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Co-designed neck exercise (EPIC-Neck) vs usual exercise care for people with chronic non-specific neck pain: protocol for a randomised feasibility study with process evaluation

Pilot and Feasibility Studies volume 11, Article number: 26 (2025) Cite this article

Abstract

Background

Clinical guidelines recommend that people with chronic non-specific neck pain self-manage symptoms with physiotherapy-led exercise. However, current exercise strategies have modest short-term effects, engagement is poor, and 48% of people continue to experience long-term and recurrent pain.

Updated exercise strategies co-produced using complex intervention development frameworks are required that consider the behavioural, psychological, environmental, and technical aspects of exercise prescription and patient adherence to optimise symptom outcomes, long-term engagement, and self-management.

This study tests the feasibility and acceptability of the EPIC-Neck programme (“Exercise Prescription Improved through Co-design”) which is grounded in evidence and theory and was co-produced using intervention mapping principles. The aim of the EPIC-Neck programme is to optimise the short-term outcomes of and long-term engagement with neck exercise.

Methods

This is a randomised feasibility study with process evaluation to assess the feasibility and acceptability of the EPIC-Neck programme and inform the design of a large-scale definitive trial evaluating the clinical and cost-effectiveness of the EPIC-Neck programme. A multicentre two-arm randomised controlled feasibility study aiming to recruit 45 adults with chronic non-specific neck pain will be conducted in UK NHS musculoskeletal physiotherapy departments. Recruitment will be from waiting lists and clinic advertisements. Participants will be individually randomised in 2:1 ratio to either the EPIC-Neck programme (n = 30) or usual exercise care (n = 15). The primary feasibility objective is to determine whether to continue to a large-scale definitive trial by evaluating delivery fidelity, acceptability, contamination, and rates of recruitment and retention (outcome completion at follow-up). Other feasibility objectives are to evaluate safety, define usual exercise care, refine the EPIC-Neck programme and training, and explore the demographics of people who do and do not enrol onto the study. Outcomes will be assessed by questionnaires at baseline and at 3- and 6-month post-randomisation, appointment audio-recordings, and one-to-one semi-structured interviews with participants receiving the EPIC-Neck programme (n = 12–15) and physiotherapists.

Discussion

This feasibility study will provide evidence of the feasibility and acceptability of the EPIC-Neck programme and guide the development of a definitive randomised controlled trial evaluating its clinical and cost-effectiveness within the NHS.

Trial registrations

ISRCTN81746901.

Peer Review reports

Background

Neck pain is the third most common cause of years lived with disability in the United Kingdom (UK) [1] leading to personal financial burden [2] and poor quality of life [3]. Personal impact is greatest for people with recurring or chronic, non-specific symptoms (chronic non-specific neck pain) [4] which accounts for up to 75% of all people with neck pain [5, 6]. These individuals will experience moderate to severe disability on two or more occasions each year [7].

International [8, 9] and National Institute for Health and Care Excellence [10] guidelines recommend people with chronic non-specific neck pain to engage in long-term self-management of symptoms via physiotherapy-led neck exercise programmes. Although physiotherapists follow treatment guidelines and prescribe neck exercise [11], the short-term effects of exercise on symptoms are modest [12, 13], engagement in self-management exercise is poor [13, 14], and 48% of people continue to experience long-term and recurrent episodes of disability [15]. Current exercise programmes for people with chronic non-specific neck pain have scope for improvement, and work is required to develop exercise interventions that people will engage with, maximise improvements in symptoms, and enable long-term self-management.

When developing an optimised exercise intervention, the Cochrane review of exercise for neck pain [12], the Cochrane review of exercise for chronic pain [16], other neck exercise systematic reviews [17, 18], and the Medical Research Council [19] recommend co-development with patients and experts using a complex intervention framework. This approach guides exercise intervention developers to consider the behavioural, psychological, environmental, and technical aspects of exercise when developing an intervention, to optimise engagement and symptom outcomes.

This feasibility study is part of a body of work to co-develop an exercise programme (“Exercise Prescription Improved through Co-design” — EPIC-Neck) using intervention mapping principles [20] to be later evaluated in a larger randomised trial to assess its clinical and cost-effectiveness within the NHS. The EPIC-Neck programme is grounded in evidence and theory, aiming to optimise the short-term outcomes of and long-term engagement with neck exercise.

Aims and objectives

The overall aims of this study are to evaluate the feasibility and acceptability of the EPIC-Neck programme and to inform the design of a large-scale definitive trial evaluating the clinical and cost-effectiveness of the EPIC-Neck programme.

The main feasibility objective is to determine whether to conduct a large-scale definitive trial by evaluating delivery fidelity, acceptability, contamination, and rates of recruitment and retention (completion of the planned definitive trial outcome measures at 6-month follow-up). Other objectives for this feasibility study are as follows:

  • Evaluate the safety of the EPIC-Neck intervention.

  • Define usual exercise care for chronic non-specific neck pain.

  • Obtain feedback to refine and improve the physiotherapist training and intervention materials/procedures.

  • Refine the EPIC-Neck Behavioural Logic Model and Biopsychosocial Exercise Prescription Framework.

  • Explore the demographics of people who do and do not enrol onto the study

Methods

Study design and setting

A multicentre, two-arm, parallel group, individually randomised controlled feasibility study with process evaluation. Patient participants will be randomised to either the intervention group (EPIC-Neck programme) or usual exercise care. Both groups will receive any other non-exercise usual care (e.g. work-place advice, postural advice, manual therapy). The feasibility study will be conducted across two sites, with 45 patient participants recruited over a 12-month period with 3- and 6-month post-randomisation. We have chosen to use a 2:1 ratio in favour of the intervention group, to ensure sufficient feedback on the intervention is obtained [21]. Recruitment will be from NHS community based and secondary care musculoskeletal services. See Fig. 1 for study flow chart and Table 1 for schedule of procedures.

Fig. 1
figure 1

Study flow chart

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Table 1 Schedule of procedures
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Eligibility

People with chronic non-specific neck pain (> 3 months), aged ≥ 18 years old, and willing and able to give informed consent will be eligible. Individuals will be excluded for the following reasons:

  1. 1.

    Received physiotherapy and chiropractic or osteopathic treatment (exercise, manual therapy, acupuncture, etc.) for neck pain in the past 6 months

  2. 2.

    Previous cervical spine surgery

  3. 3.

    Neck pain due to trauma (e.g. whiplash-associated disorders)

  4. 4.

    Neck pain due to a specific diagnosis (e.g. rheumatoid arthritis, osteoarthritis)

  5. 5.

    The presence or suspicion of neurological involvement (e.g. cervical radiculopathy or cervical myelopathy)

  6. 6.

    The presence or suspicion of serious pathology requiring onwards referral

  7. 7.

    Headache as the primary complaint

  8. 8.

    Unable to understand or follow study procedures with support from family members or professional interpreters

Identification of patient participants

Potential patient participants will be identified through two methods.

NHS musculoskeletal waiting lists and new referrals

NHS clinical staff will identify potentially eligible patients from referrals on existing waiting lists and new referrals (GP, specialist, or self-referral).

NHS clinical staff will contact potentially eligible patients via telephone to explain their organisation is participating in the study, provide an initial description of the study procedures, and perform an initial telephone screen. Interested potentially eligible individuals will be sent a patient participant information leaflet (PIL) and a formal study invitation letter via post or email by NHS clinical staff. The patient PIL will be available in paper format (English), electronic.pdf (English), and electronic video (audio in English or Urdu).

A follow-up call by NHS clinical staff will provide potential patient participants the opportunity to discuss the study further and to ask any questions they may have after receiving and reading the PIL. Any potential patient participants who on this follow-up call express an interest in taking part in the study will be invited to a research assessment for consent and final screening and eligibility checks to be undertaken.

NHS musculoskeletal department advertisements

EPIC-Neck study adverts will be placed strategically in NHS musculoskeletal departments. The adverts will include a QR code directing people to a.pdf and video of the patient participant information leaflet and details of who to contact should they be interested in taking part.

Once an expression of interest is received, the NHS clinical staff member will contact the potential patient participant via phone to perform an initial telephone screen, discuss the study further, and provide them with the opportunity to ask any questions. If an individual is still interested in taking part, they will be invited to a research assessment.

Research assessment

At this visit, informed consent will be obtained before the final screening and eligibility assessment are undertaken. For those that are eligible, baseline data will be collected, and then the patient participant can be randomised into the study. This visit will be undertaken by a musculoskeletal physiotherapist (NHS clinical staff) trained in the study procedures.

Consent

Prior to any study-related procedures being undertaken, written informed consent will be obtained from the patient participant by a local site NHS physiotherapist.

For potential patient participants unable to read English, the questions on the informed consent form will be read verbatim by the local site NHS physiotherapist or a professional interpreter, with the potential patient participant then signing the consent form. The consent process will be audio recorded for potential patient participants unable to read English.

