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Pain-at-Work Toolkit (Definitive Trial)

14 maggio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

685

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Altro
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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
Altro: 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.
Altri nomi:
  • Pain-at-Work Managers Toolkit
Altro: Control (Standard treatment)
Support as Usual
Comparatore attivo: Contol
This is a cluster randomized trial. The level of randomization is organization. Participants (employees) receive Support as Usual
Altro: Control (Standard treatment)
Support as Usual

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Work Ability
Lasso di tempo: 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).

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Accettabilità dell'intervento
Lasso di tempo: 6 mesi
Esito per valutare se i partecipanti trovano l'intervento accettabile. Questo sarà auto-riportato nelle interviste ai partecipanti a 6 mesi.
6 mesi
Stress lavorativo
Lasso di tempo: Per valutare il cambiamento tra il tempo 0 (basale), il tempo 1 (3 mesi) e il tempo 2 (6 mesi).
Misura globale a singolo elemento. Usando l'item: 'In generale, quanto trovi stressante il tuo lavoro?' con risposte su una scala a 5 punti che vanno da 1 = 'per niente stressante' a 5 = 'estremamente stressante'. Un punteggio più alto indica un risultato peggiore.
Per valutare il cambiamento tra il tempo 0 (basale), il tempo 1 (3 mesi) e il tempo 2 (6 mesi).
Intenzioni di fatturato
Lasso di tempo: Per valutare il cambiamento tra il tempo 0 (basale), il tempo 1 (3 mesi) e il tempo 2 (6 mesi).
Misura globale del singolo articolo. Usando l'oggetto: 'Stai pensando di lasciare il tuo lavoro a causa del tuo dolore?' (sì o no). La risposta negativa è un risultato migliore.
Per valutare il cambiamento tra il tempo 0 (basale), il tempo 1 (3 mesi) e il tempo 2 (6 mesi).
Depressione
Lasso di tempo: Per valutare il cambiamento tra il tempo 0 (basale), il tempo 1 (3 mesi) e il tempo 2 (6 mesi).
Utilizzo del questionario sulla salute del paziente (PHQ-2). La scala viene utilizzata per schermare la depressione. I punteggi vanno da 0 a 6. Punteggi più alti indicano risultati peggiori.
Per valutare il cambiamento tra il tempo 0 (basale), il tempo 1 (3 mesi) e il tempo 2 (6 mesi).
Ansia
Lasso di tempo: Per valutare il cambiamento tra il tempo 0 (baseline), il tempo 1 (3 mesi) e il tempo 2 (6 mesi).
Utilizzando il disturbo d'ansia generale (GAD-7). Utilizzato come strumento di screening e misura di gravità per il disturbo d'ansia generalizzato. Il punteggio GAD-7 viene calcolato assegnando punteggi pari a 0, 1, 2 e 3 alle categorie di risposta "per niente", "diversi giorni", "più della metà dei giorni" e "quasi tutti i giorni" , rispettivamente, e sommando i punteggi delle sette domande. Il punteggio totale varia da 0 a 21. Punteggi più alti indicano risultati peggiori.
Per valutare il cambiamento tra il tempo 0 (baseline), il tempo 1 (3 mesi) e il tempo 2 (6 mesi).
Qualità della vita correlata alla salute
Lasso di tempo: Per valutare il cambiamento tra il tempo 0 (baseline), il tempo 1 (3 mesi) e il tempo 2 (6 mesi).
Utilizzando il questionario sulle cinque dimensioni EuroQol (EQ-5D-5L). Comprende cinque dimensioni: mobilità, cura di sé, attività abituali, dolore/disagio e ansia/depressione. Ogni dimensione ha 5 livelli: nessun problema, problemi lievi, problemi moderati, problemi gravi e problemi estremi. Le risposte sono codificate come numeri a una cifra che esprimono il livello di gravità selezionato in ciascuna dimensione. Ad esempio, "problemi lievi" (ad es. "Ho qualche problema a camminare") è sempre codificato come "2". Le cifre per le cinque dimensioni possono essere combinate in un codice a 5 cifre che descrive lo stato di salute dell'intervistato. Punteggi più alti indicano risultati peggiori.
Per valutare il cambiamento tra il tempo 0 (baseline), il tempo 1 (3 mesi) e il tempo 2 (6 mesi).
Health-related quality of life VAS
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Registri delle assenze per malattia segnalati dall'organizzazione
Lasso di tempo: Per valutare il cambiamento tra il tempo 0 (basale), il tempo 1 (3 mesi) e il tempo 2 (6 mesi).
Registri organizzativi dei tassi di assenza per malattia dei dipendenti partecipanti.
Per valutare il cambiamento tra il tempo 0 (basale), il tempo 1 (3 mesi) e il tempo 2 (6 mesi).
Natura del lavoro
Lasso di tempo: Documentare qualsiasi cambiamento nella natura del lavoro del partecipante tra il tempo 0 (baseline), il tempo 1 (3 mesi) e il tempo 2 (6 mesi).
Utilizzo della classificazione delle competenze lavorative standard del Regno Unito (livello delle competenze lavorative 1-4): principale titolo di lavoro e settore in cui si lavora.
Documentare qualsiasi cambiamento nella natura del lavoro del partecipante tra il tempo 0 (baseline), il tempo 1 (3 mesi) e il tempo 2 (6 mesi).
Employment Status
Lasso di tempo: 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).

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Nottingham

Collaboratori

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

Investigatori

  • Investigatore principale: Holly Blake, PhD, University of Nottingham

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 aprile 2026

Completamento primario (Stimato)

1 ottobre 2028

Completamento dello studio (Stimato)

28 febbraio 2029

Date di iscrizione allo studio

Primo inviato

7 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

14 maggio 2026

Primo Inserito (Effettivo)

22 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

22 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

14 maggio 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • IRAS 367449
  • OBF/FR-000025871 (Altro numero di sovvenzione/finanziamento: Nuffield Foundation / Arthritis UK Oliver Bird Fund)
  • FMHS 120-0226 (Altro identificatore: Faculty of Medicine and Health Sciences Ethics Committee, University of Nottingham, UK)
  • 26011 (Altro identificatore: Sponsor, University Of Nottingham, UK)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

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)

Periodo di condivisione IPD

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

Criteri di accesso alla condivisione IPD

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.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA
  • ICF

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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