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

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

Tracking Information

• First Submitted Date: April 5, 2016
• First Posted Date: April 15, 2016
• Last Update Posted Date: April 15, 2016
• Study Start Date: August 2011
• Actual Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Enhanced Function and Quality of Life Following 5 Months of Exercise Therapy for Patients With Rotator Cuff Tears
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Full Thickness Rotator Cuff Tear

Intervention

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

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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 14, 2016): 30
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: January 2015
• Actual Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Denmark

Administrative Information

• NCT Number: NCT02740946
• Other Study ID Numbers: N-20120040
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Yes

• Responsible Party: Northern Orthopaedic Division, Denmark
• Study Sponsor: Northern Orthopaedic Division, Denmark
• Collaborators: Not Provided

Investigators

• Principal Investigator: Sten Rasmussen, MD, PhD; Northern Orthopaedic Division, Aalborg University Hospital

• PRS Account: Northern Orthopaedic Division, Denmark
• Verification Date: April 2016