The informed consent form will ask for explicit consent for the EPIC-Neck study team to contact the potential patient participant to be involved in the optional process evaluation qualitative interviews. Following the research assessment, a letter will be sent to the patient participants’ GP notifying them of their involvement in the study.

Screening

Following informed consent, final confirmation of the potential patient participant’s eligibility will be completed. This will include confirmation of the diagnosis of chronic non-specific neck pain, and that all the exclusion criteria are met. To determine the presence of osteoarthritis that is the primary source of patient symptoms, physiotherapists will use clinical reasoning from patient history and physical examination. Radiological findings are not required for eligibility but may assist physiotherapists in their decision-making. Routine care arranged for people not meeting the inclusion criteria.

Randomisation

Patient participants will be randomised at the level of individual in a 2:1 ratio to either the intervention arm (EPIC-Neck programme) or usual exercise care arm. Participants will be randomised through a web-based randomisation system from a third party (https://www.sealedenvelope.com/), which creates allocation codes using random permuted blocks of sizes 3 and 6. These codes are securely concealed from local site investigators until after baseline data collection. Following randomisation, participants are informed of their allocation, and an appointment is arranged with a physiotherapist delivering the respective treatment allocation. As such, patient participants are unblinded at the point of treatment allocation. The randomisation process will be conducted by the local site principal investigator (PI) or a delegated person. Following randomisation, a confirmatory email will be sent to the chief investigator (CI), local principal investigator (PI), and person completing randomisation (if different to the PI).

Blinding

Patient participant blinding is not feasible due to the nature of the intervention, control conditions, and resource constraints. We do not believe this will introduce bias, as the aim of this trial is to assess the feasibility and acceptability of the EPIC-Neck programme to inform a future definitive trial, and these outcomes are not affected by knowledge of group allocation.

Physiotherapist process evaluation consent procedures

Physiotherapists delivering the EPIC-Neck programme

The PI at the local site will approach physiotherapists via email to invite them to participate in the study and deliver the EPIC-Neck programme. The selection of physiotherapists will be purposive to give adequate cover across clinic locations and appointment availability throughout the week at each site. Physiotherapists will be provided with a study invite letter and information leaflet, as well as a consent form. The information leaflet will state that their involvement in delivering the EPIC-Neck programme requires participating in a questionnaire on their confidence in exercise prescription and behaviour change interventions, training feedback, audio-recording of physiotherapy appointments, and a one-to-one interview. Physiotherapists will express an interest in taking part by contacting the CI and will provide written informed consent prior to undergoing any study-related training or delivering the EPIC-Neck programme.

Physiotherapists delivering usual exercise care

When a patient participant is allocated to usual exercise care and booked with a physiotherapist, the site PI will approach the physiotherapist asking them to participate in the EPIC-Neck study process evaluation (appointment audio-recordings, one-to-one interviews, and questionnaire). They will be provided with a study invite letter, an information leaflet, and a consent form. The information leaflet will state the purpose of audio-recording of physiotherapy appointments, the one-to-one interview, and questionnaire. Physiotherapists will express an interest in taking part by contacting the CI, who will then take written informed consent. A physiotherapist may decline participating in the process evaluation but will still be permitted to deliver usual exercise care.

The allocation of physiotherapists to either the EPIC-Neck programme or usual exercise care is pre-planned to ensure adequate coverage across clinic locations and appointment availability throughout the week at each site.

Study interventions

EPIC-Neck programme (intervention arm)

The EPIC-Neck programme was developed using intervention mapping principles [20] and is an evidence-informed, theory driven, and co-produced (with patients, experts, and service providers) biopsychosocial intervention for self-management of chronic non-specific neck pain through a home-based neck exercise programme. Full details of the intervention development process will be published separately. The EPIC-Neck programme consists of two intervention components:

  1. 1.

    A behavioural component utilising behaviour change strategies to maximise participant engagement in their neck exercise self-management programme.

  2. 2.

    A neck exercise component utilising tailored and targeted exercise to optimise exercise prescription for maximum short- and long-term outcomes.

