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临床试验/NCT03089008
NCT03089008已完成不适用

Eccentric Exercise in Treatment of Achilles Tendinopathy

Copenhagen Trial Unit, Center for Clinical Intervention Research1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 1999年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
45
试验地点
1
主要终点
Change in manually assessed tenderness after 12 weeks

研究概览

简要总结

The purpose of the present study is to examine the long-term effect of eccentric exercises compared with stretching exercises on patients with achillodynia.

详细描述

Patients with achillodynia for at least 3 months are randomly allocated to one of two exercise regimens. Exercise is performed daily for a 3-month period. Symptom severity is evaluated by tendon tenderness, ultrasonography, a questionnaire on pain and other symptoms, and a global assessment of improvement. Follow-up is performed at time points 3, 6, 9, 12 weeks and 1 year.

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
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Pain in the Achilles tendon area with one of the two following findings. a) Distinct tenderness of Achilles tendon with no pain in the neighboring structures. b) Ultrasonographic changes defined as local thickening of the symptomatic tendon or a globally more than 2mm thicker tendon on the sick side.
  • Diffuse pain in the posterior region of the ankle with local tenderness of the Achilles tendon and ultrasonographic changes (as described above).

排除标准

  • Treatment of achillodynia with stretching or eccentric training for more than 2 weeks within the last 2 years.
  • Other injuries in the lower extremity or the knee, which by the examining doctor was evaluated to influence the evaluation of symptoms or the ability to perform the training program.
  • Acute symptoms with ultrasonographic changes consistent with a partial rupture of the tendon.
  • Age less than 18 years or over 70 years.
  • Previous operation on the tendon or steroid injections.

结局指标

主要结局

Change in manually assessed tenderness after 12 weeks

时间窗: 12 weeks

The tenderness of the symptomatic tendons was determined manually by applying a moderate amount of pressure (about 1 kg) with the first and second finger on each side of the tendon. The tendon was palpated 0, 1, 3, 5, 7 and 10 cm proximal to the calcaneal insertion, and at each level the tenderness score was noted according to the subjects' answers of the pain perceived (0 = none, 1 = mild, 2 = moderate and 3 = severe).

Manually assessed tenderness at inclusion

时间窗: At inclusion

The tenderness of the symptomatic tendons was determined manually by applying a moderate amount of pressure (about 1 kg) with the first and second finger on each side of the tendon. The tendon was palpated 0, 1, 3, 5, 7 and 10 cm proximal to the calcaneal insertion, and at each level the tenderness score was noted according to the subjects' answers of the pain perceived (0 = none, 1 = mild, 2 = moderate and 3 = severe).

Change in manually assessed tenderness after 39 weeks

时间窗: 39 weeks

The tenderness of the symptomatic tendons was determined manually by applying a moderate amount of pressure (about 1 kg) with the first and second finger on each side of the tendon. The tendon was palpated 0, 1, 3, 5, 7 and 10 cm proximal to the calcaneal insertion, and at each level the tenderness score was noted according to the subjects' answers of the pain perceived (0 = none, 1 = mild, 2 = moderate and 3 = severe).

次要结局

未报告次要终点

研究者

发起方
Copenhagen Trial Unit, Center for Clinical Intervention Research
申办方类型
Other
责任方
Sponsor

研究点 (1)

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