Sonoelastography of the Supraspinatus Tendon

Tendinopathy Clinical Trial

Official title:

Responsiveness of Sonoelastography in the Supraspinatus Tendon

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03425357
• Other study ID #: Sonoelastography_Supraspinatus
• Status: Completed
• Phase: N/A
• Start date: March 25, 2018
• Est. completion date: August 21, 2019

Study information

• Verified date: August 2019
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims a determine the responsiveness of sonoelastography in the tendinopathy-affected supraspinatus tendon.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: August 21, 2019
• Est. primary completion date: August 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Elasticity Imaging Techniques
• Musculoskeletal Disease
• Musculoskeletal Diseases
• Rotator Cuff Injuries
• Rotator Cuff Tendinitis
• Tendinopathy

Intervention

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).

Locations

Country	Name	City	State
Denmark	University of Southern Denmark	Odense

Sponsors (6)

Lead Sponsor	Collaborator
Karen Brage	Gigtforeningen, Odense University Hospital, Radiograf Rådet, Region of Southern Denmark, Sygehus Lillebaelt

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quality of life	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).	Baseline and 12 weeks
Other	Disability	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.	Baseline and 12 weeks
Other	Demographic	Gender, age, bmi, education (level), duration of symptoms, symptom history	Baseline
Primary	Tendon quality (SEL)	Change from baseline in tendon quality (sonoelastography - strain elasticity)	Baseline and 12 weeks
Secondary	Tendon quality (MRI)	Change from baseline in tendon quality (MRI)	Baseline and 12 weeks
Secondary	Tendon quality (US)	Change from baseline in tendon quality (conventional ultrasound)	Baseline and 12 weeks
Secondary	Strength	Change from baseline in Isometric Strength (MVC)	Baseline and 12 weeks
Secondary	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.	12 weeks
Secondary	Pain	Change from baseline in Visual Analogue Scale (VAS). Ranging from 0 to 10; 0 being no pain and 10 being severe pain.	Baseline and 12 weeks