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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alison Hammond, University of Salford
ClinicalTrials.gov Identifier:
NCT01874067
First received: June 6, 2013
Last updated: March 1, 2016
Last verified: March 2016
  Purpose

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.


Condition Intervention
Inflammatory Arthritis
Rheumatoid Arthritis
Hand Osteoarthritis
Device: Arthritis glove

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: C-GLOVES: an Evaluation of the Effectiveness of Compression Gloves in Arthritis: a Feasibility Study

Resource links provided by NLM:


Further study details as provided by University of Salford:

Primary Outcome Measures:
  • Hand pain on movement [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    10 point numeric rating scale of hand pain during moderate activities (eg housework, gardening, work) with end points of no to severe pain


Secondary Outcome Measures:
  • Measure of Activity Performance in the Hand: patient reported outcome [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    patient reported outcome of hand function

  • Grip Ability Test [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    objective measure of hand function


Enrollment: 75
Study Start Date: October 2013
Study Completion Date: March 2015
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Arthritis glove
Early inflammatory, rheumatoid or hand osteoarthritis with hand/wrist swelling and pain
Device: Arthritis glove
Isotoner three-quarter finger arthritis glove

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Rheumatology Occupational Therapy and Hand Therapy out-patient departments
Criteria

Inclusion Criteria:

  • experiencing hand pain and swelling

Exclusion Criteria:

  • unable to give informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01874067

Locations
United Kingdom
Occupational Therapy, Leighton Hospital
Crewe, Cheshire, United Kingdom, CW1 4QJ
Occupational Therapy, Victoria Infirmary
Northwich, Cheshire, United Kingdom, CW8 1AW
Occupational Therapy Department, Stepping Hill Hospital
Stockport, Greater Manchester, United Kingdom, SK2 7JE
Ocupational Therapy, St Helens Hospital
St Helens, Knowsley, United Kingdom, WA9 3DA
Occupational Therapy, Southport District General Hospital
Southport, Merseyside, United Kingdom, PR8 6PN
Sponsors and Collaborators
University of Salford
Investigators
Principal Investigator: Alison Hammond, PhD University of Salford
  More Information

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

Study Data/Documents: Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 35110
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

Responsible Party: Alison Hammond, Professor in Rheumatology Rehabilitation, University of Salford
ClinicalTrials.gov Identifier: NCT01874067     History of Changes
Other Study ID Numbers: C-GLOVES v2 26.7.13  13/EM/0253 
Study First Received: June 6, 2013
Last Updated: March 1, 2016
Health Authority: United Kingdom: Research Ethics Committee
United Kingdom: National Health Service
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Osteoarthritis
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on September 26, 2016