Sonoelastography of the Supraspinatus Tendon

NCT ID: NCT03425357

Last Updated: 2019-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-25

Study Completion Date

2019-08-21

Brief Summary

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

Detailed Description

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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

Conditions

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Elasticity Imaging Techniques Tendinopathy Rotator Cuff Tendinitis Musculoskeletal Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Low Load Exercises

Intervention Type 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).

Interventions

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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).

Intervention Type OTHER

Other Intervention Names

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Scapular stabilization Rotator Cuff Exercise Physiotherapy Posture Progressive exercise Strength training

Eligibility Criteria

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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)
Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Odense University Hospital

OTHER

Sponsor Role collaborator

Sygehus Lillebaelt

OTHER

Sponsor Role collaborator

Gigtforeningen

OTHER

Sponsor Role collaborator

Region of Southern Denmark

OTHER

Sponsor Role collaborator

Radiograf Rådet

UNKNOWN

Sponsor Role collaborator

Karen Brage

OTHER

Sponsor Role lead

Responsible Party

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Karen Brage

Ph.D-student

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Birgit Juul-Kristensen, Assoc Prof

Role: STUDY_DIRECTOR

Department of Sport Science and Biomechanics

Locations

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University of Southern Denmark

Odense, , Denmark

Site Status

Countries

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Denmark

References

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Brage K, Juul-Kristensen B, Hjarbaek J, Boyle E, Kjaer P, Ingwersen KG. Strain Elastography and Tendon Response to an Exercise Program in Patients With Supraspinatus Tendinopathy: An Exploratory Study. Orthop J Sports Med. 2020 Dec 16;8(12):2325967120965185. doi: 10.1177/2325967120965185. eCollection 2020 Dec.

Reference Type DERIVED
PMID: 33403207 (View on PubMed)

Other Identifiers

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Sonoelastography_Supraspinatus

Identifier Type: -

Identifier Source: org_study_id

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