Clinical and cost effectiveness of arthritis gloves in rheumatoid arthritis (A-GLOVES): randomised controlled trial with economic analysis
Clinical and cost effectiveness of arthritis gloves in rheumatoid arthritis (A-GLOVES): randomised controlled trial with economic analysis
Background: Arthritis (or compression) gloves are widely prescribed to people with rheumatoid arthritis and other forms of hand arthritis. They are prescribed for daytime wear to reduce hand pain and improve hand function, and/or night-time wear to reduce pain, improve sleep and reduce morning stiffness. However, evidence for their effectiveness is limited. The aims of this study were to investigate the clinical and cost effectiveness of arthritis gloves compared to placebo gloves on hand pain, stiffness and function in people with rheumatoid arthritis and persistent hand pain. Methods: A parallel randomised controlled trial, in adults (≥ 18 years) with rheumatoid or undifferentiated inflammatory arthritis at 16 National Health Service sites in the UK. Patients with persistent hand pain affecting function and/or sleep were eligible. Randomisation (1:1) was stratified by recent change (or not) in medication, using permuted blocks of random sizes. Three-quarter-finger length arthritis gloves (Isotoner®: applying 23-32 mmHg pressure) (intervention) were compared to loose-fitting placebo gloves (Jobskin® classic: providing no/minimal pressure) (control). Both gloves (considered to have similar thermal qualities) were provided by occupational therapists. Patients and outcome assessors were blinded; clinicians were not. The primary outcome was dominant hand pain on activity (0–10) at 12 weeks, analysed using linear regression and intention to treat principles. Results: Two hundred six participants were randomly assigned (103 per arm) and 163 (84 intervention: 79 control) completed 12-week follow-up. Hand pain improved by 1.0 (intervention) and 1.2 (control), an adjusted mean difference of 0.10 (95% CI: − 0.47 to 0.67; p = 0.72). Adverse events were reported by 51% of intervention and 36% of control group participants; with 6 and 7% respectively, discontinuing glove wear. Provision of arthritis gloves cost £129, with no additional benefit. Conclusion: The trial provides evidence of no clinically important effect of arthritis gloves on any of the trial outcomes (hand pain, function and stiffness) and arthritis gloves are not cost-effective. The clinical and cost-effectiveness results support ceasing provision of arthritis gloves in routine clinical practice. Funding: National Institute for Health Research. Trial registration: ISRCTN, ISRCTN25892131; Registered 05/09/2016: retrospectively registered.
Clinical trial, Hand, Orthotic devices, Pain, Rehabilitation, Rheumatoid arthritis
1-13
Hammond, Alison
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Prior, Yeliz
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Cotterill, Sarah
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Sutton, Chris
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Camacho, Elizabeth
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Heal, Calvin
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Adams, Jo
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Hough, Yvonne
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O’neill, Terence W.
153e17da-1c52-448a-b432-955806920210
Firth, Jill
e418e95d-50fe-4e72-8d60-1fcb87f937b1
8 January 2021
Hammond, Alison
bcbbb91c-3084-4c68-8aa6-4a5062703ecb
Prior, Yeliz
b975bd46-8ff2-402a-a4a1-d7c894da8d63
Cotterill, Sarah
905f508b-375b-4045-b952-b650b93d1567
Sutton, Chris
3890014a-49ea-4c8c-906c-38d68f5e176b
Camacho, Elizabeth
f68ab5a9-1f93-414a-b179-89625f5d2b85
Heal, Calvin
c459d920-c9c3-4204-b13f-04858503355e
Adams, Jo
6e38b8bb-9467-4585-86e4-14062b02bcba
Hough, Yvonne
7bc5de23-cd70-4984-8681-5690e54b3463
O’neill, Terence W.
153e17da-1c52-448a-b432-955806920210
Firth, Jill
e418e95d-50fe-4e72-8d60-1fcb87f937b1
Hammond, Alison, Prior, Yeliz, Cotterill, Sarah, Sutton, Chris, Camacho, Elizabeth, Heal, Calvin, Adams, Jo, Hough, Yvonne, O’neill, Terence W. and Firth, Jill
(2021)
Clinical and cost effectiveness of arthritis gloves in rheumatoid arthritis (A-GLOVES): randomised controlled trial with economic analysis.
BMC Musculoskeletal Disorders, 22 (1), , [47].
(doi:10.1186/s12891-020-03917-8).
