Randomized Controlled Trial Comparing Botulin Toxin Versus Hyaluronic Acid by Intra-articular Injection for the Treatment of Painful Knee Osteoarthritis
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Evaluation of pain measured using the WOMAC pain sub-score
研究概览
简要总结
In France, osteoarthritis affects about 10 million people and knee osteoarthritis represents 35% of cases. It is thought that more than 2.5 million people older than 65 years have knee osteoarthritis.
Currently, osteoarthritis management is based on three major axes:
-
Non-pharmacological means, such as patient education, loss of weight and physical activity
-
General pharmacological treatments: mainly paracetamol and then schedule II and III painkillers as well as nonsteroidal anti-inflammatory agent.
-
Intra-articular pharmacological treatments:
-
Intra-articular injections of corticosteroids: they are recommended during hydarthrotic flare-ups
-
Intra-articular injections of hyaluronic acid (HA) (viscosupplementation) in the absence of intra-articular effusion. However, their efficacy is questioned by most experts in the case of symptomatic knee osteoarthrosis.
-
Sometimes, surgery is the only therapeutic option. However, besides the fact of exposing patients, who are sometimes frail, to several peri- and post-operative complications, the recovery rate (variable according to the prosthesis type and ranging from 5% to 25% at 9 years) in an ageing population justifies waiting as much as possible before surgery. Therefore, it is important to test new therapeutic options for symptomatic osteoarthrosis that will allow postponing the surgical treatment.
-
The use of botulinum toxin (BoNT-A) could thus represents an interesting alternative. BoNT-A is habitually used by intra-muscular injection for its myorelaxant effect in the management of painful reactive periarticular muscle contractures. However, BoNT-A has also antalgic activity independently of the myorelaxant effect. This allows explaining in part the antalgic effect of intra-articular BoNT-A injection. In the literature, six randomized controlled studies (RCS) have compared BoNT-A and intra-articular injections of corticosteroids, hyaluronic acid, or placebo. Only two RCS concerned knee osteoarthritis and compared BoNT-A to corticosteroids and a placebo, respectively, with a significant antalgic effect only in the groups treated with BoNT-A. No study has compared yet the intra-articular injection of BoNT-A to the viscosupplementation by HA in knee osteoarthritis and this is the aim of this trial.
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
- Single (Outcomes Assessor)
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
- •Painful, or predominantly unilateral painful, knee osteoarthritis of any etiology
- •Knee without clinical signs of intra-articular effusion
- •Kellgren score ≥ II on X-ray
- •WOMAC pain sub-score ≥ 5 in the month preceding the inclusion visit
排除标准
- •Inflammatory arthropathy,infectious, neoplastic within the past year
- •Neuromuscular pathology
- •Cardiorespiratory pathology or any other severe disease that interferes with the functional capacities
- •Any decompensated or unstable chronic pathology
- •Glomerular filtration rate (GFR)<15 mL/min/1.73m²) within the past 6 months
- •HBA1c in diabetic people > 12% within the past 6 months
- •BMI ≥ 35kg/m2
- •Infection: joint, general, distant, cutaneous
- •Foreign material in the knee to be treated: prosthesis, osteosynthesis material
- •Severe coagulation problem: platelets <100000/mm3 within the past 6 months
- •Allergy to BoNT-A
- •Allergy to HA
- •Pregnant or breast-feeding women
- •Treatment with aminoglycosides or direct oral anticoagulants
- •Treatment with VKA (antihemorrhagic vitamin) if INR (International Normalized Ratio) higher than 3 within the past month
- •Change of anti-pain treatment less than 2 weeks before enrolment
- •Treatment with III pain killers or corticosteroids because of intense pain that does not respond to schedule I and II pain-killers
- •Intra-articular injection of corticosteroids in the previous two months
- •Viscosupplementation and/or injection of BoNT-A in the knee to be treated within the past 6 months
- •Injection of BoNT-A (except the knee to be treated) within the past 3 months
- •Swallowing troubles
研究组 & 干预措施
Intra-articular injection of botulinum toxin A
干预措施: Botulinum toxin A ( BoNT-A) (Drug)
Intra-articular injection of hyaluronic acid
干预措施: Hyaluronic acid (HA) (Device)
结局指标
主要结局
Evaluation of pain measured using the WOMAC pain sub-score
时间窗: Change from baseline WOMAC pain sub-score at 3 months
次要结局
- Evaluation of the quality of life based on the SF-36 score(Before injection, 1 month, 3 months and 6 months following injection)
- Frequency, seriousness and severity of adverse event reactions(during the 6 months following injection)
- Changes in passive and active articular knee amplitude, by goniometry(Before injection, 1 month, 3 months and 6 months following injection)
- Evaluation of the patients' functional improvement using the Timed Up-and-go Test(Before injection, 1 month, 3 months and 6 months following injection)
- Evaluation of the patients' functional improvement based on the WOMAC score ("stiffness and function sub-score" and total score)(Before injection, 1 month, 3 months and 6 months following injection)
- Evaluation of the antalgic effect of BoNT-A vs hyaluronic acid measured using a verbal rating scale (VRS)(1 week after injection)
- Changes in muscular strenght et muscular trophicity (using dynanometer and measure of knee and thin circumference)(Before injection, 1 month, 3 months and 6 months following injection)
- Changes in pain treatment score (using a correspondence table)(Change from baseline pain treatment score at 6 months)