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临床试验/NCT03184181
NCT03184181已完成不适用

Application of Ultrasound-guided Electrolysis, Percutaneous Neuromodulation and Eccentric Exercise in Supraspinatus Tendinopathy

University of Cadiz2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2017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
32
试验地点
2
主要终点
The intensity of shoulder pain

研究概览

简要总结

The supraspinatus muscle tendinopathy show a big impact, however, there is a lack of awareness about the options of the physiotherapist treatment. It is necessary to do studies about effectiveness of therapeutic percutaneous electrolysis (EPTE®). This technique enables treatment of the tendinopathies and the broken muscle fibrilare. It is base on the application of galvanic current through a acupuncture needle. To analyze the effectiveness of therapeutic percutaneous electrolysis (EPTE®) in the treatment of supraspinatus muscle tendinopathy. Single center randomized controlled trial, parallel treatment design. A specialist physician will be diagnosed the supraspinatus muscle tendinopathy. Participants will be randomly assigned to receive treatmen for 4 weeks: EPTE® associated with eccentric exercises or dry needling with the same eccentric exercises. Both interventions were performed under ultrasound guidance with a portable ultrasound (General Electric LogicE). Data will be collected by a blinded evaluator.

详细描述

Eccentric exercises of the supraspinatus muscle were performed in 3 sets of 10 repetitions. Participants were asked to perform the exercise program on an individual basis twice every day for 4 weeks. The eccentric program consisted of 3 exercises, focusing on the supraspinatus, infraspinatus, and scapular muscles. Participants were asked to do a normal abduction (concentric phase) and a slow return to the initial position (eccentric phase) included first the concentric phase, and the eccentric phase was slowly conducted. The exercise program was taught by a physiotherapist in the first session and monitored in the subsequent sessions.

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
Single (Outcomes Assessor)

入排标准

年龄范围
25 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients diagnosed with supraspinatus tendinopathies that do not improve with conventional physiotherapy or pharmacological therapy protocols.
  • Subjects who are in an active state of pain, who present painful symptoms in a sensitive and painful area of the tendon of insertion of the supraspinatus muscle in the humerus.

排除标准

  • Individuals who have received surgery intervention in the same shoulder, or have suffered fractures or dislocations in the same shoulder.
  • Individuals have received the proposed treatment in one month´s period previously.
  • Individuals who suffering from cervical radiculopathies, fibromialgia síndrome, cardiac patients with pacemakers, cancer, infectious processes, or generalized lymphedema.
  • Pregnant women can not receive this treatment intervention.

结局指标

主要结局

The intensity of shoulder pain

时间窗: Baseline

A 10-point Numerical Pain Rating Scale (NPRS; 0: no pain, 10: maximum pain) will be used to assess the patients' current level of shoulder pain, and the worst and lowest level of pain experienced in the preceding week in the shoulder area. The minimal clinically important difference (MCID) for the NPRS in patients with shoulder pain was 1.1 points (Mintken, Glynn, and Cleland 2009).

次要结局

  • The intensity of shoulder pain(One year)
  • Active shoulder range of motion(Baseline, four weeks and one year.)
  • Pressure pain thresholds in supraspinatus trigger points(Baseline, four weeks and one year.)

研究者

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

Manuel Rodriguez Huguet

Degree Physiotherapy

University of Cadiz

研究点 (2)

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