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临床试验/NCT03274557
NCT03274557已完成不适用

Treatment of Achilles Tendinose

University Hospital of North Norway2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2017年1月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
2
主要终点
Pain reduction

研究概览

简要总结

Prospective randomized controlled study using radio-frequency microtenotomy or physical therapy (eccentric training) for treatment of Achilles tendinose

详细描述

Achilless tendinosis is a major clinical problem. There is a need for new studies to map the effectiveness of treatment. This study will compare treatment effectiveness between traditional physical therapy with surgical treatment using (RFM). The tendinosis grade will be evaluated using MRI and /or ultrasound before and after intervention. The outcome measurment include VAS and function using ( FAOS FOOT & ANKLE SURVEY) at 6,12 weeks and 6, 12 months after intervention.

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, Investigator)

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with pain in Achilles tendon for at least 6 weeks.
  • MR / ultrasound confirms diagnosis tendinose.
  • Pain in sport and daily activities

排除标准

  • Other co-morbidity that constitutes contraindication for surgery, serious illness, bad compliance

研究组 & 干预措施

Radiofrequency microtenotomy

Active Comparator

Treatment of Achilles tendinose with radio-frequency microtenotomy

干预措施: RFM (Procedure)

Phusical therapy

Active Comparator

Supervised eccentric training

干预措施: RFM (Procedure)

结局指标

主要结局

Pain reduction

时间窗: 6.12 weeks and 6,12 months

Pain reduction. Change of pain from baseline measured with VAS

次要结局

  • Function(6.12 weeks and 6,12 months)

研究者

发起方
University Hospital of North Norway
申办方类型
Other
责任方
Sponsor

研究点 (2)

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