Behavioural component

Key behaviour change strategies (mapped to specific mechanisms of action) will be utilised to enable a participant to achieve behavioural performance objectives (performing exercise, adapting and progressing exercise, using exercise during flare-ups, and commencing secondary prevention and/or general exercise). In turn, these performance objectives will enable participants to perform the overarching behaviour of self-managing their neck pain using a home exercise programme. Full details on the behaviour change strategies are presented in the EPIC-Neck Behavioural Logic Model (Fig. 2), but in brief, strategies will be used to improve self-efficacy (beliefs about capabilities), perceived importance (beliefs about consequences) and safety (perceived susceptibility/vulnerability), and social support (social influences) in self-managing neck pain using exercise. Participants will be supported in setting exercise action plans, self-monitoring exercise and symptoms, and developing problem-solving skills. Delivery of the behavioural components is supported by resources (mobile/paper workbook, exercise diaries, wall charts, and friends and family leaflets) co-produced by the study team and patient representatives.

Fig. 2
figure 2

EPIC-Neck Behavioural Logic Model

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Neck exercise component

The neck exercises are prescribed using the EPIC-Neck Biopsychosocial Exercise Prescription Framework (Fig. 3) designed to support physiotherapists in prescribing individually tailored and targeted exercise to maximise short- and long-term outcomes.

Fig. 3
figure 3

EPIC-Neck Biopsychosocial Exercise Prescription Framework

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There are two stages of prescribing exercises:

  • Stage 1: Normalising movement — Active exercise for the neck and surrounding region to restore normal movement, e.g. to address poor motor control, fear, or low self-efficacy.

  • Stage 2: Improving tolerance — Active exercise with increasing demands is prescribed to improve the tolerance of the neck to cope with the individuals’ functional requirements.

The selection of exercise and its dosage variables used at each stage will be prescribed collaboratively with the participant and agreed by them as an “achievable challenge” [22]. The exercise programme will be tailored to each participant by matching key exercise prescription components to the most important short-term outcome(s) and exercise objective(s). These are determined collaboratively between the physiotherapist and participant based on participant history, physical examination, and goals of treatment.

Outcomes and exercise objectives may change throughout treatment as outcomes and objectives are achieved. The Biopsychosocial Exercise Prescription Framework is designed to be used iteratively throughout a course of treatment to enable tailoring of exercise prescription to match the desired objectives and outcomes at different time points.

Delivery

The EPIC-Neck programme will be delivered face-to-face during physiotherapy appointments and is structured so that the rate of progression between the behavioural performance objectives and exercise objectives/outcomes is individualised. Follow-up appointments are used to review progress towards neck pain outcomes and behavioural performance objectives, providing opportunity for the physiotherapist to provide feedback, support problem-solving, and make any necessary changes to the exercise programme. Throughout all appointments, physiotherapists will use a patient-centred communication style (e.g. open questions, reflective listening, using an ask-tell-discuss approach) and involve participants in shared decision-making.

To reflect clinical practice and the individualised nature of the intervention, the number of appointments is not pre-determined and will be evaluated during feasibility testing. Participants will be discharged when both the physiotherapist and participant agree they have made suitable progress towards their short-term outcomes and have adequate confidence, perceived importance, and social support to self-manage using exercise and the behavioural performance objectives.

Participants randomised to the EPIC-Neck programme will also receive any other non-exercise usual care at the discretion of the treating physiotherapist (e.g. work-place advice, postural advice, manual therapy).

Usual exercise care (control arm)

The usual exercise care group will receive physiotherapy exercise as per normal practice, and exercises will be determined by the treating physiotherapist and not using a pre-specified or standardised approach.

There is significant exercise heterogeneity in neck pain clinical trials [12, 17], and there is no consensus over the exercise that should currently be used in clinical practice. To meet intervention reporting requirements for a definitive study [23, 24], this feasibility study will be used to describe usual/current exercise prescription for chronic non-specific neck pain. This will be done by integrating data from appointment audio-recordings, observations of usual exercise care appointments, and qualitative one-to-one interviews with physiotherapists delivering usual exercise care [25].

Patient participants randomised to usual exercise care will also receive any other non-exercise usual care at the discretion of the treating physiotherapist (e.g. work-place advice, postural advice, manual therapy).

Training of treating physiotherapists

Physiotherapists delivering the usual exercise care intervention will not undergo any training and will be advised to prescribe exercise as per their normal practice.

Physiotherapists delivering the EPIC-Neck programme will undergo a single day face-to-face training programme informed by the EPIC-Neck Behavioural Logic Model and Biopsychosocial Exercise Prescription Framework. Training will include a mixture of lecture-based learning, mock demonstrations, and behavioural practice [26, 27] covering patient-centred communication techniques and the key behavioural and exercise intervention components. Ongoing support will be provided through a physiotherapist EPIC-Neck training manual, booster sessions as required, and points of contact for questions throughout the study from within the study team and a clinical champion based within the clinic [26, 28].

