Comparison of The Effect of Cooled Versus Thermocoagulant Radiofrequency Ablation on Pain Relief of Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 入组人数
- 88
- 主要终点
- The primary outcome will be the ability to compare between cooled versus Thermocoagulant RF in the change from the baseline of the VAS for pain at the completion of treatment at 24 weeks.
研究概览
简要总结
Introduction
Osteoarthritis (OA) is a chronic, progressive disease with high disability and teratogenicity in the joints. Deterioration of the articular cartilage is the main problem associated with osteoarthritis, which decreases joint space between the two bones[1].
Clinically, patients with knee OA typically present with a chief complaint of pain, often associated with limited range of motion, stiffness, osteophytes, crepitus, and effusions. Due to the progressive degenerative nature of OA and the associated pain, patients become more physically impaired through the course of the disease [6].
One of the main tissues affected by this disease is the articular cartilage, which is a thin tissue covering the bony end in the joint that mainly provides mechanical support and lubrication during joint movement [7].
Age, previous knee injuries, but also obesity(increased body mass index(BMI)) ,joint malalignment and instability that result in increased mechanical stress are all strong risk factors for the development of knee OA [8-10].
Magnetic resonance imaging (MRI), arthroscopy examination, high-frequency color ultrasound and thermal texture maps are the four most acceptable types of imaging examinations. These examinations cannot only help diagnose KOA, but they can also assess the severity of joint damage and evaluate disease progression and treatment [11,12].
Treatment options for patients with OA include: conservative approaches, such as weight loss, physical therapy, and pharmacological interventions, while the more invasive approaches include intraarticular injections, joint preserving surgical treatment, and total knee arthroplasty (TKA). [13, 14] Radiofrequency ablation (RFA) is a novel technique that also recently gained popularity in alleviating chronic pain in patients with musculoskeletal disorders such as OA [15] Radiofrequency (RF) ablation, or modulation of the sensory innervation surrounding the knee, specifically the genicular nerves (GNs), has emerged as a therapeutic option to treat chronic knee OA pain for patients who are unresponsive to conservative treatments or are unsuitable candidates for total knee arthroplasty (TKA). [16, 17]
详细描述
Introduction
Osteoarthritis (OA) is a chronic, progressive disease with high disability and teratogenicity in the joints. Deterioration of the articular cartilage is the main problem associated with osteoarthritis, which decreases joint space between the two bones[1].
Because of the higher prevalence of asymptomatic OA, it is approximated that 250 million people all over the world suffer from OA [2,3].
The prevalence of knee OA increased significantly over the last decades and continues to rise, partially because of the increasing prevalence of obesity and other risk factors, [4].
It is estimated that the prevalence of knee OA among adults 60 years of age or older is approximately 10% in men and 13% in women [5].
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 (Investigator, Outcomes Assessor)
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
- 是
入选标准
- •Patients with intractable knee pain intensity >5 on an 11-point visual analog scale (VAS) (where 0=no pain and 10=worst pain imaginable) for longer than three months and unable to do knee replacement surgery.
- •Age > 50 years.
- •Grade 2 or 3 KOA based on the Kellgren-Lawrence classification.
- •Patients who did not respond to conservative treatment (physiotherapy, oral NSAIDs, and/or intraarticular injections of hyaluronic acid and corticosteroid) for 3 months.
- •Duration of knee pain ≥ 3 months.
- •Numeric rating scale (NRS) ≥ 5 points within 24 h prior to admission.
排除标准
- •Grade 1 or 4 KOA based on the Kellgren-Lawrence classification.
- •Severe liver, kidney, cardiovascular, and respiratory disease.
- •Abnormal blood coagulation.
- •Skin infections in the puncture region.
- •Patients who previously underwent knee arthroscopy, TKA, RFTGN, or IAPRF.
- •Mental disorders or inability to complete the follow-up observational form.
结局指标
主要结局
The primary outcome will be the ability to compare between cooled versus Thermocoagulant RF in the change from the baseline of the VAS for pain at the completion of treatment at 24 weeks.
时间窗: 24weeks
The primary outcome will be the ability to compare between cooled versus Thermocoagulant RF in the change from the baseline of the VAS for pain at the completion of treatment at 24 weeks.
次要结局
未报告次要终点
研究者
Saif Eldeen Gamal Khalaf
Assistant lecturer
Assiut University
