Progressive Heavy Strength Training Compared to General Low-load Exercises in Patients With Rotator Cuff Tendinopathy: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 6
- 主要终点
- Change from baseline in Disability of the Arm, Shoulder and Hand questionnaire at 12 weeks
研究概览
简要总结
This study aims at determine if Progressive Heavy Load Exercises (PHLE) as treatment for patients diagnosed with Rotator Cuff Tendinopathy is superior to "Standard Low-Load Exercises" (LLE).
详细描述
The trial will be performed as a multicenter randomised controlled trail, including 110 patients diagnosed with Rotator Cuff Tendinopathy from four orthopaedic shoulder clinics in secondary sector in Denmark.
The PHLE intervention will consist of progressive strengthening exercises performed with heavy load dumbbells, targeting the rotator cuff in a 12 weeks home-exercise program with six control visits at a physiotherapy department at the hospitals.
The LLE exercise program consists of the same exercises as the PHLE, but performed with low load dumbbells.
"Disability of the Arm, Shoulder and Hand (DASH) questionnaire" is used as the primary outcome and is measured 12 weeks post baseline.
12 months post baseline a secondary follow-up will be performed primarily measuring the number of patients referred to an operation.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between 18 and 65 years of age
- •history of shoulder complaints lasting at least 3 months prior to enrolment
- •Pain located in the proximal lateral aspect of the upper arm (C5 dermatome) aggravated by abduction
- •Positive "Full Can test" AND/OR "Jobes test/Empty Can test" AND/OR "Resisted External Rotation test"
- •Positive "Hawkins-Kennedy test AND/OR Neers test
- •Ultra-sonographic verification of tendon swelling, hypo echoic areas, fibrillar disruption or neovascularization in the RC.
排除标准
- •Resting pain more than 40 mm on a visual analogue scale (VAS);
- •Bilateral shoulder pain
- •Less than 90 degrees of active elevation of the arm;
- •Full thickness RC rupture verified by ultra-sonography;
- •Corticosteroid injection within the last 6 weeks;
- •Radiologic verified fracture, calcification larger then 5 mm (vertical distance) in the RC tendon, glenohumeral arthrosis or malalignment in the shoulder complex;
- •Prior surgery or dislocation of the affected shoulder;
- •Clinically suspected labrum lesion, arthritis in the AC-joint, frozen shoulder or symptoms derived from the cervical spine;
- •Sensory or motor deficit in neck or arm;
- •Suspected competing diagnoses (e.g., Rheumatoid arthritis, Cancer, Neurological disorders, Fibromyalgia, Schizophrenia, Suicidal threatened, Borderline personality disorder, or Obsessive Compulsive Disorder);
- •Pregnancy;
- •Inability to fluently understand written and spoken Danish.
结局指标
主要结局
Change from baseline in Disability of the Arm, Shoulder and Hand questionnaire at 12 weeks
时间窗: Baseline and 12 weeks
次要结局
- Change from baseline in Isometric Strength (MVC)(Baseline and 12 weeks)
- Change from baseline in Range of movement(Baseline and 12 weeks)
- Hospital Anxiety and Depressions score - (HAD)(Baseline)
- Scapula Assisted Test(Baseline)
- Scapula Retraction test(Baseline)
- Change in Euro Qol 5D index (EQ 5D) at 52 weeks(Baseline and 52 weeks)
- Change in Euro Qol 5D index (EQ 5D) at 12 weeks(Baseline and 12 weeks)
- Number of patients referred to or completed arthroscopic shoulder operation(12 months)
- Change in Shoulder injury and Osteoarthritis Outcome Score - (SOOS) at 12 weeks(Baseline and 12 weeks)
- Change in Disability of the Arm, Shoulder and Hand questionnaire at 52 weeks(Baseline and 52 weeks)
- Change in Shoulder injury and Osteoarthritis Outcome Score - (SOOS) at 52 weeks(Baseline and 52 weeks)
研究者
Kim Gordon Ingwersen
MSc, PhD.stud.
University of Southern Denmark