In the United Kingdom, chronic or persistent pain affects approximately one-third to one-half of the population [1,2]. This figure is predicted to increase largely owing to an aging population [1-3]. Chronic pain poses a high societal and economic burden [4,5]. In England, the direct medical costs of chronic pain amount to approximately £580 million (US $707.6 million), including the total prescription of analgesic medication and pain-related primary care appointments [6]. The broader economic costs to individuals with chronic pain, their employers, and society are substantial because of the costs of health and social care, productivity losses, sickness absenteeism, and early retirement [7,8], estimated to be over £100 billion (US $122 billion) annually [7]. People living with chronic pain report significant impacts on physical and mental health [9] and lower quality of life than the general population and patients with other long-term conditions [10]. The COVID-19 pandemic has increased the overall burden of chronic pain worldwide through the emergence of newly diagnosed conditions and by exacerbating existing conditions or their risk factors [11-13].

The importance of promoting and improving the way in which people self-manage chronic pain conditions is advocated in clinical guidelines [14]. Self-management interventions can be effective in improving pain, mental health, and health-related quality of life outcomes [15]. However, self-management interventions for chronic pain often focus on specific conditions or pain types (eg, back pain [16-20], chronic musculoskeletal conditions [21,22], arthritis [18,23], chronic orofacial pain [24], and cancer pain [25]). This potentially excludes a broader spectrum of chronic primary or secondary pain conditions (as in Korwisi et al [14]) and individuals who experience pain but lack a medical diagnosis or do not access health care services.

Studies on the management of chronic pain commonly focus only on medical, physical, or psychological strategies for pain management, whereas very few studies have reported on work-related impacts, strategies, or outcomes [26]. However, interventions focused on changes at work for people with chronic conditions (eg, to working conditions, work environment, and work organization) may enhance work participation across a range of chronic diseases [27]. Chronic pain affects people’s ability to be productive at work, be fulfilled at work, or remain in the active workforce [9,28-30] and leads to social inequalities (eg, disability pay gap). Retaining vocationally active adults in the workforce is important for reducing health and social inequalities because employment is inversely related to pain severity [31] and worklessness is associated with poorer physical and mental health [8,32,33], social exclusion [34], and all-cause mortality [35].

In clinical services, access to work-related advice (eg, occupational therapy) for people with chronic pain is highly variable and influenced by many factors such as referrals, provider availability, and resources [36]. Occupational therapists (OTs) work within health care and occupational health settings, providing interventions for pain management and return to or staying at work, but access to OTs is limited [37].

Researcher-led interventions targeting work-related outcomes are promising (eg, vocational rehabilitation [38,39]), but such studies tend to focus on specific conditions (eg, arthritis) and recruit participants from clinical settings (eg, rheumatology clinics), excluding people with other chronic pain conditions and those who are self-managing their condition outside of health care services.

Similar to self-management interventions, workplace-delivered interventions for the management of chronic pain also tend to focus on specific conditions (eg, back pain [40-45], neck pain [46-48], shoulder pain [49,50], and musculoskeletal conditions [51-54]); target specific occupational groups or job types (eg, workers with physically demanding work [52] or nurses [43]); or focus on specific types of intervention (eg, exercise or physical activity [41,42,51,55], physical conditioning [44], rehabilitation interventions [45,56], ergonomic interventions [57,58], and return-to-work or retention interventions [59-64]). Therefore, many workplace-delivered interventions will not reach the wider population of adults with chronic pain (with or without a formal diagnosis) or the wider spectrum of occupational groups. In addition, the narrow focus of existing interventions means that people with chronic pain need to access information and support from multiple places and may not know where and how to access it.

In practice, employers do not routinely provide support for and advice to employees with chronic pain conditions [65], and the provision of education and supportive materials for employees with chronic pain is therefore inconsistent or lacking across organizations and sectors. Only 30% to 34% of the UK workforce has access to specialized occupational health care [66]; a more recent estimate of 51% with access [67] was argued to be vastly overestimated [68]. Even when occupational health services are available, some occupational health professionals are not necessarily knowledgeable about chronic pain [69].

