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Sonoelastography of the Supraspinatus Tendon

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ClinicalTrials.gov Identifier: NCT03425357
Recruitment Status : Recruiting
First Posted : February 7, 2018
Last Update Posted : May 2, 2018
Sponsor:
Collaborators:
Odense University Hospital
Sygehus Lillebaelt
Gigtforeningen
Region of Southern Denmark
Radiograf Rådet
Information provided by (Responsible Party):
Karen Brage, University of Southern Denmark

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

Condition or disease Intervention/treatment Phase
Elasticity Imaging Techniques Tendinopathy Rotator Cuff Tendinitis Musculoskeletal Disease Other: Low Load Exercises Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Responsiveness of Sonoelastography in the Supraspinatus Tendon
Actual Study Start Date : March 25, 2018
Estimated Primary Completion Date : September 15, 2018
Estimated Study Completion Date : July 1, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Tendon quality (SEL) [ Time Frame: Baseline and 12 weeks ]
    Change from baseline in tendon quality (sonoelastography - strain elasticity)


Secondary Outcome Measures :
  1. Tendon quality (MRI) [ Time Frame: Baseline and 12 weeks ]
    Change from baseline in tendon quality (MRI)

  2. Tendon quality (US) [ Time Frame: Baseline and 12 weeks ]
    Change from baseline in tendon quality (conventional ultrasound)

  3. Strength [ Time Frame: Baseline and 12 weeks ]
    Change from baseline in Isometric Strength (MVC)

  4. 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.

  5. 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.


Other Outcome Measures:
  1. 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).

  2. 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.

  3. Demographic [ Time Frame: Baseline ]
    Gender, age, bmi, education (level), duration of symptoms, symptom history



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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03425357


Contacts
Contact: Karen Brage, MSc +4551787381 kabr2@ucl.dk

Locations
Denmark
University of Southern Denmark Recruiting
Odense, Denmark, 5230
Contact: Karen Brage, Ph.D-student    +45 51787381    kabr2@ucl.dk   
Sponsors and Collaborators
Karen Brage
Odense University Hospital
Sygehus Lillebaelt
Gigtforeningen
Region of Southern Denmark
Radiograf Rådet
Investigators
Study Director: Birgit Juul-Kristensen, Assoc Prof Department of Sport Science and Biomechanics

Responsible Party: Karen Brage, Ph.D-student, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT03425357     History of Changes
Other Study ID Numbers: Sonoelastography_Supraspinatus
First Posted: February 7, 2018    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: May 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Tendinopathy
Musculoskeletal Diseases
Rotator Cuff Injuries
Muscular Diseases
Tendon Injuries
Wounds and Injuries
Rupture
Shoulder Injuries