Feasability Study on the Use of Botulinum Toxin A in Primary Adductor Tendinopathies Refractory to Medical Treatment
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Proportion of patients with a pain reduction (VAS)
研究概览
简要总结
Pubalgia is a pain syndrome located in the groin area. This syndrome is mainly described in young male athletes and typically affect the superficial muscles defining the boundaries of the femoral triangle, i.e. gracilis, pectineus, adductor brevis and especially adductor longus, and less commonly the deep muscles.
Clinically, the pain is located in the inner aspect of the thigh, where the tendons attach onto the pubic symphysis. It is usually unilateral, and sometimes associated with neuropathic pain suggestive of obturator nerve irritation.
There is no official recommendation or expert consensus on the management of pubalgia. However, a few protocols recommend a period of rest with Non-Inflammatory Anti-Steroidien Drugs (NSAIDs), icing and massages, as well as rehabilitation with passive stretching and muscle reinforcement.
The use of botulinum toxin type A could be an option in cases of treatment failure. However, a feasibility study must be performed beforehand, and if results are positive, a controlled study on a larger cohort could be conducted.
The major potential impact is a great effective pain relief for patients with neurological diseases.
详细描述
The incidence of pubalgia in the literature varies, with large series reporting an incidence close to 5-10%, representing 15 to 18% of all injuries.
Recurrences are also common, affecting 30 to 35% of cases.
Once other differential diagnoses (such as spondylarthropathy, colorectal cancer, kidney disease…) have been ruled out, athletic pubalgia is typically divided into three main categories based on the site of the injury:
- Abdominal wall, the most common form, representing 38 to 50% of all cases;
- Pubic symphysis due to osteoarthropathy of the pubic bone caused by repetitive stress injury, accounting for 10 to 15% of all cases of pubalgia;
- Adductor tendons, on which this study focuses, representing 22 to 38% of all cases of pubalgia, caused by repetitive tractions on the tendon insertions.
There is no official recommendation or expert consensus on the management of pubalgia. However, a few protocols recommend a period of rest with Non-Inflammatory Anti-Steroidien Drugs (NSAIDs), icing and massages, as well as rehabilitation with passive stretching and muscle reinforcement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patient 18 to 65 years old
- •Patient with episode of adductor tendinopathy, refractory to appropriate medical treatment lasting 3 months
- •Tendinopathy confirmed by clinical investigation, echography and MRI.
- •Patient naïve to intramuscular botulinum toxin injections
- •Patient able to self-evaluate pain on a VAS
- •Intensity of exercise-induced pain > 5 on a VAS of 10
- •Patient able to provide a signed informed consent freely for the study protocol and data collection
排除标准
- •Subject participating or having participated in the last 3 months in another study which could interfere with the objective of the study
- •Neuralgia
- •Acute muscle injury
- •Progressive disease at the time of inclusion
- •Anticoagulant treatment: heparin administered with an electrical syringe or AVK therapy with effective doses
- •Exclusion criteria related to Dysport injection (botulinum toxin type A) :
- •Known hypersensitivity to botulinum toxin type A or to any of the components in the formulation (20% human albumin solution, lactose monohydrate)
- •Subject with a significant deficit of clinical or subclinical neuromuscular transmission (myasthenia or Lambert-Eaton syndrome)
- •Treatment that directly or indirectly interferes with neuromuscular transmission (aminoglycosides, curare, anticholinesterase, aminoquinoline, cyclosporine, etc.)
- •Previous surgery with curarisation less than a month ago
- •History of neuromuscular disorders
- •Pregnant or breastfeeding woman
- •Women of child-bearing potential not using contraceptive methods during the study duration
研究组 & 干预措施
Dysport
Dysport administration by intramuscular injection Each patient will receive one dose of Dysport at Visit 1.
At least 2 of the 4 muscles below will be injected, depending on which muscles are affected:
250 IU for the gracilis muscle 200 IU for the pectineus muscle 300 IU for the adductor longus muscle 200 IU for the adductor brevis muscle
These injections will be uni or bilateral, it will depend on clinical diagnosis.
If necessary, the 4 muscles will be injected with a maximum of 1500U Dysport. The total dose cannot exceed 1500 units.
干预措施: Dysport 500 Unit Powder for Injection (Drug)
结局指标
主要结局
Proportion of patients with a pain reduction (VAS)
时间窗: Between Day 80 and Day 90
Proportion of patients with a pain reduction of over 50% compared to baseline, as shown by the average pain intensity measured between D80 and D90 on a Visual Analogic Scale (VAS) from 0 to 10 (0 = no pain; 10 = worst pain imaginable). Pain intensity will be daily collected by the patient in his patient's diary.
次要结局
- Exercise-induced pain intensity (VAS)(Daily between Day 0 and Day 90)
- Pain relief(On Day 30 and Day 90)
- Goal Attainment Scaling (GAS)(On Day 30 and Day 90)
- Blazina clinical classification system(On Day 30 and Day 90)
- Adductor strength(On Day 30 and Day 90)
- Cure rate based on patients' self-evaluation(On Day 30 and Day 90)
- Cure rate based on physician's evaluation(On Day 30 and Day 90)
- Treatment(On Day 30 and Day 90)
- Pain diary(On Day 30 and Day 90)
- Tolerance(Day 1, Day 7, Day 14, Day 30, Day 90)
- HAGOS self-reported questionnaire(On Day 30 and Day 90)