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Completed

NCT Number: NCT02740946

Enhanced Function and Quality of Life Following 5 Months of Exercise Therapy for Patients With Rotator Cuff Tears

This study aims to evaluate the effect of 5 months of exercise therapy for patients with irreparable rotator cuff tears.

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Key information

Conditions

Full Thickness Rotator Cuff Tear

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northern Orthopaedic Division, Aalborg University Hospital

Aalborg, North Denmark, 9000, Denmark

About this study

All included patients will receive exercise therapy consisting of two exercises focusing on strengthening m. deltoideus anterior and m. teres minor.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • symptoms of rotator cuff rupture for at least three months with rupture of minimum musculus supraspinatus and musculus infraspinatus visualized by ultrasonography or arthroscopy
  • no neurological conditions which could affect muscle strength or activity
  • able to read and understand Danish
  • both patients with and without a history of shoulder trauma were included

Exclusion criteria

  • former rotator cuff surgery
  • history of shoulder fracture or inflammatory conditions in the shoulder
  • significant osteoarthritic changes on antero-posterior and/or lateral (outlet view) radiographs

Treatment and study plan

Exercise therapy

Other

5 months of exercise therapy with two strengthening exercises focusing on m. deltoideus anterior and m. teres minor. Furthermore, a warm up exercise was applied.

Primary outcomes

  1. Oxford Shoulder Score

    Time frame: Baseline, 3 months and 5 months

    Change is measured from baseline to 3 and 5 months

Secondary outcomes

  1. EuroQuol 5 Dimensions 5 Level EQ-5D-5L

    Time frame: baseline and 5 months

    Change is measured from baseline to 5 months

  2. Range of motion

    Time frame: Baseline and 5 months

    Range of motion measured in flexion, abduction and external rotation using a goniometer. Change is measured from baseline to 5 months

  3. Strength

    Time frame: Baseline and 5 months

    Strength was measured in flexion, abduction, internal and external rotation using af dynamometer. Change is measured from baseline to 5 months

  4. Dynamic flexion in degrees from 0 to 180

    Time frame: Baseline and 5 months

    Change is measured from baseline to 5 months

  5. Muscle activity using surface electromyography

    Time frame: Baseline and 5 months

    Muscle activity was measured using surface electromyography of m. trapezius superior and m. deltoideus anterior Change is measured from baseline to5 months

  6. Pain

    Time frame: Baseline and 5 months

    Furthermore, patients were asked to evaluate their pain on a Visual Analogue Scale while performing flexion

Sponsors and collaborators

Lead sponsor

Northern Orthopaedic Division, Denmark

Other

Registry information

Official study title

Enhanced Function and Quality of Life Following 5 Months of Exercise Therapy for Patients With Irreparable Rotator Cuff Tears - an Intervention Study

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Apr 15, 2016
Registry last updated
Apr 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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