SPiRIT (Shoulder Pain: Randomised trial of Injectable Treatments)
Research type
Research Study
Full title
SPiRIT (Shoulder Pain: Randomised trial of Injectable Treatments) A randomised feasibility of Autologous Protein Solution (APS) vs Corticosteroids for treating subacromial shoulder pain.
IRAS ID
294982
Contact name
Steve Gwilym
Contact email
Sponsor organisation
University of Oxford / Clinical Trials an Research Governance
Duration of Study in the UK
1 years, 5 months, 31 days
Research summary
Shoulder pain is very common, accounting for thousands of appointments each year in the UK. Currently treatments are steroid injections combined with physiotherapy, or keyhole surgery. There have been questions about whether using steroids is safe long term, with concerns that they may affect tendons or contribute to development of arthritis. Some research suggests that operations may not be as effective as previously thought. Healthcare workers therefore need to investigate other safe and effective treatments for this condition. Recently there have been improvements in injection treatments which aim to help tendons repair and reduce inflammation and pain. Whilst they have been found to be safe, no one has conducted a study to see if such treatments are more effective than steroid injections. Our feasibility study will compare one of these biologic-injection treatments against steroid injections. We will take a sample of the person’s blood and inject some of the most useful parts back into the shoulder. The injection kit to be used in the study (nSTRIDE) is fully licensed for use in the UK. The patient will then receive physiotherapy, regardless of what injection they receive. In this study we will aim to recruit 50 patients. We will ask patients who have already been referred to us for shoulder pain and are about to start normal treatment to join the study. If they decide to join the only change in their treatment will be the difference in the type of injection they receive. Before we can conduct a full study, we need to do this smaller study to see how quickly we can recruit patients and whether all involved are happy with the how the study works. If our study is successful, we will then conduct a larger study to see whether the new type of injection is better than steroids for shoulder pain.
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
21/EE/0211
Date of REC Opinion
20 Sep 2021
REC opinion
Favourable Opinion