Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT07600892

Pain-at-Work Toolkit (Definitive Trial)

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.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pain, Chronic Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Health Sciences, University of Nottingham

Nottingham, Nottinghamshire, NG7 2HA, United Kingdom

About this study

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.

  • To determine the effectiveness of the Pain-at-Work Toolkit for improving work ability in working-age adults with chronic pain
  • To determine intervention fidelity.
  • To explore the relationship between implementation fidelity and outcomes.
  • To understand the barriers and facilitators to successful implementation and rollout.
  • To generate strategies for future implementation, maintenance, and scalability.

Protocol/ Method

The study consists of 3 work packages:

  • Effectiveness trial (WP1),
  • Health economic evaluation (WP2),
  • Process and implementation evaluation (WP3).

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Working-age adults (employees), aged 18 and over,
  • Working in a participating organisation in the UK.
  • With chronic pain interfering with their ability to undertake or enjoy productive work,
  • Able to comprehend the English language and provide informed consent.

Exclusion criteria

  • Working-age adults (employees), aged 18 and over,
  • Working in a participating organisation in the UK.
  • With chronic pain interfering with their ability to undertake or enjoy productive work,
  • Able to comprehend the English language and provide informed consent.

Treatment and study plan

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.

Other names: Pain-at-Work Managers Toolkit

Control (Standard treatment)

Other

Support as Usual

Primary outcomes

  1. Work Ability

    Time frame: To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months).

    Using the Work Ability Index 3 items (WAI).

    • Assesses current work ability compared to highest work ability ever. Scale range is 0-10. Higher scores indicate better outcome.
    • Assesses current work ability with respect to physical demands of work. Scale range 1-5. Higher scores indicate better outcome.
    • Assesses current work ability with respect to mental demands of work. Scale range 1-5. Higher scores indicate better outcome.

Secondary outcomes

  1. Job stressfulness

    Time frame: To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months).

    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.

  2. Turnover intentions

    Time frame: To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months).

    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.

  3. Depression

    Time frame: To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months).

    Using the Patient Health Questionnaire (PHQ-2). Scale is used to screen for depression. Scores ranges from 0-6. Higher scores indicate worse outcome.

  4. Anxiety

    Time frame: To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months).

    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.

  5. Health-related quality of life

    Time frame: To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months).

    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.

  6. Health-related quality of life VAS

    Time frame: To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6months).

    Evaluates health today in a single score. The range 0-100.

  7. Impairments in work and activities

    Time frame: To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months).

    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).

  8. Health resource use questionnaire

    Time frame: Cumulative health resource use at time 0 (baseline), time 1 (3 months), time 2 (6 months).

    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.

  9. Social support at work

    Time frame: To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months).

    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).

  10. Work Self-Efficacy

    Time frame: To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months).

    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.

  11. Occupational Self-Efficacy

    Time frame: To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months).

    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.

  12. Pain severity

    Time frame: To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months).

    Measuring the current pain severity (0-10)

  13. Technology Acceptance

    Time frame: 3 months intervention only

    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.

  14. Fidelity of intervention (Pain at Work Toolkit)

    Time frame: At 6 months

    Intervention fidelity will be checked through collection of usage data for the Pain at Work Toolkit, to assess engagement with the intervention.

  15. Acceptability of Intervention

    Time frame: 6 months

    Outcome to assess whether participants find the intervention acceptable. This will be self-reported in participant interviews at 6 months.

Other outcomes

  1. Organisation-reported sickness absence records

    Time frame: To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months).

    Organisational records of sickness absence rates for participating employees.

  2. Employment Status

    Time frame: To document any changes in participant's employment status between time 0 (baseline), time 1 (3 months) and time 2 (6 months).

    Using items from the Work Transitions Index (WTI) covering employment status, occupation and working hours

  3. Nature of work

    Time frame: To document any changes in participant's nature of work between time 0 (baseline), time 1 (3 months) and time 2 (6 months).

    Using UK Standard Job Skill Classification (Job Skill Level 1-4): Main job title and industry working in.

Sponsors and collaborators

Lead sponsor

University of Nottingham

Other

Collaborators

  • Arthritis UK
  • Monash University
  • The Nuffield Foundation
  • University of Aberdeen
  • University of Exeter
  • University of Salford

Registry information

Official study title

Pain-at-Work Toolkit for Employees With Chronic Pain (Definitive Trial)

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
May 22, 2026
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.