C-GLOVES: the Effectiveness of Compression Gloves in Arthritis
Condition: Inflammatory Arthritis; Rheumatoid Arthritis; Hand Osteoarthritis
MeSH terms: Arthritis
Study type: Observational

Summary: 
      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: 
      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:

        1. Meet the criteria agreed by NWCOTSS-R members for receiving compression gloves as part
           of usual OT care.

        2. 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.
    

Intervention name(s): Arthritis glove
Intervention type(s): Device
Intervention description(s): Isotoner three-quarter finger arthritis glove
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Rheumatology Occupational Therapy and Hand Therapy out-patient departments