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临床试验/NCT02964819
NCT02964819已完成不适用

Influence of Interferential Current Therapy in the Treatment of Individuals With Shoulder Impact Syndrome: A Randomized, Placebo Controlled Clinical Trial.

University of Nove de Julho1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2016年1月1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
入组人数
45
试验地点
1
主要终点
physical function and pain

研究概览

简要总结

This project will analyze the influence of interferential current therapy in an exercise program for individuals with a unilateral impact syndrome diagnosis. To that end, volunteers of both genders, aged 18-59 years, had an unilateral, unilateral pain in the shoulder with more than 3 months duration, at least grade 4 pain by the numerical scale of pain assessment, positivity In at least 2 of 3 orthopedic tests for impact syndrome, will be randomized into the following groups: exercise group, exercise + ultrasound group, exercise group + interferential current. Sixteen consecutive treatment sessions will be performed, and the volunteers will be evaluated before and after, by means of the following instruments: Numerical scale of evaluation of pain, Shoulder pain and disability index (SPADI), Pain-Related Catastrophizing Thoughts Scale, being applied the Numerical scale of evaluation of pain at the end of Each session and one month after the end of treatment.

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, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 59 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • History of anterolateral, unilateral pain in the shoulder with more than 3 months duration.
  • Medical diagnosis,
  • minimal grade 4 pain by numerical scale of pain assessment,
  • positivity in at least 2 of 3 orthopedic tests for impact syndrome: Neer, Hawkins or Jobe.

排除标准

  • Fibromyalgia diagnosis,
  • pregnancy,
  • numbness or tingling in the upper limb
  • History of shoulder trauma, other shoulder related diseases,
  • ruptured tendons, ligament laxity,
  • symptoms of numbness and / or Tingling in the upper limbs, history of shoulder and / or cervical surgery
  • use of corticosteroid injection in the shoulder, and analgesic, anti-inflammatory or muscle relaxant use and have or have undergone physiotherapeutic treatment in the last 6 months.

研究组 & 干预措施

exercise group

Active Comparator

Manual cervical traction, Myofascial release of upper trapezius muscle, 3 sets of 1 minute;Sleeper's stretch, during 3 series of 30 seconds,Punch exercise, Knee push-up plus, Prone V-raise exercise (arms abducted at 120°), rotador cuff exercise (internal rotation), rotador cuff exercise (external rotation), Rotation on the wall using a ball (internal rotation), Rotation on the wall using a ball (external rotation).

干预措施: exercise (Other)

exercise + Interferential current group

Experimental

Addition to the exercise protocol performed in the exercise group the interferential current. Four self-adhesive electrodes (8x5 cm), two upper and two lower ones (forming a square) will be placed around the center of the shoulder. The electrodes will be positioned crosswise, following the parameters: 4KHz (carrier frequency), 1/1 second (swing pattern), 100 Hz Frequency modulation amplitude (AMF), 50 Hz (sweep frequency), automatic vector mode, With intensity at the motor threshold of sensation, with duration of 50 minutes.

干预措施: exercise (Other)

exercise + Interferential current group

Experimental

Addition to the exercise protocol performed in the exercise group the interferential current. Four self-adhesive electrodes (8x5 cm), two upper and two lower ones (forming a square) will be placed around the center of the shoulder. The electrodes will be positioned crosswise, following the parameters: 4KHz (carrier frequency), 1/1 second (swing pattern), 100 Hz Frequency modulation amplitude (AMF), 50 Hz (sweep frequency), automatic vector mode, With intensity at the motor threshold of sensation, with duration of 50 minutes.

干预措施: Interferential current therapy (Device)

exercise + US group

Placebo Comparator

In addition to the exercise protocol performed in the exercise group, an ultrasound device will be used. The appliance will be used off, without any individual participant having knowledge. For this, the individual will be asked to position himself in the dorsal position on the stretcher, the therapist will perform the application of the transducer head, with gel on its surface, in the anterolateral region of the affected shoulder.

干预措施: exercise (Other)

exercise + US group

Placebo Comparator

In addition to the exercise protocol performed in the exercise group, an ultrasound device will be used. The appliance will be used off, without any individual participant having knowledge. For this, the individual will be asked to position himself in the dorsal position on the stretcher, the therapist will perform the application of the transducer head, with gel on its surface, in the anterolateral region of the affected shoulder.

干预措施: Therapeutic Ultrasound (Device)

结局指标

主要结局

physical function and pain

时间窗: 10 months

The Shoulder pain and disability index in the numerical version consists of 13 items distributed in the domain of pain (five items) and function (eight items), each item being scored on a numerical rating scale of 0 to 10 points. The final score of the questionnaire, as well as the score obtained separately by each domain, is converted into a percentage for values ranging from 0 to 100, with the highest score indicating worse shoulder dysfunction condition.

次要结局

  • pain(10 months)
  • Catastrophizing of the Pain(10 months)

研究者

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

Cid André Fidelis de Paula Gomes

Professor

University of Nove de Julho

研究点 (1)

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