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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
100
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).
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).
Odense University Hospital - Svendborg Hospital
Odense, Fyn, Denmark
Aalborg University Hospital - Himmerland Hospital
Aalborg, Jutland, Denmark
Hospital Lillebaelt - Vejle Hospital
Vejle, Jutland, Denmark
Change from baseline in Disability of the Arm, Shoulder and Hand questionnaire at 12 weeks
Time frame: Baseline and 12 weeks
Change from baseline in Isometric Strength (MVC)
Time frame: Baseline and 12 weeks
Change from baseline in Range of movement
Time frame: Baseline and 12 weeks
Number of patients referred to or completed arthroscopic shoulder operation
Time frame: 12 months
Change in Shoulder injury and Osteoarthritis Outcome Score - (SOOS) at 12 weeks
Time frame: Baseline and 12 weeks
Hospital Anxiety and Depressions score - (HAD)
Time frame: Baseline
Scapula Retraction test
Time frame: Baseline
Scapula Assisted Test
Time frame: Baseline
Change in Euro Qol 5D index (EQ 5D) at 12 weeks
Time frame: Baseline and 12 weeks
Change in Disability of the Arm, Shoulder and Hand questionnaire at 52 weeks
Time frame: Baseline and 52 weeks
Change in Shoulder injury and Osteoarthritis Outcome Score - (SOOS) at 52 weeks
Time frame: Baseline and 52 weeks
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Change in Euro Qol 5D index (EQ 5D) at 52 weeks
Time frame: Baseline and 52 weeks