This trial is designed as a cluster RCT with an internal pilot, process evaluation and economic evaluation in UK National Health Service (NHS) physiotherapy services to test the superiority of a personalised guided consultation (intervention arm) compared with care as usual (control arm).

This cluster trial will take place in NHS physiotherapy services. For the purpose of the trial, and to minimise cross-contamination, a physiotherapy service will be defined as follows: a team of physiotherapists, working together at one clinic site for the large majority of their clinical practice. If staff work across multiple locations within a service, those locations will be considered as one cluster. People presenting with shoulder pain will be invited to participate in questionnaire data collection and interview studies. They will either receive the intervention or usual care, depending on the randomisation of the physiotherapy service they have been referred to.

A summary of the participant identification, invitation and recruitment procedures for the study is outlined in the trial flow chart (see figure 2).

People referred or self-referred to participating physiotherapy services, aged 18 years or over presenting with shoulder pain will be invited to participate.

People with shoulder pain will be excluded if they present to the physiotherapy service with symptoms or signs indicative of serious pathology (eg, fractures, infection, inflammation, malignancy or referred pain from other sites (eg, cardiac, hepatobiliary)), have been referred for rehabilitation after shoulder surgery, have shoulder pain caused by stroke-related subluxation, have a diagnosis of inflammatory arthritis, including rheumatoid arthritis and polymyalgia rheumatica, have shoulder pain caused by cervical pathology or predominantly neck pain or are considered by the staff triaging to be vulnerable (eg, severe physical and/or mental health problems, dementia).

We aim to recruit 832 people with shoulder pain from 16 services across England (see sample size calculation). Services will be identified through prior involvement in the wider research programme, response to an NIHR Research Delivery Network call for interest or direct contact with Keele University Clinical Trials Unit (CTU) after learning about the trial via NIHR’s Open Data Platform.

After a service is identified, feasibility to take part will be assessed by discussion. This will consider: (1) referral numbers–the estimated number of eligible participants each month, (2) waitlist length–services with waitlists shorter than 4 weeks will be considered unsuitable, (3) service capacity–the ability to deliver the trial within the set recruitment period.

Participant recruitment started in November 2023 and is expected to close in March 2025. Potential participants will be identified from physiotherapy service waiting lists. Recruitment will be led by the physiotherapy service and integrated with their usual processes, using the PANDA-S eligibility checklist to support participant identification.

Potential participants will receive a study pack by post or an online link (via text message (SMS) or email). The packs will contain an invitation to participate, participant information sheet (PIS), a baseline questionnaire with consent form, preconsultation form (for intervention arm only) and a reply-paid envelope (not included in the online invitation). Study packs will be sent directly from each physiotherapy service, with no reminders issued. Those who provide consent and their contact details will be considered enrolled. Completed packs will be returned to Keele CTU for processing.

In line with a cluster RCT design, the NHS physiotherapy services will be the unit of randomisation. As the number of clusters will be small (envisaged to be up to eight clusters per arm), we will use block randomisation stratified by the size of the physiotherapy service, based on the average number of patients treated for shoulder pain (large sites≥150 per month, small sites<150 per month). We will use block sizes of 2 within each stratum to randomly allocate the physiotherapy services to the intervention or control arms. The randomisation sequence will be computer generated using blockrand in R.21

To minimise the risk of participation bias, all participants will receive the same PIS which informs participants that the study is looking at how the discussion between patients and physiotherapists can best be supported. The PIS does not refer to the trial having two arms (intervention and control). Participants will be asked to consent to participating in a study investigating the delivery of care for shoulder pain by physiotherapists, consisting of the completion of self-report questionnaires (over a period of 12 months). Participants will be informed that they can withdraw from the study at any time without giving a reason, and that a decision to withdraw will not affect their current or future healthcare.

Trial processes will be managed by an online database: Research Electronic Data Capture (REDCap).22 Data collection will be carried out by self-completed questionnaires. Participants who complete a baseline questionnaire and consent to the study will be sent follow-up questionnaires at 6 weeks, 6 months and 12 months. Questionnaires will either be paper-based or online depending on participant preference. While the baseline study packs are sent directly from sites, follow-up questionnaires will be sent by Keele CTU. For paper-based questionnaires, reminders will be sent after 2 and 4 weeks. At each follow-up point, participants who do not respond to reminders and have provided a telephone number will be contacted for minimum data collection (MDC) by phone after 6 weeks with a MDC questionnaire after 8 weeks. Participants engaging online will receive reminders at weeks 1–4 inclusive. Vouchers will be sent with all follow-up questionnaires as a token of appreciation. Electronic Case Report Forms (CRFs) embedded in REDCap will be used to collect data from intervention sites. A schedule of the data to be collected is summarised in table 1.

