C-GLOVES: the Effectiveness of Compression Gloves in Arthritis

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2013 by University of Salford
Sponsor:
Information provided by (Responsible Party):
Alison Hammond, University of Salford
ClinicalTrials.gov Identifier:
NCT01874067
First received: June 6, 2013
Last updated: NA
Last verified: June 2013
History: No changes posted
  Purpose

This is a collaborative study with 11 Occupational Therapy (OT) departments in North-West England. The OTs provide compression gloves to 25% of out-patients with inflammatory, rheumatoid and osteoarthritis. The glove pressure aims to 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 compression 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 compression 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 compression 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: Compression 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:
  • Hand function [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Measure of Activity Performance in the Hand: patient reported outcome measure


Estimated Enrollment: 120
Study Start Date: September 2013
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Compression glove
Early inflammatory, rheumatoid or hand osteoarthritis with hand/wrist swelling and pain
Device: Compression glove
Isotoner three-quarter finger compression glove

  Eligibility

Ages Eligible for Study:   18 Years and older
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

Contacts
Contact: Alison Hammond, PhD 44(0)1612950038 a.hammond@salford.ac.uk
Contact: Yeliz Prior, PhD 44(0)1612950211 y.prior@salford.ac.uk

Locations
United Kingdom
Occupational Therapy, Leighton Hospital Not yet recruiting
Crewe, Cheshire, United Kingdom, CW1 4QJ
Contact: Nicky Walker, DipCOT       Nicky.walker1@nhs.net   
Principal Investigator: Nicky Walker, DipCOT         
Occupational Therapy, Victoria Infirmary Not yet recruiting
Northwich, Cheshire, United Kingdom, CW8 1AW
Contact: Jan Coleclough, DipCOT       jan.coleclough@mcht.nhs.uk   
Principal Investigator: Jan Coleclough, DipCOT         
Occupational Therapy Department, Stepping Hill Hospital Not yet recruiting
Stockport, Greater Manchester, United Kingdom, SK2 7JE
Contact: Angela Jacklin, DipCOT       Angela.Jacklin@stockport.nhs.uk   
Principal Investigator: Angela Jacklin, DipCOT         
Ocupational Therapy, St Helens Hospital Not yet recruiting
St Helens, Knowsley, United Kingdom, WA9 3DA
Contact: Yvonne Hough, DipCOT       Yvonne.hough@5bp.nhs.uk   
Principal Investigator: Yvonne Hough, DipCOT         
Occupational Therapy, Southport District General Hospital Not yet recruiting
Southport, Merseyside, United Kingdom, PR8 6PN
Contact: Mary Dooley, DipCOT       marypbdooley@aol.com   
Principal Investigator: Mary Dooley, DipCOT         
Sponsors and Collaborators
University of Salford
Investigators
Principal Investigator: Alison Hammond, PhD University of Salford
  More Information

No publications provided

Responsible Party: Alison Hammond, Professor in Rheumatology Rehabilitation, University of Salford
ClinicalTrials.gov Identifier: NCT01874067     History of Changes
Other Study ID Numbers: C-GLOVES v1 5.6.13, 13/EM/0253
Study First Received: June 6, 2013
Last Updated: June 6, 2013
Health Authority: UK: Research Ethics Committee
UK: National Health Service

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

ClinicalTrials.gov processed this record on October 19, 2014