Ultrasound-Guided Microendoscopic Versus Fluoroscopic-Guided Lumbar Transforaminal Epidural Steroid Injections: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Intervention success rate
研究概览
简要总结
The purpose of this study is to compare the Microendoscopic combined with ultrasound technique to the standard routinely used X-ray guided transforaminal steroid injection technique.
详细描述
After being informed about the study and potential risks, all patients giving written informed consent will undergo screening to determine eligibility. Patients who meet the eligibility criteria will be randomized in a double-blind manner to two groups. Patients assigned to Group A will undergo a fluoroscopy guided procedure while patients in Group B will undergo a microendoscopic combined with ultrasound technique.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 64 years old of either sex
- •Disease status of American Society of Anesthesiologists grades I to II
- •Patients presenting with single-level disc disease and radiculopathy (L2-L3; L3-L4; L4-L5) for steroid injection
- •Confirmation of herniated disk by CT or MRI
- •Able to give informed consent
排除标准
- •Age under 18 or over 64 years old
- •Pregnant women
- •Disease status of American Society of Anesthesiologists grades III to IV
- •Unable to provide an informed consent
- •Radiculopathies at multiple spinal levels
- •Non-lumbar herniated discs
- •Clinically obvious or known spinal deformity or stenosis
- •Previous spine surgery
- •Local or systemic infection
- •Allergy to steroids, anesthetics, or contrast material
- •Uncorrectable coagulopathy and patients on anticoagulation therapy
- •Patients who refuse the procedure
- •Spine tuberculosis or tumors
- •Prior injections within 3 months
结局指标
主要结局
Intervention success rate
时间窗: During the procedure.
The success of the procedure would be indicated by a questionnaire (yes/no answer). This includes the success of visualization under ultrasound and the insertion of the needle within the target position.
次要结局
- NRS pain score(Before procedure, 30 minutes after the procedure, 1 week and 3 weeks after the procedure.)
- Complications(During procedure.)
- Ultrasound visibility(During procedure.)
- Patient satisfaction(3 weeks after discharge.)
- Procedure time(Beginning of procedure till the end.)
研究者
Marwan Rizk
Principal Investigator
American University of Beirut Medical Center