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| Name | Class |
|---|---|
| Region of Southern Denmark | OTHER |
| Sygehus Lillebaelt | OTHER |
| Aalborg University Hospital | OTHER |
| Odense University Hospital |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Progressive Heavy Strength Exercises | Experimental | 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. |
|
| Low Load Exercises | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low Load Exercises | Other | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Disability of the Arm, Shoulder and Hand questionnaire at 12 weeks | Baseline and 12 weeks |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in tendon quality measured on ultra-sonography at 12 weeks | Baseline and 12 weeks | |
| Baseline demographic and Socioeconomic variables measured at 52 weeks | Age, sex, duration of symptoms, symptom history, number of patients receiving corticosteroid injections, visits at the patients general practitioner related to their shoulder problem, visits at the secondary healthcare system related to their shoulder problem, sick leave |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Birgit Juul-Kristensen, Ass. Prof | University of Southern Denmark | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Odense University Hospital - Svendborg Hospital | Odense | Fyn | 5000 | Denmark | ||
| Aalborg University Hospital - Himmerland Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28875153 | Derived | 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. | |
| 27221128 |
| Label | URL |
|---|---|
| Protocol article | View source |
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| ID | Term |
|---|---|
| D000070636 | Rotator Cuff Injuries |
| D019534 | Shoulder Impingement Syndrome |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D012421 | Rupture |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
| D013708 | Tendon Injuries |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| D026741 | Physical Therapy Modalities |
| D011187 | Posture |
| D055070 | Resistance Training |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| OTHER |
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|
|
| Progressive Heavy Strength Exercises | Other | 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). |
|
|
| 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 |
| Baseline and 52 weeks |
| Aalborg |
| Jutland |
| 9800 |
| Denmark |
| Hospital Lillebaelt - Vejle Hospital | Vejle | Jutland | 7100 | Denmark |
| Derived |
| 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. |
| 25622594 | Derived | 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. |
| D007592 |
| Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D001519 | Behavior |
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
| D005081 | Exercise Therapy |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D064797 | Physical Conditioning, Human |