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| ID | Type | Description | Link |
|---|---|---|---|
| OBF/FR-000025871 | Other Grant/Funding Number | Nuffield Foundation / Arthritis UK Oliver Bird Fund | |
| FMHS 120-0226 | Other Identifier | Faculty of Medicine and Health Sciences Ethics Committee, University of Nottingham, UK | |
| 26011 | Other Identifier | Sponsor, University Of Nottingham, UK |
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| Name | Class |
|---|---|
| Monash University | OTHER |
| University of Aberdeen | OTHER |
| University of Exeter | OTHER |
| University of Salford |
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The Pain-at-Work Toolkit has been created together with people who live with chronic pain, employers, healthcare professionals, and a national pain charity. The aim of the toolkit is to help employees with ongoing pain feel more confident in managing their condition at work, know where to find support, and improve their workplace experience, so they can remain in the workforce. People with lived experience of chronic pain will help guide the project throughout, including reviewing study documents and helping choose what outcomes to measure.
The investigators will work with around 30 organisations from different types of workplaces in the UK and invite more than 600 employees who live with pain to take part in the study. Organisation's employees will either receive access to the Pain-at-Work Toolkit and the Pain-at-Work Managers Toolkit ( to help managers support their staff) or the usual care that their organisation offers. Participants will be asked to complete online surveys at three points during the study. Intervention participants may be asked to take part in an interview at the end of the study to find out more about their experiences.
The study will examine whether the toolkit improves people's experience of work, including their productivity and ability to remain productive in their jobs. The investigators will also explore whether the toolkit offers good value for money.
Finally, the investigators will examine how the toolkit is used in practice-what works well, what might need improving, and how it could be made available to more employees in the future. The investigators will do this by interviewing employers or stakeholders involved in the employment of, support for, or policy development for adults with chronic pain.
Background Chronic pain affects 28 million adults in the UK, significantly impacting their ability to be productive at work, feel fulfilled at work and/or remain in the active workforce. However, most people living with chronic pain cannot access work-related support from healthcare services, and the majority of employers do not routinely provide it. The Pain-at-Work Toolkit is a web-based resource that could help to reduce unfair differences in working lives for people with chronic pain, and positively impact their health and wellbeing, enhancing their productivity in the wider community. Co-created with people who live with pain, healthcare professionals and employers, this toolkit provides education and self-management advice to help people with chronic pain stay in, and thrive, at work.
The investigators tested the Pain-at-Work Toolkit in a preliminary trial in England ('feasibility trial' NCT05838677) . This showed that the Pain-at-Work Toolkit can be a very helpful support tool in the workplace for those living with chronic pain. The investigators recruited 18 organisations and 380 employees (50% and 217% more than expected, respectively), demonstrating that this toolkit meets a gap in employer provisions. Employees who received access to the toolkit valued its content and engaged with it without technical issues. Workers told investigators that their ability to work had improved after 6 months but these results need to be confirmed in a larger trial. Employers told investigators that they valued being able to offer it to their staff. The investigators are now updating the toolkit content to ensure it is relevant to employees across the UK.
The next step is to carry out a larger UK-wide study ('definitive trial'). The aim is to find out whether The Pain-at-Work Toolkit helps people to feel more able and confident at work, take fewer sick days, and be productive at work, and whether it provides good value for money.
The investigators will recruit at least 30 different organisations from across UK. These organisations will be randomly placed into one of two groups: one will access and use the Pain-at-Work Toolkit (the intervention group), and the other will continue as usual (the control group), to compare results fairly. A Pain-at-Work Manager Toolkit will be made available to line managers of organisations in the intervention group.
Over 600 employees will be recruited from these organisations. They will all be invited to complete online questionnaires at three time points: at recruitment, 3 months, and 6 months. The investigators will ask about their health and wellbeing, and factors relating to work, such as work ability, self-efficacy (confidence), sickness absence, work productivity, and intentions to leave.
This larger trial will include an 'implementation study'. This will involve conducting interviews with up to 60 people who have taken part in the trial and other stakeholders (such as employer representatives, line managers, HR or occupational health specialists, policymakers, professional bodies). The findings will shape our plans to make the Pain-at-Work Toolkit available widely to all workers with pain in the future.