Intervention fidelity

Fidelity of training

Demographics (age, gender, qualifications, years’ experience, and prior training) of physiotherapist delivering the EPIC-Neck programme will be collected. A Neck Exercise Questionnaire will evaluate training fidelity [29, 30] by measuring physiotherapists confidence (5-point Likert scale) to deliver key components of the EPIC-Neck programme (informed by the Behavioural Logic Model and Biopsychosocial Exercise Prescription Framework) prior to and after training [27, 31]. Training satisfaction will also be evaluated with a questionnaire at the end of the training.

Fidelity of delivery

To assess fidelity of delivery, all EPIC-Neck appointments will be audio-recorded and coded against a checklist based on the functional intervention components specified in the EPIC-Neck Behavioural Logic Model and Biopsychosocial Framework and use of patient-centred communication techniques [32, 33]. Each item will be scored using Dreyfus criteria for assessing clinical competence [1,2,3,4,5], with pre-defined anchor points of 0 representing total absence of delivery for each item, 3 representing acceptable delivery, and 5 perfect delivery [34]. Initially, two auditors will independently code 3–4 EPIC-Neck appointments and then discuss the coding. This process will be repeated two to three times to ensure a reasonable consensus is achieved (defined as at least 75% of scores being within one point of each other), at which point the remaining appointment recordings will be coded by a single auditor only. A single appointment for each EPIC-Neck physiotherapist will be observed in person by the CI to monitor delivery fidelity for any active ingredients that are not detectable from audio-recordings (e.g. tailoring to neuromuscular dysfunctions; correct demonstration of exercise) [35, 36].

Appointment information (total appointments, total non-attended appointments, frequency of appointments) will also be collected.

Fidelity of receipt

Fidelity of receipt refers to the patient participants understanding of what is being asked of them and whether they have developed the necessary skills and ability to perform the intervention components [29]. Fidelity of receipt will be evaluated through a participant questionnaire. Patient participants in both groups will receive the same questionnaire at 3- and 6-month follow-up. Receipt fidelity will also be evaluated qualitatively using one-to-one semi-structured interviews with EPIC-Neck patient participants at 4-month post-randomisation [37].

Fidelity of enactment

Fidelity of enactment refers to whether a participant actually adopts and uses the key active ingredients of the intervention [29]. One-to-one semi-structured interviews with EPIC-Neck patient participants will be used to evaluate the use, barriers, and facilitators of the EPIC-Neck programme components (e.g. achieving performance objectives and using the supporting resources) [37].

Contamination

Strategies will be used to reduce contamination of the control group with components of the intervention. Physiotherapists will deliver either EPIC-Neck or usual exercise care, so only physiotherapists delivering EPIC-Neck will be trained in the intervention and logic model and will be asked not to share details of the intervention with colleagues.

As the definition of usual exercise care is unknown, it is unclear what components of the EPIC-Neck Programme might also be delivered in routine clinical practice, and this will be assessed in this feasibility study [38, 39]. Usual exercise care appointments will be audio-recorded and coded using the same checklist used for fidelity of delivery assessment. Content will then be compared between the two treatment groups.

Qualitative interviews with physiotherapists delivering usual exercise care will help to identify any reasons for contamination. Prior to the interviews, physiotherapists delivering usual care will also complete the Neck Exercise Questionnaire (measuring physiotherapists confidence (5-point Likert scale) in delivering key components of the EPIC-Neck programme) EPIC-Neck physiotherapists completed at training.

Outcome measures

The main feasibility study objective is to determine whether it is feasible to conduct a large-scale definitive trial, which would require further funding and approvals. Based on recommendations for progression criteria in feasibility studies [40], five key areas of uncertainty will be evaluated against a traffic light system (Table 2). The Study Management Group and PPIE group will examine the nature of all progression criteria findings and decide whether any shortcomings are fixable and the extent to which these might undermine the potential effectiveness of the intervention or study procedures.

Table 2 Traffic light progression criteria
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Additional data will be collected to assess the other objectives of the feasibility study (Table 3).

Table 3 Other feasibility objectives
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Planned definitive trial outcome measures

The feasibility study will also assess the completeness (especially at follow-up) of the outcome measures planned for the definitive trial. As no core outcome set exists for chronic non-specific neck pain, the choice of planned definitive study outcome measures was informed by the existing literature and discussion with the EPIC-Neck patient and public involvement and engagement (PPIE) group.

