Ultrasound-Guided Genicular Nerve Block for Knee Osteoarthritis: A Double-Blind, Randomized Controlled Trial of Corticosteroid v/s Phenol Neurolysis
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Assess and compare the reduction in knee pain during activities of daily living using NPRS between two treatment groups
研究概览
简要总结
This clinical study is a Double Blinded Randomized, active controlled, parallel group trial designed to evaluate and compare the efficacy of 6 percent phenol for ultrasound guided genicular nerves neurolysis v/s combination of local anesthetic with corticosteroid for treatment of patients with chronic knee pain due to osteoarthritis. This study will be conducted in department of Physical Medicine and Rehabilitation at AIIMS, New Delhi
A total of 30 participants having osteoarthritis knee with KL grade 3 or 4 radiographic changes and having Knee pain with NPRS more than 5 during activities of daily living will be enrolled in the study and randomized equally into two groups.
The intervention group will receive 6 percent phenol and active control group will receive combination of local anesthetic and corticosteroid perineural around 3 genicular nerves namely superomedial, inferomedial and superolateral genicular nerves under ultrasound guidance. All patients will be given standard medical and rehabilitation program comprising of lifestyle modification, home based exercise protocol, knee orthosis as required. Patient will be followed up at 2 weeks, 1 month, 2 months after injection.
Medical treatment will be continued to all patients in both groups for entire period of study. If patient in either group developed pain with NPRS more than 5 during study period, tablet paracetamol 500 mg PO SOS to maximum of 500 mg qid can be given as rescue medication.
Primary outcome of the study include pain in knee during activities of daily living using NPRS. Secondary outcomes include KOOS score, patient satisfaction score, amount of rescue medications taken
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
- 40.00 Year(s) 至 80.00 Year(s)(—)
- 性别
- All
入选标准
- •Adult patients having OA knee (as diagnosed by American College of Rheumatology 1986 clinical and radiographical criteria for OA knee) with KL grade 3 or 4 radiographic changes Pain Knee (NRS more than 5) during activities of daily living Patients willing to participate in the study.
排除标准
- •Patient refusal Uncontrolled Diabetes mellitus or immunosuppression Local site infection or systemic infection Allergy to Local Aesthetics Coagulopathy Cognitive or behavioral abnormalities Inflammatory arthritis (Rheumatoid arthritis, Gout) Radicular pain from spine or hip joint.
结局指标
主要结局
Assess and compare the reduction in knee pain during activities of daily living using NPRS between two treatment groups
时间窗: day 0, day 14, day 30, day 60
次要结局
- Evaluate and compare functional improvement using KOOS score following both treatment modalities(Assess and compare patient satisfaction with each treatment approach using patient satisfaction score)
研究者
Dr Shiv Lal Yadav
All India Institute of Medical Sciences, New Delhi
