Clinical trial NCT03425357: Sonoelastography of the Supraspinatus Tendon
Official title: Responsiveness of Sonoelastography in the Supraspinatus Tendon
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elasticity Imaging Techniques
Tendinopathy
Rotator Cuff Tendinitis
Musculoskeletal Disease
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Odense University Hospital
name: Sygehus Lillebaelt
name: Gigtforeningen
name: Region of Southern Denmark
name: Radiograf Rådet
First posted: 2018-02-07
Enrollment: 23
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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

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)

Primary outcomes:
measure: Tendon quality (SEL)
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Tendon quality (MRI)
timeFrame: Baseline and 12 weeks
measure: Tendon quality (US)
timeFrame: Baseline and 12 weeks
measure: Strength
timeFrame: Baseline and 12 weeks
measure: Recovery
timeFrame: 12 weeks
measure: Pain
timeFrame: Baseline and 12 weeks
Other outcomes:
measure: Quality of life
timeFrame: Baseline and 12 weeks
measure: Disability
timeFrame: Baseline and 12 weeks
measure: Demographic
timeFrame: Baseline
Locations:
city: Odense
country: Denmark
facility: University of Southern Denmark
Study officials:
affiliation: Department of Sport Science and Biomechanics
name: Birgit Juul-Kristensen, Assoc Prof
role: STUDY_DIRECTOR
References:
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.