Skip to main content
OpenTrials
Completed

NCT Number: NCT03425357

Sonoelastography of the Supraspinatus Tendon

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Elasticity Imaging Techniques Muscular Diseases Musculoskeletal Disease Musculoskeletal Diseases Rotator Cuff Injuries Rotator Cuff Tendinitis Rupture Shoulder Injuries Tendinopathy Tendon Injuries Wounds and Injuries

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Southern Denmark

Odense, 5230, Denmark

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Low Load Exercises

Other

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).

Other names: Scapular stabilization, Rotator Cuff, Exercise, Physiotherapy, Posture, Progressive exercise, Strength training

Primary outcomes

  1. Tendon quality (SEL)

    Time frame: Baseline and 12 weeks

    Change from baseline in tendon quality (sonoelastography - strain elasticity)

Secondary outcomes

  1. Tendon quality (MRI)

    Time frame: Baseline and 12 weeks

    Change from baseline in tendon quality (MRI)

  2. Tendon quality (US)

    Time frame: Baseline and 12 weeks

    Change from baseline in tendon quality (conventional ultrasound)

  3. Strength

    Time frame: Baseline and 12 weeks

    Change from baseline in Isometric Strength (MVC)

  4. 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.

  5. 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.

Other outcomes

  1. 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).

  2. 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.

  3. Demographic

    Time frame: Baseline

    Gender, age, bmi, education (level), duration of symptoms, symptom history

Sponsors and collaborators

Lead sponsor

Karen Brage

Other

Collaborators

  • Gigtforeningen
  • Odense University Hospital
  • Radiograf Rådet
  • Region of Southern Denmark
  • Sygehus Lillebaelt

Registry information

Official study title

Responsiveness of Sonoelastography in the Supraspinatus Tendon

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 7, 2018
Registry last updated
Aug 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.