Does Early Mobilisation Improve Outcomes After Rotator Cuff Repair?
Primary Purpose
Shoulder, Rehabilitation
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Physiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Shoulder focused on measuring Rotator Cuff Tears
Eligibility Criteria
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.
Sites / Locations
- Wrightington Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Early
Conservative
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Change from baseline range of motion
Secondary Outcome Measures
Change from baseline muscle activity in millivolts
The muscle activity will be measured using non-invasive electromyography
Re-tears ratio
Full Information
NCT ID
NCT02631486
First Posted
December 10, 2015
Last Updated
April 17, 2019
Sponsor
University of Central Lancashire
Collaborators
Wrightington, Wigan and Leigh NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT02631486
Brief Title
Does Early Mobilisation Improve Outcomes After Rotator Cuff Repair?
Official Title
Does Early Mobilisation After Surgical Repair of Rotator Cuff Tears Improve Biomechanical and Clinical Outcomes?
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
April 2018 (Actual)
Study Completion Date
July 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Central Lancashire
Collaborators
Wrightington, Wigan and Leigh NHS Foundation Trust
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Shoulder pain is among the most common musculoskeletal complaints, leading to high number of General Practioners consultations in the United Kingdom. On the top list of the disorders causing pain and dysfunction of shoulder is rotator cuff tears. The aetiology of rotator cuff tears is multifactorial and is likely to be a combination of age-related degenerative changes and trauma during life. It is present in approximately 25% of individuals in their 60s and 50% of individuals in their 80s and have been shown to start developing during the 40s. To recover functional status of this patients group, surgical repair is often recommended, but for optimal results the rehabilitation is of great importance and must be adequately planned. After surgery a period of movement restriction is followed, however, the optimal time of immobilisation is unknown. As a common practice, patients use a sling for six weeks and avoid any activities with the affected shoulder. This period is important to protect the tendon, allow good healing and to possibly prevent re-tear episodes. Although, the delayed motion may increase the risk of postoperative shoulder stiffness, muscle atrophy and potentially delay improvement of functionality. Based on the available evidence, it is difficult to make a clinical decision for a well-programmed rehabilitation regime and establish the most favourable postoperative time to start it. Moreover, it is not clear if early mobilisation will benefit more severe stages as published studies have methodological flaws that compromises the clinical decision for patients with higher commitments. The question whether early mobilisation application is beneficial is of high importance as the results will not just help improving patients quality of life, but also may reduce costs as further complication may be avoided.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder, Rehabilitation
Keywords
Rotator Cuff Tears
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Early
Arm Type
Experimental
Arm Description
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.
Arm Title
Conservative
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Physiotherapy
Intervention Description
Passive exercises, active exercises, strengthening, stretching
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Change from baseline muscle activity in millivolts
Description
The muscle activity will be measured using non-invasive electromyography
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
Title
Re-tears ratio
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jim Richards, Professor
Organizational Affiliation
University of Central Lancashire
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wrightington Hospital
City
Wigan
State/Province
Lancashire
ZIP/Postal Code
WN6 9EP
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
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Does Early Mobilisation Improve Outcomes After Rotator Cuff Repair?
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