Study of the Treatment of Tendinopathy Unruptured of Rotator Cuff by Intramuscular Injection of Botulinum Toxin
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Significant improvement in shoulder pain objectified by analogy Visual Scale (VAS) in patients with unruptured tendinopathy of the rotator cuff impingement, debilitating, lasting for more than 3 months and resistant to usual medical treatment.
研究概览
简要总结
Botulinum toxin is used in musculoskeletal therapy routinely for 15 years. This is one of the most potent neurotoxins. It comes in 7 serotypes (A to G).Therapeutic application of botulinum toxin are mainly based on its ability to block the neuromuscular transmission by preventing the release of acetylcholine, creating paralysis muscle relative and reversible.
It has been used in the treatment of cervical dystonia, migraine headaches, and an antinociceptive effect. The analgesic effect occurred even prior to the release muscular. Several randomized studies have been published about it. The investigators assume that intramuscular injection of botulinum toxin is effective in the treatment of tendinopathy rotator cuff.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed consent
- •Active social care
- •Compliant patient with protocol
- •Patient more than 18 years
- •Positive Neer Test
排除标准
- •Prior study exclusion period
- •Protected patient
- •Study refusal
- •Deficient patient
- •Rheumatoid arthritis, osteoarthritis, chondrocalcinosis.
- •Microcrystalline arthritis.
- •Active infection .
- •History of hypersensitivity reaction during a previous injection of botulinum toxin
- •Bilateral involvement
- •Neurological deficit
- •Depression
- •History of shoulder surgery
- •Pregnant or breast feeding women
- •Systemic disease (diabeta, vascularitis)
- •Known neurological disease
- •Intraarticular associate disease
- •Acromioclavicular associate disease
- •Myasthenia
- •Botulinum toxin is not recommended in combination with aminoglycosides
研究组 & 干预措施
Botox arm
intramuscular injection of botulinum toxin
干预措施: Botox arm (Drug)
结局指标
主要结局
Significant improvement in shoulder pain objectified by analogy Visual Scale (VAS) in patients with unruptured tendinopathy of the rotator cuff impingement, debilitating, lasting for more than 3 months and resistant to usual medical treatment.
时间窗: 3 months
次要结局
- Significant improvement in life quality : functional clinical scores (Constant, ASES, Oxford)(24 months)
研究者
Nicolas Pujol
Investigator coordinator
Versailles Hospital