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临床试验/NCT02870257
NCT02870257已完成不适用

Effects of Overload Progressive in the Treatment of Shoulder Impingement Syndrome Associated With Scapular Dyskinesis: a Randomized Controlled Trial

University of Nove de Julho2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2016年8月最近更新:
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
70
试验地点
2
主要终点
Change in Numeric pain rating scale (0-10)

研究概览

简要总结

Seventy subjects with shoulder impingement syndrome associated with scapular dyskinesis will be recruited and randomized into two groups of treatment. The group "a" will receive a strenghtening protocol with progressive overload during 20 sessions and group "b" will receive the same protocol with minimal load, without change during the 20 sessions. The primary outcomes measures will be pain, function, quality of life, global impression of recovery. The change will be measure from baseline at 10 weeks (after 20 sessions), 3 and 6 months (follow-up). The secundary outcomes will be disability, quality of life measure by other instruments, shoulder muscle strength and scapular 3d kinematic variables. For these data, change will be measure from baseline at 10 weeks (after 20 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
Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • People with diagnosis shoulder impingement syndrome or supraspinatus/rotator cuff tendinopathy or subacromial bursitis
  • shoulder pain for more than 4 months, at least 4 points of pain in 0-10 NPRS
  • at least 130° shoulder active elevation
  • 3 or more positive of 5 physical examination tests (painful arc, external rotation resistence, Neer, empty can (Jobe) and Hawkins-Kennedy
  • positive dynamic scapular dyskinesis in clinical observation

排除标准

  • Referred pain from vertebral spine
  • previous shoulder, elbow or neck surgery
  • complete rotator cuff tear (positive drop arm sign or substantial shoulder elevation or rotation weakness)
  • neoplastic or neurological disorders
  • previous fracture or dislocation injury (shoulder, humerus, clavicle)
  • adhesive capsulitis signs
  • inflammatory diseases
  • specific treatment for the shoulder in the previous four months (injection, physiotherapy)
  • using drugs in the previous week
  • inability to understand portuguese language

研究组 & 干预措施

Progressive overload strengthening group

Experimental

Strengthening protocol with progressive load

Strengthening muscle exercises for the shoulder and scapular with progressive increase of load during 10 weeks (20 sessions)

干预措施: Strengthening protocol with progressive load (Other)

Strengthening group

Active Comparator

Strengthening protocol without progressive load

Strengthening muscle exercises for the shoulder and scapular without increase of load (minimal load) during 10 weeks (20 sessions)

干预措施: Strengthening protocol without progressive load (Other)

结局指标

主要结局

Change in Numeric pain rating scale (0-10)

时间窗: baseline, 10 weeks, 3 months and 6 months

Change in SPADI (Shoulder Pain and Disability Index) Questionnaire (0-100)

时间窗: baseline, 10 weeks, 3 months and 6 months

Change in ASES (American Shoulder and Elbow Surgeons) Questionnaire (0-100)

时间窗: baseline, 10 weeks, 3 months and 6 months

次要结局

  • Disabilities(Change from baseline at 10 weeks)
  • Muscle Strength(Change from baseline at 10 weeks)
  • Quality of life(Change from baseline at 10 weeks)
  • Scapular kinematic(Change from baseline at 10 weeks)
  • Global impression of recovery(Change from baseline at 10 weeks, 3 months and 6 months)

研究者

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

André Serra Bley

Principal Investigator

University of Nove de Julho

研究点 (2)

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