Efficacy of Ultrasound-Guided Genicular Nerve Block in Patients With Gonarthrosis: A Randomized, Placebo-Controlled, Double-Blind Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Effect on gait kinematics
研究概览
简要总结
This study planned to enroll a minimum of 30 patients aged 50 years and older, with a diagnosis of gonarthrosis classified as stage 2 or higher according to the Kellgren-Lawrence grading system, and who report complaints of knee pain and walking difficulties. Patients will be randomized into two groups, and they will be blinded to the group to which they are assigned.
In the first group, ultrasound-guided genicular nerve block will be performed using a combination of lidocaine and triamcinolone hexacetonide injection (4 mL Priloc 2% + 1 mL Artropan 20 mg). In the second group, a placebo injection (5 mL saline solution) will be administered. Both groups will be instructed to follow an appropriate exercise program after the treatment.
Patients will undergo a detailed physical examination, 6-minute walk test, VAS pain score, WOMAC questionnaire, and 3D kinematic gait analysis with pressure parameters evaluated by a blinded researcher. Evaluations will take place before treatment, 1 hour after treatment, and 1 month post-treatment.
The collected data will be analyzed for differences between the two groups and changes over time. The potential positive effects of the treatment will be measured and compared with the placebo group to assess the therapeutic efficacy.
详细描述
In addition to the fact that genicular nerve block is highlighted in the literature as a potential alternative to surgery, it is also crucial to consider the reality that the pain symptoms in these patients have a more significant negative impact on walking than initially expected, potentially creating a comorbidity of its own. Given this, this study aims to contribute to the medical literature by observing the improvement in walking parameters secondary to the reduction of pain symptoms in patients with gonarthrosis.
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, Care Provider)
盲法说明
The study is conducted as a randomized, double-blind, placebo-controlled trial. Both participants and care providers administering the injections are blinded to group assignments. Syringes are prepared and covered by an independent researcher to ensure identical appearance across groups
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Knee pain persisting for 3 months or longer
- •Diagnosis of gonarthrosis with Grade 2 or higher tibiofemoral osteoarthritis detected on plain radiographs
- •Patients aged 50 years and older
- •Continued pain despite conservative treatment (exercise, simple analgesics such as paracetamol, or nonsteroidal anti-inflammatory drugs)
排除标准
- •Clinical diagnoses that could cause knee pain other than gonarthrosis (rheumatologic diseases, secondary osteoarthritis, fractures, etc.)
- •Signs of inflammation/exacerbation
- •Infection at the injection site or skin lesions
- •Diagnosis of malignancy
- •Gait impairment (the patient must be able to ambulate independently)
- •Known allergy to study medications
- •Previous knee surgery
- •Uncontrolled comorbid conditions such as diabetes mellitus or hypertension, which contraindicate corticosteroid use
结局指标
主要结局
Effect on gait kinematics
时间窗: 4 weeks
Change in gait and pressure parameters measured with the DIERS Formetric 4D analysis system.
1. 6 minute walk test
时间窗: 4 weeks
It is a test used to assess the level of functional exercise or functional capacity. The patient is asked to walk, but not run, in a 25 m long corridor at the highest possible speed without stopping. At the end of 6 minutes, the number of metres walked by the patient is recorded. The 6 min walk test is an evaluation criterion used in routine and clinical research to assess functional capacity in many diseases such as heart failure, general arthrosis, multiple sclerosis.
次要结局
- (VAS) for pain and fatigue(4 weeks)
- WOMAC(4 weeks)