A Prospective Randomized Controlled Trial of Standardized C7-T1 Epidural Steroid Injections Versus Targeted Injection Via Cervical Epidural Catheter for the Treatment of Cervical Radicular Pain
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 79
- 试验地点
- 1
- 主要终点
- Percentage of Participants With ≥50% Pain Reduction on the Numeric Rating Score (NRS) for Pain
研究概览
简要总结
Cervical radicular pain is a common, disabling problem, occurs in 83:100,000 individuals per year. Symptoms are most often caused by intervertebral disc herniation (21.9%) or central or foraminal stenosis from spondylosis (68.4%). Patients complain of pain in the head, neck, scapula or arm. The diagnosis of radicular pain is made clinically by history and physical examination, supported by imaging studies and electrodiagnostic tests. No study has compared the differences in pain, medication utilization, functional outcomes, or patient satisfaction between interlaminar and targeted epidural injections in the cervical spine. In theory, the technique of targeted epidural steroid delivery with a catheter has a lower risk of accidental vascular trespass or disc penetration during the procedure, and far less risk of dural penetration or spinal cord injury at rostral levels of the cervical spinal cord as compared with the interlaminar technique. The investigators hypothesize that this technique results in superior pain control, decreased medication use, improved function and fewer repeat injections. This data could improve patient safety and affect the evolving treatment guidelines for cervical epidural injections.
详细描述
Cervical radicular pain is a common, painful, disabling problem, often treated by epidural steroid injection (ESI). Two techniques of steroid delivery into the cervical epidural space include the transforaminal and interlaminar approaches. We aimed to determine if the CIESI with versus without a catheter is associated with superior clinical outcomes at follow-up. We hypothesized that the use of a targeted epidural catheter technique would result in superior pain control, function, decreased analgesic use, and lower surgical incidence as compared to standard CIESI at C7-T1.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients ages 18-75 with C2-6 unilateral radicular pain who are scheduled to undergo cervical epidural steroid injection treatment.
- •Pain lasting greater than 2 weeks.
- •Pain resistant to a trial of conservative therapy (i.e. oral steroids,nonsteroidal anti-inflammatory drugs, opioids, muscle relaxants, physical therapy or chiropractic care)
排除标准
- •Patient refusal.
- •Lack of consent.
- •Systemic infection or local infection over planned injection site in posterior cervical spine.
- •Bleeding disorder, current use of anticoagulants or anti-platelet medications.
- •Intrinsic spinal cord lesions in the cervical region.
- •History of central neurologic, cerebrovascular, demyelinating or muscular disease.
- •Concomitant use of oral or injected steroids.
- •Allergy to medications being used for injection procedures.
- •Inability to communicate with staff or to participate in follow up.
- •Pregnancy.
- •Inability to perform handgrip or arm strength testing.
- •Cognitive deficit or motor neuron disease.
- •Daily opiate use that preceded the onset of cervical radicular symptoms or daily opiate use exceeding 3 months prior to study inclusion
研究组 & 干预措施
No Catheter delivery
Cervical epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc.
No Catheter Delivery will be used to deliver the medication.
干预措施: Triamcinolone 80mg (Drug)
Catheter targeted delivery
Cervical epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc.
Catheter targeted delivery will be used to deliver the medication.
干预措施: Triamcinolone 80mg (Drug)
结局指标
主要结局
Percentage of Participants With ≥50% Pain Reduction on the Numeric Rating Score (NRS) for Pain
时间窗: 1 month
The percentage of participants who reported ≥50% pain reduction on the numeric rating score for pain at the 1 month follow-up assessment period. Numeric Rating Scale (NRS) for pain consists of a range where 0 (is no pain) and 10 (is extreme pain). Percentage of participants with pain reduction = 100% (number of participants with pain reduction/all participants)
次要结局
- Decrease of > 6.8 Point Reduction in Medication Quntification Scale (MQS-III)(1 month)
- Patient Global Impression of Change Score (PGIC) Less Than 3(1 month)
- Greater Than or Equal to a 30% Reduction in Oswestry Neck Disability Index Score(1 month)
研究者
David Walega
Associate Professor of Anesthesiology
Northwestern University