Sonoelastography of the Supraspinatus Tendon
Primary Purpose
Elasticity Imaging Techniques, Tendinopathy, Rotator Cuff Tendinitis
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Low Load Exercises
Sponsored by
About this trial
This is an interventional diagnostic trial for Elasticity Imaging Techniques
Eligibility Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- BMI > 30
- Bilateral shoulder pain
- Supraspinatus full thickness rupture (US)
- Biceps rupture (US)
- Calcification in supraspinatus (X-ray)
- Pregnancy
- 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)
Sites / Locations
- University of Southern Denmark
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Low Load Exercises
Arm Description
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.
Outcomes
Primary Outcome Measures
Tendon quality (SEL)
Change from baseline in tendon quality (sonoelastography - strain elasticity)
Secondary Outcome Measures
Tendon quality (MRI)
Change from baseline in tendon quality (MRI)
Tendon quality (US)
Change from baseline in tendon quality (conventional ultrasound)
Strength
Change from baseline in Isometric Strength (MVC)
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.
Pain
Change from baseline in Visual Analogue Scale (VAS). Ranging from 0 to 10; 0 being no pain and 10 being severe pain.
Full Information
NCT ID
NCT03425357
First Posted
January 31, 2018
Last Updated
August 21, 2019
Sponsor
Karen Brage
Collaborators
Odense University Hospital, Sygehus Lillebaelt, Gigtforeningen, Region of Southern Denmark, Radiograf Rådet
1. Study Identification
Unique Protocol Identification Number
NCT03425357
Brief Title
Sonoelastography of the Supraspinatus Tendon
Official Title
Responsiveness of Sonoelastography in the Supraspinatus Tendon
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
March 25, 2018 (Actual)
Primary Completion Date
August 15, 2019 (Actual)
Study Completion Date
August 21, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Karen Brage
Collaborators
Odense University Hospital, Sygehus Lillebaelt, Gigtforeningen, Region of Southern Denmark, Radiograf Rådet
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Elasticity Imaging Techniques, Tendinopathy, Rotator Cuff Tendinitis, Musculoskeletal Disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low Load Exercises
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Low Load Exercises
Other Intervention Name(s)
Scapular stabilization, Rotator Cuff, Exercise, Physiotherapy, Posture, Progressive exercise, Strength training
Intervention Description
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).
Primary Outcome Measure Information:
Title
Tendon quality (SEL)
Description
Change from baseline in tendon quality (sonoelastography - strain elasticity)
Time Frame
Baseline and 12 weeks
Secondary Outcome Measure Information:
Title
Tendon quality (MRI)
Description
Change from baseline in tendon quality (MRI)
Time Frame
Baseline and 12 weeks
Title
Tendon quality (US)
Description
Change from baseline in tendon quality (conventional ultrasound)
Time Frame
Baseline and 12 weeks
Title
Strength
Description
Change from baseline in Isometric Strength (MVC)
Time Frame
Baseline and 12 weeks
Title
Recovery
Description
Change from baseline in Global Perceived Effect (GPE). Ranging from -3 to +3; - being a worsening, 0 being no change and + being an improvement.
Time Frame
12 weeks
Title
Pain
Description
Change from baseline in Visual Analogue Scale (VAS). Ranging from 0 to 10; 0 being no pain and 10 being severe pain.
Time Frame
Baseline and 12 weeks
Other Pre-specified Outcome Measures:
Title
Quality of life
Description
Change in Euro Qol 5D index (EQ-5D-3L). The system consists of a descriptive system and a visual analogue scale (EQ VAS). The descriptive system contains 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 3 levels; no problems, some problems and extreme problems. The EQ-VAS range from 0 (worst imaginable health state) to 100 (best imaginable health state).
Time Frame
Baseline and 12 weeks
Title
Disability
Description
Change in Disability of the Arm, Shoulder and Hand questionnaire (DASH). Each item is rated with a score from 1 (least disability) to 5 (most disability). All scores are added together, producing a raw score, which is then transformed into a score of 100 maximum. A higher score indicates greater disability.
Time Frame
Baseline and 12 weeks
Title
Demographic
Description
Gender, age, bmi, education (level), duration of symptoms, symptom history
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
BMI > 30
Bilateral shoulder pain
Supraspinatus full thickness rupture (US)
Biceps rupture (US)
Calcification in supraspinatus (X-ray)
Pregnancy
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Birgit Juul-Kristensen, Assoc Prof
Organizational Affiliation
Department of Sport Science and Biomechanics
Official's Role
Study Director
Facility Information:
Facility Name
University of Southern Denmark
City
Odense
ZIP/Postal Code
5230
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
33403207
Citation
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.
Results Reference
derived
Learn more about this trial
Sonoelastography of the Supraspinatus Tendon
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