NCT03425357

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 7, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

March 25, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2019

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 21, 2019

Completed
Last Updated

August 22, 2019

Status Verified

August 1, 2019

Enrollment Period

1.4 years

First QC Date

January 31, 2018

Last Update Submit

August 21, 2019

Conditions

Elasticity Imaging TechniquesTendinopathyRotator Cuff TendinitisMusculoskeletal Disease

Outcome Measures

Primary Outcomes (1)

  • Tendon quality (SEL)

    Change from baseline in tendon quality (sonoelastography - strain elasticity)

    Baseline and 12 weeks

Secondary Outcomes (5)

  • Tendon quality (MRI)

    Baseline and 12 weeks

  • Tendon quality (US)

    Baseline and 12 weeks

  • Strength

    Baseline and 12 weeks

  • Recovery

    12 weeks

  • Pain

    Baseline and 12 weeks

Other Outcomes (3)

  • Quality of life

    Baseline and 12 weeks

  • Disability

    Baseline and 12 weeks

  • Demographic

    Baseline

Study Arms (1)

Low Load Exercises

EXPERIMENTAL

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

Interventions

Low Load ExercisesOTHER

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).

Also known as: Scapular stabilization, Rotator Cuff, Exercise, Physiotherapy, Posture, Progressive exercise, Strength training
Low Load Exercises

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Southern Denmark

Odense, 5230, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 33403207DERIVED

MeSH Terms

Conditions

TendinopathyRotator Cuff InjuriesMusculoskeletal Diseases

Interventions

ExercisePhysical Therapy ModalitiesPostureResistance Training

Condition Hierarchy (Ancestors)

Muscular DiseasesTendon InjuriesWounds and InjuriesRuptureShoulder Injuries

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaTherapeuticsRehabilitationExercise TherapyAftercareContinuity of Patient CarePatient CarePhysical Conditioning, Human

Study Officials

  • Birgit Juul-Kristensen, Assoc Prof

    Department of Sport Science and Biomechanics

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Ph.D-student

Study Record Dates

First Submitted

January 31, 2018

First Posted

February 7, 2018

Study Start

March 25, 2018

Primary Completion

August 15, 2019

Study Completion

August 21, 2019

Last Updated

August 22, 2019

Record last verified: 2019-08

Locations

DK(1)