Rotator Cuff TendinitisRoCTExNCT01984203
Rotator Cuff Tendinopathy Exercise Trial
A study testing Low Load Exercises and Progressive Heavy Strength Exercises in people with Rotator Cuff Tendinitis, run by University of Southern Denmark at 3 sites in Denmark.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rotator Cuff Tendinitis
- What is being tested?
- Low Load Exercises and Progressive Heavy Strength Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesDenmark
- Study dates
- Nov 2013to Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 12Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
Aalborg University Hospital - Himmerland Hospital
Aalborg, Jutland, 9800
Odense University Hospital - Svendborg Hospital
Odense, Fyn, 5000
Hospital Lillebaelt - Vejle Hospital
Vejle, Jutland, 7100
About this study
Official title: Progressive Heavy Strength Training Compared to General Low-load Exercises in Patients With Rotator Cuff Tendinopathy: a Randomized Controlled Trial
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).
Read the detailed description
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.
- Conditions
- Rotator Cuff Tendinitis
- Being tested
- Low Load Exercises, Progressive Heavy Strength Exercises
- Keywords
- Shoulder, Impingement, Rotator Cuff Syndrome, Subacromial Impingement Syndrome, Exercise, Physiotherapy
- Medical subject headings
- Rotator Cuff Injuries, Shoulder Impingement Syndrome, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Load ExercisesOther
Also called Scapular stabilization, Rotator Cuff, Exercise, Physiotherapy
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 ExercisesOther
Also called Scapular stabilization, Rotator Cuff, Exercise, Physiotherapy
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Progressive Heavy Strength Exercises |
| 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. Receives: Other: Low Load Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Disability of the Arm, Shoulder and Hand questionnaire at 12 weeks
Measured: Baseline and 12 weeks
Secondary outcomes (11)
Change from baseline in Isometric Strength (MVC)
Measured: Baseline and 12 weeks
Change from baseline in Range of movement
Measured: Baseline and 12 weeks
Number of patients referred to or completed arthroscopic shoulder operation
Measured: 12 months
Change in Shoulder injury and Osteoarthritis Outcome Score - (SOOS) at 12 weeks
Measured: Baseline and 12 weeks
Hospital Anxiety and Depressions score - (HAD)
Measured: Baseline
Scapula Retraction test
Measured: Baseline
Scapula Assisted Test
Measured: Baseline
Change in Euro Qol 5D index (EQ 5D) at 12 weeks
Measured: Baseline and 12 weeks
Change in Disability of the Arm, Shoulder and Hand questionnaire at 52 weeks
Measured: Baseline and 52 weeks
Change in Shoulder injury and Osteoarthritis Outcome Score - (SOOS) at 52 weeks
Measured: Baseline and 52 weeks
Change in Euro Qol 5D index (EQ 5D) at 52 weeks
Measured: Baseline and 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff TendinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Region of Southern Denmark, Sygehus Lillebaelt, Aalborg University Hospital, Odense University Hospital
- Responsible party
- Principal investigator, Kim Gordon Ingwersen, University of Southern Denmark
- Investigators
- Birgit Juul-Kristensen, Ass. Prof, Study director, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01984203
- Sponsor's protocol ID
- RoCTExPRIMARY
- Acronym
- RoCTEx
- Status last verified
- Nov 2015
- First submitted
- 31 Oct 2013
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28875153Ingwersen 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.
PubMed 27221128Ingwersen 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.
PubMed 25622594
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Progressive Heavy Strength Training Compared to General Low-load Exercises in Patients With Rotator Cuff Tendinopathy: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01984203
- Acronym / sponsor ID
- RoCTEx / RoCTExPRIMARY
- Conditions
- Rotator Cuff Tendinitis
- Keywords
- Shoulder, Impingement, Rotator Cuff Syndrome, Subacromial Impingement Syndrome, Exercise, Physiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Region of Southern Denmark, Sygehus Lillebaelt, Aalborg University Hospital, Odense University Hospital
- Study start
- Nov 2013
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 14 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Progressive Heavy Strength Exercises | Experimental | Other: Progressive Heavy Strength ExercisesThe 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 | Other: Low Load ExercisesActive 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low Load ExercisesAlso: Scapular stabilization, Rotator Cuff, Exercise, PhysiotherapyAll 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). | Other | Low Load Exercises |
| Progressive Heavy Strength ExercisesAlso: Scapular stabilization, Rotator Cuff, Exercise, PhysiotherapyAll 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 | Progressive Heavy Strength Exercises |
Primary outcome
Change from baseline in Disability of the Arm, Shoulder and Hand questionnaire at 12 weeks
Time frame: Baseline and 12 weeks
11 secondary outcomes
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
Change in Euro Qol 5D index (EQ 5D) at 52 weeks
Time frame: Baseline and 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2015.
- Derived from this study: PubMed 28875153Ingwersen 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.
- Derived from this study: PubMed 27221128Ingwersen 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.
- Derived from this study: PubMed 25622594Ingwersen 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.
- Protocol articleLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Birgit Juul-Kristensen, Ass. Prof study director
University of Southern Denmark
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Load Exercises and Progressive Heavy Strength Exercises in people with Rotator Cuff Tendinitis, run by University of Southern Denmark at 3 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Disability of the Arm, Shoulder and Hand questionnaire at 12 weeks (time frame: Baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01984203, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2015.