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Pain-at-Work Toolkit (Definitive Trial)

14. mai 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Antatt)

685

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Annen
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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
Annen: 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 navn:
  • Pain-at-Work Managers Toolkit
Annen: 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
Annen: Control (Standard treatment)
Support as Usual

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
Tidsramme
Akseptabilitet av intervensjon
Tidsramme: 6 måneder
Utfall for å vurdere om deltakerne finner intervensjonen akseptabel. Dette vil bli selvrapportert i deltakerintervjuer etter 6 måneder.
6 måneder
Jobbstress
Tidsramme: For å vurdere endring mellom tid 0 (grunnlinje), tid 1 (3 måneder) og tid 2 (6 måneder).
Global enkeltvaremål. Bruke elementet: 'Generelt, hvor stressende finner du jobben din?' med svar på en 5-punkts skala fra 1 = 'ikke stressende i det hele tatt' til 5 = 'ekstremt stressende'. Høyere poengsum indikerer dårligere resultat.
For å vurdere endring mellom tid 0 (grunnlinje), tid 1 (3 måneder) og tid 2 (6 måneder).
Omsetningsintensjoner
Tidsramme: For å vurdere endring mellom tid 0 (grunnlinje), tid 1 (3 måneder) og tid 2 (6 måneder).
Global enkeltvaremål. Bruke elementet: 'Vurderer du å forlate jobben din på grunn av smertene dine?' (Ja eller nei). Negativ respons er bedre resultat.
For å vurdere endring mellom tid 0 (grunnlinje), tid 1 (3 måneder) og tid 2 (6 måneder).
Depresjon
Tidsramme: For å vurdere endring mellom tid 0 (grunnlinje), tid 1 (3 måneder) og tid 2 (6 måneder).
Bruke pasienthelsespørreskjemaet (PHQ-2). Skala brukes til å screene for depresjon. Resultatene varierer fra 0-6. Høyere score indikerer dårligere resultat.
For å vurdere endring mellom tid 0 (grunnlinje), tid 1 (3 måneder) og tid 2 (6 måneder).
Angst
Tidsramme: For å vurdere endring mellom tid 0 (grunnlinje), tid 1 (3 måneder) og tid 2 (6 måneder).
Bruk av generell angstlidelse (GAD-7). Brukes som et screeningsverktøy og alvorlighetsgradsmål for generalisert angstlidelse. GAD-7-poengsummen beregnes ved å tilordne poengsummer på 0, 1, 2 og 3 til svarkategoriene 'ikke i det hele tatt', 'flere dager', 'mer enn halvparten av dagene' og 'nesten hver dag' , henholdsvis og legge sammen poengsummene for de syv spørsmålene. Totalscore varierer fra 0-21. Høyere score indikerer dårligere resultat.
For å vurdere endring mellom tid 0 (grunnlinje), tid 1 (3 måneder) og tid 2 (6 måneder).
Helserelatert livskvalitet
Tidsramme: For å vurdere endring mellom tid 0 (grunnlinje), tid 1 (3 måneder) og tid 2 (6 måneder).
Bruke EuroQol Five Dimensions Questionnaire (EQ-5D-5L). Inneholder fem dimensjoner: mobilitet, egenomsorg, vanlige aktiviteter, smerte/ubehag og angst/depresjon. Hver dimensjon har 5 nivåer: ingen problemer, små problemer, moderate problemer, alvorlige problemer og ekstreme problemer. Svarene er kodet som ensifrede tall som uttrykker alvorlighetsgraden valgt i hver dimensjon. For eksempel "små problemer" (f.eks. 'Jeg har små problemer med å gå rundt') er alltid kodet som '2'. Sifrene for de fem dimensjonene kan kombineres i en 5-sifret kode som beskriver respondentens helsetilstand. Høyere score indikerer dårligere resultat.
For å vurdere endring mellom tid 0 (grunnlinje), 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
Tiltaksbeskrivelse
Tidsramme
Organisasjonsmeldte sykefraværsjournaler
Tidsramme: For å vurdere endring mellom tid 0 (grunnlinje), tid 1 (3 måneder) og tid 2 (6 måneder).
Organisasjonsregistrering av sykefraværstall for deltakende ansatte.
For å vurdere endring mellom tid 0 (grunnlinje), tid 1 (3 måneder) og tid 2 (6 måneder).
Arbeidets natur
Tidsramme: For å dokumentere eventuelle endringer i deltakerens arbeidsart mellom tid 0 (grunnlinje), tid 1 (3 måneder) og tid 2 (6 måneder).
Bruke britisk standard jobbferdighetsklassifisering (jobbferdighetsnivå 1-4): Hovedjobbtittel og bransje som jobber i.
For å dokumentere eventuelle endringer i deltakerens arbeidsart mellom tid 0 (grunnlinje), 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).

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Nottingham

Samarbeidspartnere

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

Etterforskere

  • Hovedetterforsker: Holly Blake, PhD, University of Nottingham

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. april 2026

Primær fullføring (Antatt)

1. oktober 2028

Studiet fullført (Antatt)

28. februar 2029

Datoer for studieregistrering

Først innsendt

7. april 2026

Først innsendt som oppfylte QC-kriteriene

14. mai 2026

Først lagt ut (Faktiske)

22. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

22. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

14. mai 2026

Sist bekreftet

1. april 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (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).

Tilgangskriterier for IPD-deling

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 Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • ICF

Legemiddel- og utstyrsinformasjon, studiedokumenter

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Nei

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