Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

Pain-at-Work Toolkit (Definitive Trial)

14 mai 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

685

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Autre
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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
Autre: 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.
Autres noms:
  • Pain-at-Work Managers Toolkit
Autre: Control (Standard treatment)
Support as Usual
Comparateur actif: Contol
This is a cluster randomized trial. The level of randomization is organization. Participants (employees) receive Support as Usual
Autre: Control (Standard treatment)
Support as Usual

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Work Ability
Délai: 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).

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Acceptabilité de l'intervention
Délai: 6 mois
Résultat pour évaluer si les participants trouvent l'intervention acceptable. Cela sera autodéclaré lors des entretiens avec les participants à 6 mois.
6 mois
Stress au travail
Délai: Pour évaluer le changement entre le temps 0 (ligne de base), le temps 1 (3 mois) et le temps 2 (6 mois).
Mesure globale à un seul élément. En utilisant l'item : « En général, à quel point trouvez-vous votre travail stressant ? » avec des réponses sur une échelle de 5 points allant de 1 = « pas du tout stressant » à 5 = « extrêmement stressant ». Un score plus élevé indique un résultat moins bon.
Pour évaluer le changement entre le temps 0 (ligne de base), le temps 1 (3 mois) et le temps 2 (6 mois).
Intentions de chiffre d'affaires
Délai: Pour évaluer le changement entre le temps 0 (ligne de base), le temps 1 (3 mois) et le temps 2 (6 mois).
Mesure globale d'un seul élément. Utilisation de l'item : « Envisagez-vous de quitter votre emploi à cause de votre douleur ? (Oui ou non). Une réponse négative est un meilleur résultat.
Pour évaluer le changement entre le temps 0 (ligne de base), le temps 1 (3 mois) et le temps 2 (6 mois).
Dépression
Délai: Pour évaluer le changement entre le temps 0 (ligne de base), le temps 1 (3 mois) et le temps 2 (6 mois).
Utilisation du questionnaire sur la santé du patient (PHQ-2). L'échelle est utilisée pour dépister la dépression. Les scores vont de 0 à 6. Des scores plus élevés indiquent des résultats moins bons.
Pour évaluer le changement entre le temps 0 (ligne de base), le temps 1 (3 mois) et le temps 2 (6 mois).
Anxiété
Délai: Pour évaluer le changement entre le temps 0 (référence), le temps 1 (3 mois) et le temps 2 (6 mois).
Utilisation du trouble d'anxiété générale (GAD-7). Utilisé comme outil de dépistage et mesure de la gravité du trouble d’anxiété généralisée. Le score GAD-7 est calculé en attribuant des scores de 0, 1, 2 et 3 aux catégories de réponse « pas du tout », « plusieurs jours », « plus de la moitié des jours » et « presque tous les jours ». , respectivement, et en additionnant les scores des sept questions. Le score total varie de 0 à 21. Des scores plus élevés indiquent un pire résultat.
Pour évaluer le changement entre le temps 0 (référence), le temps 1 (3 mois) et le temps 2 (6 mois).
Qualité de vie liée à la santé
Délai: Pour évaluer le changement entre le temps 0 (référence), le temps 1 (3 mois) et le temps 2 (6 mois).
Utilisation du questionnaire EuroQol à cinq dimensions (EQ-5D-5L). Comprend cinq dimensions : mobilité, soins personnels, activités habituelles, douleur/inconfort et anxiété/dépression. Chaque dimension comporte 5 niveaux : aucun problème, problèmes légers, problèmes modérés, problèmes graves et problèmes extrêmes. Les réponses sont codées sous forme de nombres à un chiffre exprimant le niveau de gravité sélectionné dans chaque dimension. Par exemple, de « légers problèmes » (par ex. «J'ai de légères difficultés à me déplacer») est toujours codé «2». Les chiffres des cinq dimensions peuvent être combinés dans un code à cinq chiffres décrivant l'état de santé du répondant. Des scores plus élevés indiquent un pire résultat.
Pour évaluer le changement entre le temps 0 (référence), le temps 1 (3 mois) et le temps 2 (6 mois).
Health-related quality of life VAS
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Dossiers d'absence pour maladie déclarés par l'organisation
Délai: Pour évaluer le changement entre le temps 0 (ligne de base), le temps 1 (3 mois) et le temps 2 (6 mois).
Registres organisationnels des taux d'absence pour maladie des employés participants.
Pour évaluer le changement entre le temps 0 (ligne de base), le temps 1 (3 mois) et le temps 2 (6 mois).
Nature du travail
Délai: Documenter tout changement dans la nature du travail du participant entre le temps 0 (référence), le temps 1 (3 mois) et le temps 2 (6 mois).
Utilisation de la classification standard des compétences professionnelles du Royaume-Uni (niveau de compétence professionnelle 1 à 4) : intitulé du poste principal et secteur d'activité dans lequel il travaille.
Documenter tout changement dans la nature du travail du participant entre le temps 0 (référence), le temps 1 (3 mois) et le temps 2 (6 mois).
Employment Status
Délai: 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).

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of Nottingham

Collaborateurs

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

Les enquêteurs

  • Chercheur principal: Holly Blake, PhD, University of Nottingham

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 avril 2026

Achèvement primaire (Estimé)

1 octobre 2028

Achèvement de l'étude (Estimé)

28 février 2029

Dates d'inscription aux études

Première soumission

7 avril 2026

Première soumission répondant aux critères de contrôle qualité

14 mai 2026

Première publication (Réel)

22 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

22 mai 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

14 mai 2026

Dernière vérification

1 avril 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • IRAS 367449
  • OBF/FR-000025871 (Autre subvention/numéro de financement: Nuffield Foundation / Arthritis UK Oliver Bird Fund)
  • FMHS 120-0226 (Autre identifiant: Faculty of Medicine and Health Sciences Ethics Committee, University of Nottingham, UK)
  • 26011 (Autre identifiant: Sponsor, University Of Nottingham, UK)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime 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)

Délai de partage IPD

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

Critères d'accès au partage 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.

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • SÈVE
  • CIF

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

Essais cliniques sur La douleur chronique

Rechercher des essais similaires

Sponsors et collaborateurs

Les conditions médicales

Interventions en matière de drogue

CROs by country

CROs in Saudi Arabia

Conditions

Maladies rares

Interventions en matière de drogue

Compléments alimentaires

Commanditaire / collaborateurs

Emplacements

S'abonner