The primary outcome is the Shoulder Pain and Disability Questionnaire (SPADI)23 score over 12 month follow-up, where a higher total score (0–100) indicates worse pain and/or disability.

Secondary outcome measures will assess: (1) overall patient experience (using global perceived change in shoulder pain), (2) sleep using the Jenkins Sleep Questionnaire,24 (3) work absence and the impact of shoulder pain on work performance using the single-item work performance scale,25 (4) healthcare utilisation and (5) health-related quality of life using the EQ-5D-5L.26 27

Measures of anticipated key mediators, informed by the intervention logic model, will assess: (1) reassurance using the Consultation-based Reassurance Questionnaire,28 (2) worry about shoulder pain in the past week, (3) self-efficacy (8-item Patient-Reported Outcomes Measurement Information System (PROMIS) scale for Self-Efficacy (managing symptoms of chronic conditions),29 (4) participants’ experience of shared decisionmaking using the CollaboRATE measure.30

The baseline questionnaire will be used to measure the following prognostic factors: shoulder pain characteristics (shoulder pain intensity,31 shoulder pain-related disability, duration of shoulder pain episode, acute or traumatic onset and history of shoulder pain). Psychological and behavioural characteristics (avoidance of activities, belief that movement is harmful, confidence in managing shoulder pain and treatment expectations).31 General health and lifestyle (presence of pain elsewhere,32 diabetes mellitus and level of physical activity).31 Anxiety and depression using the Generalised Anxiety Disorder-two item (GAD-2)33 questionnaire for anxiety and the Patient Health Questionnaire-two items (PHQ-2) for depression.34 These factors were chosen based on previous research, input from clinical advisors and insights from people with lived experience of shoulder pain.

Age, sex, Body Mass Index (BMI), ethnicity, education (to identify highest qualification), health literacy,35 current work situation, most recent paid job title and psychosocial work environment will be measured to enable a description of the population.

We combined best practice guidance36 with the results from a qualitative interview study8 and a series of workshops involving patient contributors and clinical advisors to codesign and develop the intervention (the personalised guided consultation and associated training package for Physiotherapists) informed by the Medical Research Council (MRC) framework for complex interventions.37 The guided consultation is based on the principles of shared decision-making,38 to include effective reassurance, building confidence (self-efficacy) and provision of personalised advice and treatment, and comprises the following three elements:

1. A consultation summary will be jointly completed by the participant and physiotherapist to support shared decision-making. The summary will outline shared decisions regarding treatment and self-management options, for the patient to keep for reference following the consultation.

Physiotherapists will be provided with training in how to deliver the intervention using the preconsultation form, assessment and consultation summary. All participating physiotherapists will complete a 4 hour training programme, which will be delivered either online or face-to-face, depending on the preference of the physiotherapy service. The training will provide content on the rationale for the guided consultation, core components of the consultation and key skills to support participating physiotherapists to work towards making shared decisions. A comprehensive package of online resources will be made available to participating physiotherapists working in services randomised to the intervention arm.

For services randomised to the control arm, which will continue to offer care as usual, training will involve a short online session to explain the objectives and overall design of the trial, the procedures for eligibility screening and for sending out study packs to potentially eligible participants (this same session will also be offered to triage teams in services randomised to the intervention arm).

The process evaluation will explore and assess factors influencing the delivery of the intervention and provide important context for interpreting the trial results. It will examine the credibility and acceptability of the intervention, gathering patient participants’ views on their satisfaction with the care they received, the perceived impact on outcomes and their experiences of taking part in the trial. It will also capture physiotherapists’ perspectives on delivering the guided consultation, including their views on the intervention’s effectiveness and its impact on their approach to shoulder pain management. These qualitative data will help identify key factors shaping the intervention’s delivery and outcomes. A multimethod approach will be used which will include semistructured interviews with participants and physiotherapists, audio-recording of the guided consultation, analysis of data collected during the consultation using CRFs, and participant questionnaires.

The internal pilot will aim to assess recruitment, retention and intervention uptake, test trial procedures and explore intervention acceptability. It will form the first phase of the main trial recruiting at least 200 participants from 4 to 6 physiotherapy services over 6 months. Recruitment will not be stopped at the end of the internal pilot period, but there will be the opportunity, while recruitment is ongoing, to potentially revise trial procedures for the main trial. To improve intervention uptake, actions may include identifying barriers to adoption with physiotherapists, revising training materials and offering refresher courses, providing mentorship and supervision from senior team members. A priori defined success criteria will be used to assess progress during the internal pilot phase (see table 2). These criteria are similar to stop/go criteria, but their purpose is to inform discussions with the Programme Steering Committee (PSC—see Trial monitoring).