Aims The aim of this study is to conduct a definitive cluster-randomised controlled trial, with a built-in process and implementation evaluation, to assess the effectiveness and cost-effectiveness of the Pain at Work Toolkit for improving work ability in working-age adults with chronic pain across a range of UK workplaces.
Protocol/ Method
The study consists of 3 work packages:
Setting is community, comprised of employment settings in different sectors (public, private, third) in UK, varying in size (small:10-49 workers; medium: 50-249 workers; large: >250 workers).
Sample size estimate: The aim is to recruit a minimum of 30 worksites ("clusters"), approximately 15 per arm. Up to 685 participants ("employees") will be recruited from these clusters.
Up to 60 participants (employees and stakeholders) will be invited to take part in the interview study. In the case of intervention employees, this will be after the 6-month survey has been completed. Stakeholders may be interviewed at any time during the study duration, but if they are from the intervention organisation, it is likely this will be after the employees have completed their 6-month survey.
Interviews will ascertain participants' views about the Pain-at-Work Toolkit, trial processes and outcome measures, and any perceived changes in individual or organisational outcomes.
Organisations are randomised to either i) active control group (SAU: support as usual), or ii) SAU plus Pain-at-Work Toolkit and Pain-at-Work Manager's Toolkit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | This is a cluster randomized trial. The level of randomization is organization. Participants (employees) receive Pain-at-Work Toolkit + Pain-at-Work Manager's Toolkit+ Support as Usual |
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| Contol | Active Comparator | This is a cluster randomized trial. The level of randomization is organization. Participants (employees) receive Support as Usual |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The Pain-at-Work Toolkit is an web-based digital resource, providing education and information about behaviour change related to the self-management of chronic pain in the workplace. | Other | This is a workplace trial, participating organisations will be randomized to intervention or control. |
| Measure | Description | Time Frame |
|---|---|---|
| Work Ability | Using the Work Ability Index 3 items (WAI).
| To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months). |
| Measure | Description | Time Frame |
|---|---|---|
| Job stressfulness | Global single-item measure. Using the item: 'In general, how stressful do you find your job?' with responses on a 5 point scale ranging from 1 = 'not at all stressful' through to 5 = 'extremely stressful'. Higher score indicates worse outcome. | To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months). |
| Measure | Description | Time Frame |
|---|---|---|
| Organisation-reported sickness absence records | Organisational records of sickness absence rates for participating employees. | To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months). |
| Employment Status |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Holly Blake, PhD | University of Nottingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Health Sciences, University of Nottingham | Nottingham | Nottinghamshire | NG7 2HA | United Kingdom |
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| Label | URL |
|---|---|
| Pain-at-Work Toolkit for employees with chronic pain (definitive trial), Nuffield Foundation Projects | View source |
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Protocol - details shared via clinical trials.gov and protocol manuscript (with informed consent form) to be submitted to an open access peer-reviewed journal within 6 months.
Data Management Plan will be publicly available on https://dmponline.dcc.ac.uk prior to study start.
Protocol - baseline (registration) 6 months (submitted protocol for publication) Statistical analysis plan - baseline Informed consent form - 6 months (submitted protocol for publication)
Protocol - baseline (registration) 6 months (submitted protocol for publication) Statistical analysis plan - baseline Informed consent form - 6 months (submitted protocol for publication).
Protocol - details shared via clinical trials.gov and protocol manuscript (with informed consent form) to be submitted to an open access peer-reviewed journal within 6 months.
Data Management Plan will be publicly available on https://dmponline.dcc.ac.uk prior to ethical approval and study start.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 17, 2026 | May 11, 2026 |
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| OTHER |
| The Nuffield Foundation | UNKNOWN |
| Arthritis UK | UNKNOWN |
This is a cluster-randomized trial, there is an intervention group that receives the Pain-at-Work Toolkit, Pain-at-Work Manager's Toolkit and the organisations support-as-usual. The Control group just receives the organisations support-as-usual
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Study statistician is blind to participant allocation.
