Title: The effects of compression gloves on people with Rheumatoid Arthritis or Early Inflammatory Arthritis with hand pain: a multi-centre randomised placebo-controlled trial
Funder: Department of Health and Social Care

Abstract: Rheumatology occupational therapists (OTs) provide &ldquo;Arthritis Gloves&rdquo; (clinically termed compression gloves) to people with early inflammatory arthritis (EIA) and rheumatoid arthritis (RA). Various arthritis gloves are also available commercially (&pound;5 &ndash; &pound;35). Gloves can be worn night and/or day to relieve hand pain, stiffness and improve hand function. They apply pressure aiming to remove extracellular fluid, thus reducing stiffness, pain, improving finger movement and providing warmth, which helps pain relief. We conducted a systematic review of compression glove studies. Nine articles were identified but only four were randomised controlled trials (RCTs: n = 8 to 23). All evaluated full length compression gloves worn at night compared to placebo gloves. There was conflicting evidence for effects, with one identifying reduced hand symptoms similarly resulting from thermal placebo gloves. Studies were limited by: small sample sizes; and poorly described measures. We conducted a national survey with Rheumatology occupational therapists (OTs n=60). Almost all provide compression gloves for both day and/or night use and on average they issue 10 (SD 8.5) gloves/month. A more detailed survey in North-West England identified OTs provide gloves to a third of their caseloads (34 (SD 28)% in EIA; 31 (SD 19)% in RA). Gloves last about six months. Nationally, about half do not provide replacement gloves and patients must purchase these. The most common brand issued is Isotoner gloves. We completed a feasibility study in 10 OT departments in North-West England to help plan this RCT. We jointly standardised compression glove eligibility criteria, hand assessment and glove treatment protocols. We determined: study eligibility criteria; trial assessment and treatment protocols; identified the most important outcome and appropriate length of follow-up from the patients perspective; and sample size calculation. Pilot participants received a pair of gloves to wear mostly during the day. Most stated reduced hand pain was the most important effect, with similar benefitis for dominant and non-dominant hands. Our Steering Group (including three research patient partners and four Rheumatology OTs) reviewed nine gloves (thermal, cotton, nylon low compression), concluding a loose fitting compression glove was the most credible placebo. This study aims to determine the effect of compression gloves, compared to placebo, on hand symptoms and hand function of people with EIA or RA. We will conduct a RCT over 30 months with 168 people to answer: do compression gloves reduce hand pain, stiffness and/or improve hand function in people with EIA or RA? Patients reporting hand symptoms during the day and/or night causing pain and/or stiffness affecting everyday abilities and/or sleep, will be identified in rheumatology and OT clinics by clinic staff/research facilitators. Following informed consent, participants will be randomised to either Isotoner compression or placebo (slightly loose fitting compression) gloves groups. Participants will complete mailed questionnaires at baseline and two months later, including self-reported hand symptoms (pain and stiffness, 10 point numeric rating scale), hand function (Measure of Activity Performance-HAND; Disability Arm Shoulder hand scale). Following randomisation, participants will attend OT within three weeks to receive either compression or placebo gloves (as allocated). OTs will deliver both gloves in a standardised manner. Two to four weeks later, OTs will review if any problems were experienced. The primary outcome is hand pain during activity. Data will be analysed (intent to treat) using ANOVA with baseline adjustment (per person) to identify differences in hand status changes at two months between compression and placebo glove groups. This definitive study will identify whether compression gloves have clinically meaningful benefits, allowing patients to determine if these are worth buying /wearing and OT departments if these should continue to be provided.

Lay abstract: &ldquo;Arthritis Gloves&rdquo; (compression gloves) are provided in the NHS to people with rheumatoid arthritis (RA) and early inflammatory arthritis (EIA). Gloves provide pressure and warmth to relieve (night and/or day) hand pain, stiffness and improve using hands in everyday activities and at work. Various arthritis gloves are also available from online and High Street stores (&pound;5 &ndash; 35). The few small studies testing gloves effects found they reduced finger swelling at night, but other effects were unclear. One study found they had similar benefits to a thermal glove (which gave warmth but not pressure). We conducted a national survey of Rheumatology OTs identifying that over 80% provide gloves to people with RA or EIA. In the North-West, we found OTs provision is highly variable: to between 5-90% of their RA and EIA caseloads. We completed a small feasibility study to help plan this application. Although many people told their OTs the gloves helped, we did not have a control group. Testing if compression gloves work will assist therapists and patients to decide if they are worth providing or buying We will conduct a randomised controlled trial (RCT) recruiting 168 people with RA or EIA from rheumatology clinics, with hand pain affecting doing daily activities and/or sleep. After consent, participants will complete a questionnaire about hand symptoms and function. Within 3 weeks, participants will receive either compression or placebo gloves (i.e slightly loose compression gloves providing warmth but no pressure) from an occupational therapist. Everyone will receive the same instructions about wearing gloves and advice on managing hand symptoms. At 2 month follow-up (after 5-6 weeks glove wear), participants will complete the questionnaire again. We will test if there is any difference between the compression and placebo gloves effects on hand pain, stiffness and using hands in everyday activities and work.

Research activity codes: 6.3 MEDICAL DEVICES
Health categories: INFLAMMATORY AND IMMUNE SYSTEM