The clinical and cost-effectiveness of corticosteroid injection versus night splints for carpal tunnel syndrome (INSTINCTS trial): an open-label, parallel group, randomised controlled trial

Linda S. Chesterton; Milica Blagojevic-Bucknall; Claire Burton; Krysia Dziedzic; Graham Davenport; Sue Jowett; Helen L. Myers; Raymond Oppong; Trishna Rathod-Mistry; Danielle A. van der Windt; Elaine M. Hay; Edward Roddy

doi:10.1016/S0140-6736(18)31572-1

The clinical and cost-effectiveness of corticosteroid injection versus night splints for carpal tunnel syndrome (INSTINCTS trial): an open-label, parallel group, randomised controlled trial

Linda S. Chesterton
, Milica Blagojevic-Bucknall
, Claire Burton
, Krysia Dziedzic
, Graham Davenport
, Sue Jowett
, Helen L. Myers
, Raymond Oppong
, Trishna Rathod-Mistry
, Danielle A. van der Windt
, Elaine M. Hay
, Edward Roddy

Research output: Contribution to journal › Article › peer-review

23 Citations (Scopus)

216 Downloads (Pure)

Abstract

Background: To our knowledge, the comparative effectiveness of commonly used conservative treatments for carpal tunnel syndrome has not been evaluated previously in primary care. We aimed to compare the clinical and cost-effectiveness of night splints with a corticosteroid injection with regards to reducing symptoms and improving hand function in patients with mild or moderate carpal tunnel syndrome.

Methods: We did this randomised, open-label, pragmatic trial in adults (≥18 years) with mild or moderate carpal tunnel syndrome recruited from 25 primary and community musculoskeletal clinics and services. Patients with a new episode of idiopathic mild or moderate carpal tunnel syndrome of at least 6 weeks' duration were eligible. We randomly assigned (1:1) patients (permutated blocks of two and four by site) with an online web or third party telephone service to receive either a single injection of 20 mg methylprednisolone acetate (from 40 mg/mL) or a night-resting splint to be worn for 6 weeks. Patients and clinicians could not be masked to the intervention. The primary outcome was the overall score of the Boston Carpal Tunnel Questionnaire (BCTQ) at 6 weeks. We used intention-to-treat analysis, with multiple imputation for missing data, which was concealed to treatment group allocation. The trial is registered with the European Clinical Trials Database, number 2013-001435-48, and ClinicalTrial.gov, number NCT02038452.

Findings: Between April 17, 2014, and Dec 31, 2016, 234 participants were randomly assigned (118 to the night splint group and 116 to the corticosteroid injection group), of whom 212 (91%) completed the BCTQ at 6 weeks. The BCTQ score was significantly better at 6 weeks in the corticosteroid injection group (mean 2·02 [SD 0·81]) than the night splint group (2·29 [0·75]; adjusted mean difference −0·32; 95% CI −0·48 to −0·16; p=0·0001). No adverse events were reported.

Interpretation: A single corticosteroid injection shows superior clinical effectiveness at 6 weeks compared with night-resting splints, making it the treatment of choice for rapid symptom response in mild or moderate carpal tunnel syndrome presenting in primary care.

Funding: Arthritis Research UK.

Original language	English
Pages (from-to)	1423-1433
Number of pages	11
Journal	The Lancet
Volume	392
Issue number	10156
DOIs	https://doi.org/10.1016/S0140-6736(18)31572-1
Publication status	Published - 18 Oct 2018

Keywords

carpal tunnel syndrome
Boston carpal Tunnel questionnaire
night splints
corticosteroid injection
randomised clinical trial
protocol

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Chesterton, L. S., Blagojevic-Bucknall, M., Burton, C., Dziedzic, K., Davenport, G., Jowett, S., Myers, H. L., Oppong, R., Rathod-Mistry, T., van der Windt, D. A., Hay, E. M., & Roddy, E. (2018). The clinical and cost-effectiveness of corticosteroid injection versus night splints for carpal tunnel syndrome (INSTINCTS trial): an open-label, parallel group, randomised controlled trial . The Lancet, 392(10156), 1423-1433. https://doi.org/10.1016/S0140-6736(18)31572-1

