NCT01874067

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2013

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 6, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 10, 2013

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

February 10, 2023

Status Verified

February 1, 2023

Enrollment Period

8 months

First QC Date

June 6, 2013

Last Update Submit

February 7, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Measure of Activity Performance in the Hand: patient reported outcome

    4 weeks

  • Grip Ability Test

    4 weeks

Study Arms (1)

Arthritis glove

Early inflammatory, rheumatoid or hand osteoarthritis with hand/wrist swelling and pain

Device: Arthritis glove

Interventions

Isotoner three-quarter finger arthritis glove

Arthritis glove

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Rheumatology Occupational Therapy and Hand Therapy out-patient departments

You may qualify if:

  • experiencing hand pain and swelling

You may not qualify if:

  • unable to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Occupational Therapy, Leighton Hospital

Crewe, Cheshire, CW1 4QJ, United Kingdom

Location

Occupational Therapy, Victoria Infirmary

Northwich, Cheshire, CW8 1AW, United Kingdom

Location

Occupational Therapy Department, Stepping Hill Hospital

Stockport, Greater Manchester, SK2 7JE, United Kingdom

Location

Ocupational Therapy, St Helens Hospital

St Helens, Knowsley, WA9 3DA, United Kingdom

Location

Occupational Therapy, Southport District General Hospital

Southport, Merseyside, PR8 6PN, United Kingdom

Location

Related Publications (4)

  • 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

    BACKGROUND
  • 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

    BACKGROUND
  • Hammond A, Prior Y. Compression gloves for patients with hand arthritis (C-GLOVES): A feasibility study. Hand Ther. 2021 Mar;26(1):26-37. doi: 10.1177/1758998320986829. Epub 2021 Jan 12.

    PMID: 37905193BACKGROUND
  • Hammond A, Prior Y. Arthritis glove provision in rheumatoid arthritis and hand osteoarthritis: A survey of United Kingdom rheumatology occupational therapists. Hand Ther. 2022 Mar;27(1):3-13. doi: 10.1177/17589983211060620. Epub 2022 Jan 5.

    PMID: 37904793BACKGROUND

MeSH Terms

Conditions

ArthritisArthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Alison Hammond, PhD

    University of Salford

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor in Rheumatology Rehabilitation

Study Record Dates

First Submitted

June 6, 2013

First Posted

June 10, 2013

Study Start

October 1, 2013

Primary Completion

June 1, 2014

Study Completion

March 1, 2015

Last Updated

February 10, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations