Sonoelastography of the Supraspinatus Tendon
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|ClinicalTrials.gov Identifier: NCT03425357|
Recruitment Status : Recruiting
First Posted : February 7, 2018
Last Update Posted : May 2, 2018
|Condition or disease||Intervention/treatment||Phase|
|Elasticity Imaging Techniques Tendinopathy Rotator Cuff Tendinitis Musculoskeletal Disease||Other: Low Load Exercises||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Responsiveness of Sonoelastography in the Supraspinatus Tendon|
|Actual Study Start Date :||March 25, 2018|
|Estimated Primary Completion Date :||September 15, 2018|
|Estimated Study Completion Date :||July 1, 2019|
Experimental: Low Load Exercises
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.
Other: 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).
- Tendon quality (SEL) [ Time Frame: Baseline and 12 weeks ]Change from baseline in tendon quality (sonoelastography - strain elasticity)
- Tendon quality (MRI) [ Time Frame: Baseline and 12 weeks ]Change from baseline in tendon quality (MRI)
- Tendon quality (US) [ Time Frame: Baseline and 12 weeks ]Change from baseline in tendon quality (conventional ultrasound)
- Strength [ Time Frame: Baseline and 12 weeks ]Change from baseline in Isometric Strength (MVC)
- Recovery [ Time Frame: 12 weeks ]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 [ Time Frame: Baseline and 12 weeks ]Change from baseline in Visual Analogue Scale (VAS). Ranging from 0 to 10; 0 being no pain and 10 being severe pain.
- Quality of life [ Time Frame: Baseline and 12 weeks ]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).
- Disability [ Time Frame: Baseline and 12 weeks ]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.
- Demographic [ Time Frame: Baseline ]Gender, age, bmi, education (level), duration of symptoms, symptom history
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03425357
|Contact: Karen Brage, MScfirstname.lastname@example.org|
|University of Southern Denmark||Recruiting|
|Odense, Denmark, 5230|
|Contact: Karen Brage, Ph.D-student +45 51787381 email@example.com|
|Study Director:||Birgit Juul-Kristensen, Assoc Prof||Department of Sport Science and Biomechanics|