Evidence map›Paper›PMID 38233904›Full record

ArticlePilot and feasibility studies2024

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.

A Howard, A Woods, I Rombach, J Achten, D Appelbe, A Athwal, E Jones, K Draper, S Gwilym

Open access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Pilot and feasibility studies, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
1.1field-weighted citation impact, top 25% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed, 2 citations in OpenAlex.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 2 institutions in 1 country.

A Howard *Oxford Clinical Trials Research Unit, Oxford Trauma, Kadoorie Centre, NDORMS, University of Oxford, Oxford, England. anthonyjhoward@aol.com.ORCID http://orcid.org/0000-0001-7746-1268
A Woods *Oxford Clinical Trials Research Unit, Oxford Trauma, Kadoorie Centre, NDORMS, University of Oxford, Oxford, England.
I RombachOxford Clinical Trials Research Unit, Oxford Trauma, Kadoorie Centre, NDORMS, University of Oxford, Oxford, England.
J AchtenOxford Clinical Trials Research Unit, Oxford Trauma, Kadoorie Centre, NDORMS, University of Oxford, Oxford, England.
D AppelbeOxford Clinical Trials Research Unit, Oxford Trauma, Kadoorie Centre, NDORMS, University of Oxford, Oxford, England.
A AthwalOxford Clinical Trials Research Unit, Oxford Trauma, Kadoorie Centre, NDORMS, University of Oxford, Oxford, England.
E JonesOxford Clinical Trials Research Unit, Oxford Trauma, Kadoorie Centre, NDORMS, University of Oxford, Oxford, England.
K DraperOxford Clinical Trials Research Unit, Oxford Trauma, Kadoorie Centre, NDORMS, University of Oxford, Oxford, England.
S GwilymOxford Clinical Trials Research Unit, Oxford Trauma, Kadoorie Centre, NDORMS, University of Oxford, Oxford, England.
University of Oxford · GBLeeds General Infirmary · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe 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.

methodsA 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 registrationThe 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.

Indexed as

Autologous protein solutionInjectionShoulder painSteroid

Identifiers

PMID38233904
PMCPMC10792946
OpenAlexW4390952855

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.