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

Primary Purpose

Full Thickness Rotator Cuff Tear

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Exercise therapy
Sponsored by
Northern Orthopaedic Division, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Full Thickness Rotator Cuff Tear

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Northern Orthopaedic Division, Aalborg University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Exercise therapy

Arm Description

Exercise therapy 5 months

Outcomes

Primary Outcome Measures

Oxford Shoulder Score
Change is measured from baseline to 3 and 5 months

Secondary Outcome Measures

EuroQuol 5 Dimensions 5 Level EQ-5D-5L
Change is measured from baseline to 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
Strength
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
Change is measured from baseline to 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
Pain
Furthermore, patients were asked to evaluate their pain on a Visual Analogue Scale while performing flexion

Full Information

First Posted
April 5, 2016
Last Updated
April 14, 2016
Sponsor
Northern Orthopaedic Division, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT02740946
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Northern Orthopaedic Division, Denmark

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Full Thickness Rotator Cuff Tear

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise therapy
Arm Type
Experimental
Arm Description
Exercise therapy 5 months
Intervention Type
Other
Intervention Name(s)
Exercise therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Oxford Shoulder Score
Description
Change is measured from baseline to 3 and 5 months
Time Frame
Baseline, 3 months and 5 months
Secondary Outcome Measure Information:
Title
EuroQuol 5 Dimensions 5 Level EQ-5D-5L
Description
Change is measured from baseline to 5 months
Time Frame
baseline and 5 months
Title
Range of motion
Description
Range of motion measured in flexion, abduction and external rotation using a goniometer. Change is measured from baseline to 5 months
Time Frame
Baseline and 5 months
Title
Strength
Description
Strength was measured in flexion, abduction, internal and external rotation using af dynamometer. Change is measured from baseline to 5 months
Time Frame
Baseline and 5 months
Title
Dynamic flexion in degrees from 0 to 180
Description
Change is measured from baseline to 5 months
Time Frame
Baseline and 5 months
Title
Muscle activity using surface electromyography
Description
Muscle activity was measured using surface electromyography of m. trapezius superior and m. deltoideus anterior Change is measured from baseline to5 months
Time Frame
Baseline and 5 months
Title
Pain
Description
Furthermore, patients were asked to evaluate their pain on a Visual Analogue Scale while performing flexion
Time Frame
Baseline and 5 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sten Rasmussen, MD, PhD
Organizational Affiliation
Northern Orthopaedic Division, Aalborg University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northern Orthopaedic Division, Aalborg University Hospital
City
Aalborg
State/Province
North Denmark Region
ZIP/Postal Code
9000
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
27278468
Citation
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.
Results Reference
derived

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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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