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NCT Number: NCT03425344

Discriminative Validity of Strain Elastography of the Supraspinatus Tendon

This study aims at testing the discriminative validity of strain elastography in the normal and abnormal/pathological Supraspinatus tendon due to tendinopathy

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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 case-control trial will include 96 participants. 48 of them diagnosed with supraspinatus tendinopathy by MRI and 48 healthy subjects.

In this study the investigators will compare the outcome of tissue elasticity measured by sonoelastography, with MRI and conventional ultrasound.

Patients will be recruited through different radiology department and healthy volunteers will be recruited primarily through advertising in local newspapers and social media.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Body mass index < 30
  • Symptomatic: Positive on 3/5 clinical tests (full can, empty can, resisted external rotation, neers, hawkins.
  • Asymptomatic: No shoulder pain in the last year, negative on 5/5 clinical tests (full can, empty can, resisted external rotation, neers, hawkins).

Exclusion criteria

  • Shoulder-fracture, operation and luxation, known-neuromuscular disease, rheumatoid arthritis, cancer, fibromyalgia, spondyloarthropathy and psychiatric disorders, pregnancy and inability to read and understand Danish. Biceps rupture, labrum lesions, supraspinatus tears (> 1/3 of the vertical tendon height) and calcifications (> 2 mm in length) (MRI).

Treatment and study plan

Diagnostic

Diagnostic Test

No traditionally intervention will be given but participants will be exposed to shoulder- MRI, ultrasound and sonoelastography..

Primary outcomes

  1. Tendon quality (SEL)

    Time frame: Baseline

    Sonoelastography - strain elasticity

Secondary outcomes

  1. Pain on a VAS scale

    Time frame: Baseline

    Change from baseline in Visual Analogue Scale (VAS). Ranging from 0 to 10; 0 being no pain and 10 being severe pain.

  2. Quality of life on the E!-5D-3L questionnaire

    Time frame: Baseline

    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).

  3. Disability

    Time frame: Baseline

    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.

  4. Tendon quality (MRI)

    Time frame: Baseline

    Magnetic Resonance

  5. Tendon quality (US)

    Time frame: Baseline

    Conventional ultrasound

Other outcomes

  1. 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

Discriminative Validity of Real-time Sonoelastography of the Supraspinatus Tendon: Comparison of Findings Between Patients With Supraspinatus Tendinopathy and Healthy Volunteers

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.

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