A Comparative Study Between Transcutaneous Pulsed Radiofrequency Application Plus Genicular Nerve Block Versus Intra-Articular Hyaluronic Acid Injection for Management of Chronic Pain in Knee Osteo-arthritis: A Prospective Randomized Controlled Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Degree of pain
研究概览
简要总结
The aim of the present study is to compare the analgesic efficacy of combined transcutaneous pulsed radiofrequency plus genicular nerve block with bupivacaine plus corticosteroid versus intraarticular Hyaluronic acid injections, in terms of clinical and functional parameters, in patients with knee osteoarthritis.
详细描述
Total knee arthroplasty is commonly used as a surgical option for the treatment of symptomatic knee osteoarthritis to relieve pain and improve function, although it is associated with increased perioperative morbidity and mortality, particularly in older patients with co morbidities. Despite high success rates after total knee arthroplasty , a significant number of patients report suffering from postoperative pain, which can be worse than reported preoperative pain.
As an alternative approach, radiofrequency treatment modalities on the knee joint have been used to reduce knee pain due to osteoarthritis. Genicular nerve block (GNB) is a recently developed therapeutic option for knee osteoarthritis. that targets the three sensory nerves of the knee: superior lateral, superior medial and inferior medial genicular nerve, to inhibit pain transmission to the central nervous system.
Early osteoarthritis. treatment combines non pharmacological techniques with oral pharmacological therapies, intraarticular injections (IAI) of hyaluronic acid (HA), corticosteroid with local anesthetic or platelet-rich plasma (PRP) are used in progressive or very symptomatic stage. Intraarticular injections (IAI) is considered one of first-line treatments in recent studies as it is effective in decreasing pain and safer than oral pharmacological therapies.
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
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged above 40 years.
- •Both sexes
- •American Society of Anesthesiologists (ASA)physical status I and II.
- •Patients radiologically proven symptomatic knee joint osteoarthritis not responding to medical treatment.
- •Patients with knee pain of moderate or greater intensity on most or all days for ≥ 3 months, showing significant radiological osteoarthritis (Kellgren-Lawrence grade 1 to 3).
- •Radiological severity was assessed using the Kellgrenand Lawrence global scale as follow: Grade 0; means absence of radiological finding; grade 1: suspected narrowing of joint space; grade 2 refers to osteophytes and possible narrowing; grade 3 is defined as multiple os-teophytes, definite narrowing of joint space and grade 4 comprises large osteophytes, marked narrowing of joint space.
排除标准
- •Patient refusal.
- •Patients who show improvement on medical treatment, patients on an oral, topical, or intra-articular steroid during the 4 weeks before the study; patients with an oral, topical, or suppository non-steroidal anti-inflammatory drugs within 2 weeks before the study.
- •Patients having secondary knee osteoarthritis.
- •Patients with severe osteoarthritis.(K/L grade >3) in a location other than the knee joint.
- •Patients with rheumatoid arthritis.
- •Patients with joint replacement surgery in either knee and/or a hip.
- •Patients with meniscal tear, ligament injury, bursitis, and popliteal cyst and blood investigations suggestive of any infection.
- •Morbid obese patients (body mass index (BMI) of >40 kg/m2)
- •Infection at site of injection.
- •Bleeding diathesis and coagulopathy.
研究组 & 干预措施
Transcutaneous pulsed radiofrequency group
Patients underwent transcutaneous pulsed radiofrequency application plus genicular nerve block.
干预措施: Transcutaneous pulsed radiofrequency (Device)
Hyaluronic Acid group
Patients underwent intra-articular hyaluronic acid injection.
干预措施: Hyaluronic acid (Drug)
结局指标
主要结局
Degree of pain
时间窗: 3 month after injection
Assessment of pain severity by visual analog scale (VAS) at the baseline (before injection), 1month and 3month, intervals after injection. The visual analog scale (VAS) score it has 10-cm scale that represents a continuum between "0 = no pain" and "10 = worst pain."
次要结局
- Functional status(3 month after injection)
- Daily activity(3 month after injection)
- Analgesic requirement(3 month after injection)
- Adverse events(3 month after injection)
研究者
Omar Hashem Mohammed
Resident of Anesthesiology,Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.
Tanta University