Ecoguided Genicular Nerve Block in Patients With Knee Osteoarthritis by Local Anesthetic or by Combination of Local Anesthetic and Corticoid: Placebo-Controlled Randomized Blind Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Reduction in Pain
研究概览
简要总结
Osteoarthritis is a pathology with high prevalence in the world and is increasing due to sedentary lifestyles. Recent researches that claim for conservative treatment have shown the utility of genicular nerve blocks for relief of chronic knee pain.
Likewise, the ultrasound-guided technique has been more popular among professionals in recent years due to its low cost and safety.
This pilot study tries to evaluate if the infiltration of local anesthetic could avoid the use of corticosteroids with the secondary effects that they entail, therefore, it is carried out with the intention of estimating the size of the effect and the use of the variable response for later carrying out a clinical trial.
For this, we propose the comparative analysis of three randomized groups of patients (n=90), where all of them will perform a quadriceps strengthening exercise at home. Moreover, we will assess the reduction of pain through the visual analog scale (VAS) after the genicular nerve block with ultrasound-guided infiltration. Group 1 (n=30) will be infiltrated with local anesthetic and steroid, group 2 (n=30) with local anesthetic and group 3 (n=30), as a control group, will receive physiological saline. We will also record demographic data, functionality and mood using validated scales.
详细描述
Osteoarthritis affects approximately 302 million people worldwide, with the knee, hip, and hands being the most commonly affected areas. Knee osteoarthritis is highly prevalent and increasing in the region due to aging, obesity, and the progressive sedentary lifestyle of the population. According to recent epidemiological studies, it has a prevalence of 29.3% in the Spanish population.
Currently, multiple treatment options are available, ranging from conservative measures to surgical procedures. Within conservative treatment, various tools benefit patients and may even avoid the need for surgery. These non-surgical options include patient education, weight control, physical exercise, orthotics, oral analgesics, topical anti-inflammatories, and interventional procedures. However, there are no prior studies demonstrating the advantages of one over another, and many do not follow up beyond three months.
When conservative treatment is ineffective, surgical intervention is usually considered. Therapeutic options include knee arthroscopy, high tibial osteotomy, total knee replacement, and unicompartmental knee replacement in patients without lateral compartment disease.
Traditionally, rest and caution in exercise were recommended for knee osteoarthritis pain. However, this paradigm has been strongly rejected. One of the current first-line treatments for knee osteoarthritis is physical exercise, with quadriceps strengthening being the most indicated. Most patients seek recommendations on what type of exercise to perform, including the duration, intensity, and frequency for better adherence. No exercise has been shown to be superior to another, with the most studied being yoga and tai chi exercises.
Despite the well-documented benefits of exercise for this condition, one emerging procedure for pain management is the genicular nerve block. This treatment option can facilitate progress in the exercise program. It is also indicated for patients who have previously had successful genicular block, those who do not wish to undergo surgery, those not eligible for surgery, or even post-surgical patients for better pain control.
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)
盲法说明
Concealed Random Assignment: Participants will be assigned to one of three treatment groups using a computer-generated sequence. Opaque, sequentially numbered envelopes with treatment assignments will be opened after patient inclusion.
Blinding of Participants: Participants will not know the specific injection content (bupivacaine with or without corticosteroids, or saline). They will only know they are receiving one of the study interventions.
Blinding of Investigators: Investigators for initial evaluation and follow-up will not administer treatments. Independent personnel will prepare and administer treatments without evaluating outcomes.
Blind Evaluations: Pain and functionality (VAS, KOOS, WOMAC, KUJALA) will be assessed by blinded investigators. Follow-up consultations will be handled by personnel unaware of treatment details.
Documentation and Verification: Secure treatment assignment records will be accessible only to the data and safety monitoring committee.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 18 years
- •Anterior knee pain of patellofemoral origin and/or femorotibial compartment osteoarthritis with no previous response to pharmacological treatment (oral and/or topical)
- •Pain duration of 3 months
- •Pain assessment scale (Numerical Rating Scale) ≥ 5
- •Radiological study with Kellgren-Lawrence classification > 2
排除标准
- •Allergy to the active ingredients and excipients of: bupivacaine, triamcinolone, or saline solution
- •Patients who have undergone total or unicompartmental knee replacement surgery
- •Viscosupplementation or intra-articular corticosteroid injection within the last 3 months
- •Pregnant women or those suspected of being pregnant
- •Cognitive impairment or additional neuropsychiatric symptoms
- •Failure to sign informed consent or revocation of it
- •Patients with heart disease requiring blockade with levobupivacaine
- •Inability to write, speak, or read in Spanish
- •Active tumoral or infectious pathology
- •Osteoarthritis secondary to inflammatory pathology
研究组 & 干预措施
Group 1: Block with 0.5% bupivacaine and corticosteroid (triamcinolone).
Injection Doses: 2.5 mL of 0.5% bupivacaine + 20 mg of triamcinolone.
干预措施: Genicular nerve block with bupivacaine and corticosteroids (Drug)
Group 2: Block with 0.5% bupivacaine.
Injection Doses: 2.5 mL of 0.5% bupivacaine.
干预措施: Genicular nerve block with bupivacaine (Drug)
Group 3 (Control): Block with saline solution.
Injection Doses: 2.5 mL of saline solution.
干预措施: Genicular nerve block with saline (Drug)
结局指标
主要结局
Reduction in Pain
时间窗: Baseline, 4 weeks, 12 weeks, and 24 weeks post-procedure
* Measurement Tool: Numeric Rating Scale (NRS) * Minimum Value: 0 * Maximum Value: 10 * Interpretation: Higher scores indicate worse pain.
次要结局
- Functionality Improvement(Baseline, 4 weeks, 12 weeks, and 24 weeks post-procedure)
- Functionality improvement(Baseline, 4 weeks, 12 weeks, and 24 weeks post-procedure)
- Incidence of Adverse Events(Through study completion, an average of 1 year)
- Demographic and clinical variables(Baseline)
- Demographic and Clinical Variables(Baseline)
- Mood Evaluation(Baseline, 4 weeks, 12 weeks, and 24 weeks post-procedure)
- Physical Examination(Baseline, 4 weeks, 12 weeks, and 24 weeks post-procedure)
- Analgesic Medication Use(Through study completion, an average of 1 year)
研究者
Claudia de la Fuente Escudero
Consultant Specialist in Physical Medicine and Rehabilitation
Hospital Universitario Fundación Alcorcón