Specialty: Musculoskeletal disorders, Primary sub-specialty: Metabolic bone disease Musculoskeletal Diseases Early inflammatory arthritis and rheumatoid arthritis
Conditions
Interventions
Participants will be randomised into two treatment arms following completion of the baseline questionnaire, using a web-based system managed by Lancashire Clinical Trials Unit.
Intervention group: Pa
Sponsors
University of Salford
Eligibility
Sex/Gender
All
Age
18 Years to 120 Years
Inclusion criteria
Inclusion criteria: 1. Adults (i.e. aged =18 years) with Rheumatoid Arthritis (RA) or Inflammatory Arthritis (IA: i.e. persistent synovitis in the hands with no other known cause but not yet meeting criteria for RA) diagnosed by a Rheumatology Consultant. Participants can have other hand conditions resulting from RA/ IA, e.g. hand osteoarthritis, fibromyalgia, mild-moderate carpal tunnel syndrome. 2. Answering YES to the following agreed criteria for glove provision (devised by Rheumatology occupational therapists in North-West England): Do you have persistent pain in the finger and/or knuckle joints causing you at least one of the following: 2.1. Difficulty using hands during the day 2.2. Disturbed sleep 2.3. Limited ability to use your hands on waking/in the morning 3. Willing to wear arthritis gloves 4. Able to read and understand English? 5. Able to provide informed consent
Exclusion criteria
Exclusion criteria: 1. Having any other diagnosed rheumatic conditions, such as gout, psoriatic arthritis, ankylosing spondylitis, connective tissue disorders (systemic lupus, systemic sclerosis), resulting in inflammatory arthritis in the hand/s 2. Severe Raynaud’s disease or other circulatory disturbances in the hand 3. Severe neuropathies (nerve damage) in the hand 4. Severe hand deformities meaning putting gloves on and off is too difficult 5. Any contraindication (e.g. eczema, infections, broken skin) meaning glove wear could potentially pose an infection risk to the patient 6. Previously worn arthritis gloves (received either from occupational therapy, or bought themselves, as they will be aware the placebo gloves are insufficiently close fitting) 7. Not able to provide informed consent DEFERRED ENTRY: If the participant has had an intramuscular (IM) or intra-articular (IA) steroid injection, or started on oral steroids, in the last 6 weeks; but are eligible in all other respects. Study entry will be deferred until 6 weeks after the IM or IA injection/ start of oral steroids, has steroids usually are effective within 6 weeks. (Steroids could be a confounding variable if the gloves are provided at the same time).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dominant Hand Pain during activity is measured using a 0-10 numerical rating scale (NRS) at baseline and 12 weeks. Anchor points used are No Pain to Severe Pain | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Non-dominant hand pain during activity; dominant and non-dominant hand pain at rest in the day, at rest in the night measured using a 0-10 numerical rating scale at baseline and 12 weeks. 2. Hand stiffness is measured using a 0-10 numerical rating scale (NRS) at baseline and 12 weeks 3. Self-reported hand condition is measured using a five point rating scale of very severe/severe/moderate/good/very good at baseline and 12 weeks 4. Hand Function is measured using the Measure of Activity Performance of the Hand (MAPHAND) and the Michigan Hand Outcomes Questionnaire (MHQ) at baseline and 12 weeks 5. Disability is measured using the Health Assessment Questionnaire (20 items of daily function) at baseline and 12 weeks 6. Health economic analysis is undertaken using the EQ5D-3L and a health resource use questionnaire at 12 weeks 7. Glove wear is measured through: 7.1. Questionnaire items at 12 weeks about: frequency and duration of glove wear during the day and/ or at night in the last 4 weeks; any benefits and/or problems resulting from glove wear 7.2. Qualitative interviews conducted with sub-sample of participants to explore their’ views on: benefits or negative effects of glove wear (including at work for those employed); glove appearance, quality, comfort, ease of applying; willingness to buy gloves in future at 12 weeks | — |
Countries
England, Scotland, United Kingdom
Contacts
Public ContactYeliz Prior
Outcome results
None listed