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title = "The clinical and cost-effectiveness of corticosteroid injection versus night splints for carpal tunnel syndrome (INSTINCTS trial): an open-label, parallel group, randomised controlled trial ",

abstract = "Background: To our knowledge, the comparative effectiveness of commonly used conservative treatments for carpal tunnel syndrome has not been evaluated previously in primary care. We aimed to compare the clinical and cost-effectiveness of night splints with a corticosteroid injection with regards to reducing symptoms and improving hand function in patients with mild or moderate carpal tunnel syndrome. Methods: We did this randomised, open-label, pragmatic trial in adults (≥18 years) with mild or moderate carpal tunnel syndrome recruited from 25 primary and community musculoskeletal clinics and services. Patients with a new episode of idiopathic mild or moderate carpal tunnel syndrome of at least 6 weeks' duration were eligible. We randomly assigned (1:1) patients (permutated blocks of two and four by site) with an online web or third party telephone service to receive either a single injection of 20 mg methylprednisolone acetate (from 40 mg/mL) or a night-resting splint to be worn for 6 weeks. Patients and clinicians could not be masked to the intervention. The primary outcome was the overall score of the Boston Carpal Tunnel Questionnaire (BCTQ) at 6 weeks. We used intention-to-treat analysis, with multiple imputation for missing data, which was concealed to treatment group allocation. The trial is registered with the European Clinical Trials Database, number 2013-001435-48, and ClinicalTrial.gov, number NCT02038452. Findings: Between April 17, 2014, and Dec 31, 2016, 234 participants were randomly assigned (118 to the night splint group and 116 to the corticosteroid injection group), of whom 212 (91\%) completed the BCTQ at 6 weeks. The BCTQ score was significantly better at 6 weeks in the corticosteroid injection group (mean 2·02 [SD 0·81]) than the night splint group (2·29 [0·75]; adjusted mean difference −0·32; 95\% CI −0·48 to −0·16; p=0·0001). No adverse events were reported. Interpretation: A single corticosteroid injection shows superior clinical effectiveness at 6 weeks compared with night-resting splints, making it the treatment of choice for rapid symptom response in mild or moderate carpal tunnel syndrome presenting in primary care. Funding: Arthritis Research UK.",

keywords = "carpal tunnel syndrome, Boston carpal Tunnel questionnaire, night splints, corticosteroid injection, randomised clinical trial, protocol",

author = "Chesterton, \{Linda S.\} and Milica Blagojevic-Bucknall and Claire Burton and Krysia Dziedzic and Graham Davenport and Sue Jowett and Myers, \{Helen L.\} and Raymond Oppong and Trishna Rathod-Mistry and \{van der Windt\}, \{Danielle A.\} and Hay, \{Elaine M.\} and Edward Roddy",

year = "2018",

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doi = "10.1016/S0140-6736(18)31572-1",

language = "English",

volume = "392",

pages = "1423--1433",

journal = "The Lancet",

issn = "0140-6736",

publisher = "Elsevier",

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Chesterton, LS, Blagojevic-Bucknall, M, Burton, C, Dziedzic, K, Davenport, G, Jowett, S, Myers, HL, Oppong, R, Rathod-Mistry, T, van der Windt, DA, Hay, EM & Roddy, E 2018, 'The clinical and cost-effectiveness of corticosteroid injection versus night splints for carpal tunnel syndrome (INSTINCTS trial): an open-label, parallel group, randomised controlled trial ', The Lancet, vol. 392, no. 10156, pp. 1423-1433. https://doi.org/10.1016/S0140-6736(18)31572-1

The clinical and cost-effectiveness of corticosteroid injection versus night splints for carpal tunnel syndrome (INSTINCTS trial): an open-label, parallel group, randomised controlled trial . / Chesterton, Linda S.; Blagojevic-Bucknall, Milica; Burton, Claire et al.
In: The Lancet, Vol. 392, No. 10156, 18.10.2018, p. 1423-1433.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - The clinical and cost-effectiveness of corticosteroid injection versus night splints for carpal tunnel syndrome (INSTINCTS trial)

T2 - an open-label, parallel group, randomised controlled trial

AU - Chesterton, Linda S.

AU - Blagojevic-Bucknall, Milica

AU - Burton, Claire

AU - Dziedzic, Krysia

AU - Davenport, Graham

AU - Jowett, Sue

AU - Myers, Helen L.

AU - Oppong, Raymond

AU - Rathod-Mistry, Trishna

AU - van der Windt, Danielle A.

AU - Hay, Elaine M.

