Extrait

Background and study aims Arthritis is a common condition affecting around 10 million people in the UK. There are various types of arthritis, including osteoarthritis and the less common inflammatory arthritis (IA). IA is a group of conditions, inkling rheumatoid arthritis (RA), in which a person’s immune system starts to attack healthy joints, causing pain, swelling (inflammation) and stiffness in the joints. Arthritis 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 (£5 – 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). The aim of this study is to investigate the effect of gloves which provide warmth and pressure and gloves which provide warmth alone on hand pain, stiffness and function of people with RA or IA. Who can participate? Adults with IA who have difficulty using their hands during the day, disturbed sleep, or limited use of hands when they wake up. What does the study involve? Participants are randomly allocated to one of two groups. Those in the first group are provided with correctly fitted mid-finger length Isotoner compression gloves, which give warmth and pressure. Those in the second group are given the same gloves but fitting one size too large so that they provide warmth but not pressure. Participants in both groups have their gloves fitted at a 45 minute appointment, where they also receive a wear and care glove information leaflet and a hand exercise booklet with photos of exercises (which they are encouraged to regularly perform). Within two to three weeks, the participant attends for a 15 minute glove review appointment to check fit of gloves and for advice if any problems have arisen. At the start of the study and after 12 weeks, participants in both groups complete a number of questionnaires in order to assess hand pain, stiffness and hand function. A small group of participants are also interviewed about their views on wearing the gloves. What are the possible benefits and risks of participating? If the trial shows that arthritis gloves are effective, then participants may benefit from relief from hand pain, stiffness, and/or swelling; improved ability to sleep (by reducing night hand pain); and improved ability to use the hands in everyday activities and at work. There are no known severe risks involved with wearing arthritis gloves, however some participants may find the gloves feel hot and/or itchy after a few hours during hot weather or that they occasionally feel too tight (causing temporary pins and needles or numbness). Where is the study run from? 22 NHS hospitals in England and Scotland (UK) When is the study starting and how long is it expected to run for? April 2015 to December 2017 Who is funding the study? National Institute for Health Research (UK) Who is the main contact? 1. Dr Yeliz Prior (public) [email protected] 2. Professor Alison Hammond (scientific) [email protected]

Critère d'inclusion

• Specialty: Musculoskeletal disorders, Primary sub-specialty: Metabolic bone disease

Liens

• isrctn