SPiRIT (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

Research question Is it feasible to conduct a definitive randomised controlled trial to assess the clinical and cost-effectiveness of an Autologous Protein Solution (APS) injection into the subacromial space compared to corticosteroid injections, to manage subacromial pain symptoms?

Background Shoulder pain is very common and may be disabling in terms of the patient`s ability to carry out daily activities at home and at the workplace, resulting in time off work. This poses a substantial burden to the individual and society. Shoulder pain does not always have a favourable outcome with current treatments.

Evidence for the efficacy of both surgical and non-surgical treatments of shoulder pain is limited.

British Elbow and Shoulder Society/British Orthopaedic Association guidelines recommends research into the clinical and cost-effectiveness of injectable treatments for subacromial shoulder pain.

Currently, Corticosteroid injections remain the mainstay of initial treatment in the majority of cases of shoulder pain.

However, in addition to the lack of strong evidence towards the efficacy of Corticosteroid injections there have also been reports of deleterious effects of corticosteroids on tendon biology.

In light of these potential harmful effects, health researchers have been considering alternative pharmacological or bioactive therapies to replace Corticosteroid injections. One such of these is the injection of an Autologous Protein Solution.

Autologous Protein Solution is prepared using a single-use device that produces a cell concentrate from autologous blood.

The Autologous Protein Solution production process preferentially concentrates anti-inflammatory cytokines production by white blood cells, including IL-1 receptor antagonist and TNF receptor inhibitor. No work currently exists to assess the efficacy of Autologous Protein Solution in treating shoulder pain.

Objectives • Record and report recruitment and retention rates from study participants • Obtain estimates for a sample size calculation for a definitive trial • Ensure it is possible to collect appropriate outcomes measures to allow a comprehensive efficacy assessment in a fully powered trial • Ensure it is possible to collect data to furnish a robust cost-effectiveness assessment in a fully powered study Methods Fifty eligible adult patients will be recruited from NHS musculoskeletal-triage centres in England.

Patients will be randomised (1:1) and will undergo physiotherapy and ultra-sound guided injection of either Corticosteroid injections or Autologous Protein Solution.

Blood collection and preparation of the injections (both Autologous Protein Solution and Corticosteroid injections) will be performed by an independent clinician. The injectable solution will be provided to the radiologist in an opaque syringe to ensure blinding. Timelines for delivery This trial will commence in autumn 2020 and will be conducted over a 25 months period.

Anticipated Impact and Dissemination Dissemination will be via conference presentations and publication in high-impact journals.

Further, we will ensure links with NICE are established to contribute to NICE recommendations on treatment options for shoulder pain at their scheduled update.

We will also ensure a broad public dissemination through use of social media outlets (e.g. twitter) with an explainer video and infographics.