Does wearing a sling after keyhole tendon repair surgery in the shoulder give a better outcome than not wearing a sling?
| ISRCTN | ISRCTN27389669 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN27389669 |
| ClinicalTrials.gov number | NCT03913611 |
| Secondary identifying numbers | 4.1 |
- Submission date
- 04/04/2019
- Registration date
- 17/04/2019
- Last edited
- 10/09/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Plain English summary of protocol
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
Contact information
Scientific
Department of Shoulder and Elbow Surgery
Manchester University Foundation Trust
Manchester
M23 9LT
United Kingdom
 ORCID ID |
0000-0002-2516-4760 |
|---|---|
| Phone | +44 (0)161 291 6150 |
| chris.peach@mft.nhs.uk |
Study information
| Study design | Randomised clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| 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 acronym | S-START |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | |
| 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 study start date | 08/01/2017 |
| Completion date | 01/08/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 120 |
| Key inclusion criteria | All patients awaiting arthroscopic rotator cuff tear surgery |
| Key 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 |
| Date of first enrolment | 01/10/2019 |
| Date of final enrolment | 01/10/2021 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Manchester
M23 9LT
United Kingdom
Sponsor information
Hospital/treatment centre
Southmoor Road
Manchester
M23 9LT
England
United Kingdom
| Phone | +44 (0)161 291 6150 |
|---|---|
| chris.peach@mft.nhs.uk | |
| Website | mft.nhs.uk |
"ROR" |
https://ror.org/00he80998 |
Funders
Funder type
Other
No information available
No information available
Results and Publications
| Intention to publish date | 01/04/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| 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 plan | The data sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
10/09/2021: The NCT number has been added.
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.