The planned primary outcome measure for the future trial will be the Neck Disability Index (NDI). Other secondary measures will be as follows: neck pain (visual analogue scale) (VAS) [43], health-related quality of life (EQ-5D-5L) [44], mental well-being (Hospital Anxiety and Depression Scale) [45], sleep quality (the Sleep Condition Indicator) [46], specific functional or activity limitations (Patient-Specific Functional Scale) (PSFS) [47], and social and relationships impacts (Relationships and Self-Worth domains of Assessment of Quality-of-Life 8D) [48, 49].

Other measures will be collected to assist with identifying changes in the expected mediators of outcomes (specified in the logic model) and exercise prescription framework: pain beliefs (single-item survey of Pain Attitudes Questionnaire) [50], pain-related fear (Tampa Scale of Kinesiophobia-13) [51], pain self-efficacy (pain self-efficacy questionnaire) [52], and pain at night (VAS) [43].

Data collection

A summary of the data to be collected is provided in Table 4.

Table 4 Data collection summary
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Patient participant questionnaires

Baseline data will be collected at the research assessment, after informed consent procedures. At 3- and 6-month post-randomisation, the same questionnaires will be posted to the patient participants to complete. For those unable to complete a postal questionnaire, follow-up will be completed via a telephone call with the CI. Questions will be read verbatim for the patient participant to answer. Professional interpreters will be provided for the questionnaire phone call if required. A £20 voucher will be offered for each patient participant returning (all of) the baseline and 3- and 6-month questionnaires.

Patient participant qualitative interviews

Qualitative one-to-one semi-structured interviews will be conducted with EPIC-Neck patient participants (n = 12–15) at 4-month post-randomisation to evaluate EPIC-Neck acceptability and fidelity (receipt & enactment) and to suggest refinements to the intervention and the study procedures. A topic guide for the interviews has been developed, based on the aims of the study, the EPIC-Neck logic model, and consultation with the EPIC-Neck PPIE group.

An explanation of the purpose of the interviews will be included in the PIL and will be discussed with the patient participant during the consent process. Those willing to be interviewed will provide permission to be contacted by the study team, and consent to participate in the interviews, on the feasibility study consent form. It will be made clear that not all patient participants will be required for the interviews. If a patient participant declines taking part in the interview, they will still be eligible to take part in the feasibility study.

Following the 3-month follow-up questionnaire, patient participants who were allocated to the EPIC-Neck programme and who agreed to be contacted will be purposively sampled by the study team to ensure diversity in ethnicity, deprivation, baseline neck pain disability, and confidence in completing the EPIC-Neck performance objectives (as rated on the 3-month follow-up questionnaire). Attempts will be made to (briefly) interview those who do not return questionnaires at 3 months to evaluate the reasons underlying any loss to follow-up.

Interviews will take place using a mode that is preferred by the patient participant (phone, video, face to face). Professional interpreters will be provided for those that require one. Interviews will be semi-structured, audio-recorded, and a maximum of 90 min.

Physiotherapist qualitative interviews

Semi-structured one-to-one interviews will be completed with the physiotherapists who consent to take part in the process evaluation once ≥ 35 patient participants have completed treatment.

Interviews with physiotherapists delivering the EPIC-Neck programme will be conducted to explore the training in more depth, evaluate acceptability of delivering the EPIC-Neck programme, and assist with refining the intervention. A topic guide for the interviews will be developed, based on the aims of the study, the EPIC-Neck logic model, and fidelity delivery findings.

Interviews with physiotherapists delivering usual exercise care will be conducted to further define usual exercise care and to evaluate reasons for contamination.

Interviews will take place using a mode that is preferred for the physiotherapist (phone or video). Interviews will be semi-structured, audio-recorded, and a maximum of 90 min.

Sample size justification

This feasibility study aims to recruit 45 patient participants over 12 months [54]. This means that we will be able to estimate a retention rate of 80% [55] to within a 95% confidence interval of ± 12%.

We expect to recruit 8–10 physiotherapists to deliver the EPIC-Neck programme. This provides 3–4 patient participants per physiotherapist, providing a reasonable sample to estimate intervention fidelity for each physiotherapist. The minimum target sample size for physiotherapists delivering usual exercise care to take part in the process evaluation is eight, and the maximum is 15.

