corticosteroid Injection
Participants received an epidural injection of 12 mg betamethasone in 8 ml sterile saline without pulsed radiofrequency.
干预措施: Betamethasone (Epidural Corticosteroid Injection) (Drug)
结局指标
主要结局
Change in pain intensity measured by Visual Analogue Scale (VAS)
时间窗: Baseline to 6 months (with assessments at 1, 2, 4, and 6 months).
Change in pain intensity measured by the Visual Analogue Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain).
次要结局
- Change in neuropathic pain measured by DN4 questionnaireeuropathic pain, as measured by DN4 questionnaire(Time Frame: Baseline to 6 months (assessments at 1, 2, 4, and 6 months).)
- Change in functional disability measured by Oswestry Disability Index (ODI)(Baseline to 6 months (assessments at 1, 2, 4, and 6 months))
- Change in overall improvement measured by Patient Global Impression of Improvement (PGI-I) questionnaire(Baseline to 6 months (assessments at 1, 2, 4, and 6 months).)
研究者
Agustin Mendiola de la Osa
MD, PhD, MBA, FIPP, CIPS, EDPM
Puerta de Hierro University Hospital