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

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

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

Study Overview

• Status: Completed
• Conditions: Full Thickness Rotator Cuff Tear
• Intervention / Treatment: Other: Exercise therapy

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
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • North Denmark Region
    • Aalborg, North Denmark Region, Denmark, 9000
      • Northern Orthopaedic Division, Aalborg University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxford Shoulder Score	Change is measured from baseline to 3 and 5 months	Baseline, 3 months and 5 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EuroQuol 5 Dimensions 5 Level EQ-5D-5L	Change is measured from baseline to 5 months	baseline and 5 months
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
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
Dynamic flexion in degrees from 0 to 180	Change is measured from baseline to 5 months	Baseline and 5 months
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
Pain	Furthermore, patients were asked to evaluate their pain on a Visual Analogue Scale while performing flexion	Baseline and 5 months

Collaborators and Investigators

• Sponsor: Northern Orthopaedic Division, Denmark
• Investigators: Principal Investigator: Sten Rasmussen, MD, PhD, Northern Orthopaedic Division, Aalborg University Hospital

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: April 5, 2016
• First Submitted That Met QC Criteria: April 14, 2016
• First Posted (Estimate): April 15, 2016

Study Record Updates

• Last Update Posted (Estimate): April 15, 2016
• Last Update Submitted That Met QC Criteria: April 14, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: N-20120040

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES