SPiRIT study protocol (Shoulder Pain: Randomised trial of Injectable Treatments): a randomised feasibility and pilot study of autologous protein solution (APS) vs corticosteroids for treating subacromial shoulder pain

Abstract Background The management of subacromial shoulder pain represents a significant challenge and is typically managed through either physiotherapy, joint injection or surgical intervention. Recent surgical trials have questioned the efficacy and there is a need to improve the evidence base for...

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Main Authors: A. Howard, A. Woods, I. Rombach, J. Achten, D. Appelbe, A. Athwal, E. Jones, K. Draper, S. Gwilym
Format: Article
Language:English
Published: BMC 2024-01-01
Series:Pilot and Feasibility Studies
Subjects:
Online Access:https://doi.org/10.1186/s40814-023-01425-9
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author A. Howard
A. Woods
I. Rombach
J. Achten
D. Appelbe
A. Athwal
E. Jones
K. Draper
S. Gwilym
author_facet A. Howard
A. Woods
I. Rombach
J. Achten
D. Appelbe
A. Athwal
E. Jones
K. Draper
S. Gwilym
author_sort A. Howard
collection DOAJ
description Abstract Background The management of subacromial shoulder pain represents a significant challenge and is typically managed through either physiotherapy, joint injection or surgical intervention. Recent surgical trials have questioned the efficacy and there is a need to improve the evidence base for the non-surgical management of this condition. The study aims to provide evidence of the feasibility of conducting a randomised controlled trial to compare the efficacy of autologous protein solution (APS) against the current standard of care, corticosteroid injection (CSI) for subacromial shoulder pain. Autologous protein solution (APS) is a blood-derived biological injection which has been shown to have anti-inflammatory effects. Methods A parallel-group two-arm randomised control trial will be conducted, comparing APS and CSI for shoulder pain. Fifty patients will be recruited. Feasibility will be assessed by examination of the conversion rate of eligible participants to the total number of participants recruited, whether it is possible to collect the appropriate outcome measures and the levels of retention/data compliance at follow-up dates. Discussion CSI is the mainstay of conservative management of subacromial shoulder pain. Trials and systematic reviews have reported differing conclusions, but the consensus view is that any benefits seen from CSI use are most likely to be short-term and there remains a significant number of patients who go on to have surgical intervention despite CSI. Biological injections, such as APS are being increasingly used, in the anticipation they may offer improved longer lasting outcomes for shoulder pain. However, the evidence to demonstrate the comparative efficacy of CSI versus APS does not currently exist. If feasible, a fully powered study will offer clarity to the treatment pathway of thousands of patients each year with subacromial pain. Trial registration The study is funded by the National Institute for Health Research–Research for Patient Benefit, NIHR 201473, Trial Registration Number (ISRCTN12536844: SPiRIT. Shoulder pain: randomised trial of injectable treatments–date of Registration 15/9/2021). Protocol Version V1.0_30Jul2021. IRAS Project ID: 294,982.
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spelling doaj.art-de4670c35d344d78923f649e1433dc022024-01-21T12:10:58ZengBMCPilot and Feasibility Studies2055-57842024-01-011011810.1186/s40814-023-01425-9SPiRIT study protocol (Shoulder Pain: Randomised trial of Injectable Treatments): a randomised feasibility and pilot study of autologous protein solution (APS) vs corticosteroids for treating subacromial shoulder painA. Howard0A. Woods1I. Rombach2J. Achten3D. Appelbe4A. Athwal5E. Jones6K. Draper7S. Gwilym8Oxford Clinical Trials Research Unit, Oxford Trauma, Kadoorie Centre, NDORMS, University of OxfordOxford Clinical Trials Research Unit, Oxford Trauma, Kadoorie Centre, NDORMS, University of OxfordOxford Clinical Trials Research Unit, Oxford Trauma, Kadoorie Centre, NDORMS, University of OxfordOxford Clinical Trials Research Unit, Oxford Trauma, Kadoorie Centre, NDORMS, University of OxfordOxford Clinical Trials Research Unit, Oxford Trauma, Kadoorie Centre, NDORMS, University of OxfordOxford Clinical Trials Research Unit, Oxford Trauma, Kadoorie Centre, NDORMS, University of OxfordOxford Clinical Trials Research Unit, Oxford Trauma, Kadoorie Centre, NDORMS, University of OxfordOxford Clinical Trials Research Unit, Oxford Trauma, Kadoorie Centre, NDORMS, University of OxfordOxford Clinical Trials Research Unit, Oxford Trauma, Kadoorie Centre, NDORMS, University of OxfordAbstract Background The management of subacromial shoulder pain represents a significant challenge and is typically managed through either physiotherapy, joint injection or surgical intervention. Recent surgical trials have questioned the efficacy and there is a need to improve the evidence base for the non-surgical management of this condition. The study aims to provide evidence of the feasibility of conducting a randomised controlled trial to compare the efficacy of autologous protein solution (APS) against the current standard of care, corticosteroid injection (CSI) for subacromial shoulder pain. Autologous protein solution (APS) is a blood-derived biological injection which has been shown to have anti-inflammatory effects. Methods A parallel-group two-arm randomised control trial will be conducted, comparing APS and CSI for shoulder pain. Fifty patients will be recruited. Feasibility will be assessed by examination of the conversion rate of eligible participants to the total number of participants recruited, whether it is possible to collect the appropriate outcome measures and the levels of retention/data compliance at follow-up dates. Discussion CSI is the mainstay of conservative management of subacromial shoulder pain. Trials and systematic reviews have reported differing conclusions, but the consensus view is that any benefits seen from CSI use are most likely to be short-term and there remains a significant number of patients who go on to have surgical intervention despite CSI. Biological injections, such as APS are being increasingly used, in the anticipation they may offer improved longer lasting outcomes for shoulder pain. However, the evidence to demonstrate the comparative efficacy of CSI versus APS does not currently exist. If feasible, a fully powered study will offer clarity to the treatment pathway of thousands of patients each year with subacromial pain. Trial registration The study is funded by the National Institute for Health Research–Research for Patient Benefit, NIHR 201473, Trial Registration Number (ISRCTN12536844: SPiRIT. Shoulder pain: randomised trial of injectable treatments–date of Registration 15/9/2021). Protocol Version V1.0_30Jul2021. IRAS Project ID: 294,982.https://doi.org/10.1186/s40814-023-01425-9Shoulder painInjectionSteroidAutologous protein solution
spellingShingle A. Howard
A. Woods
I. Rombach
J. Achten
D. Appelbe
A. Athwal
E. Jones
K. Draper
S. Gwilym
SPiRIT study protocol (Shoulder Pain: Randomised trial of Injectable Treatments): a randomised feasibility and pilot study of autologous protein solution (APS) vs corticosteroids for treating subacromial shoulder pain
Pilot and Feasibility Studies
Shoulder pain
Injection
Steroid
Autologous protein solution
title SPiRIT study protocol (Shoulder Pain: Randomised trial of Injectable Treatments): a randomised feasibility and pilot study of autologous protein solution (APS) vs corticosteroids for treating subacromial shoulder pain
title_full SPiRIT study protocol (Shoulder Pain: Randomised trial of Injectable Treatments): a randomised feasibility and pilot study of autologous protein solution (APS) vs corticosteroids for treating subacromial shoulder pain
title_fullStr SPiRIT study protocol (Shoulder Pain: Randomised trial of Injectable Treatments): a randomised feasibility and pilot study of autologous protein solution (APS) vs corticosteroids for treating subacromial shoulder pain
title_full_unstemmed SPiRIT study protocol (Shoulder Pain: Randomised trial of Injectable Treatments): a randomised feasibility and pilot study of autologous protein solution (APS) vs corticosteroids for treating subacromial shoulder pain
title_short SPiRIT study protocol (Shoulder Pain: Randomised trial of Injectable Treatments): a randomised feasibility and pilot study of autologous protein solution (APS) vs corticosteroids for treating subacromial shoulder pain
title_sort spirit study protocol shoulder pain randomised trial of injectable treatments a randomised feasibility and pilot study of autologous protein solution aps vs corticosteroids for treating subacromial shoulder pain
topic Shoulder pain
Injection
Steroid
Autologous protein solution
url https://doi.org/10.1186/s40814-023-01425-9
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