Pain-at-Work Toolkit (Definitive Trial)

NCT07600892 | Not Yet Recruiting

• 4 other identifiers: IRAS 367449OBF/FR-000025871FMHS 120-022626011
• Study Type: interventional
• Target: 685
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Chronic Pain; Pain, Chronic

Keywords

Pain-at-Work; chronic pain; eHealth; disability; workplace; randomized control trial

Outcome Measures

Primary Outcomes (1)

• Work Ability

  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).

Secondary Outcomes (15)

• Job stressfulness

  To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months).

• Turnover intentions

  To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months).

• Depression

  To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months).

• Anxiety

  To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months).

• Health-related quality of life

  To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months).

Other Outcomes (3)

• Organisation-reported sickness absence records

  To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months).

• Employment Status

  To document any changes in participant's employment status between time 0 (baseline), time 1 (3 months) and time 2 (6 months).

• Nature of work

  To document any changes in participant's nature of work between time 0 (baseline), time 1 (3 months) and time 2 (6 months).

Study Arms (2)

Intervention

EXPERIMENTAL

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

Other: 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.; Other: Control (Standard treatment)

Contol

ACTIVE COMPARATOR

This is a cluster randomized trial. The level of randomization is organization. Participants (employees) receive Support as Usual

Other: Control (Standard treatment)

Interventions

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. OTHER

This is a workplace trial, participating organisations will be randomized to intervention or control.

Also known as: Pain-at-Work Managers Toolkit

Intervention

Control (Standard treatment) OTHER

Support as Usual

Contol; Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nottingham: lead
• Monash University: collaborator
• University of Aberdeen: collaborator
• University of Exeter: collaborator
• University of Salford: collaborator
• The Nuffield Foundation: collaborator
• Arthritis UK: collaborator

Related Links

• Pain-at-Work Toolkit for employees with chronic pain (definitive trial), Nuffield Foundation Projects

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Holly Blake, PhD

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Holly Blake, PhD

CONTACT

+44 (0)115 95 15559; holly.blake@nottingham.ac.uk

Wendy J Chaplin, PhD

CONTACT

+44 (0)115 74 85786; Wendy.Chaplin@nottingham.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Study statistician is blind to participant allocation.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a cluster-randomized trial, there is an intervention group that receives the Pain-at-Work Toolkit, Pain-at-Work Manager's Toolkit and the organisations support-as-usual. The Control group just receives the organisations support-as-usual

Study Record Dates

• First Submitted: April 7, 2026
• First Posted: May 22, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): February 28, 2029
• Last Updated: May 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Protocol - baseline (registration) 6 months (submitted protocol for publication) Statistical analysis plan - baseline Informed consent form - 6 months (submitted protocol for publication).
• Access Criteria: 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.