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

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ClinicalTrials.gov Identifier: NCT02740946
Recruitment Status : Completed
First Posted : April 15, 2016
Last Update Posted : April 15, 2016
Sponsor:
Information provided by (Responsible Party):
Northern Orthopaedic Division, Denmark

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

Condition or disease Intervention/treatment Phase
Full Thickness Rotator Cuff Tear Other: Exercise therapy Not Applicable

Detailed Description:
All included patients will receive exercise therapy consisting of two exercises focusing on strengthening m. deltoideus anterior and m. teres minor.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Enhanced Function and Quality of Life Following 5 Months of Exercise Therapy for Patients With Irreparable Rotator Cuff Tears - an Intervention Study
Study Start Date : August 2011
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Exercise therapy
Exercise therapy 5 months
 Other: Exercise therapy
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.


Outcome Measures
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Primary Outcome Measures :
  1. Oxford Shoulder Score [ Time Frame: Baseline, 3 months and 5 months ]
    Change is measured from baseline to 3 and 5 months


Secondary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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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): NCT02740946


Locations
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Denmark
Northern Orthopaedic Division, Aalborg University Hospital
Aalborg, North Denmark Region, Denmark, 9000
Sponsors and Collaborators
Northern Orthopaedic Division, Denmark
Investigators
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Principal Investigator: Sten Rasmussen, MD, PhD Northern Orthopaedic Division, Aalborg University Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Northern Orthopaedic Division, Denmark
ClinicalTrials.gov Identifier: NCT02740946    
Other Study ID Numbers: N-20120040
First Posted: April 15, 2016    Key Record Dates
Last Update Posted: April 15, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Rotator Cuff Injuries
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries