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Pain-at-Work Toolkit (Definitive Trial)

14. Mai 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

685

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Sonstiges
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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
Sonstiges: 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.
Andere Namen:
  • Pain-at-Work Managers Toolkit
Sonstiges: Control (Standard treatment)
Support as Usual
Aktiver Komparator: Contol
This is a cluster randomized trial. The level of randomization is organization. Participants (employees) receive Support as Usual
Sonstiges: Control (Standard treatment)
Support as Usual

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Work Ability
Zeitfenster: 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).

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Akzeptanz der Intervention
Zeitfenster: 6 Monate
Ergebnis, um zu beurteilen, ob die Teilnehmer die Intervention für akzeptabel halten. Dies wird in Teilnehmerinterviews nach 6 Monaten selbst berichtet.
6 Monate
Arbeitsstress
Zeitfenster: Um die Veränderung zwischen Zeitpunkt 0 (Basislinie), Zeitpunkt 1 (3 Monate) und Zeitpunkt 2 (6 Monate) zu beurteilen.
Globales Einzelelementmaß. Mit dem Item: „Wie stressig empfinden Sie Ihre Arbeit im Allgemeinen?“ mit Antworten auf einer 5-Punkte-Skala von 1 = „überhaupt nicht belastend“ bis 5 = „extrem belastend“. Eine höhere Punktzahl weist auf ein schlechteres Ergebnis hin.
Um die Veränderung zwischen Zeitpunkt 0 (Basislinie), Zeitpunkt 1 (3 Monate) und Zeitpunkt 2 (6 Monate) zu beurteilen.
Umsatz Absichten
Zeitfenster: Um die Veränderung zwischen Zeitpunkt 0 (Basislinie), Zeitpunkt 1 (3 Monate) und Zeitpunkt 2 (6 Monate) zu beurteilen.
Globales Einzelelementmaß. Verwendung des Items: „Denkst du darüber nach, deinen Job wegen deiner Schmerzen aufzugeben?“ (ja oder nein). Negative Reaktion ist besseres Ergebnis.
Um die Veränderung zwischen Zeitpunkt 0 (Basislinie), Zeitpunkt 1 (3 Monate) und Zeitpunkt 2 (6 Monate) zu beurteilen.
Depression
Zeitfenster: Um die Veränderung zwischen Zeitpunkt 0 (Basislinie), Zeitpunkt 1 (3 Monate) und Zeitpunkt 2 (6 Monate) zu beurteilen.
Verwendung des Patienten-Gesundheitsfragebogens (PHQ-2). Scale wird verwendet, um nach Depressionen zu suchen. Die Werte reichen von 0-6. Höhere Werte weisen auf ein schlechteres Ergebnis hin.
Um die Veränderung zwischen Zeitpunkt 0 (Basislinie), Zeitpunkt 1 (3 Monate) und Zeitpunkt 2 (6 Monate) zu beurteilen.
Angst
Zeitfenster: Zur Beurteilung der Veränderung zwischen Zeitpunkt 0 (Grundlinie), Zeitpunkt 1 (3 Monate) und Zeitpunkt 2 (6 Monate).
Verwendung der Allgemeinen Angststörung (GAD-7). Wird als Screening-Instrument und Schweregradmaß für generalisierte Angststörungen verwendet. Der GAD-7-Score wird berechnet, indem den Antwortkategorien „überhaupt nicht“, „mehrere Tage“, „mehr als die Hälfte der Tage“ und „fast jeden Tag“ Scores von 0, 1, 2 und 3 zugewiesen werden. , und addieren Sie die Ergebnisse für die sieben Fragen. Die Gesamtpunktzahl reicht von 0-21. Höhere Werte weisen auf ein schlechteres Ergebnis hin.
Zur Beurteilung der Veränderung zwischen Zeitpunkt 0 (Grundlinie), Zeitpunkt 1 (3 Monate) und Zeitpunkt 2 (6 Monate).
Gesundheitsbezogene Lebensqualität
Zeitfenster: Zur Beurteilung der Veränderung zwischen Zeitpunkt 0 (Grundlinie), Zeitpunkt 1 (3 Monate) und Zeitpunkt 2 (6 Monate).
Verwendung des EuroQol Fünf-Dimensionen-Fragebogens (EQ-5D-5L). Umfasst fünf Dimensionen: Mobilität, Selbstfürsorge, übliche Aktivitäten, Schmerzen/Beschwerden und Angst/Depression. Jede Dimension hat 5 Stufen: keine Probleme, leichte Probleme, mäßige Probleme, schwere Probleme und extreme Probleme. Die Antworten werden als einstellige Zahlen kodiert, die den in jeder Dimension ausgewählten Schweregrad ausdrücken. Zum Beispiel „leichte Probleme“ (z. B. „Ich habe leichte Probleme beim Gehen“) wird immer mit „2“ kodiert. Die Ziffern für die fünf Dimensionen können zu einem 5-stelligen Code zusammengefasst werden, der den Gesundheitszustand des Befragten beschreibt. Höhere Werte weisen auf ein schlechteres Ergebnis hin.
Zur Beurteilung der Veränderung zwischen Zeitpunkt 0 (Grundlinie), Zeitpunkt 1 (3 Monate) und Zeitpunkt 2 (6 Monate).
Health-related quality of life VAS
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Von der Organisation gemeldete Krankenstandsaufzeichnungen
Zeitfenster: Um die Veränderung zwischen Zeitpunkt 0 (Basislinie), Zeitpunkt 1 (3 Monate) und Zeitpunkt 2 (6 Monate) zu beurteilen.
Organisatorische Aufzeichnungen der Krankenstände der teilnehmenden Mitarbeiter.
Um die Veränderung zwischen Zeitpunkt 0 (Basislinie), Zeitpunkt 1 (3 Monate) und Zeitpunkt 2 (6 Monate) zu beurteilen.
Art der Arbeit
Zeitfenster: Dokumentieren Sie alle Änderungen in der Art der Arbeit des Teilnehmers zwischen Zeitpunkt 0 (Basis), Zeitpunkt 1 (3 Monate) und Zeitpunkt 2 (6 Monate).
Unter Verwendung der UK Standard Job Skill Classification (Job Skill Level 1-4): Hauptberufsbezeichnung und Branche, in der gearbeitet wird.
Dokumentieren Sie alle Änderungen in der Art der Arbeit des Teilnehmers zwischen Zeitpunkt 0 (Basis), Zeitpunkt 1 (3 Monate) und Zeitpunkt 2 (6 Monate).
Employment Status
Zeitfenster: 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).

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of Nottingham

Mitarbeiter

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

Ermittler

  • Hauptermittler: Holly Blake, PhD, University of Nottingham

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. April 2026

Primärer Abschluss (Geschätzt)

1. Oktober 2028

Studienabschluss (Geschätzt)

28. Februar 2029

Studienanmeldedaten

Zuerst eingereicht

7. April 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

14. Mai 2026

Zuerst gepostet (Tatsächlich)

22. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

22. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

14. Mai 2026

Zuletzt verifiziert

1. April 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • IRAS 367449
  • OBF/FR-000025871 (Andere Zuschuss-/Finanzierungsnummer: Nuffield Foundation / Arthritis UK Oliver Bird Fund)
  • FMHS 120-0226 (Andere Kennung: Faculty of Medicine and Health Sciences Ethics Committee, University of Nottingham, UK)
  • 26011 (Andere Kennung: Sponsor, University Of Nottingham, UK)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

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-Sharing-Zeitrahmen

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

IPD-Sharing-Zugriffskriterien

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.

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • SAFT
  • ICF

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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