- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02631486
Does Early Mobilisation Improve Outcomes After Rotator Cuff Repair?
Does Early Mobilisation After Surgical Repair of Rotator Cuff Tears Improve Biomechanical and Clinical Outcomes?
Study Overview
Detailed Description
The study will be a randomised controlled trial, which means that each participant will have equal chances to be assigned to one of 2 groups.
The first group will start the rehabilitation after 3 weeks post-surgery and the second group will start after 6 weeks.
The rehabilitation stages will start with passive movements, progressing to more active stages phases until full recovery. The whole program will last about 3 months, which is in accordance to what is normally used at the Wrightington Hospital.
Each participant will have 4 assessment sessions: 1 pre-surgery, after 3 months post-surgery, after 6 months and the last after 12 months post-surgery.
The assessment sessions will consist on answering questionnaires and a clinical assessment with equipment, which measures muscle activity and joint angles during clinical tasks.
An ultrasound scan of the shoulder to assess the integrity of the rotator cuff would be carried out one year after surgery by a consultant radiologist.
These assessments are timed with the routine orthopaedic clinic assessments so that patients do not have to make extra trips to take part in the research.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Lancashire
-
Wigan, Lancashire, United Kingdom, WN6 9EP
- Wrightington Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age between 40 and 70 years old,
- Confirmed diagnosis of rotator cuff tear
- No previous shoulder surgery
- No other musculoskeletal impairment in the assessed limb or cervical and thoracic spine.
Exclusion Criteria:
- Previous shoulder surgery
- Fixation which does not allow early mobilisation
- Other musculoskeletal impairment in the assessed limb or cervical and thoracic spine,
- People with special needs who are unable to understand the instructions needed,
- Non-English or non-Portuguese speakers.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Early
The first group will use sling for comfort only. Active assisted exercises in closed chain and in safe zone are allowed in the first 4 weeks. The rehabilitation stages will start from active assisted progressing to more active stages phases until full recovery. The whole program will last about 3 months. |
Passive exercises, active exercises, strengthening, stretching
|
Active Comparator: Conservative
The second group will use a sling for 6 weeks.
The rehabilitation stages will start with active assisted/closed chain movements with short levers, it will progress to more active stages phases until full recovery.
The whole program will last about 3 months.
|
Passive exercises, active exercises, strengthening, stretching
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline range of motion
Time Frame: Pre-surgery (baseline), change from baseline range of motion at 3 months, change from baseline range of motion at 6 months, change from baseline range of motion at 1 year
|
Pre-surgery (baseline), change from baseline range of motion at 3 months, change from baseline range of motion at 6 months, change from baseline range of motion at 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline muscle activity in millivolts
Time Frame: Pre-surgery (baseline), change from baseline range of motion at 3 months, change from baseline range of motion at 6 months, change from baseline range of motion at 1 year
|
The muscle activity will be measured using non-invasive electromyography
|
Pre-surgery (baseline), change from baseline range of motion at 3 months, change from baseline range of motion at 6 months, change from baseline range of motion at 1 year
|
Re-tears ratio
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jim Richards, Professor, University of Central Lancashire
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STEMH 277
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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