Pain at Work Toolkit in Employees With Chronic Pain

NCT05838677 | Completed DMC

• 3 other identifiers: Blake_PAWFeasibilityTrial_2023DERR1-10.2196/51474OBF/FR-000023820
• Study Type: interventional
• Target: 380
• Locations: 1 country
• Sites: 1

Brief Summary

This project will test the feasibility and acceptability of the Pain at Work (PAW) Toolkit which aims to help employees self-manage chronic or persistent pain at work. Ultimately, the investigators want to discover if it improves employees' health, wellbeing, confidence to self-manage their condition, and reduces impacts on their ability to work and be productive at work. Prior to testing the effectiveness and cost-effectiveness of the PAW Toolkit in a large-scale randomised trial, the investigators are conducting a multicentre pragmatic cluster randomised controlled feasibility trial. This will establish whether the PAW Toolkit, and our research processes, are feasible and acceptable in workplace settings, and will inform the design of a future trial. In this feasibility study, organisations will be randomised at site level to receive the intervention (PAW Toolkit plus occupational therapist (OT) support calls) or control (treatment as usual) for any individual employees who consent to take part. The investigators aim to recruit around 120 participants ("individual employees") from around 8 sites ("clusters"). Data will be collected from employees and organisations at baseline, 3 months and 6 months, using online surveys. At 6 months, up tp 40 people from across different sites and job roles will be interviewed, including employees who have accessed the PAW Toolkit, and other stakeholders (people who have been involved in supporting them at work, such as their line manager). The data will be used assess whether the intervention and the research processes are acceptable and feasible, and the information collected will be used to plan a large-scale randomised controlled trial.

Conditions

Chronic Pain; Pain, Chronic

Outcome Measures

Primary Outcomes (6)

• Recruitment to the study

  Number recruited to assess whether it would be possible to recruit to a definitive trial. The investigators will record the number recruited, characteristics of those recruited, and the timescale to recruit.

  Baseline

• Acceptability of Intervention

  Outcome to assess whether participants find the intervention acceptable. This will be self-reported in participant interviews at 6 months.

  6 months

• Fidelity of intervention (PAW Toolkit)

  Intervention fidelity will be checked through collection of usage data for the PAW Toolkit, to assess engagement with the intervention. This data will be collected through a feedback form at 3 months.

  3 months

• Fidelity of intervention (OT support calls)

  Intervention fidelity will be checked through recording of the uptake of occupational therapy support calls (to assess engagement with the intervention). This data will be collected through forms completed by the therapist at the time of each phone call which will be summed at 3 months.

  3 months

• Retention to the study at 3 months

  Number of participants who complete the first follow-up outcome measures survey.

  3 months

• Retention to the study at 6 months

  Number of participants who complete the second follow-up outcome measures survey.

  6 months

Secondary Outcomes (12)

• Work presenteeism

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

• Work Ability

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

• Work Self-Efficacy

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

• Job satisfaction

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

• Job stressfulness

  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 Group: Pain at Work Toolkit

EXPERIMENTAL

Intervention participants receive the PAW toolkit plus 3 x optional occupational therapy calls (approximately 30 minutes each) involving orientation to the PAW Toolkit and individually tailored advice and behavioural strategies for managing pain at work. This digital web-based toolkit is designed to support people with chronic pain in self-managing their condition at work. PAW offers evidence-based advice about chronic or persistent pain, disability rights, work capacity, pain self-management strategies and signposting to support.

Behavioral: Pain at Work Toolkit

Active Control Group: Treatment as Usual

ACTIVE COMPARATOR

Participants do not receive the PAW Toolkit but instead have treatment as usual (TAU) from their employer. The nature of TAU will be recorded as part of the feasibility study. Depending on the employing organisation, TAU may consist of (but is not limited to) any combination of the following: occupational health, counselling, line manager support, signposting to education about factors that may have positive or negative effects on chronic pain. Participants can access non-specialist telephone calls from a researcher to discuss their participation in the study.

Other: Active control

Interventions

Active control OTHER

Treatment as usual which will vary depending on the employing organisation but may include, for example, line manager support, occupational health input etc. Access to optional non-specialist phone call support from a study researcher.

Also known as: Treatment as usual (TAU)

Active Control Group: Treatment as Usual

Pain at Work Toolkit BEHAVIORAL

Online toolkit providing advice and signposting to help people self-manage chronic or persistent pain at work. Access to optional phone call support from an occupational therapist providing individually tailored advice.

Also known as: PAW Toolkit

Intervention Group: Pain at Work Toolkit

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• organisations in England
• organisations with 10 or more employees.
• working-age adults (employees)
• aged 18 and over
• self-reported chronic pain interfering with their ability to undertake or enjoy productive work
• able to comprehend English language
• able to provide informed consent.
• access to the internet to be able to access the web-based intervention and online surveys for data collection.

You may not qualify if:

• organisations outside of England
• micro-organisations with fewer than 10 employees
• unemployed at recruitment
• under 18 years of age
• no chronic pain at recruitment
• unable to comprehend English language
• unable to provide informed consent

Sponsors & Collaborators

• University of Exeter: collaborator
• Monash University: collaborator
• Versus Arthritis: collaborator
• Nuffield Trust: collaborator
• University of Aberdeen: collaborator
• University of Nottingham: lead

Study Sites (1)

University of Nottingham

Nottingham, NG7 2HA, United Kingdom

Location

Related Publications (3)

• Blake H, Somerset S, Greaves S. The Pain at Work Toolkit for Employees with Chronic or Persistent Pain: A Collaborative-Participatory Study. Healthcare (Basel). 2021 Dec 29;10(1):56. doi: 10.3390/healthcare10010056.

  PMID: 35052220 BACKGROUND

• Blake H, Chaplin WJ, Wainwright E, Taylor G, McNamee P, McWilliams D, Abbott-Fleming V, Holmes J, Fecowycz A, Walsh DA, Walker-Bone K. The Web-Based Pain-at-Work Toolkit With Telephone Support for Employees With Chronic or Persistent Pain: Protocol for a Cluster Randomized Feasibility Trial. JMIR Res Protoc. 2023 Oct 30;12:e51474. doi: 10.2196/51474.

  PMID: 37902814 BACKGROUND

• Blake H, Abbott-Fleming V, Greaves S, Somerset S, Chaplin WJ, Wainwright E, Walker-Bone K. Five years of patient and public involvement and engagement (PPIE) in the development and evaluation of the Pain-at-Work toolkit to support employees' self-management of chronic pain at work. Res Involv Engagem. 2025 Jul 15;11(1):81. doi: 10.1186/s40900-025-00757-5.

  PMID: 40665420 DERIVED

Related Links

• Nuffield Foundation and Arthritis UK Research Funding (Award Ref: OBF/FR-000023820)

MeSH Terms

Conditions

Chronic Pain

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

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

Study Officials

• Holly Blake, PhD

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is an open-label, two-arm, multicentre, pragmatic cluster randomised controlled feasibility trial.

Study Record Dates

• First Submitted: March 27, 2023
• First Posted: May 1, 2023
• Study Start: July 1, 2023
• Primary Completion: July 22, 2025
• Study Completion: November 30, 2025
• Last Updated: December 18, 2025

Record last verified: 2023-11

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.

Locations

GB (1)