CTRI/2024/04/065591招募中2/3 期
Effect of 10% dextrose as an adjuvant in lumbar epidural adhesiolysis : a prospective randomized controlled study
AIIMS, New Delhi1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年4月29日最近更新:
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- NRS for pain (on scale of 0-10)
研究概览
简要总结
| Low back pain is a debilitating condition with a lifetime prevalence of 50-80% and results in severe biopsychosocial impact. Compression of nerves is common in low back pain leading to severe radicular pain and can be due to disc degeneration, spinal stenosis, inflammation and epidural adhesions. Post lumbar laminectomy syndrome or failed back surgery syndrome can affect up to 40% of patients and epidural fibrosis is thought to contribute to 60% of such cases . Adhesiolysis is a commonly performed procedure for such conditions which releases the nerve from entrapment. It is performed by a specialized spring coiled catheter (Racz catheter) which breaks the fibrous tissue my mechanical means and use of hyaluronidase. Epidural steroids are given afterwards to reduce inflammation, but may cause side effects like increases blood sugar levels, hypertension, water retention, lowering of immunity and infections. Dextrose is now being commonly employed for chronic pain conditions. The postulated mechanisms of dextrose in managing chronic pain include tissue regeneration, sensorineural effect, reduction of sensitization and hydrodissection All these factors may help in adhesiolysis procedure and attenuation of pain. We hypothesize that epidural administration of 10% dextrose would result in better pain relief than steroid after epidural adhesiolysis in patients with chronic lumbar radicular pain |
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Low back with radicular pain more than 6 months with pain of 6 or more on 11 point NRS scale
- •Radicular pain present post lumbar spine surgery evident by MRI imaging and clinical examination
- •Failure to respond to conservative therapy and fluoroscopic guided epidural injections
- •Filling defects observed on contrast injection during previous epidural steroid injections.
排除标准
- •Pain due to facet joint, sacroiliac joint or myofascial pain
- •Sequestered disc
- •Foraminal stenosis
- •Allergy to contrast or local anesthetics
- •Pregnant patients
- •Bleeding or coagulation disorders
- •Uncontrolled systemic disorders
- •Opioid addiction of psychiatric disorders.
结局指标
主要结局
NRS for pain (on scale of 0-10)
时间窗: Preprocedure | 15 days, 1, 3 and 6 months post procedure
次要结局
- Oswestry Disability Index score(Preprocedure)
- Successful outcome(Preprocedure)
- Reduction in medication usage(Preprocedure)
研究者
Dhruv Jain
All India Institute of Medical Sciences, New Delhi
研究点 (1)
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