CTRI/2025/01/079751尚未招募4 期
Comparative Evaluation of Cervical Epidural Adhesiolysis and Selective Nerve Root Block in Managing Chronic Pain of Cervical Post-Surgery Syndrome: An Exploratory Pilot Study.
未提供1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年2月23日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Pain relief as assessed by Numerical Rating Scale (NRS) on a scale of 1-10
研究概览
简要总结
This pilot study compares the effectiveness and safety of cervical epidural adhesiolysis and selective nerve root block in managing chronic pain in cervical post-surgery syndrome. Primary outcomes include pain relief, functional improvement, and safety, aiming to guide treatment optimization for Cervical post surgery syndrome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Had cervical surgery performed at least one year before enrollment.
- •(cervical pain either persisting despite surgical intervention or appearing after surgical intervention) Had a history of chronic, function-limiting neck and upper extremity pain lasting for at least 6 months following surgery.
- •Pain unresponsive to conservative treatment including medical management, physical therapy, and previous interventions.
- •Average pain score of more than 4 on an 11 point NRS.
- •competent to understand the study protocol.
- •Will be willing to provide voluntary, written informed consent and willing to participate in the assessment of outcome measurements.
排除标准
- •Patient refusal Pain for less than 6 months Coagulopathy and/or patients on anticoagulants.
- •Infection at the site of injection.
- •Hypersensitivity to local anesthetic agent.
- •Evidence of severe psychiatric illness.
- •Absence of prior cervical spine surgery.
- •Uncontrolled or unstable opioid use Any conditions that might compromise the interpretation of outcome assessments.
- •Pregnancy or lactation.
- •History of any major comorbid medical conditions, those interfere with recording of study outcomes (neurological disorders, auto-immune diseases), multiple sclerosis, and pregnancy.
结局指标
主要结局
Pain relief as assessed by Numerical Rating Scale (NRS) on a scale of 1-10
时间窗: at baseline and 3 months
次要结局
- Improvement in functional status as measured by Neck disability index at(respective time intervals.)
- Analgesic usage(Procedural complications (if any))
研究者
DR AJIT KUMAR
AIIMS Rishikesh
研究点 (1)
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