Effectiveness of Genicular Nerve Block on Pain and Disability in Chronic Knee Osteoarthritis: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Pain intensity
研究概览
简要总结
The goal of this clinical trial is to evaluate whether genicular nerve block (GNB) is effective in reducing pain in patients with knee osteoarthritis. It will also assess the comparative efficacy of different injection protocols.
The main questions it aims to answer are:
Does genicular nerve block with corticosteroid and local anesthetic provide superior pain relief compared with local anesthetic alone or placebo?
Are there differences in clinical outcomes between the three treatment groups?
Researchers will compare three groups:
GNB with corticosteroid plus local anesthetic
GNB with local anesthetic alone
Sham procedure with saline (placebo control)
Participants will:
Receive the assigned injection protocol in accordance with their group
Be evaluated at baseline and scheduled follow-up visits for pain intensity and functional status
Report their pain scores and functional limitations using standardized assessment tools
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 45 and 75
- •diagnosed with knee osteoarthritis (OA) according to the American College of Rheumatology (ACR) criteria
- •possessing a Kellgren-Lawrence radiological grade of 2-3
排除标准
- •any joint injection to the target knee in the past 3 months
- •physical therapy for the target knee within the last 3 months
- •previous knee surgery
- •inflammatory rheumatic diseases
- •active lumbar radiculopathy on the same side
- •neurological disorders (e.g., Alzheimer's or dementia)
- •uncontrolled cardiopulmonary diseases
- •pregnancy or lactation
- •obesity (body mass index [BMI] >35)
- •presence of a pacemaker
- •active malignancy
研究组 & 干预措施
genicular nerve block with local anesthetic
Group 1 (GNB with local anesthetic only): Patients received a genicular nerve block (GNB) with 6 mL of 2% prilocaine and participated in a knee exercise program.
干预措施: Genicular nerve block with prilocaine (Drug)
genicular nerve block with local anesthetic and corticosteroid
Group 2 (GNB with local anesthetic and corticosteroid): Patients received GNB with 5 mL of 2% prilocaine in combination with 1 mL/40 mg of triamcinolone and followed the same exercise regimen.
干预措施: genicular nerve block with prilocaine and triamcinolone (Drug)
sham injection with saline
Group 3 (Control group): Patients received a placebo injection (6 mL of 0.9% saline) with the knee exercise program.
干预措施: Sham injection (Drug)
结局指标
主要结局
Pain intensity
时间窗: at baseline, 1 week, and 1 month after treatment
Visual Analog Scale (VAS): The VAS assesses pain intensity on a 10-centimeter scale. Patients indicate their pain levels using two verbal descriptors at the end of each scale.
次要结局
- Functional status using WOMAC(baseline, 1 week, and 1 month after treatment)
- Functional status using 40-Meter Fast Walking Test(at baseline, 1 week, and 1 month after treatment)
- Pressure Pain Threshold (PPT)(baseline, 1 week, and 1 month after treatment)
研究者
Berna Gunay, MD
Medical Doctor
Haydarpasa Numune Training and Research Hospital