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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
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
1471-2474
1-13
Hammond, Alison
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Prior, Yeliz
b975bd46-8ff2-402a-a4a1-d7c894da8d63
Cotterill, Sarah
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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
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O’neill, Terence W.
153e17da-1c52-448a-b432-955806920210
Firth, Jill
e418e95d-50fe-4e72-8d60-1fcb87f937b1
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), 1-13, [47]. (doi:10.1186/s12891-020-03917-8).

Record type: Article

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.

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Clinical and cost effectiveness of arthritis gloves in rheumatoid arthritis (A-GLOVES) - Accepted Manuscript
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Accepted/In Press date: 8 January 2021
Published date: 8 January 2021
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
ORCID for Jo Adams: ORCID iD orcid.org/0000-0003-1765-7060

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Date deposited: 11 Feb 2021 17:30
Last modified: 18 Feb 2021 16:44

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Contributors

Author: Alison Hammond
Author: Yeliz Prior
Author: Sarah Cotterill
Author: Chris Sutton
Author: Elizabeth Camacho
Author: Calvin Heal
Author: Jo Adams ORCID iD
Author: Yvonne Hough
Author: Terence W. O’neill
Author: Jill Firth

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