Data will be reported according to the reporting guidelines for randomised clinical trials: Consolidated Standards of Reporting Trials (CONSORT 2010) statement42 43 including extensions to cluster randomised trials44 and pragmatic trials.45 A CONSORT style flow diagram will be used to show the flow of participants through the trial, including reasons (where given) for withdrawal at both the physiotherapy service and individual participant level. These will be recorded on REDCap. Analysis will be conducted by a statistician who will remain blind to the allocation of physiotherapy clusters to either intervention or control arm.

The PSC was appointed and approved by the funders to oversee the scientific conduct of the programme grant. Providing independent oversight of the trial, the PSC includes a chair, patient partner, senior statistical representative and two experienced clinical academics with relevant expertise. The committee met during the set-up of the trial and will meet every 6 months thereafter, for the duration of the trial. Given the low risk of the trial, the PSC and funders agreed that an independent Data Monitoring Committee (DMC) was not needed. Data monitoring responsibilities have therefore been adopted by the PSC.

Reporting to the PSC, a Trial Management Group (TMG) has been formed and comprises the chief investigator, associate investigators, coapplicants, trial managers from Keele University CTU and statistician plus other stakeholders as required. In addition to the management and monitoring of the trial, the TMG is responsible for optimal delivery of the trial, analysis and interpretation of the results.

In the PANDA-S trial, the guided consultation involves introduction of preconsultation form, a semistructured assessment, consultation summary documents and personalised information and advice. Adverse events (AEs) are expected to be rare and minor. Events such as temporary pain or discomfort from physiotherapy assessments and hospital treatments for planned shoulder surgeries will not be recorded as highly unlikely to be related to the intervention. However, if a participant becomes distressed during the delivery of the guided consultation and the physiotherapist deems this related to the intervention, it will be reported as AE. In the event of either an AE or serious adverse events (SAEs), there are systems in place to inform the CTU. Any SAEs will be reported to the Research Ethics Committee (REC) within the relevant time frame, and to the Trial Steering Committee as appropriate.

This trial was provided with ethical approval by the Yorkshire & The Humber (South Yorkshire) Research Ethics Committee (REC reference: 23/YH/0070) on 28 April 2023.

A Model Agreement for Non-Commercial Research56 will be signed by the sponsor at Keele University prior to randomisation outlining the responsibilities of all participating physiotherapy services. Written informed consent for data collection will be obtained from eligible participants presenting with shoulder pain who are willing to participate in the trial (see online supplemental material).

The PANDA-S trial will follow Good Clinical Practice (GCP) principles and the UK Policy Framework for Health and Social Care Research (HSCR). Keele University, as the sponsor, has a HSCR Quality Management System with Standard Operating Procedures in place which will be adhered to in the conduct of the trial. An independent external audit may be carried out by the sponsor. For quality assurance purposes, trials supported by the sponsor may be subject to an independent audit. The Head of Project Assurance at Keele University (the trial sponsor) can be contacted by email: [email protected].

The trial sponsor will be notified of all amendments to the protocol.

Deviations from the protocol and GCP will be documented. Keele CTU will implement corrective and preventative actions where appropriate. The Chief Investigator will take responsibility for these actions, with approval from the PSC if necessary.

All information collected during the trial will be kept strictly confidential and securely managed by Keele University through the CTU. Keele CTU adheres to General Data Protection Regulation57 and maintains a duty of confidentiality. All sensitive and personal electronic data will be stored in the CTU’s secure virtual network, requiring two-factor authentication for access. User roles and permissions will limit access to specific data and operations. After data collection has been completed, all data will be anonymised and cannot be linked to identifiable participants. Hard copies, such as consent forms, will be securely stored in lockable filing cabinets at Keele CTU.

All participants will receive care from their treating physiotherapist. The trial will not provide treatment or make recommendations regarding specific diagnostic procedures or clinical treatments, either during or after its completion.

Keele University, a member of the UK Reproducibility Network, is committed to the principles of the UK Concordat on Open Research Data. Keele CTU has a longstanding commitment to sharing trial data to enhance research reproducibility and maximise benefits for patients, the public and the health and social care system. All data are available on following the School of Medicine at Keele University data request process by contacting the corresponding author and [email protected].

Having already provided input into the development of the PANDA-S intervention, patient contributors will advise on procedures integral to the success of the trial. Meetings with patient partners will be arranged at critical time points during the trial to discuss the following key areas:

Trial results will be presented at local, national and international conferences and published in free-access peer-reviewed journals. Following publication, further dissemination will occur through updates on Keele University’s website (https://www.keele.ac.uk/), summaries for participating physiotherapy services, and communication with related patient groups. To ensure these findings inform policy and practice, a dissemination plan has been developed based on National Institute for Health and Care Research (NIHR) ‘Push the Pace’ guidance.58 To implement this plan, the PANDA-S team will seek advice from Keele University’s Impact Accelerator Unit, which has a designated team working towards accelerating the uptake of research into practice.

Not applicable.