A Prospective Randomized Comparative Trial of Targeted Injection Via a Transforaminal Approach With Dexamethasone Versus an Epidural Catheter Via an Interlaminar Approach With Particulate Steroid for the Treatment of Cervical Radicular Pain
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- The Percentage of Participants With Reduction of 50% or More of Neck and Arm Pain NRS Score
研究概览
简要总结
Do cervical epidural steroid injections done by transforaminal catheter targeted approach improve pain and function in patients with cervical radicular pain?
详细描述
Two distinct techniques used to administer epidural steroids specifically to the nerve root affected in a radicular pain syndrome, which include transforaminal access at the level of pathology and interlaminar interlaminar access at the C7-T1 level with subsequent advancement of an epidural cathether to the level of pathology. Use of an epidural catheter is necessary in order to achieve a targeted injection via an interlaminar approach in order to prevent dural puncture or direct spinal cord trauma. Anatomic studies confirm the distance between the ligamentum flavum and dura is on average, 4 mm at the C7-T1 or C6-C7 levels, but 1mm or smaller at C5-C6 and more rostral levels. Therefore, there is likely greater risk of dural puncture and spinal cord injury when "targeting" steroid delivery using only the interlaminar technique directly at the level where pathology is located (C4-C5, or C5-C6, for example). Thus, the interlaminar placement of a needle rostral to the C6-C7 level has been strongly discouraged.
Both the transforaminal injection approach and the targeted catheter approach demonstrate effectiveness. Studies have demonstrated the effectiveness of transforaminal epidural steroid injection for the treatment of cervical radicular pain. Our own recent work demonstrates the clinical effectiveness of the catheter-based targeted approach. However, these two approaches have never been directly compared. Thus, we aim to compare the differences in pain reduction, medication utilization, functional outcomes, patient satisfaction, and surgical rate reduction between these two approaches to the treatment of cervical radicular pain.
Cervical radicular pain is a common syndrome, often treated with epidural steroid injection (ESI). An approach that targets the therapeutic agent, corticosteroid, at the site of spinal pathology can be performed via a transforaminal approach or via a interlaminar approach at C7-T1 with subsequent epidural catheter advancement to the symptomatic level. There are no universal guidelines that recommend the use of one technique over the other. We will directly compare the clinical effectiveness of these two approaches as measured by pain reduction, medication utilization, functional outcomes, patient satisfaction, and surgical rate reduction. The results of this study will potentially influence clinical practice recommendations regarding the treatment of cervical radicular pain. If one technique proves superior, instating this technique will have implications potentially for reducing opioid use, surgery and other healthcare utilization, and general healthcare cost related to the treatment of cervical radicular 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
- Single (Participant)
盲法说明
Each subject will be randomized into a group assignment in a 1:1 manner, #1 or #2, as outlined in the Methods section
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of unilateral C4-C8 radicular pain.
- •Magnetic resonance imaging pathology consistent with clinical symptoms/signs.
- •Numerical Rating Scale (NRS) pain score of 4 or higher.
- •Pain duration of more than 6 weeks despite trial of conservative therapy (medications, physical therapy, or chiropractic care).
排除标准
- •Refusal to participate, provide consent, or provide follow-up information for the 6-month duration of the study.
- •Contraindications to Cervical Epidural Steroid Iinjection (CESI) (active infection, bleeding disorders, current anticoagulant or antiplatelet medication use, allergy to medications used for Cervical epidural steroid injection (CESI), and pregnancy).
- •Cervical spinal cord lesions; cerebrovascular, demyelinating, or other neuro-muscular muscular disease.
- •Current glucocorticoid use or Epidural Steroid Injection (ESI) within past 6 months.
- •Prior cervical spine surgery.
- •Patient request for or requirement of conscious sedation for the injection procedure.
研究组 & 干预措施
Transforaminal ESI with dexamethasone
Group 1: Transforaminal cervical ESI with dexamethasone sodium phosphate
干预措施: Transforaminal ESI with dexamethasone (Procedure)
Transforaminal ESI with dexamethasone
Group 1: Transforaminal cervical ESI with dexamethasone sodium phosphate
干预措施: Dexamethasone Sodium Phosphate 10 MG/ML (Drug)
Transforaminal ESI with dexamethasone
Group 1: Transforaminal cervical ESI with dexamethasone sodium phosphate
干预措施: Lidocaine (Drug)
Transforaminal catheter-targeted ESI with triamcinolone
Group 2: Catheter-targeted cervical ESI with triamcinolone acetonide
干预措施: Transforaminal catheter-targeted ESI with triamcinolone (Procedure)
Transforaminal catheter-targeted ESI with triamcinolone
Group 2: Catheter-targeted cervical ESI with triamcinolone acetonide
干预措施: Lidocaine (Drug)
Transforaminal catheter-targeted ESI with triamcinolone
Group 2: Catheter-targeted cervical ESI with triamcinolone acetonide
干预措施: Triamcinolone Acetonide 40mg/mL (Drug)
结局指标
主要结局
The Percentage of Participants With Reduction of 50% or More of Neck and Arm Pain NRS Score
时间窗: 1 month follow up
The Percentage of Participants with Reduction of 50% or More of Neck and Arm Pain NRS score
次要结局
- Neck Disability Index-5(1 month, 3 month, 6 month, and 1 year follow up)
- The Percentage of Participants Reporting Patient Global Impression of Change Score of 6-7 (Indicating "Much Improved" and "Very Much Improved")(1 month, 3 month, 6 month, and 1 year follow up)
- Percentage of Participants Reporting >6.8 Reduction on the Medication Quantification Scale III(1 month, 3 month, 6 month, and 1 year follow up)
研究者
Zack McCormick
Zachary L. McCormick, MD
University of Utah