Statistical considerations and data analysis

The data analysis for this feasibility trial will mainly be descriptive. Quantitative data will be summarised using descriptive statistics (means, standard deviations, frequencies, or proportions, as appropriate) and 95% confidence intervals to evaluate uptake rate, retention, outcomes completion rates, intervention acceptability, and fidelity. As this is a feasibility study, no formal between-group analysis will be conducted [21]. Qualitative data from one-to-one interviews will be transcribed verbatim and analysed by the lead author via thematic analysis using both inductive coding and deductive coding against the constructs of the healthcare intervention acceptability theoretical framework [41] and the EPIC-Neck logic model.

Quantitative and qualitative data will be analysed using IBM SPSS Statistics Version 25 and QSR International’s NVivo 12 Plus software respectively.

Adverse events

Adverse events will be recorded using a study adverse event (AE) form from randomisation up until the 6-month follow-up and evaluated as part of process evaluation (Table 5) [56]. A “medical occurrence” is any problem a participant experiences that interferes with function, lasting > 2 days and/or requiring medication or seeking health professional support [57].

Table 5 Adverse event reporting
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The following criteria will be used to define serious: results in death, is life-threatening, requires hospitalisation or prolongation of hospitalisation, results in persistent or significant disability or incapacity, and consists of a congenital abnormality or birth defect. When a local site becomes aware of any serious events, reporting procedures will be following in accordance with Good Clinical Practice guidelines.

Withdrawal criteria

Participants will be made aware at the beginning of the study that they can freely withdraw (discontinue participation) from the study (or part of, e.g. from the intervention and/or the interviews) at any time without giving a reason. Patient participants who wish to discontinue the intervention will be asked if they would be willing to continue in the study and complete the follow-up assessment.

Data management

Data will be collected using paper case report forms (CRFs) and questionnaires. Data will be sent to the EPIC-Neck study office and transcribed by a member of the research team onto the EPIC-Neck database. All study-specific documentation will refer to the participant with a unique study participant number, other than the consent form and follow-up contact details. Contact details will be stored separately from outcome data and deleted when they are no longer required as part of the study (within 12 months after last data collection point).

Password-protected dictaphones will be used for all audio-recordings. Audio-recordings will be collected by the study office, and the files were transferred onto a sponsor-owned laptop. Once transferred, files on the dictaphone will be deleted.

All investigators and study site staff will comply with the requirements of the Data Protection Act 2018 with regard to the collection, storage, processing, and disclosure of personal information and will uphold the Act’s core principles.

Monitoring, audit, and inspection

Quality assurance checks will be completed by the CI including a single inspection of the investigator site files at each site, observation of one research assessment, and fidelity assessments.

As this is a low-risk feasibility study, there will be no Study Steering or Data Monitoring Committee.

Study management group

A Study Management Group consisting of methodological and subject expertise and patient representation will be responsible for the overall running of the study. The role of the group is to monitor all aspects of the conduct and progress of the trial, ensure that the protocol is adhered to, and take appropriate action to safeguard participants and the quality of the trial itself. The Study Management Group will meet sufficiently frequently to fulfil its function.

The CI will be responsible for the day-to-day study management and training conducted at research sites.

Public and patient involvement and engagement

A PPIE group consist of 17 diverse members (age, gender, ethnic background, deprivation, and physical activity levels) with chronic non-specific neck pain assisted with co-design and production of the EPIC-Neck programme and in the development of this protocol and supporting PIL. Key involvement was as follows: (1) identifying important outcome measures, (2) developing study procedures to support inclusivity, and (3) pilot testing CRF’s and questionnaires. The wider PPIE group will be involved in interpretation of study findings, evaluating progression criteria, and developing public facing dissemination material. PPIE will be reported using the GRIPP2 checklist in the final publication [58].

Ethics and dissemination

The trial will be conducted in accordance with the United Kingdom (UK) Policy Framework for Health and Social Care Research, the applicable UK Statutory Instruments (which include the Data Protection Act 2018), and the principles of Good Clinical Practice. This study was approved by the South Central — Oxford B Research Ethics Committee (24/SC/0006). This protocol is written using the suggested adaptations [59] to the SPIRIT [60, 61] and CONSORT reporting guidelines for feasibility studies [62] (Additional file 1).

Outputs from the study will be disseminated via academic publication, conference presentations, and social media. The criteria for individually named authors or group authorship will follow the guidance of the International Committee of Medical Journal Editors.

The study participants and PPIE representatives will be informed of the findings via lay summary provided by post or email to the participants. PPIE representatives will be involved in producing dissemination material and/or attending conferences to disseminate the findings.

