Plain English Summary
Background and study aims
A rotator cuff tear is a damaged tendon around the shoulder. It can cause pain and weakness when moving the shoulder. It is commonly treated using keyhole surgery to reattach the torn tendon to the bone. After surgery, people go through a rehabilitation programme with a physiotherapist that lasts several months. This may involve wearing a sling after surgery. The aim of this study is to see whether a sling is beneficial or detrimental to your recovery after having your torn rotator cuff tendon repaired. Some surgeons prefer to rest the shoulder in a sling for several weeks after surgery to give the repaired tendon some time to heal. This may lead to stiffness due to lack of movement, and weakness of the other muscles around your shoulder, both of which require additional treatment from a physiotherapist. Modern tendon repair techniques are now stronger than ever and a period of rest may no longer be necessary. It is also known that the quality of healing may be improved by early movement.
Who can participate?
Patients undergoing a keyhole repair of a torn tendon in the shoulder
What does the study involve?
Participants' shoulder movements are measured and they complete some questionnaires. They also have a scan 6 months after surgery to check whether the repaired tendon has healed. After surgery, if the surgeon is satisfied that the repair is sound, participants are given an individualised exercise programme by the physiotherapist. This is selected at random from one of two options. One involves wearing a sling for 1-2 days (maximum 1 week), and the other involves using a sling for 4 weeks after surgery. Participants have regular visits to the physiotherapist to monitor their progress over the following 12 months using standard outcome scores, measure their range of movement, and also measure the electrical activity in their shoulder muscles. A scan of their shoulder is also performed after 6 months to determine whether the tendon has healed.
What are the possible benefits and risks of participating?
It is not yet known whether patients benefit more from shorter- or longer-term sling use after rotator cuff repair. Participation will help to determine the answer to this and if participants are allocated to the treatment that is found to be more successful, then they may derive a benefit.
Where is the study run from?
Manchester University NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
January 2017 to August 2020
Who is funding the study?
British Elbow and Shoulder Society (UK)
Who is the main contact?
Chris Peach
chris.peach@mft.nhs.uk
Trial website
Contact information
Type
Scientific
Primary contact
Mr Chris Peach
ORCID ID
http://orcid.org/0000-0002-2516-4760
Contact details
Department of Shoulder and Elbow Surgery
Manchester University Foundation Trust
Manchester
M23 9LT
United Kingdom
+44 (0)161 291 6150
chris.peach@mft.nhs.uk
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
4.1
Study information
Scientific title
Traditional versus accelerated rehabilitation programmes following double-row rotator cuff repair: a randomised trial to compare patient outcomes and structural failure rates
Acronym
S-START
Study hypothesis
There is a difference in Oxford Shoulder Score 3 months after rotator cuff repair in patients who have an accelerated rehabilitation programme versus traditional rehabilitation.
Ethics approval
Approved 01/04/2019, West of Scotland REC 5 (West of Scotland Research Ethics Service, West Glasgow Ambulatory Care Hospital, Dalnair Street, Glasgow, G3 8SW; Tel: +44 (0)141 232-1804; Email: WoSREC5@ggc.scot.nhs.uk), ref: 19/WS/0008
Study design
Randomised clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet.
Condition
Rotator cuff tears
Intervention
The study will involve patients who are having keyhole surgery to repair their torn rotator cuff tendons. If the surgeon achieves a secure repair, patients will be randomly allocated by sealed envelope to traditional rehabilitation or accelerated rehabilitation.
Traditional rehabilitation will require use of a sling for 4-6 weeks, and those in the accelerated group will be asked to wear it for comfort, for up to 1 week. Over the following 12 months, the researchers shall assess patients’ outcomes using standard outcome scores (e.g. Oxford Shoulder Score), measure their range of movement, and also measure the electrical activity in their shoulder muscles. They shall also perform a scan of their shoulder after 6 months to determine whether the tendon has healed to see whether accelerated rehabilitation affects healing.
Intervention type
Device
Phase
Not Applicable
Drug names
Primary outcome measure
Primary functional outcome measured using Oxford Shoulder Score (OSS) at 3 months post op (at patient consultation)
Secondary outcome measures
1. Pain and function measured using Shoulder Pain and Disability Index (SPADI) at 6 weeks, 3 months, 6 months and 12 months
2. Quality of life measured using EQ5D-5L at 6 weeks, 3 months, 6 months and 12 months
3. Pain measured using VAS at 6 weeks, 3 months, 6 months and 12 months
4. Range of movement measured by clinical assessment with long arm goniometer at 6 weeks, 3 months, 6 months and 12 months at patient consultation
5. Integrity of the repair assessed using MRI scan at 6 months post op
Overall trial start date
08/01/2017
Overall trial end date
01/08/2020
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
All patients awaiting arthroscopic rotator cuff tear surgery
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
120
Participant exclusion criteria
1. Non-English speaker
2. Concomitant musculoskeletal disease in ipsilateral arm
3. Unfit for surgical intervention
4. Subscapularis tear
5. Massive cuff tear
6. Intra-operatively, if the tear is found not to be repairable
7. If only a partial repair was possible
8. If the repair was under tension
Recruitment start date
01/10/2019
Recruitment end date
01/10/2021
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Manchester University NHS Foundation Trust
Southmoor Road
Manchester
M23 9LT
United Kingdom
Sponsor information
Organisation
Manchester University NHS Foundation Trust
Sponsor details
Southmoor Road
Manchester
M23 9LT
United Kingdom
+44 (0)161 291 6150
chris.peach@mft.nhs.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Other
Funder name
British Elbow and Shoulder Society; Grant Codes: Ltr014PPG/PO. No. CPRD063001
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
NIHR Central Commissioning Facility (CCF)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
1. Results to be presented at national and international scientific meetings
2. Results will be disseminated to trial participants in plain English form
3. Results will be published in peer-reviewed scientific journals
4. The protocol will be available on the study website
IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date
Intention to publish date
01/04/2021
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list