Digital approaches to the delivery of self-management are gaining popularity. Immersive technologies such as mobile health (the use of mobile phones and other wireless technology) and eHealth (the use of information and communication technology to support health and health care) have been used to provide pain therapy, education, symptom monitoring, lifestyle advice, health coaching, and cognitive behavioral therapy via virtual reality, mobile apps, or web-delivered programs in adults with diverse pain conditions [70-86]. Such interventions are primarily focused on improving pain, functional disability, or psychological outcomes but do not address barriers to work, facilitators of work ability, or pain self-management in the context of work, and work-related outcomes are often not measured.

In summary, there is a clear need for workplace interventions aimed at building the knowledge, skills, and confidence of vocationally active adults to effectively self-manage their condition at work (eg, through help seeking, adjusting job roles or physical environments, accessing support, and healthy lifestyle behaviors). Intervention is required that delivers comprehensive advice and support across a range of self-management areas, which is suitable for employees with any type of chronic pain working in any type of employment setting. Digital solutions are a potentially low-cost and scalable approach for the delivery of health interventions [87]. They have wide geographic reach and offer flexibility to the end user, which is increasingly valuable in the context of changes in job roles, work patterns, and locations (eg, hybrid or remote working) that have escalated in recent years [88,89].

The Pain-at-Work (PAW) Toolkit is the first accessible digital resource [65,90] designed to support people with chronic or persistent pain in self-managing their condition at work. It is designed to be relevant to any vocationally active adult with chronic pain in any organization type, size, or sector. The PAW Toolkit offers evidence-based advice about chronic or persistent pain, disability rights, work capacity, pain self-management strategies, and signposting to support. The design of the PAW Toolkit considers known enablers and barriers to engagement in digital interventions for people with chronic pain (eg, flexibility for access, inclusivity for people with disabilities, and low technological skill requirement). This intervention has been cocreated, pilot-tested, and evaluated with employees from public, private, and third sector organizations across the United Kingdom, and the comprehensive development processes are described elsewhere [65]. The feasibility and acceptability of the PAW Toolkit across employment sectors and different organization sizes and types, and the feasibility of testing the PAW Toolkit within a trial is yet to be determined.

This study is an important next step toward establishing the effectiveness and cost-effectiveness of the PAW Toolkit as a workplace intervention to support employees with chronic pain. Ultimately, the PAW Toolkit could contribute to reducing social inequalities (ie, disability pay gap) and the overall health, societal, and economic burden of chronic pain.

The overall aim of the study is to determine the feasibility of conducting a definitive cluster randomized controlled trial (cRCT) on the effectiveness and cost-effectiveness of the PAW Toolkit with telephone support for vocationally active adults with chronic or persistent pain.

To achieve this, the objectives are as follows:

This study is an open-label, 2-arm multicenter pragmatic cluster randomized controlled feasibility trial of the PAW Toolkit compared with a no-intervention control group in working adults with chronic or persistent pain. Both groups will continue to receive treatment as usual (TAU; ie, standard support from their employer). The analysis will be performed on an intention-to-treat basis. The feasibility trial included an exploratory health economics evaluation and a nested qualitative interview study. The study aligns with the Medical Research Council framework for developing and testing complex interventions [91] and will be conducted in accordance with the CONSORT (Consolidated Standards of Reporting Trials) extension to randomized pilot and feasibility trials [92]. The protocol was developed using the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) guidelines [93].

The University of Nottingham Faculty of Medicine and Health Sciences Research Ethics Committee granted ethics approval on March 31, 2023 (Faculty of Medicine and Health Sciences 237-0323). The trial was prospectively registered on May 1, 2023 (ClinicalTrials.gov NCT05838677).

