C-GLOVES: the Effectiveness of Compression Gloves in Arthritis

Study Overview
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Brief Summary
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This is a collaborative study with 11 Occupational Therapy (OT) departments in North-West England. The OTs provide arthritis gloves to 25% of out-patients with inflammatory, rheumatoid and osteoarthritis. The pressure applied by the glove(s) may help relieve hand pain, swelling and stiffness. People find they help but there is little research testing this. Of the five small studies published: two found little or no benefit; one found similar effects from arthritis and ordinary thermal gloves; two found some benefits. Testing if gloves work helps therapists and patients judge if they will help. This is a feasibility study to help us plan a future trial testing if arthritis gloves work for people with arthritis. We aim to find out: the rate we can recruit people to the study; if OTs can assess people's hands and provide gloves as agreed; how many people do we need to take part in a trial; what do people think (if any) is the gloves' most important effect and how long should we test them for? We will analyse the data to see what effect the gloves have. The study will last 12 months. People will get arthritis gloves as part of their usual care. The OTs have agreed a standard way of assessing and providing the gloves to ensure best practice across departments. The assessments include: difficulties using hands, pain and stiffness levels, and measuring hand and finger joint size and movement. People can take part if they: have one of the three types of arthritis; are willing to wear Isotoner three-quarter length gloves; can attend the usual 4 week review appointment for re-assessment; will allow us to use their anonymized hand assessments. We will also interview some people about their views of the assessment and their treatment. Each patient will be involved for 4-8 weeks.

Detailed Description
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Design: An observational study of usual care providing arthritis gloves with pre- and 4 weeks post-treatment assessment. Participants are screened and recruited (if eligible and consenting) as they attend for glove provision as part of routine care. (Participants are not randomly assigned). Intervention: Three-quarter length finger Isotoner glove(s) for one or both hands, as required. The participating OTs determine if patients meet their agreed criteria for gloves as part of usual care. Usually at the same appointment the OT then assesses for and provides these using the assessment and treatment protocols agreed by North West England College of Occupational Therapists Specialist Section - Rheumatology (NWCOTSS-R) members as part of their usual care. Four weeks later, patients attend a review appointment (as part of their usual care) for re-assessment of their hand(s), and to identify any effects the gloves have had and if any problems arose meaning glove wear should be stopped or the wear regimen altered. Normally the patient attends for two appointments only. Occupational therapist (OT) training The members of the NWCOTSS-R group agreed the glove provision criteria, hand assessment and treatment protocols and glove instruction sheet in order to improve standards of usual care in glove provision across Rheumatology OT departments. Prior to recruitment commencing, the participating OTs attended a training meeting to ensure they: performed the hand assessments (i.e. swelling, finger flexion and Grip Ability Test) reliably. Know how to correctly size and fit the gloves following training by an experienced Rheumatology OT understand the study procedures, know how to take study specific consent and complete study site documentation. A standardised assessment kit and manual was provided to the OTs by the University research centre. Study criteria: Inclusion: Meet the criteria agreed by NWCOTSS-R members for receiving compression gloves as part of usual OT care. Adults with either: i. early inflammatory, probable or definite RA, diagnosed by a Rheumatology Consultant ii. hand OA, diagnosed by a GP, Consultant or Advanced Practitioner. c) Willing and able to wear three-quarter length Isotoner glove(s), following the glove fitting process. d) Willing to attend for the glove review appointment (part of usual care) approximately four weeks following glove provision. Exclusion: e) Has a terminal illness, or other health or personal issues, such that the OT considers the patient's participation may be an undue burden. f) Has any other condition which could alter hand symptoms and function between assessments (eg stroke, multiple sclerosis) g) In early IA/RA or hand OA: received an intra-articular or intra-muscular steroid injection or started a new anti-inflammatory drug within the last 4 weeks h) In established RA only: started a new DMARD within the last 6 weeks Sample size: 40 people from each of the: early IA or RA; and Hand OA, condition groups will be recruited. As this is a feasibility study no sample size has been calculated.

Official Title
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C-GLOVES: an Evaluation of the Effectiveness of Compression Gloves in Arthritis: a Feasibility Study

Conditions
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Inflammatory Arthritis, Rheumatoid Arthritis, Hand Osteoarthritis

Intervention / Treatment
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* Device: Arthritis glove


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: experiencing hand pain and swelling Exclusion Criteria: unable to give informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Arthritis glove<br>Early inflammatory, rheumatoid or hand osteoarthritis with hand/wrist swelling and pain | Device: Arthritis glove<br>* Isotoner three-quarter finger arthritis glove<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hand pain on movement | 10 point numeric rating scale of hand pain during moderate activities (eg housework, gardening, work) with end points of no to severe pain | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of Activity Performance in the Hand: patient reported outcome | patient reported outcome of hand function | 4 weeks | 
| Grip Ability Test | objective measure of hand function | 4 weeks |