JMIR Publications

ABSTRACT

Background:

Chronic or persistent pain can limit an individual’s ability to work or be productive at work, creating substantial societal and economic burden. Despite this, evidence-based work‑related advice and support for people with chronic pain is inconsistent. The Pain‑at‑Work Toolkit was co‑created with people living with pain, health care professionals, and employers to increase knowledge of employee rights, improve access to workplace support, and provide guidance on lifestyle behaviors that facilitate pain self‑management.

Objective:

This study aimed to establish the feasibility of conducting a definitive cluster randomized controlled trial comparing access to the Pain‑at‑Work Toolkit plus optional occupational therapist telephone support (intervention) with support-as-usual (SAU) from the employer (control). Primary outcomes were feasibility, acceptability, usability, and safety of the digital intervention. We also assessed the feasibility of candidate primary and secondary outcomes and tested research processes required for a definitive trial.

Methods:

We conducted an open‑label, parallel, two‑arm pragmatic feasibility cluster randomized controlled trial with exploratory health‑economics analysis and a nested qualitative study. Eligible organizations were based in England, had ≥10 employees, and were recruited through professional networks and direct approach. Individual participants were working adults aged ≥18 years, with internet access and self‑reported chronic pain interfering with their ability to undertake or enjoy productive work. A restricted 1:1 cluster‑level randomization allocated organizations to the intervention or control arms. After organizational and individual consent, participants completed a web‑based baseline survey (T0) assessing work capacity, health and wellbeing, and health‑care resource use. Follow‑up occurred at 3 months (T1) and 6 months (T2). Feasibility outcomes included recruitment, intervention fidelity (delivery, reach, uptake, engagement), retention, and follow‑up completion. Qualitative interviews with employees and stakeholders at T2 explored acceptability and contextual factors influencing delivery and uptake.

Results:

A total of 380 employees from 18 organizations participated. Recruitment exceeded targets at both organizational and individual levels, demonstrating strong feasibility and engagement. Follow‑up completion met predefined feasibility criteria but showed variability, largely due to employee turnover, providing realistic attrition estimates for a future trial. Outcome measures showed acceptable completion rates and variability, supporting their suitability for use in a future definitive trial. Employees and stakeholders reported high acceptability of the Pain‑at‑Work Toolkit, and qualitative findings highlighted improved knowledge, confidence, and self‑management among employees. Stakeholders endorsed the Toolkit’s relevance and practicality within workplace settings.

Conclusions:

The feasibility trial demonstrated that the Pain‑at‑Work Toolkit and trial procedures are acceptable, scalable, and deliverable across diverse workplaces. Findings identify responsive outcome measures, emphasize the need for strengthened retention strategies, and support the Toolkit’s use as a standalone intervention. Overall, the study provides a strong foundation for progressing to a fully powered definitive trial. Clinical Trial: ClinicalTrials.gov NCT05838677; https://clinicaltrials.gov/study/NCT05838677 International Registered Report Identifier (IRRID): DERR1-10.2196/51474