Condition category
Injury, Occupational Diseases, Poisoning
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status

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

Trial website

Contact information



Primary contact

Mr Chris Peach


Contact details

Department of Shoulder and Elbow Surgery
Manchester University Foundation Trust
M23 9LT
United Kingdom
+44 (0)161 291 6150

Additional identifiers

EudraCT number

Nil known number

Nil known

Protocol/serial number


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



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:, ref: 19/WS/0008

Study design

Randomised clinical trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.


Rotator cuff tears


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



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


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

All patients awaiting arthroscopic rotator cuff tear surgery

Participant type


Age group




Target number of participants


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


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Manchester University NHS Foundation Trust
Southmoor Road
M23 9LT
United Kingdom

Sponsor information


Manchester University NHS Foundation Trust

Sponsor details

Southmoor Road
M23 9LT
United Kingdom
+44 (0)161 291 6150

Sponsor type

Hospital/treatment centre



Funder type


Funder name

British Elbow and Shoulder Society; Grant Codes: Ltr014PPG/PO. No. CPRD063001

Alternative name(s)

Funding Body Type

Funding Body Subtype


Funder name

NIHR Central Commissioning Facility (CCF)

Alternative name(s)

Funding Body Type

Funding Body Subtype


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


Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

07/08/2020: Recruitment for this study is no longer paused and the following changes have been made: 1. The recruitment start date has been changed from 01/04/2019 to 01/10/2019. 2. The recruitment end date has been changed from 01/12/2020 to 01/10/2021. 17/04/2020: Due to current public health guidance, recruitment for this study has been paused. 15/04/2019: Trial's existence confirmed by the NIHR.