Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
380 participants
INTERVENTIONAL
2023-07-01
2025-11-30
Brief Summary
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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.
Detailed Description
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Chronic or persistent pain affects around 28 million adults in the United Kingdom (UK), reducing quality of life and people's ability to work or be productive at work. Sickness absence and reduced productivity costs the UK economy £73 billion per year.
Access to work advice and support for people living with pain is variable. Most people with chronic pain do not receive work advice through healthcare services, and employers do not routinely provide education or support for people with chronic pain. The Pain at Work (PAW) Toolkit aims to equip people who have pain with the knowledge, skills and confidence to: effectively self-manage a painful condition at work; access help and support; enjoy a better work experience; remain in the workforce.
Aims:
The aim of the trial is to determine the feasibility of conducting a definitive cluster randomised controlled trial (cRCT) of the effectiveness and cost-effectiveness of the PAW Toolkit for working-age adults with chronic or persistent pain. To achieve this, the objectives are:
* To measure feasibility outcomes to assess whether it would be possible to recruit to a definitive trial (recruitment, retention).
* To test the feasibility of reaching different employee groups (e.g., age, gender, ethnicity, job role or type), sectors (e.g., public, private, third) and organisation types (e.g., small-to-medium, or large enterprises).
* To explore whether participants and employers find the intervention and trial design acceptable.
* To obtain an estimate of the intra-cluster correlation coefficient to inform the future sample size calculation for the main trial.
* To collect a range of outcome measures to help identify the most appropriate primary outcome for a definitive trial.
* To collect data to assess the feasibility of capturing health economic data in a future trial.
* To design a future trial and implementation plan.
Protocol/ Method:
Trial configuration includes 3 work packages (WP's): feasibility trial (WP1); health economics evaluation (WP2); nested interview study (WP3).
Setting is community, comprised of employment settings in different sectors (public, private, third) in England, 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 8 worksites ("clusters"), approximately 4 per arm. Up to 120 participants ("employees") will be recruited from these clusters over 12 months.
A nested interview study will be conducted, in which up to 40 people will be interviewed after 6 months. Participants in the interview study will include employees from the intervention arm, and stakeholders (identified by employees as having been involved in their support at work). Stakeholders may include line managers, company owners, human resources or occupational health specialists, or trade union representatives).
Organisations are randomised to either i) active control group (TAU: treatment as usual), or ii) TAU plus PAW Toolkit. Intervention participants can also opt in to receive up to 3 telephone calls with an occupational therapist. The content of the calls will include orientation to the PAW Toolkit and individually tailored advice on managing pain at work.
The following outcome measures will be collected (for detail, see Outcome Measures section):
A. Feasibility and acceptability outcomes:
B. Employer-reported outcome measures
C. Participant-reported outcome measures (PROMs)
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Intervention Group: Pain at Work Toolkit
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.
Pain at Work Toolkit
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.
Active Control Group: Treatment as Usual
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.
Active control
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.
Interventions
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Pain at Work Toolkit
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.
Active control
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
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Nuffield Trust
UNKNOWN
University of Aberdeen
OTHER
University of Exeter
OTHER
Monash University
OTHER
Versus Arthritis
OTHER
University of Nottingham
OTHER
Responsible Party
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Principal Investigators
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Holly Blake, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Nottingham
Locations
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University of Nottingham
Nottingham, , United Kingdom
Countries
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References
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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.
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.
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.
Related Links
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Nuffield Foundation and Arthritis UK Research Funding (Award Ref: OBF/FR-000023820)
Other Identifiers
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DERR1-10.2196/51474
Identifier Type: REGISTRY
Identifier Source: secondary_id
OBF/FR-000023820
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
Blake_PAWFeasibilityTrial_2023
Identifier Type: -
Identifier Source: org_study_id