Transforaminal Epidural Steroid Injection in Conjunction With Pulsed Radiofrequency Treatment of the Lumbar Dorsal Root Ganglion for the Management of Chronic Lumbosacral Radicular Pain: a Randomized, Double-blind Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 120
- 主要终点
- pain scores
研究概览
简要总结
The purpose of this study is to examine the potential changes in levels of pain, quality of life (QoL) and activities of daily living (ADL) observed when transforaminal epidural steroid injection is administered in conjunction with pulsed radiofrequency treatment of the lumbar dorsal root ganglion during the initial 3 months follow-up period. Safety (monitoring side effects) of the treatment is determined.
The study hypothesis is that the application of transforaminal epidural steroid injection (TFESI) in conjunction with pulsed radiofrequency treatment (PRF) treatment of the lumbar dorsal root ganglion would increase the treatment response of PRF and thereby provide a measurable difference in the pain scores, quality of life and activities of daily living for the patients suffering from chronic lumbosacral radicular pain.
详细描述
The study sample:
120 (one hundred and twenty) patients diagnosed with chronic lumbosacral radicular pain were elected by their pain specialists to undergo pulsed radiofrequency treatment adjacent to lumbosacral dorsal root ganglion(s). A patient with radicular pain affecting more than one segment on one side will be treated for all the involved segments with the same technique and this will be considered a single intervention for the study.
60 (sixty) patients (the experimental Celestone group) undergoing pulsed radiofrequency treatment will receive transforaminal epidural injection of the solution of 1 cc of Lidocaine 1% with 1 cc of Celestone Chronodose around each dorsal root ganglion immediately after the radiofrequency treatment has been performed. 60 (sixty) patients (the control group) undergoing pulsed radiofrequency treatment will receive transforaminal epidural injection of the solution of 1 cc of Lidocaine 1% with 1 cc of normal saline around each dorsal root ganglion immediately after the radiofrequency treatment will be performed.
Randomization and blinding:
Patients will be randomly assigned to the Celestone group (N = 60) or the control group (N = 60). The allocation of patients into either group will be performed using a computer-generated randomization program. Each patient's randomization number will be concealed until the end of the study from both the patients and the outcome assessor, who will be an independent research coordinator at the investigators pain clinic. The patients will be explained that they will not know which medicine they will receive until the study completion.
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
- Triple (Participant, 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
- 否
入选标准
- •men and women
- •age ≥18 years old,
- •pain intensity≥4 out of 10 on the numerical rating scale (NRS),
- •chronic lumbosacral radicular pain lasting ≥12 weeks,
- •dominant leg pain with less intense back pain,
- •the previous failure of conservative management such as physiotherapy, exercise therapy, or analgesic medications.
- •segmental pain of a radicular nature originating from the lumbar segments and with a shooting or lancinating quality corresponding to a dermatome suggestive of the involved nerve root.
- •availability of computed tomography/magnetic resonance imaging findings of pathology concordant with the side and level of their clinical features.
排除标准
- •patient refusal to participate in the study,
- •age <18 years,
- •pregnant or nursing
- •pain <4-points on NRS,
- •acute pain of onset lasting<12 weeks,
- •progressive motor weakness in the affected leg,
- •allergies to local anesthetics, contrast dyes or steroids
- •significant anatomic deformity (either congenital or acquired) making it difficult to access the foramen as evidenced by computed tomography/magnetic resonance imaging
- •presence of cancer accounting for back pain
- •patients with platelet dysfunction, bleeding disorder or continuing anticoagulant treatment
- •steroid injection within the previous 12 weeks,
- •systemic infection,
- •injection site infection,
- •unstable medical or psychiatric condition
研究组 & 干预措施
Celestone
all patients of the experimental Celestone group will receive transforaminal epidural injection of the solution of 1 cc of Lidocaine 1% with 1 cc of Celestone® Chronodose® around each dorsal root ganglion immediately after the radiofrequency treatment has been performed.
干预措施: Celestone (Drug)
Celestone
all patients of the experimental Celestone group will receive transforaminal epidural injection of the solution of 1 cc of Lidocaine 1% with 1 cc of Celestone® Chronodose® around each dorsal root ganglion immediately after the radiofrequency treatment has been performed.
干预措施: pulsed radiofrequency treatment (Procedure)
Control
all patients of the control group will receive transforaminal epidural injection of the solution of 1 cc of Lidocaine 1% with 1 cc of normal saline around each dorsal root ganglion immediately after the radiofrequency treatment will be performed.
干预措施: pulsed radiofrequency treatment (Procedure)
Control
all patients of the control group will receive transforaminal epidural injection of the solution of 1 cc of Lidocaine 1% with 1 cc of normal saline around each dorsal root ganglion immediately after the radiofrequency treatment will be performed.
干预措施: Control (Drug)
结局指标
主要结局
pain scores
时间窗: before the procedure and at 1, 2 and 3 months after the treatment
Changes in pain scores, as reported by the patients via the NRS scores, will be analyzed before the procedure and at 1, 2 and 3 months after the treatment
quality of life and activities of daily living
时间窗: before the procedure and at 1, 2 and 3 months after the treatment
The potential changes in quality of life and activities of daily living will be measured by validated Roland Disability Questionnaire or Oswestry Disability Index scores
次要结局
- adverse events(immediately and for up to 72 hours after the treatment)
研究者
Dr. Vadim Tashlikov
Senior Doctor
Sheba Medical Center