Our extensive preparatory work to inform the PAW Toolkit development (n=472) was a rigorous collaborative participatory process involving surveys with employees (n=274) and employers (n=107), a stakeholder workshop (n=27), and expert peer review (n=40) [65]. Content was cocreated with “Burning Nights” (a pain charity in the United Kingdom), people living with chronic pain, health care professionals, occupational health and trade union advisers, and employers. Our trial protocol was discussed with 6 members of the patient and public involvement groups at 2 national pain centers. People with lived experience of chronic pain are represented in our trial management group, trial steering group, and trial advisory group. This paper is coauthored by the chair of The Patient Voices Committee of the British Pain Society.

A formal sample size calculation is not required for feasibility studies, although based on prior studies with a similar design [94-96], our aim is to recruit 120 employees from at least 8 organizations. Given the variability in organization size, if 120 employees are not recruited from 8 organizations, additional organizations may be recruited. Owing to the variability in the number of employees agreeing to participate in individual organizations, the total number of employees may exceed 120.

Employees will be made aware that they can withdraw their consent at any time during the trial without it affecting their employment. If a participant chooses to leave the study prematurely, the primary reason for discontinuation will be determined and recorded if possible. Participants who have withdrawn will not be replaced. They will be made aware (via the information sheet and consent form) that should they withdraw, the data collected to date cannot be erased and may still be used in the final analysis. In the unlikely event that an organization withdraws participation after randomization, the organization will not be replaced. The organization will be made aware that the data collected on the organization and employees at that organization to date cannot be erased and may still be used in the final analysis. Participants will be advised that their organization has withdrawn.

Organizations are randomized by the study statistician to either (1) active control group or (2) the PAW Toolkit with telephone support. Cluster randomization (rather than individual randomization) is required because of the nature of the intervention and risk of contamination between intervention and control participants working in the same organization. Organizations are randomized into the intervention or control group using an allocation ratio of 1:1. As this is an eHealth intervention, the researcher and participants will not be blinded to group allocation.

Participants in both the control and intervention groups will receive SMS text message reminders delivered through an automated system because SMS text messages can improve responses to web-based data collection surveys [102]. For intervention participants only, messages will include reminders to access the PAW Toolkit and OT support, as SMS text message reminders can increase the uptake of health interventions [103]. Message content will be informed by the COM-B model [101], an approach used previously for SMS text messaging aligned with workplace health intervention [104]. The content, frequency, and duration of messages will be determined through patient and public involvement consultation, message peer review, and prior research.

Outcomes are separated into (1) those that determine the feasibility and acceptability of a large definitive trial, (2) employer outcomes, and (3) participant-reported outcome measures (PROMs) to inform the choice of the primary outcome for the definitive trial. Outcomes will be measured at baseline (time 0: T0), 3 months (time 1: T1), and 6 months (time 2: T2). Items from the Checklist for Reporting Results of Internet E-Surveys (CHERRIES) [105] will be applied when reporting the findings from our web-based surveys. Multimedia Appendices 4 and 5 provide details of all feasibility and acceptability (Multimedia Appendix 4), employer- and participant-reported (Multimedia Appendix 5) data collection measures, and timeframes.

At the time of recruitment, details about the employment setting (Multimedia Appendix 5) will be collected from the organization representative (“gatekeeper”). This will document the sector, organization type, and size; number of staff; role of the “gatekeeper” employee representative; views toward workplace culture at the organization; and description of TAU in terms of existing provisions to support staff with long-term health conditions. Sickness absence data will be requested from the organization’s records, with consent from the participants at T0, T1, and T2.

The analysis will primarily be descriptive in line with the aims of a feasibility study. This will include estimates of recruitment and retention rates and descriptive statistics for baseline and follow-up outcome measures. For PROMs, we will undertake a dummy-run analysis presenting total scores (T0 and T1) and change from T0 to T2 (adjusting for baseline). Differences between arms may be presented with 95% CIs, where appropriate. Health economic measures (TAU costs, health care resource use costs comprising medicine use, primary care consultations, hospital stays, and outpatient visits for reasons related to chronic pain, anxiety, or depression) and quality of life measurement using EQ-5D-5L will be presented as unadjusted mean (SD) and median (IQR) values. Regression-based adjusted costs and EQ-5D-5L utility values will also be calculated, with baseline cost, quality of life values, treatment group, PAW Toolkit engagement (time spent), work absence, and respondent demographics as covariates. The percentage of missing data per resource use item and EQ-5D-5L dimension will also be presented. This analysis, along with a framework analysis of patients’ views on the relevance of PROMs to self-management of their chronic pain condition (captured as a part of the questionnaires and nested interviews), will guide the choice of relevant PROMs for use in a definitive trial of the PAW Toolkit.