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| Control (Standard treatment) | Other | Support as Usual |
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| Turnover intentions | Global single item measure. Using the item: 'Are you considering leaving your job due to your pain?' (yes or no). Negative response is better outcome. | To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months). |
| Depression | Using the Patient Health Questionnaire (PHQ-2). Scale is used to screen for depression. Scores ranges from 0-6. Higher scores indicate worse outcome. | To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months). |
| Anxiety | Using the General Anxiety Disorder (GAD-7). Used as a screening tool and severity measure for generalised anxiety disorder. The GAD-7 score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of 'not at all', 'several days', 'more than half the days', and 'nearly every day', respectively, and adding together the scores for the seven questions. Total score ranges from 0-21. Higher scores indicate worse outcome. | To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months). |
| Health-related quality of life | Using the EuroQol Five Dimensions Questionnaire (EQ-5D-5L). Comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. Responses are coded as single-digit numbers expressing the severity level selected in each dimension. For instance, 'slight problems' (e.g. 'I have slight problems in walking about') is always coded as '2'. The digits for the five dimensions can be combined in a 5-digit code that describes the respondent's health state. Higher scores indicate worse outcome. | To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months). |
| Health-related quality of life VAS | Evaluates health today in a single score. The range 0-100. | To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6months). |
| Impairments in work and activities | Using the Work Productivity and Impairments Scale (WPAI-GH). Measures impairments in both paid work and unpaid work. It measures absenteeism, presenteeism as well as the impairments in unpaid activity because of health problem during the past seven days. The WPAI yields four types of scores: 1. Absenteeism (work time missed); 2. Presenteeism (impairment at work / reduced on-the-job effectiveness); 3. Work productivity loss (overall work impairment/ absenteeism plus presenteeism); 4. Activity Impairment. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity (worse outcomes). | To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months). |
| Health resource use questionnaire | Using a health care resource use questionnaire to measure completion rates for items of resource use, such as frequency of use of secondary and primary care, social care, private health care, and medications. Items are adapted from health economics data capture in previous research with pain populations. Minimum score zero, no maximum. Higher scores indicate greater frequency of resource use. | Cumulative health resource use at time 0 (baseline), time 1 (3 months), time 2 (6 months). |
| Social support at work | Using the Demand Control Support Questionnaire (DCSQ) - Social Support Sub-Scale, consisting of 6 items covering: pleasant atmosphere, spirit of unity, colleagues' support, helpful colleagues, relationship with superiors, relationship with colleagues. Respondents are asked to report their levels of agreement or disagreement on a four-point Likert scale. Higher values indicate better outcomes (higher social support at work, score range 6-24). | To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months). |
| Work Self-Efficacy | This included six items, three ask about current: confidence to work, manage their condition and that working would not make the condition worse. The other three ask about future in one year: motivation to continue working, importance to continue and confidence to continue working. All rated 0-10, higher score equals higher self-efficacy. | To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months). |
| Occupational Self-Efficacy | The Occupational Self-Efficacy Scale Short Form (OSS-SF) rated from stongly disagree to strongly agree asks six items about the ability to remain calm, problem solve, handle difficulties, use experience, meet goals and cope with problems and job demands. | To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months). |
| Pain severity | Measuring the current pain severity (0-10) | To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months). |
| Technology Acceptance | Using the technology acceptance model questionnaire to access the acceptability of the Pain at Work Toolkit and the intention to use. Alongside and actual behaviour change. | 3 months intervention only |
| Fidelity of intervention (Pain at Work Toolkit) | Intervention fidelity will be checked through collection of usage data for the Pain at Work Toolkit, to assess engagement with the intervention. | At 6 months |
| Acceptability of Intervention | Outcome to assess whether participants find the intervention acceptable. This will be self-reported in participant interviews at 6 months. | 6 months |
Using items from the Work Transitions Index (WTI) covering employment status, occupation and working hours
| To document any changes in participant's employment status between time 0 (baseline), time 1 (3 months) and time 2 (6 months). |
| Nature of work | Using UK Standard Job Skill Classification (Job Skill Level 1-4): Main job title and industry working in. | To document any changes in participant's nature of work between time 0 (baseline), time 1 (3 months) and time 2 (6 months). |
| Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: Informed consent Employee | Apr 17, 2026 | May 11, 2026 | ICF_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: Informed Consent Stakeholder | Apr 17, 2026 | May 11, 2026 | ICF_003.pdf |
| ICF | No | No | Yes | Informed Consent Form: Informed Consent NHS | Apr 17, 2026 | May 11, 2026 | ICF_002.pdf |
| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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