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

Full Thickness Rotator Cuff Tear Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02740946
• Other study ID #: N-20120040
• Status: Completed
• Phase: N/A
• First received: April 5, 2016
• Last updated: April 14, 2016
• Start date: August 2011
• Est. completion date: January 2015

Study information

• Verified date: April 2016
• Source: Northern Orthopaedic Division, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• 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.

Locations

Country	Name	City	State
Denmark	Northern Orthopaedic Division, Aalborg University Hospital	Aalborg	North Denmark Region

Sponsors (1)

Lead Sponsor	Collaborator
Northern Orthopaedic Division, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxford Shoulder Score	Change is measured from baseline to 3 and 5 months	Baseline, 3 months and 5 months	No
Secondary	EuroQuol 5 Dimensions 5 Level EQ-5D-5L	Change is measured from baseline to 5 months	baseline and 5 months	No
Secondary	Range of motion	Range of motion measured in flexion, abduction and external rotation using a goniometer. Change is measured from baseline to 5 months	Baseline and 5 months	No
Secondary	Strength	Strength was measured in flexion, abduction, internal and external rotation using af dynamometer. Change is measured from baseline to 5 months	Baseline and 5 months	No
Secondary	Dynamic flexion in degrees from 0 to 180	Change is measured from baseline to 5 months	Baseline and 5 months	No
Secondary	Muscle activity using surface electromyography	Muscle activity was measured using surface electromyography of m. trapezius superior and m. deltoideus anterior Change is measured from baseline to5 months	Baseline and 5 months	No
Secondary	Pain	Furthermore, patients were asked to evaluate their pain on a Visual Analogue Scale while performing flexion	Baseline and 5 months	No