Active not recruitingNAINTERVENTIONAL

Shoulder Surgery Traditional vs Accelerated Rehabilitation Trial

This study is looking at the best way to recover after keyhole surgery for a common shoulder problem called a rotator cuff tear. Some patients will follow a 'traditional' recovery plan, meaning they'll wear a sling for 6 weeks and do specific exercises. Others will follow an 'accelerated' plan, meaning they won't need to wear a sling and will also do specific exercises. The main goal is to see if there's any difference in how well people's shoulders recover after 6 months, using a common shoulder health score. Researchers will also check pain levels, movement range, and use MRI scans to see how well the repair holds up in both groups.

At a glance

Status

Active not recruiting

Phase

Sponsor

Manchester University NHS Foundation Trust

Enrolment target

Start

18 Oct 2019

Estimated completion

31 Dec 2026

Rotator Cuff Tear Rotator Cuff Tear or Rupture, Not Specified as Traumatic

What is this study about?

If you've had keyhole surgery for a torn tendon in your shoulder (called a rotator cuff tear), you might be wondering about the best way to recover. This study aims to find out if there's a difference between two common approaches to rehabilitation. One approach, called 'traditional,' involves keeping your arm in a sling for 6 weeks to protect the repair while it heals, along with a programme of exercises. The other approach, called 'accelerated,' involves starting exercises sooner without the need for a sling after the initial recovery period.

The researchers want to see which of these approaches leads to better results for patients in the long run. They'll be carefully following people who have had a specific type of shoulder surgery for a rotator cuff tear. They'll compare how well people recover, how much pain they have, how much movement they get back, and even check the surgical repair using MRI scans. This is important because understanding the best rehabilitation could help many people recover more quickly and successfully after shoulder surgery.

This study is designed to be fair. Patients will be randomly put into one of the two groups, like flipping a coin, so that researchers can properly compare the recovery methods. This helps to ensure that any differences seen are truly because of the rehabilitation method and not other factors.

Key takeaways

Compares two shoulder recovery methods: sling for 6 weeks vs. no sling.
Aims to find out which rehabilitation approach leads to better results for patients.
Involves regular check-ups and an MRI scan to assess recovery and repair.
Participants are assigned to groups randomly for a fair comparison.
Study lasts for one year after surgery, with follow-up appointments.

Who may be eligible?

This study is looking for adults aged 40 to 80 years old who have a full-thickness tear in the upper and back part of their rotator cuff that has developed over time and are having keyhole surgery to repair it. You might also be eligible if you're having other related procedures at the same time, like a procedure on your biceps tendon or to create more space in your shoulder.

However, there are reasons why you might not be able to join. For example, if you have another bone or muscle problem in the same arm, a very large rotator cuff tear, or a tear in a specific part of your rotator cuff called the subscapularis. If your surgeon can't fully repair the tear during surgery, or if the repair is under a lot of strain, you also wouldn't be able to participate.

Finally, to make sure everyone can understand and follow the study instructions safely, participants need to be able to speak English and follow instructions clearly after their surgery.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 40 and 80 years old?
Are you having keyhole surgery for a specific type of rotator cuff tear that developed over time?
Do you have any other major muscle or bone problems in the same arm?
Are you able to understand and follow instructions in English after your surgery?

Answer every question to see your result.

What does participation involve?

If you choose to take part in this study, you'll first have some measurements and scores taken before your shoulder surgery. After your surgery, and once your surgeon confirms the repair is successful, you'll be randomly assigned to either the 'traditional' or 'accelerated' rehabilitation group. If you're in the traditional group, you'll use a sling for 6 weeks. If you're in the accelerated group, you won't need a sling after the initial recovery. Everyone will follow a structured exercise program.

You'll have follow-up appointments over one year at 6 weeks, 3 months, 6 months, and 12 months after your surgery. During these visits, researchers will ask you questions about your shoulder, measure your shoulder movement, and at the 6-month mark, you will have an MRI scan to check the repair. The total duration of your active involvement in the study will be one year.

Potential risks and benefits

Taking part in this study may offer the potential benefit of a carefully monitored rehabilitation programme after your shoulder surgery, which could contribute to a better understanding of optimal recovery for everyone in the future. As with any medical procedure, there are inherent risks associated with surgery and rehabilitation, though participation in this study does not introduce additional specific medical risks beyond standard care. There is always a possibility that one rehabilitation approach might not be as effective as the other for you. You are free to withdraw from the study at any time without affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Manchester University Foundation NHS Trust
Verified postcode
Manchester, United Kingdom

Common questions

What is a rotator cuff tear?

A rotator cuff tear is when one or more of the tendons that connect your shoulder muscles to your arm bone gets torn. These tendons help you lift and rotate your arm.

What does 'keyhole surgery' mean?

Keyhole surgery, or arthroscopic surgery, uses small cuts and a tiny camera to repair your shoulder from the inside, which usually means less pain and quicker recovery compared to traditional open surgery.

What is 'randomised controlled trial'?

This means that participants are put into groups by chance, like flipping a coin. This helps make sure the study results are fair and reliable, allowing researchers to accurately compare the two rehabilitation methods.

Will I know which group I'm in?

Yes, after your surgery, you will be told whether you are in the group that uses a sling for 6 weeks or the group that doesn't.

What is an MRI scan for?

An MRI scan uses magnets and radio waves to create detailed pictures inside your body. In this study, it will be used to check how well your shoulder repair is holding up at 6 months after surgery.