Abstract
Background: Arthritis (or compression) gloves are widely prescribed to people with rheumatoid arthritis and other forms of hand arthritis. They are prescribed for daytime wear to reduce hand pain and improve hand function, and/or night-time wear to reduce pain, improve sleep and reduce morning stiffness. However, evidence for their effectiveness is limited. The aims of this study were to investigate the clinical and cost effectiveness of arthritis gloves compared to placebo gloves on hand pain, stiffness and function in people with rheumatoid arthritis and persistent hand pain. Methods: A parallel randomised controlled trial, in adults (≥ 18 years) with rheumatoid or undifferentiated inflammatory arthritis at 16 National Health Service sites in the UK. Patients with persistent hand pain affecting function and/or sleep were eligible. Randomisation (1:1) was stratified by recent change (or not) in medication, using permuted blocks of random sizes. Three-quarter-finger length arthritis gloves (Isotoner®: applying 23-32 mmHg pressure) (intervention) were compared to loose-fitting placebo gloves (Jobskin® classic: providing no/minimal pressure) (control). Both gloves (considered to have similar thermal qualities) were provided by occupational therapists. Patients and outcome assessors were blinded; clinicians were not. The primary outcome was dominant hand pain on activity (0–10) at 12 weeks, analysed using linear regression and intention to treat principles. Results: Two hundred six participants were randomly assigned (103 per arm) and 163 (84 intervention: 79 control) completed 12-week follow-up. Hand pain improved by 1.0 (intervention) and 1.2 (control), an adjusted mean difference of 0.10 (95% CI: − 0.47 to 0.67; p = 0.72). Adverse events were reported by 51% of intervention and 36% of control group participants; with 6 and 7% respectively, discontinuing glove wear. Provision of arthritis gloves cost £129, with no additional benefit. Conclusion: The trial provides evidence of no clinically important effect of arthritis gloves on any of the trial outcomes (hand pain, function and stiffness) and arthritis gloves are not cost-effective. The clinical and cost-effectiveness results support ceasing provision of arthritis gloves in routine clinical practice. Funding: National Institute for Health Research. Trial registration: ISRCTN, ISRCTN25892131; Registered 05/09/2016: retrospectively registered.
Text
Clinical and cost effectiveness of arthritis gloves in rheumatoid arthritis (A-GLOVES)
- Accepted Manuscript
More information
Accepted/In Press date: 8 January 2021
Published date: 8 January 2021
Additional Information:
Funding Information:
This paper presents independent research funded by the National Institute of Health Research (NIHR) under its Research for Patient Benefit (RfPB) Programme (Grant Reference Number PB-PG-0214-33010 ). The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care.
Funding Information:
This trial was undertaken with the support of Lancashire Clinical Trials Unit (CTU), University of Central Lancashire, Preston, UK. The authors would like to thank Denise Forshaw, Principal Clinical Trial Manager, and all staff in the CTU involved in the study, Glenn Holt, Alison Hedley and Jane Fitzgerald. We would also like to thank: all the trial participants for their time and support; Wendy Jones and Barbara Birtwistle (patient research partners) for their invaluable advice during trial planning, focus group participation and throughout; Dr. Helen Myers, Centre for Primary Care Research, Keele University, focus group participation; Angela Jacklin, Rheumatology occupational therapist, Mid Cheshire Hospitals NHS Foundation Trust, focus group participation and assisting with training therapists in glove provision; Nazina Arafin (trial assistant, Centre for Health Services Research, University of Salford); Owen Summers (Research Contracts, University of Salford); the R&D department and Finance Office, Salford Royal NHS Foundation Trust for assistance with grant financial planning and management; members of the Trial Steering Committee (Chair: Dr. Peter Klimiuk, Consultant Rheumatologist, Pennine MSK Partnership, Oldham; Mike Bradburn, Senior Medical Statistician, Sheffield Clinical Trials Unit, SCHARR, University of Sheffield; Cathy Ball, Research Clinical Specialist Hand Therapist, Kennedy Institute for Rheumatology, Oxford; Dr. Michael Callaghan, Research Fellow, University of Manchester); and the participating clinicians and sites for their support: Prof David Walsh, Debbie Wilson, Rachael Murphy, Charlotte Brooks, Phil Avery (Sherwood Forest Hospitals NHS Foundation Trust); Nicky Walker, Jan Colclough, Helen Sawle (Mid Cheshire Hospitals NHS Foundation Trust); Yvonne Hough and Denise Graham (St Helens and Knowsley Teaching Hospitals NHS Trust); Dr. Jill Firth, Charlotte Critchley, Helen Light, Katherine Kinsey (Pennine MSK Partnership, Oldham); Mary Dooley (Southport and Ormskirk Hospital NHS Trust): Anne Boulton (Northumbria Healthcare NHS Foundation Trust); Jo Harness, Jane Hunt (Northern Devon Healthcare NHS Trust); Janet Perkins (Manchester University NHS Foundation Trust); Dervil Dockrell, Sarah Wilson (Sheffield Teaching Hospitals NHS Foundation Trust); Jill Spicer, Christine Mate (The Royal Wolverhampton NHS Trust); Anne Bontoft, Sandra Lyle, Carol Gray (Northern Lincolnshire and Goole NHS Foundation Trust); Aviva Richards (Pennine Acute Hospitals NHS Trust); Carole Graham (Midlands Partnership NHS Foundation Trust); Christine Beck, Kirstie Neat (Leeds Teaching Hospitals NHS Trust); Nicky Gray (NHS Borders); Kate McAlarey, Patricia Bissett (NHS Greater Glasgow and Clyde).
Publisher Copyright:
© 2021, The Author(s).
Keywords:
Clinical trial, Hand, Orthotic devices, Pain, Rehabilitation, Rheumatoid arthritis
Identifiers
Local EPrints ID: 446477
URI: http://eprints.soton.ac.uk/id/eprint/446477
ISSN: 1471-2474
PURE UUID: 9a95eeae-d03f-4fae-8203-7f7b054308a2
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Date deposited: 11 Feb 2021 17:30
Last modified: 17 Mar 2024 02:42
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Contributors
Author:
Alison Hammond
Author:
Yeliz Prior
Author:
Sarah Cotterill
Author:
Chris Sutton
Author:
Elizabeth Camacho
Author:
Calvin Heal
Author:
Yvonne Hough
Author:
Terence W. O’neill
Author:
Jill Firth
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