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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
23

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Karen Brage

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Odense University Hospital
Sygehus Lillebaelt
Region of Southern Denmark
Gigtforeningen
Radiograf Rådet

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 25, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 15, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 21, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 31, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 7, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 22, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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