Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2013-11-30
2015-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Progressive Heavy Strength Exercises
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.
Progressive Heavy Strength Exercises
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).
Low Load Exercises
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.
Low Load Exercises
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).
Interventions
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Low Load Exercises
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).
Progressive Heavy Strength Exercises
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).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Region of Southern Denmark
OTHER
Sygehus Lillebaelt
OTHER
Aalborg University Hospital
OTHER
Odense University Hospital
OTHER
University of Southern Denmark
OTHER
Responsible Party
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Kim Gordon Ingwersen
MSc, PhD.stud.
Principal Investigators
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Birgit Juul-Kristensen, Ass. Prof
Role: STUDY_DIRECTOR
University of Southern Denmark
Locations
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Odense University Hospital - Svendborg Hospital
Odense, Fyn, Denmark
Aalborg University Hospital - Himmerland Hospital
Aalborg, Jutland, Denmark
Hospital Lillebaelt - Vejle Hospital
Vejle, Jutland, Denmark
Countries
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References
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Ingwersen KG, Jensen SL, Sorensen L, Jorgensen HR, Christensen R, Sogaard K, Juul-Kristensen B. Three Months of Progressive High-Load Versus Traditional Low-Load Strength Training Among Patients With Rotator Cuff Tendinopathy: Primary Results From the Double-Blind Randomized Controlled RoCTEx Trial. Orthop J Sports Med. 2017 Aug 28;5(8):2325967117723292. doi: 10.1177/2325967117723292. eCollection 2017 Aug.
Ingwersen KG, Hjarbaek J, Eshoej H, Larsen CM, Vobbe J, Juul-Kristensen B. Ultrasound assessment for grading structural tendon changes in supraspinatus tendinopathy: an inter-rater reliability study. BMJ Open. 2016 May 24;6(5):e011746. doi: 10.1136/bmjopen-2016-011746.
Ingwersen KG, Christensen R, Sorensen L, Jorgensen HR, Jensen SL, Rasmussen S, Sogaard K, Juul-Kristensen B. Progressive high-load strength training compared with general low-load exercises in patients with rotator cuff tendinopathy: study protocol for a randomised controlled trial. Trials. 2015 Jan 27;16:27. doi: 10.1186/s13063-014-0544-6.
Related Links
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Protocol article
Other Identifiers
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RoCTExPRIMARY
Identifier Type: -
Identifier Source: org_study_id