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Sonoelastography of the Supraspinatus Tendon

Sponsor
Karen Brage (Other)
Overall Status
Completed
CT.gov ID
NCT03425357
Collaborator
Odense University Hospital (Other), Sygehus Lillebaelt (Other), Gigtforeningen (Other), Region of Southern Denmark (Other), Radiograf Rådet (Other)
23
Enrollment
1
Location
1
Arm
16.9
Actual Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: Low Load Exercises
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
23 participants
Allocation:
N/A
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 :
Mar 25, 2018
Actual Primary Completion Date :
Aug 15, 2019
Actual Study Completion Date :
Aug 21, 2019

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Tendon quality (SEL) [Baseline and 12 weeks]

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

    Secondary Outcome Measures

    1. Tendon quality (MRI) [Baseline and 12 weeks]

      Change from baseline in tendon quality (MRI)

    2. Tendon quality (US) [Baseline and 12 weeks]

      Change from baseline in tendon quality (conventional ultrasound)

    3. Strength [Baseline and 12 weeks]

      Change from baseline in Isometric Strength (MVC)

    4. Recovery [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 [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 [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 [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 [Baseline]

      Gender, age, bmi, education (level), duration of symptoms, symptom history

    Eligibility Criteria

    Criteria

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Southern Denmark Odense Denmark 5230

    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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Karen Brage, Ph.D-student, University of Southern Denmark
    ClinicalTrials.gov Identifier:
    NCT03425357
    Other Study ID Numbers:
    • Sonoelastography_Supraspinatus
    First Posted:
    Feb 7, 2018
    Last Update Posted:
    Aug 22, 2019
    Last Verified:
    Aug 1, 2019
    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

    Study Results

    No Results Posted as of Aug 22, 2019