Protocol for a pilot cluster randomised controlled trial of a multicomponent sustainable return to work IGLOo intervention.

BACKGROUND: Long-term sickness costs businesses in the United Kingdom (UK) approximately £7 billion per annum. Most long-term sickness absences are attributed to common mental health conditions, which are also highly prevalent in people with acute or musculoskeletal health conditions. This study will pilot the IGLOo (Individual, Group, Leaders, Organisation, overarching context) intervention which aims to support workers in returning to and remaining in work following long-term sickness absence. The potential impact of the intervention is a timely return to work (main trial primary outcome) and prevention of a further episode of long-term sick leave. The intervention will be piloted in a randomised controlled trial (RCT) to examine the feasibility of the intervention (pilot trial primary outcome) and to inform a fully powered definitive trial to evaluate sustainable return to work (RTW) in people with primary or secondary mental ill-health who go on long-term sick leave. METHODS AND DESIGN: A two-arm feasibility randomised controlled trial (with a 30-month study period including 12-month follow-up) of the IGLOo intervention will be conducted in large organisations (≥ 600 workers) from the Yorkshire and Humberside regions, in the UK. Eight consenting organisations will be recruited and randomised to the intervention or control arms of the study (1:1 ratio), with a minimum recruitment target of 13 workers eligible to participate from each. Organisations assigned to the control group will continue with their usual practice. Feasibility data will include data collected on recruitment, retention and attrition of participants; completion of research outcome measures; and intervention compliance. Measurements of mental health, RTW, work outcomes, quality-of-life, workplace support and communication and other demographic data will be taken at baseline, 3, 6, 9 and 12 months in all participants. Qualitative interviews and survey data with all participants will explore the experiences of participants, acceptability of the intervention components and evaluation measures. Exploratory economic evaluation will be conducted to further inform a definitive trial. DISCUSSION: The findings from this pilot study will help to inform the development of a definitive cluster RCT designed to examine the efficacy of this intervention on health and work-related outcomes in UK workers on long-term sick leave. TRIAL REGISTRATION: ISRCTN11788559 (prospectively registered, date registered 6 October 2022).

Is it safe for patients with metal implants to have iontophoresis treatment?

BACKGROUND: Iontophoresis passes electrical charge through skin to deliver drugs or reduce excessive sweating. Treatments can be performed by patients at home following initial instruction. A limitation of the technique is that patients are not permitted to have metal implants. These are hypothesized to increase the risk of electric shock, cause localized heating and/or corrosion. OBJECTIVES: To investigate whether metallic materials (titanium, stainless steel and copper) placed in the iontophoresis circuit would lead to an unfavourable outcome regarding corrosion or local heating of the metallic object. METHODS: This was carried out using mass loss and temperature change experiments, together with atomic force microscopy for stainless steel, to assess any surface roughness changes. The investigations were carried out under accelerated conditions (70 V compared with standard use 20-30 V). RESULTS: No changes in mass or clinically significant changes in temperature of any of the metallic objects (or surface roughness for stainless steel) were observed. CONCLUSIONS: This study suggests that patients with these metallic implants can safely undergo iontophoresis treatment. Further work is needed to review the impact on metallic implants with repeated exposure to the iontophoresis system to represent real-world evidence.