AU - Roddy, Edward

PY - 2018/10/18

Y1 - 2018/10/18

N2 - Background: To our knowledge, the comparative effectiveness of commonly used conservative treatments for carpal tunnel syndrome has not been evaluated previously in primary care. We aimed to compare the clinical and cost-effectiveness of night splints with a corticosteroid injection with regards to reducing symptoms and improving hand function in patients with mild or moderate carpal tunnel syndrome. Methods: We did this randomised, open-label, pragmatic trial in adults (≥18 years) with mild or moderate carpal tunnel syndrome recruited from 25 primary and community musculoskeletal clinics and services. Patients with a new episode of idiopathic mild or moderate carpal tunnel syndrome of at least 6 weeks' duration were eligible. We randomly assigned (1:1) patients (permutated blocks of two and four by site) with an online web or third party telephone service to receive either a single injection of 20 mg methylprednisolone acetate (from 40 mg/mL) or a night-resting splint to be worn for 6 weeks. Patients and clinicians could not be masked to the intervention. The primary outcome was the overall score of the Boston Carpal Tunnel Questionnaire (BCTQ) at 6 weeks. We used intention-to-treat analysis, with multiple imputation for missing data, which was concealed to treatment group allocation. The trial is registered with the European Clinical Trials Database, number 2013-001435-48, and ClinicalTrial.gov, number NCT02038452. Findings: Between April 17, 2014, and Dec 31, 2016, 234 participants were randomly assigned (118 to the night splint group and 116 to the corticosteroid injection group), of whom 212 (91%) completed the BCTQ at 6 weeks. The BCTQ score was significantly better at 6 weeks in the corticosteroid injection group (mean 2·02 [SD 0·81]) than the night splint group (2·29 [0·75]; adjusted mean difference −0·32; 95% CI −0·48 to −0·16; p=0·0001). No adverse events were reported. Interpretation: A single corticosteroid injection shows superior clinical effectiveness at 6 weeks compared with night-resting splints, making it the treatment of choice for rapid symptom response in mild or moderate carpal tunnel syndrome presenting in primary care. Funding: Arthritis Research UK.

AB - Background: To our knowledge, the comparative effectiveness of commonly used conservative treatments for carpal tunnel syndrome has not been evaluated previously in primary care. We aimed to compare the clinical and cost-effectiveness of night splints with a corticosteroid injection with regards to reducing symptoms and improving hand function in patients with mild or moderate carpal tunnel syndrome. Methods: We did this randomised, open-label, pragmatic trial in adults (≥18 years) with mild or moderate carpal tunnel syndrome recruited from 25 primary and community musculoskeletal clinics and services. Patients with a new episode of idiopathic mild or moderate carpal tunnel syndrome of at least 6 weeks' duration were eligible. We randomly assigned (1:1) patients (permutated blocks of two and four by site) with an online web or third party telephone service to receive either a single injection of 20 mg methylprednisolone acetate (from 40 mg/mL) or a night-resting splint to be worn for 6 weeks. Patients and clinicians could not be masked to the intervention. The primary outcome was the overall score of the Boston Carpal Tunnel Questionnaire (BCTQ) at 6 weeks. We used intention-to-treat analysis, with multiple imputation for missing data, which was concealed to treatment group allocation. The trial is registered with the European Clinical Trials Database, number 2013-001435-48, and ClinicalTrial.gov, number NCT02038452. Findings: Between April 17, 2014, and Dec 31, 2016, 234 participants were randomly assigned (118 to the night splint group and 116 to the corticosteroid injection group), of whom 212 (91%) completed the BCTQ at 6 weeks. The BCTQ score was significantly better at 6 weeks in the corticosteroid injection group (mean 2·02 [SD 0·81]) than the night splint group (2·29 [0·75]; adjusted mean difference −0·32; 95% CI −0·48 to −0·16; p=0·0001). No adverse events were reported. Interpretation: A single corticosteroid injection shows superior clinical effectiveness at 6 weeks compared with night-resting splints, making it the treatment of choice for rapid symptom response in mild or moderate carpal tunnel syndrome presenting in primary care. Funding: Arthritis Research UK.

KW - carpal tunnel syndrome

KW - Boston carpal Tunnel questionnaire

KW - night splints

KW - corticosteroid injection

KW - randomised clinical trial

KW - protocol

U2 - 10.1016/S0140-6736(18)31572-1

DO - 10.1016/S0140-6736(18)31572-1

M3 - Article

SN - 0140-6736

VL - 392

SP - 1423

EP - 1433

JO - The Lancet

JF - The Lancet

IS - 10156

ER -

The clinical and cost-effectiveness of corticosteroid injection versus night splints for carpal tunnel syndrome (INSTINCTS trial): an open-label, parallel group, randomised controlled trial

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Keywords

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