C-GLOVES: the Effectiveness of Compression Gloves in Arthritis (C-GLOVES)

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

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.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis; Hand Osteoarthritis; Inflammatory Arthritis
• Intervention / Treatment: Device: Arthritis glove

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.

• Study Type: Observational
• Enrollment (Actual): 75

Contacts and Locations

Study Locations

• United Kingdom
  • Cheshire
    • Crewe, Cheshire, United Kingdom, CW1 4QJ
      • Occupational Therapy, Leighton Hospital
    • Northwich, Cheshire, United Kingdom, CW8 1AW
      • Occupational Therapy, Victoria Infirmary
  • Greater Manchester
    • Stockport, Greater Manchester, United Kingdom, SK2 7JE
      • Occupational Therapy Department, Stepping Hill Hospital
  • Knowsley
    • St Helens, Knowsley, United Kingdom, WA9 3DA
      • Ocupational Therapy, St Helens Hospital
  • Merseyside
    • Southport, Merseyside, United Kingdom, PR8 6PN
      • Occupational Therapy, Southport District General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Rheumatology Occupational Therapy and Hand Therapy out-patient departments

Description

Inclusion Criteria:

• experiencing hand pain and swelling

Exclusion Criteria:

• unable to give informed consent

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Arthritis glove; Early inflammatory, rheumatoid or hand osteoarthritis with hand/wrist swelling and pain	Device: Arthritis glove; Isotoner three-quarter finger arthritis glove

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Salford

Publications and helpful links

General Publications

• Hammond A, Prior Y, Jones V, Dooley M, Hough Y, Jacklin A. A Pre-Test Post-test pilot trial of compression gloves in early inflammatory and rheumatoid arthritis. Rheumatology 54(S1):i111-112, 2015. doi:10.1093/rheumatology/kev089.045
• Hammond A, Prior Y, Jones V, Dooley M, Hough Y, Jacklin A. The Effect of Compression Gloves in Hand Osteoarthritis: A Pre-Pest-Test Trial. Arthritis and Rheumatism 66(11 Supplement): S436, 2014
• Hammond A, Prior Y. Compression gloves for patients with hand arthritis (C-GLOVES): a feasibility study. Hand Therapy 2021:26 (1); 26-37 doi:10.1177/1758998320986829
• Hammond A, Prior Y. Arthritis glove provision in rheumatoid arthritis and hand osteoarthritis: a survey of United Kingdom rheumatology occupational therapists. Hand Therapy 2022: 27 (1) 3-13. https://doi.org/10.1177/17589983211060620

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (ACTUAL): June 1, 2014
• Study Completion (ACTUAL): March 1, 2015

Study Registration Dates

• First Submitted: June 6, 2013
• First Submitted That Met QC Criteria: June 6, 2013
• First Posted (ESTIMATE): June 10, 2013

Study Record Updates

• Last Update Posted (ACTUAL): February 10, 2023
• Last Update Submitted That Met QC Criteria: February 7, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Arthritis
• Other Study ID Numbers: C-GLOVES v2 26.7.13; 13/EM/0253 (OTHER: NHS Research Ethics Committee (UK))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Study Data/Documents

1. Clinical Study Report
   Information identifier: 35110
   Information comments: Conference Abstract: Hammond, A, Prior, Y, Jones, V, Dooley, M, Hough, Y and Jacklin, A 2015, 'A pre-post test pilot trial of compression gloves in early inflammatory and rheumatoid arthritis' , Rheumatology, 54 (S1) , i111-112