Rotator Cuff Tendinopathy Exercise Trial

Study Overview
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Brief Summary
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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).

Detailed Description
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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. Patients will be randomised to either PHLE or LLE regime by blocks according to whether they have been referred to corticosteroid injection by their orthopaedic shoulder specialist. *April 2015: (We originally expected to be able to include 260 patients in order to analyze our data according to the sub-groups of exercise group +/- Corticosteroid injection, but inclusion rate has been much lower then expected, and due to time restraints we only expect to include 110 patients) Primary investigator and patients will be blinded towards group assignment.

Official Title
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Progressive Heavy Strength Training Compared to General Low-load Exercises in Patients With Rotator Cuff Tendinopathy: a Randomized Controlled Trial

Conditions
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Rotator Cuff Tendinitis

Intervention / Treatment
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* Other: Low Load Exercises
* Other: Progressive Heavy Strength Exercises


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Progressive Heavy Strength Exercises<br>The Progressive Heavy Load Exercise group gradually increases the external load from 60%RM to 90%RM and correspondently decreases the number of performed repetitions pr. set for the two rotator cuff exercises. Furthermore 4 sets is performed. A progressive exercise program consisting of 6 active exercises. Two exercises for the rotator cuff: Full Can and Sidelying external rotation Two exercises for the scapulae stabilizing muscles: Low Row and Push-Up Plus Two glenohumeral/postural corrective exercises: Posterior GH stretch and Scapular Retraction. | Other: Progressive Heavy Strength Exercises<br>* All scapular exercises are performed with 3 sets of 20 repetitions 3 times per week for 12 weeks. The load is set at around 60% of 1 RM (20 reps). The rotator cuff exercises are performed with 4 sets of gradually progressive loading and decreasing the repetitions performed in each set. Week 1: 15reps (70% 1RM) Week 2-3: 12 reps (75% 1RM) Week 4-5: 10 reps (80% 1RM) Week 6-8: 8 reps (85% 1RM) Week 9-12: 6 reps (90% 1RM) The glenohumeral/postural corrective exercises are performed with 3 sets of 5 repetitions (The position is held for 15 seconds per repetition).<br>* Other names: Strength training;|
| Active Comparator: Low Load Exercises<br>Active exercises comparator continuously training with 60%RM through 12 weeks. An exercise program consisting of 6 active exercises. Two exercises for the rotator cuff: Full Can and Sidelying external rotation Two exercises for the scapulae stabilizing muscles: Low Row and Push-Up Plus Two glenohumeral/postural corrective exercises: Posterior GH stretch and Scapular Retraction. | Other: Low Load Exercises<br>* All rotator cuff and scapular exercises are performed with 3 sets of 20 repetitions 3 times per week for 12 weeks. The load is set at around 60% of 1 RM (20 reps). The glenohumeral/postural corrective exercises are performed with 3 sets of 5 repetitions (The position is held for 15 seconds per repetition).<br>* Other names: Strength training;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Disability of the Arm, Shoulder and Hand questionnaire at 12 weeks |  | Baseline and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Isometric Strength (MVC) |  | Baseline and 12 weeks | 
| Change from baseline in Range of movement |  | 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 | 
| Hospital Anxiety and Depressions score - (HAD) |  | Baseline | 
| Scapula Retraction test |  | Baseline | 
| Scapula Assisted Test |  | Baseline | 
| Change in Euro Qol 5D index (EQ 5D) 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 | 
| Change in Euro Qol 5D index (EQ 5D) at 52 weeks |  | Baseline and 52 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Shoulder, Impingement, Rotator Cuff Syndrome, Subacromial Impingement Syndrome, Exercise, Physiotherapy