Pilot Study of Transforaminal Epidural Injection of Clonidine for the Treatment of Acute Lumbosacral Radiculopathy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Pain Intensity Score at 4 Weeks as Measured by Pain Intensity Numerical Rating Scale (PI-NRS)
研究概览
简要总结
This was a randomized, blinded study of transforaminal epidural injection of clonidine versus a similar injection of corticosteroid for acute lumbosacral radiculopathy. The hypothesis was that clonidine will be as effective as steroid for this condition.
详细描述
Patients with approximately 3 months of low back pain and leg pain due to intervertebral disc herniation were randomized to transforaminal epidural injections of 2% lidocaine and either clonidine (200 or 400 micrograms) or triamcinolone (40 mg) (corticosteroid). Patients received one to three injections administered at about 2 weeks apart. Patients, investigators, and study coordinators were blinded to the treatment. The primary outcome was an 11-point Pain Intensity Numerical Rating Scale at 1 month. The hypothesis was that clonidine will be as effective as steroid for this condition.
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
- Quadruple (Participant, Care Provider, 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
- 是
入选标准
- •Residents 18 years or older of Olmsted or contiguous counties and identified as having an acute unilateral radicular syndrome of less than 3 months duration (leg pain>back, discogenic cause, one or more of the following:
- •Positive Straight Leg Raise (SLR) test
- •Myotomal weakness
- •Dermatomal sensory loss) and with concordant
- •Confirmatory findings on recent MRI or CT myelogram
排除标准
- •History of recent spinal trauma
- •Cauda equina syndrome (This is a serious neurologic condition in which there is acute loss of function of the lumbar plexus, neurologic elements of the spinal canal below the termination of the spinal cord.)
- •Progressive neurological deficit
- •Motor deficit
- •Pathological or infectious etiology
- •Involvement in workers' compensation claim
- •History of adverse reaction to corticosteroids, local anesthetic or clonidine
- •History of one or more corticosteroid injection(s) (equivalent to 40 mg of triamcinolone acetate) in the preceding 4 months
- •Severe medical disease
研究组 & 干预措施
Clonidine
Transforaminal epidural clonidine injection
干预措施: Clonidine (Drug)
Clonidine
Transforaminal epidural clonidine injection
干预措施: Lidocaine HCl (Drug)
Steroid
Transforaminal epidural steroid injection
干预措施: Triamcinolone hexacetonide (Drug)
Steroid
Transforaminal epidural steroid injection
干预措施: Lidocaine HCl (Drug)
结局指标
主要结局
Pain Intensity Score at 4 Weeks as Measured by Pain Intensity Numerical Rating Scale (PI-NRS)
时间窗: 4 weeks
11-point ordinal scale measuring patient pain, ranging from 0 (no pain) to 10 (most severe/disabling pain).
次要结局
- Pain Intensity Score at 2 Weeks as Measured by Pain Intensity Numerical Rating Scale (PI-NRS)(2 weeks)
- Pain Disability Score at 2 Weeks as Measured by the Roland-Morris Disability Questionnaire(2 weeks)
- Pain Disability Score at 4 Weeks as Measured by the Roland-Morris Disability Questionnaire(4 weeks)
- Pain Disability Score at 2 Weeks as Measured by Oswestry Low Back Pain Disability Questionnaire (ODI)(2 weeks)
- Pain Disability Score at 4 Weeks as Measured by Oswestry Low Back Pain Disability Questionnaire(4 weeks)
- Pain Score at 2 Weeks as Measured by the Multidimensional Pain Inventory (MPI)(2 weeks)
- Pain Score at 4 Weeks as Measured by the Multidimensional Pain Inventory (MPI)(4 weeks)