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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03425357
Other study ID # Sonoelastography_Supraspinatus
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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)

Study Design


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
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