Study status

Recruitment started June 2024. A total of 26 patient participants have been randomised.

Discussion

The proposed randomised feasibility study will assess a co-produced biopsychosocial exercise programme for people with chronic non-specific neck pain that is evidence informed and theory driven. The EPIC-Neck programme has been designed to optimise the short-term outcomes of exercise and increase long-term engagement with self-management neck pain using exercise. In this feasibility study, we are aiming to determine whether the EPIC-Neck programme is feasible and acceptable and whether to progress to a definitive trial evaluating both clinical and cost-effectiveness in the NHS. This feasibility study will provide good evidence of the feasibility and acceptability of the EPIC-Neck programme and guide the development of a definitive RCT evaluating clinical and cost-effectiveness within the NHS.

Data availability

Not applicable.

Abbreviations

AE:

Adverse event

AQoL:

Assessment of quality of life

BCHC:

Birmingham Community Healthcare NHS Foundation Trust

CI:

Chief investigator

CRF:

Case report form

EPIC-Neck:

Exercise Prescription Improved through Co-design for people with chronic non-specific Neck pain

GP:

General practitioner

HCI:

Health and care innovation

HCP:

Healthcare professional

HEE:

Health Education England

HRA:

Health Research Authority

ICA:

Integrated Clinical and Practitioner Academic

ICF:

Informed consent form

IMD:

Indices of multiple deprivation

IP:

Intellectual property

NDI:

Neck Disability Index

NHS:

National Health Service

NIHR:

National Institute for Health and Care Research

PI:

Principal investigator

PIL:

Participant information leaflet

PPIE:

Patient and public involvement and engagement

PSFS:

Patient Specific Functional Scale

REC:

Research Ethics Committee

SAE:

Serious adverse event

SPIRIT:

Standard Protocol Items: Recommendations for Interventional Trials

UK:

United Kingdom

VAS:

Visual analogue scale

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Acknowledgements

We thank the EPIC-Neck patient and public involvement and engagement group for their contributions to the study design and set-up.

Funding

Jonathan Price, Clinical Doctoral Research Fellow, NIHR302141, is funded by HEE/NIHR for this research project. The views expressed in this publication are those of the author(s) and not necessarily those of the NIHR, NHS, or the UK Department of Health and Social Care.

The funders are not involved in study design, data collection, management, analysis, writing of the report, or the decision to submit this report for publication.

The study sponsor is Birmingham Community Healthcare NHS Foundation Trust (BCHC.researchinnovation@nhs.net).

Author information

Authors and Affiliations

  1. Musculoskeletal Physiotherapy Services, Birmingham Community Healthcare NHS Foundation Trust, Birmingham, UK

    Jonathan Price

  2. School of Sport, Exercise and Rehabilitation Sciences, College of Life and Environmental Sciences, University of Birmingham, Birmingham, UK

    Jonathan Price & Colin Greaves

  3. School of Physical Therapy, Western University, London, ON, Canada

    Alison Rushton

  4. Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK

    Natalie Ives & Kate Jolly

  5. Research and Innovation, Birmingham Community Healthcare NHS Foundation Trust, Birmingham, UK

    Priti Parmar

Authors
  1. Jonathan Price
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  2. Alison Rushton
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  3. Natalie Ives
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  4. Kate Jolly
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  5. Priti Parmar
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  6. Colin Greaves
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Contributions

JP is the chief investigator and conceived and designed the study, was awarded the funding, and drafted the manuscript. CG, AR, NI, KJ, and PP contributed to the study design and edited the study protocol. All authors have reviewed and approved the final manuscript.

Corresponding author

Correspondence to Jonathan Price.

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Ethics approval and consent to participate

The study was approved by the South Central — Oxford B Research Ethics Committee (24/SC/0006).

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Not applicable.

Competing interests

The authors declare that they have no competing interests.

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Supplementary Information

40814_2025_1608_MOESM1_ESM.doc

Additional file 1: SPIRIT 2013 Checklist: Recommended items to address in a clinical trial protocol and related documents.

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Price, J., Rushton, A., Ives, N. et al. Co-designed neck exercise (EPIC-Neck) vs usual exercise care for people with chronic non-specific neck pain: protocol for a randomised feasibility study with process evaluation. Pilot Feasibility Stud 11, 26 (2025). https://doiorg.publicaciones.saludcastillayleon.es/10.1186/s40814-025-01608-6

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Keywords

Pilot and Feasibility Studies

ISSN: 2055-5784