Sonoelastography of the Supraspinatus Tendon

August 21, 2019 updated by: Karen Brage

Responsiveness of Sonoelastography in the Supraspinatus Tendon

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Low Load Exercises
An exercise program consisting of 6 active exercises. Two exercises for the rotator cuff: Full Can and Sidelying external rotation Two exercises for the scapulae stabilizing muscles: Low Row and Push-Up Plus Two glenohumeral/postural corrective exercises: Posterior GH stretch and Scapular Retraction.
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).

Other Names:
  • Exercise
  • Strength training
  • Physiotherapy
  • Scapular stabilization
  • Rotator Cuff
  • Posture
  • Progressive exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tendon quality (SEL)
Time Frame: Baseline and 12 weeks
Change from baseline in tendon quality (sonoelastography - strain elasticity)
Baseline and 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tendon quality (MRI)
Time Frame: Baseline and 12 weeks
Change from baseline in tendon quality (MRI)
Baseline and 12 weeks
Tendon quality (US)
Time Frame: Baseline and 12 weeks
Change from baseline in tendon quality (conventional ultrasound)
Baseline and 12 weeks
Strength
Time Frame: Baseline and 12 weeks
Change from baseline in Isometric Strength (MVC)
Baseline and 12 weeks
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.
12 weeks
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.
Baseline and 12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline and 12 weeks
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.
Baseline and 12 weeks
Demographic
Time Frame: Baseline
Gender, age, bmi, education (level), duration of symptoms, symptom history
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 25, 2018

Primary Completion (ACTUAL)

August 15, 2019

Study Completion (ACTUAL)

August 21, 2019

Study Registration Dates

First Submitted

January 31, 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

Other Study ID Numbers

  • Sonoelastography_Supraspinatus

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Tendinopathy

Clinical Trials on Low Load Exercises

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uganda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe