Condition category
Injury, Occupational Diseases, Poisoning
Date applied
04/04/2019
Date assigned
17/04/2019
Last edited
07/08/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
Recruiting

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

mft.nhs.uk

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

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.