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Pain-at-Work Toolkit (Definitive Trial)

14. maj 2026 opdateret af: University of Nottingham

Pain-at-Work Toolkit for Employees With Chronic Pain (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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

685

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Intervention
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
Andet: 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.
This is a workplace trial, participating organisations will be randomized to intervention or control.
Andre navne:
  • Pain-at-Work Managers Toolkit
Andet: Control (Standard treatment)
Support as Usual
Aktiv komparator: Contol
This is a cluster randomized trial. The level of randomization is organization. Participants (employees) receive Support as Usual
Andet: Control (Standard treatment)
Support as Usual

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Work Ability
Tidsramme: To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months).

Using the Work Ability Index 3 items (WAI).

  1. Assesses current work ability compared to highest work ability ever. Scale range is 0-10. Higher scores indicate better outcome.
  2. Assesses current work ability with respect to physical demands of work. Scale range 1-5. Higher scores indicate better outcome.
  3. Assesses current work ability with respect to mental demands of work. Scale range 1-5. Higher scores indicate better outcome.
To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months).

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Acceptabilitet af intervention
Tidsramme: 6 måneder
Resultat for at vurdere, om deltagerne finder interventionen acceptabel. Dette vil blive selvrapporteret i deltagerinterviews efter 6 måneder.
6 måneder
Jobstress
Tidsramme: For at vurdere ændring mellem tid 0 (baseline), tid 1 (3 måneder) og tid 2 (6 måneder).
Global enkeltvaremål. Ved at bruge emnet: 'Generelt, hvor stressende finder du dit job?' med svar på en 5-punkts skala fra 1 = 'slet ikke stressende' til 5 = 'ekstremt stressende'. Højere score indikerer dårligere resultat.
For at vurdere ændring mellem tid 0 (baseline), tid 1 (3 måneder) og tid 2 (6 måneder).
Omsætningsintentioner
Tidsramme: For at vurdere ændring mellem tid 0 (baseline), tid 1 (3 måneder) og tid 2 (6 måneder).
Global enkelt varemål. Brug af punktet: 'Overvejer du at forlade dit job på grund af dine smerter?' (Ja eller nej). Negativt svar er et bedre resultat.
For at vurdere ændring mellem tid 0 (baseline), tid 1 (3 måneder) og tid 2 (6 måneder).
Depression
Tidsramme: For at vurdere ændring mellem tid 0 (baseline), tid 1 (3 måneder) og tid 2 (6 måneder).
Brug af Patient Health Questionnaire (PHQ-2). Skala bruges til at screene for depression. Score spænder fra 0-6. Højere score indikerer dårligere resultat.
For at vurdere ændring mellem tid 0 (baseline), tid 1 (3 måneder) og tid 2 (6 måneder).
Angst
Tidsramme: For at vurdere ændring mellem tid 0 (baseline), tid 1 (3 måneder) og tid 2 (6 måneder).
Brug af den generelle angstlidelse (GAD-7). Anvendes som screeningsværktøj og sværhedsgradsmål for generaliseret angstlidelse. GAD-7-scoren beregnes ved at tildele score på 0, 1, 2 og 3 til svarkategorierne 'slet ikke', 'flere dage', 'mere end halvdelen af ​​dagene' og 'næsten hver dag' , henholdsvis og sammenlægning af scorerne for de syv spørgsmål. Samlet score spænder fra 0-21. Højere score indikerer dårligere resultat.
For at vurdere ændring mellem tid 0 (baseline), tid 1 (3 måneder) og tid 2 (6 måneder).
Sundhedsrelateret livskvalitet
Tidsramme: For at vurdere ændring mellem tid 0 (baseline), tid 1 (3 måneder) og tid 2 (6 måneder).
Brug af EuroQol Five Dimensions Questionnaire (EQ-5D-5L). Omfatter fem dimensioner: mobilitet, egenomsorg, sædvanlige aktiviteter, smerte/ubehag og angst/depression. Hver dimension har 5 niveauer: ingen problemer, små problemer, moderate problemer, alvorlige problemer og ekstreme problemer. Svar er kodet som enkeltcifrede tal, der udtrykker sværhedsgraden valgt i hver dimension. For eksempel "små problemer" (f.eks. 'Jeg har små problemer med at gå') er altid kodet som '2'. Cifrene for de fem dimensioner kan kombineres i en 5-cifret kode, der beskriver respondentens helbredstilstand. Højere score indikerer dårligere resultat.
For at vurdere ændring mellem tid 0 (baseline), tid 1 (3 måneder) og tid 2 (6 måneder).
Health-related quality of life VAS
Tidsramme: 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.
To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6months).
Impairments in work and activities
Tidsramme: 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).
To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months).
Health resource use questionnaire
Tidsramme: 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.
Cumulative health resource use at time 0 (baseline), time 1 (3 months), time 2 (6 months).
Social support at work
Tidsramme: 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).
To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months).
Work Self-Efficacy
Tidsramme: 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.
To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months).
Occupational Self-Efficacy
Tidsramme: 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.
To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months).
Pain severity
Tidsramme: To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months).
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
Tidsramme: 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.
3 months intervention only
Fidelity of intervention (Pain at Work Toolkit)
Tidsramme: 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.
At 6 months

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Organisationsanmeldte sygefraværsjournaler
Tidsramme: For at vurdere ændring mellem tid 0 (baseline), tid 1 (3 måneder) og tid 2 (6 måneder).
Organisatoriske registreringer af sygefraværsprocenter for deltagende medarbejdere.
For at vurdere ændring mellem tid 0 (baseline), tid 1 (3 måneder) og tid 2 (6 måneder).
Arbejdets art
Tidsramme: At dokumentere eventuelle ændringer i deltagerens karakter af arbejde mellem tid 0 (baseline), tid 1 (3 måneder) og tid 2 (6 måneder).
Brug af UK Standard Job Skill Classification (Jobfærdighedsniveau 1-4): Hovedjobtitel og branche, der arbejder i.
At dokumentere eventuelle ændringer i deltagerens karakter af arbejde mellem tid 0 (baseline), tid 1 (3 måneder) og tid 2 (6 måneder).
Employment Status
Tidsramme: 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
To document any changes in participant's employment status between time 0 (baseline), time 1 (3 months) and time 2 (6 months).

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Nottingham

Samarbejdspartnere

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

Efterforskere

  • Ledende efterforsker: Holly Blake, PhD, University of Nottingham

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. april 2026

Primær færdiggørelse (Anslået)

1. oktober 2028

Studieafslutning (Anslået)

28. februar 2029

Datoer for studieregistrering

Først indsendt

7. april 2026

Først indsendt, der opfyldte QC-kriterier

14. maj 2026

Først opslået (Faktiske)

22. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. maj 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IRAS 367449
  • OBF/FR-000025871 (Andet bevillings-/finansieringsnummer: Nuffield Foundation / Arthritis UK Oliver Bird Fund)
  • FMHS 120-0226 (Anden identifikator: Faculty of Medicine and Health Sciences Ethics Committee, University of Nottingham, UK)
  • 26011 (Anden identifikator: Sponsor, University Of Nottingham, UK)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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)

IPD-delingstidsramme

Protocol - baseline (registration) 6 months (submitted protocol for publication) Statistical analysis plan - baseline Informed consent form - 6 months (submitted protocol for publication).

IPD-delingsadgangskriterier

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.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF

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