Discriminative Validity of Strain Elastography of the Supraspinatus Tendon

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

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

Study Overview

• Status: Completed
• Conditions: Tendinopathy; Musculoskeletal Disease; Rotator Cuff Tendinitis; Elasticity Imaging Techniques
• Intervention / Treatment: Diagnostic test: Diagnostic

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Odense, Denmark, 5230
    • University of Southern Denmark

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Diagnostic; All participants will be exposed to shoulder- MRI, ultrasound and sonoelastography.	Diagnostic test: Diagnostic; No traditionally intervention will be given but participants will be exposed to shoulder- MRI, ultrasound and sonoelastography..

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tendon quality (SEL)	Sonoelastography - strain elasticity	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain on a VAS scale	Change from baseline in Visual Analogue Scale (VAS). Ranging from 0 to 10; 0 being no pain and 10 being severe pain.	Baseline
Quality of life on the E!-5D-3L questionnaire	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
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
Tendon quality (MRI)	Magnetic Resonance	Baseline
Tendon quality (US)	Conventional ultrasound	Baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographic	Gender, age, bmi, education (level), duration of symptoms, symptom history	Baseline

Collaborators and Investigators

• Sponsor: Karen Brage
• Collaborators: Odense University Hospital; Sygehus Lillebaelt; Region of Southern Denmark; Gigtforeningen; Radiograf Rådet
• Investigators: Study Director: Birgit Juul-Kristensen, Assoc. Prof, Department of Sport Science and Biomechanics

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2018
• Primary Completion (Actual): July 1, 2019
• Study Completion (Actual): August 21, 2019

Study Registration Dates

• First Submitted: February 1, 2018
• First Submitted That Met QC Criteria: February 6, 2018
• First Posted (Actual): February 7, 2018

Study Record Updates

• Last Update Posted (Actual): August 22, 2019
• Last Update Submitted That Met QC Criteria: August 21, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Muscular Diseases; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries; Tendinopathy; Musculoskeletal Diseases
• Other Study ID Numbers: SEL_Supraspinatus_cross

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No