At T2, we will conduct semistructured individual interviews with up to 40 stakeholders from intervention sites to explore the views of employees who received the intervention and key stakeholders that employees identify as involved in their support (eg, line managers, company owners, human resources, occupational health, or trade union). Participants will be purposively selected to reflect diverse views from across self-identified employee groups (eg, age, gender, ethnicity, and job type), sectors, organization size, and type. The eligibility criteria for the nested interview study are (1) working for an organization participating in the trial and selected for participation in the nested interview study (employees) and (2) employed in a role providing management or support for employees in a participating organization (stakeholders). The interviews will be held by telephone or videoconferencing (eg, Teams [Microsoft Corporation]) at a mutually convenient time and will be audio recorded with consent. The recordings will be transcribed in full and anonymized. We expect the interviews to last approximately 45 to 60 minutes.

Questions will be developed using a framework for qualitative research in feasibility randomized controlled trials [135,136] and reviewed by people with lived experiences of pain. Interviews will ascertain participants’ views about the feasibility and acceptability of the intervention, trial processes and outcome measures, and any perceived changes in individual or organizational outcomes. Employee questions are mapped to the COM-B model [101] to explore influencers of capability, opportunity, and motivation to self-manage their condition at work (including knowledge, attitudes, and confidence).

Employees and other stakeholders will provide informed consent via a web-based consent form. Verbal consent will be audio recorded before the interview. The qualitative researchers undertaking the interviews will provide information to the participants, explain the study, and obtain consent. It will be explained to the potential participant that entry into the study is entirely voluntary and that their employment will not be affected by their decision. Using framework analysis [137], we will explore barriers to or facilitators of engagement with or use of the intervention and recommendations for future implementation.

The aim of this study is to determine the feasibility of conducting a definitive cRCT on the effectiveness and cost-effectiveness of the PAW Toolkit with telephone support for vocationally active adults with chronic or persistent pain. The ultimate aim is to retain vocationally active adults in the workforce, which is important for reducing health and social inequalities. This feasibility trial will ascertain whether it is possible to recruit and retain organizations and eligible participants in a cluster randomized trial and provide insights into the feasibility of reaching different types of organization (of diverse sizes, types, and sectors) and employees (of diverse occupational and demographic groups). The data will determine whether the intervention and trial processes are acceptable to employers and employees. The knowledge gained from the study will inform the design of a definitive trial, including sample size estimation, approaches to cluster site identification, selection of primary and secondary outcomes, and the final health economic model. This trial will ascertain how the PAW Toolkit can be best optimized in future research and implementation in real-world employment settings.

Our study addresses the limitations of prior studies on (1) self-management of chronic conditions, (2) workplace-delivered interventions for the management of chronic pain, and (3) studies that target work-related outcomes. Through this trial, we provide an intervention that delivers comprehensive advice and support across a range of self-management areas, which is suitable for employees with any type of chronic pain working in any type of employment setting.

We are unable to collect data from employees who do not participate in the trial. Workplace research presents challenges in terms of recruitment and high risk of attrition [138]. However, we have also included strategies intended to maximize uptake and retention.

The PAW Toolkit is the first evidence-based digital health intervention aimed at supporting the self-management of chronic or persistent pain at work in vocationally active adults. The PAW feasibility trial will provide novel evidence on the feasibility of a cRCT evaluation of this digital intervention to support vocationally active adults at work, who are living with chronic or persistent pain.