Elasticity Imaging TechniquesNCT03425357
Sonoelastography of the Supraspinatus Tendon
A study testing Low Load Exercises in people with Elasticity Imaging Techniques and Tendinopathy, run by Karen Brage at 1 site in Denmark.
Trial summary
This study aims a determine the responsiveness of sonoelastography in the tendinopathy-affected supraspinatus tendon. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Elasticity Imaging Techniques, Tendinopathy, Rotator Cuff Tendinitis
- What is being tested?
- Low Load Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteDenmark
- Study dates
- 25 Mar 2018to 21 Aug 2019
- 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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Able to read and understand Danish
- Shoulder pain > 3 months
- Positive on 3/5 clinical tests (full can, empty can, resisted external rotation, neers, hawking)
- Tendinopathy (MRI)
Who cannot join
- BMI > 30
- Bilateral shoulder pain
- Supraspinatus full thickness rupture (US)
- Biceps rupture (US)
- Calcification in supraspinatus (X-ray)
- Pregnancy
Show all 13Show fewer
- Glenohumeral arthrosis (X-ray)
- Frozen shoulder
- Shoulder symptoms originating from neck
- Shoulder fracture, operation or luxation
- Known neuromuscular disease, rheumatoid arthritis, cancer, fibromyalgia, spondylarthropathy or psychiatric disorders
- Labrum lesion (MRI)
- Tear (˃1/3 of supraspinatus, vertical height) (MRI)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Responsiveness of Sonoelastography in the Supraspinatus Tendon
This study aims a determine the responsiveness of sonoelastography in the tendinopathy-affected supraspinatus tendon.
Read the detailed description
The trial will include 20 patients diagnosed with supraspinatus tendinopathy from one orthopaedic shoulder clinic in Denmark.
The intervention will consist of an exercise program including lowload exercises with elastics and dumbbells, targeting the rotator cuff in a 12 weeks home-exercise program with two control visits at a physiotherapy department at the hospitals.
Tissue elasticity (measured by sonoelastography) is used as the primary outcome and is measured 12 weeks post baseline
- Conditions
- Elasticity Imaging Techniques, Tendinopathy, Rotator Cuff Tendinitis, Musculoskeletal Disease
- Being tested
- Low Load Exercises
- Medical subject headings
- Tendinopathy, Rotator Cuff Injuries, Musculoskeletal Diseases
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).
| Study group | Role | What they receive |
|---|---|---|
| Low Load Exercises | Experimental | 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.
Tendon quality (SEL)
Change from baseline in tendon quality (sonoelastography - strain elasticity)
Measured: Baseline and 12 weeks
Secondary outcomes (5)
Tendon quality (MRI)
Change from baseline in tendon quality (MRI)
Measured: Baseline and 12 weeks
Tendon quality (US)
Change from baseline in tendon quality (conventional ultrasound)
Measured: Baseline and 12 weeks
Strength
Change from baseline in Isometric Strength (MVC)
Measured: Baseline and 12 weeks
Recovery
Change from baseline in Global Perceived Effect (GPE). Ranging from -3 to +3; - being a worsening, 0 being no change and + being an improvement.
Measured: 12 weeks
Pain
Change from baseline in Visual Analogue Scale (VAS). Ranging from 0 to 10; 0 being no pain and 10 being severe pain.
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2018
- Study start25 Mar 2018
- Primary completion15 Aug 2019
- Study completion21 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Elasticity Imaging TechniquesStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karen Brage
- Sponsor type
- University, hospital or other
- Collaborators
- Odense University Hospital, Sygehus Lillebaelt, Gigtforeningen, Region of Southern Denmark, Radiograf Rådet
- Responsible party
- Sponsor-investigator, Karen Brage, University of Southern Denmark
- Investigators
- Birgit Juul-Kristensen, Assoc Prof, Study director, Department of Sport Science and Biomechanics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03425357
- Sponsor's protocol ID
- Sonoelastography_Supraspinatus
- Status last verified
- Aug 2019
- First submitted
- 31 Jan 2018
- Last updated
- 22 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Brage K, Juul-Kristensen B, Hjarbaek J, Boyle E, Kjaer P, Ingwersen KG. Strain Elastography and Tendon Response to an Exercise Program in Patients With Supraspinatus Tendinopathy: An Exploratory Study. Orthop J Sports Med. 2020 Dec 16;8(12):2325967120965185. doi: 10.1177/2325967120965185. eCollection 2020 Dec.
PubMed 33403207
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Responsiveness of Sonoelastography in the Supraspinatus Tendon
- ClinicalTrials.gov ID
- NCT03425357
- Acronym / sponsor ID
- Sonoelastography_Supraspinatus
- Conditions
- Elasticity Imaging Techniques, Tendinopathy, Rotator Cuff Tendinitis, Musculoskeletal Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Karen BrageUniversity, hospital or other
- Collaborators
- Odense University Hospital, Sygehus Lillebaelt, Gigtforeningen, Region of Southern Denmark, Radiograf Rådet
- Study start
- 25 Mar 2018 (actual)
- Primary completion
- 15 Aug 2019 (actual)
- Study completion
- 21 Aug 2019 (actual)
- First posted
- 7 Feb 2018 (actual)
- 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 a determine the responsiveness of sonoelastography in the tendinopathy-affected supraspinatus tendon.
Detailed description
The trial will include 20 patients diagnosed with supraspinatus tendinopathy from one orthopaedic shoulder clinic in Denmark.
The intervention will consist of an exercise program including lowload exercises with elastics and dumbbells, targeting the rotator cuff in a 12 weeks home-exercise program with two control visits at a physiotherapy department at the hospitals.
Tissue elasticity (measured by sonoelastography) is used as the primary outcome and is measured 12 weeks post baseline
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Low Load Exercises | Experimental | Other: Low Load ExercisesAn 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
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Able to read and understand Danish
- Shoulder pain > 3 months
- Positive on 3/5 clinical tests (full can, empty can, resisted external rotation, neers, hawking)
- Tendinopathy (MRI)
Key exclusion criteria (13 listed)
- BMI > 30
- Bilateral shoulder pain
- Supraspinatus full thickness rupture (US)
- Biceps rupture (US)
- Calcification in supraspinatus (X-ray)
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 |
Primary outcome
Tendon quality (SEL)
Time frame: Baseline and 12 weeks
Change from baseline in tendon quality (sonoelastography - strain elasticity)
5 secondary outcomes
Tendon quality (MRI)
Time frame: Baseline and 12 weeks
Tendon quality (US)
Time frame: Baseline and 12 weeks
Strength
Time frame: Baseline and 12 weeks
Recovery
Time frame: 12 weeks
Pain
Time frame: Baseline and 12 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 22 Aug 2019.
- Derived from this study: PubMed 33403207Brage K, Juul-Kristensen B, Hjarbaek J, Boyle E, Kjaer P, Ingwersen KG. Strain Elastography and Tendon Response to an Exercise Program in Patients With Supraspinatus Tendinopathy: An Exploratory Study. Orthop J Sports Med. 2020 Dec 16;8(12):2325967120965185. doi: 10.1177/2325967120965185. eCollection 2020 Dec.
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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, Assoc Prof study director
Department of Sport Science and Biomechanics
1 site 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 in people with Elasticity Imaging Techniques and Tendinopathy, run by Karen Brage at 1 site 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 4 inclusion and 13 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 22 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Tendon quality (SEL) (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 NCT03425357, which also lists 1 linked publication.
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 22 Aug 2019; AzTrials last refreshed its copy on 1 Nov 2026.