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临床试验/NCT05561959
NCT05561959已完成不适用

Efficacy of Phonophoresis With Topical Glyceryl Trinitrate in Treatment of Non-insertional Achilles Tendinopathy: a Randomized Controlled Trial

Cairo University2 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2022年11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
64
试验地点
2
主要终点
the change in thickness of Achilles tendon

研究概览

简要总结

The aim of study is to investigate the effect of Phonophoresis with topical glyceryl trinitrate versus traditional treatment in in patients with non-insertional Achilles tendinopathy.

详细描述

Pain in the Achilles tendon is quite common in individuals who participate in sports It is also common, however, in nonathletic individuals, particularly in persons of middle age who are of heavier weight Treating this condition can be very challenging. It is seen most commonly in the mid-portion of the tendon. The pathologic changes that occur to an Achilles tendon under repetitive stress will initially be a disruption of collagen fibers that have been unable to adapt to the persistent demand. This results in a cascade of events that, if left unchecked, will ultimately lead to significant pain and dysfunction. Repetitive loading leads to tendon degeneration, manifested as loss of normal collagen patterns and replacement of normal tissue with disorganized arrays of collagen and proliferative extracellular matrix. The tendon becomes infiltrated with mucoid material, calcification, fibrocartilage, and lipid droplets.

Historically, one of the most well-established exercise regimens for Achilles tendinopathy is eccentric strength training. Eccentric exercise has been shown to improve tendon structure, which historically was considered a mechanism for improvement in some persons with Achilles tendinopathy.

Nitric oxide is a small-free radical generated by a family of enzymes, the nitric oxide synthases. In a series of experiments performed over the last 15 years, nitric oxide played a crucial beneficial role in restoring tendon function. Oxygen free radicals, in the correct dose, stimulated fibroblast proliferation. Nitric oxide can enhance tendon healing. Nitric oxide is 1 of the 10 smallest molecules. Its size and its high reactivity allow it to travel across nearly all biologic structures and to readily react with other atoms or molecules to effect a change.

so the aim of our study to compare between Phonophoresis with topical glyceryl trinitrate and eccentric strength training in treatment of Achilles tendinopathy

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
20 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 20-50 years old
  • The diagnosis was based on pain located in the Achilles tendon for at least 3 months.
  • Pain in the Achilles tendon area with distinct tenderness of the tendon 2 to 6 cm above the Achilles tendon insertion on the calcaneus
  • Ultrasonographic changes defined as local thickening of the symptomatic tendon, irregular tendon structure and fiber orientation, and separated tendon fibers or a globally more than 2 mm 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.

排除标准

  • Symptoms of <3 months, previous surgery, previous ankle dislocation, distal neurology, steroid injections in last 3 month, pregnancy, and contraindication to GTN
  • 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

结局指标

主要结局

the change in thickness of Achilles tendon

时间窗: at first week and after 12 week of treatment

measured by Ultrasonography.

the change in Functional performance

时间窗: at first week and after 12 week of treatment

measured by vertical countermovement jump test.

the change in Pain in patients with non-insertional Achilles tendinopathy.

时间窗: at first week and after 12 week of treatment

measured by Visual Analog Scale

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Doaa Rafat

lecturer of physical therapy Basic Science department faculty of physical therapy

Cairo University

研究点 (2)

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