Intraarticular Injection of Botox and Hyaluronic Acid in Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
研究概览
简要总结
This study aims to compare the efficacy of intra-articular injection of Botulinum toxin and hyaluronic acid on pain in knee osteoarthritis.
详细描述
Osteoarthritis (OA) is a widespread musculoskeletal disease and a leading cause of chronic disability. Conservative estimates state that up to 240 million people worldwide suffer from it. Knee osteoarthritis (KOA) is associated with chronic inflammation that causes persistent oxidative damage, which subsequently leads to joint degeneration.
Therefore, intra-articular (IA) therapies might be an alternative and safe treatment for these patients.
IA injection of hyaluronic acid (HA) is still a controversial treatment for knee osteoarthritis and comparative studies of HA versus more established treatments are warranted.
Botulinum toxin (BTX), produced by the bacterium Clostridium botulinum, acts on both sensory and motor neurons. Irreversible binding of BTX to presynaptic receptors of motor endplates inhibits acetylcholine release.
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, Outcomes Assessor)
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
- •Age ≥ 50 years.
- •Both genders.
- •Chronic knee osteoarthritis (KOA) according to American College of Rheumatology criteria for the diagnosis of knee osteoarthritis.
- •Third or fourth grade Kellgren and Lawrence system for classification of osteoarthritis based on radiological data, it is a common method of classifying the severity of osteoarthritis (OA) using five grades according to the following sites and projections.
排除标准
- •History of intra-articular injection within the last 6 months,
- •History of surgery on the knee joint or major trauma to the lower limb causing fracture.
- •Body mass index (BMI) more than 40 kg/m
- •Medical conditions affecting the joint or lower extremity function such as severe osteoporosis, rheumatoid arthritis, collagen vascular diseases, and gout.
- •Diabetic patient.
- •Any contraindication to intra-articular injections for instance immunodeficiency, coagulation defect or anticoagulation therapy taking or skin infection at the site of injection.
- •Hypersensitivity to Botulinum toxin or hyaluronic acid.
研究组 & 干预措施
Group HA
Patients will be given intra-articular injection of 2 ml of hyaluronic acid into the joint space three times weekly.
干预措施: Hyaluronic acid (Drug)
Group BTX
Patients will be given intra-articular injection of 100 units of Botulinum toxin type A, diluted with 5 ml of normal saline three times weekly.
干预措施: Botulinum toxin type A (Drug)
研究者
Mohammed Said ElSharkawy
Lect urer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.
Tanta University