Enhanced Function and Quality of Life Following 5 Months of Exercise Therapy for Patients With Rotator Cuff Tears
1 other identifier
interventional
30
1 country
1
Brief Summary
This study aims to evaluate the effect of 5 months of exercise therapy for patients with irreparable rotator cuff tears.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 5, 2016
CompletedFirst Posted
Study publicly available on registry
April 15, 2016
CompletedApril 15, 2016
April 1, 2016
3.4 years
April 5, 2016
April 14, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Oxford Shoulder Score
Change is measured from baseline to 3 and 5 months
Baseline, 3 months and 5 months
Secondary Outcomes (6)
EuroQuol 5 Dimensions 5 Level EQ-5D-5L
baseline and 5 months
Range of motion
Baseline and 5 months
Strength
Baseline and 5 months
Dynamic flexion in degrees from 0 to 180
Baseline and 5 months
Muscle activity using surface electromyography
Baseline and 5 months
- +1 more secondary outcomes
Study Arms (1)
Exercise therapy
EXPERIMENTALExercise therapy 5 months
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Northern Orthopaedic Division, Aalborg University Hospital
Aalborg, North Denmark, 9000, Denmark
Related Publications (1)
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.
PMID: 27278468DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sten Rasmussen, MD, PhD
Northern Orthopaedic Division, Aalborg University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 5, 2016
First Posted
April 15, 2016
Study Start
August 1, 2011
Primary Completion
January 1, 2015
Study Completion
January 1, 2015
Last Updated
April 15, 2016
Record last verified: 2016-04
Data Sharing
- IPD Sharing
- Will share