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临床试验/NCT05430893
NCT05430893已完成不适用

Intra-muscular Botulinum Toxin A in Chronic Athletic Pubalgia: a Retrospective Observational Study

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2017年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Numerical rating scale

研究概览

简要总结

Chronic athletic pubalgia is a frequent sport condition in which the effectiveness of medical treatment has not been proven. Intra-muscular injection of botulinum toxin A may have positive effects on pain in some chronic tendinitis.

The investigators hypothesized that similar analgesic effect of intra-muscular botulinum toxin A may be observed in individuals with chronic AP. In the present study, the investigators aimed to describe the short-term evolution of pain and of activity limitations and quality of life, after an injection of the adductor longus with botulinum toxin A, in individuals with chronic AP, for whom medical and/or surgical treatments have failed.

详细描述

The investigators included consecutive individuals with chronic athletic pubalgia for whom medical and/or surgical treatments have failed and who were treated with an intra-muscular injection of botulinum toxin A under ultrasound guidance. Participants were assessed 50 days after injection for pain using a numerical rating scale (NRS) (0, no pain, and 100, maximal pain) and for activity limitations and quality of life using the Copenhagen Hip and Groin Outcome Score (HAGOS) (0, worse outcome, and 100, most favorable outcome). Participants were also asked to self-report adverse events.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • chronic AP
  • symptom duration ≥ 3 months
  • consistent clinical and magnetic resonance imaging findings according to the clinician
  • failure of medical and/or surgical treatments with persistent pain and inability to return to play
  • treatment with an intra-muscular injection of botulinum toxin A injection

排除标准

  • age under 18 years
  • ongoing pregnancy or breastfeeding
  • treatments by anticoagulants
  • muscular disorder (e.g. polymyositis, myopathy or other neuromuscular conditions)
  • guardianship or curatorship
  • individuals who had received botulinum toxin type A treatment for less than one year

结局指标

主要结局

Numerical rating scale

时间窗: 50 days

Mean pain

次要结局

  • HAGOS score(50 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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