Back to resultsRehabilitation After Rotator Cuff Repair
Primary Purpose
Rotator Cuff Injury
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Early mobilization
Post surgery shoulder lock
Sponsored by
About this trial
This is an interventional treatment trial for Rotator Cuff Injury focused on measuring shoulder surgery, rotator cuff injury, rehabilitation, function, pain, quality of life
Eligibility Criteria
Inclusion Criteria:
- planned shoulder surgery, rotator cuff repair
Exclusion Criteria:
- not swedish speaking
- reoperation
Sites / Locations
- Department of Orthopaedic surgery, Physiotherapy
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Early mobilization
Post surgery shoulder lock
Arm Description
Intervention is early mobilization, four weeks immobilization postsurgery with collar´n cuff only.
Post surgery shoulder lock with abduction cushion 3 weeks and after this period collar´n cuff 3 weeks
Outcomes
Primary Outcome Measures
Shoulder function
Shoulder function is assessed by Constant score
Secondary Outcome Measures
Pain
Visual analogue scale
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02261701
Brief Title
Rehabilitation After Rotator Cuff Repair
Official Title
Rehabilitation After Rotator Cuff Repair a Randomised Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
September 2014 (Actual)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
October 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Uppsala University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
A new postoperative regimen with a new bandage technique after surgery results in a better shoulder function and quality of life after surgery - than traditional postoperative regimen with shoulder lock and abductor cushion.
Detailed Description
A new postoperative regimen , with a new bandage technique with shorter immobilization time and without shoulder lock, is supposed to results in a better shoulder function 6 and 12 months after surgery. Function is measured by Constant score, pain with VAS and quality of life with EQ5D, 3 and 12 months after surgery. The two treatment groups are compared.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Injury
Keywords
shoulder surgery, rotator cuff injury, rehabilitation, function, pain, quality of life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
76 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Early mobilization
Arm Type
Experimental
Arm Description
Intervention is early mobilization, four weeks immobilization postsurgery with collar´n cuff only.
Arm Title
Post surgery shoulder lock
Arm Type
Other
Arm Description
Post surgery shoulder lock with abduction cushion 3 weeks and after this period collar´n cuff 3 weeks
Intervention Type
Other
Intervention Name(s)
Early mobilization
Other Intervention Name(s)
Collar´n cuff 4 weeks post surgery and early mobilization
Intervention Description
Early mobilization, collar´n cuff 4 weeks post surgery and after this light exercises start and no further bandage.
Intervention Type
Other
Intervention Name(s)
Post surgery shoulder lock
Other Intervention Name(s)
Shoulder lock three weeks post surgery
Intervention Description
Post surgery: Shoulder lock with abduction cushion, additionally 3 weeks with collar´n cuff, and after this period light exercises are allowed and nu further bandage.
Primary Outcome Measure Information:
Title
Shoulder function
Description
Shoulder function is assessed by Constant score
Time Frame
6 months after surgery
Secondary Outcome Measure Information:
Title
Pain
Description
Visual analogue scale
Time Frame
6 months after surgery
Other Pre-specified Outcome Measures:
Title
EQ-5D
Description
Quality of life
Time Frame
6 months after surgery
Title
Quality of life shoulder specific
Description
Western Ontario Rotator Cuff Index (WORC)
Time Frame
6 months after surgery
Title
Pain
Description
Visual analogue scale
Time Frame
12 months after surgery
Title
Euro quality of Life 5D
Description
Quality of life
Time Frame
12 months after surgery
Title
Quality of life shoulder specific
Description
Western Ontario Rotator Cuff Index (WORC)
Time Frame
12 months after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
planned shoulder surgery, rotator cuff repair
Exclusion Criteria:
not swedish speaking
reoperation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ann Christin Johansson, PhD
Organizational Affiliation
Center for Clinical Research County Västmanland, Sweden
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Orthopaedic surgery, Physiotherapy
City
Västerås
State/Province
Västmanland
ZIP/Postal Code
721 89
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Rehabilitation After Rotator Cuff Repair
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