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Trial record 1 of 1 for:    NCT02740946
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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

Tracking Information
First Submitted Date  ICMJE April 5, 2016
First Posted Date  ICMJE April 15, 2016
Last Update Posted Date April 15, 2016
Study Start Date  ICMJE August 2011
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 14, 2016)
Oxford Shoulder Score [ Time Frame: Baseline, 3 months and 5 months ]
Change is measured from baseline to 3 and 5 months
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 14, 2016)
  • EuroQuol 5 Dimensions 5 Level EQ-5D-5L [ Time Frame: baseline and 5 months ]
    Change is measured from baseline to 5 months
  • 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
  • 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
  • Dynamic flexion in degrees from 0 to 180 [ Time Frame: Baseline and 5 months ]
    Change is measured from baseline to 5 months
  • 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
  • Pain [ Time Frame: Baseline and 5 months ]
    Furthermore, patients were asked to evaluate their pain on a Visual Analogue Scale while performing flexion
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Enhanced Function and Quality of Life Following 5 Months of Exercise Therapy for Patients With Rotator Cuff Tears
Official Title  ICMJE Enhanced Function and Quality of Life Following 5 Months of Exercise Therapy for Patients With Irreparable Rotator Cuff Tears - an Intervention Study
Brief Summary This study aims to evaluate the effect of 5 months of exercise therapy for patients with irreparable rotator cuff tears.
Detailed Description All included patients will receive exercise therapy consisting of two exercises focusing on strengthening m. deltoideus anterior and m. teres minor.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Full Thickness Rotator Cuff Tear
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Exercise therapy
Exercise therapy 5 months
Intervention: Other: Exercise therapy
Publications * Christensen BH, Andersen KS, Rasmussen S, Andreasen EL, Nielsen LM, Jensen SL. Enhanced function and quality of life following 5 months of exercise therapy for patients with irreparable rotator cuff tears - an intervention study. BMC Musculoskelet Disord. 2016 Jun 8;17:252. doi: 10.1186/s12891-016-1116-6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 14, 2016)
30
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2015
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02740946
Other Study ID Numbers  ICMJE N-20120040
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Northern Orthopaedic Division, Denmark
Study Sponsor  ICMJE Northern Orthopaedic Division, Denmark
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sten Rasmussen, MD, PhD Northern Orthopaedic Division, Aalborg University Hospital
PRS Account Northern Orthopaedic Division, Denmark
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP