Mechanisms of neurodynamic treatments (MONET): a protocol for a mechanistic, randomised, single-blind controlled trial in patients with carpal tunnel syndrome.
Carpal tunnel syndrome
Exercises
MRI
Mechanisms
Neurodynamic
Quantitative sensory testing
Journal
BMC musculoskeletal disorders
ISSN: 1471-2474
Titre abrégé: BMC Musculoskelet Disord
Pays: England
ID NLM: 100968565
Informations de publication
Date de publication:
27 Jul 2024
27 Jul 2024
Historique:
received:
17
01
2024
accepted:
19
07
2024
medline:
28
7
2024
pubmed:
28
7
2024
entrez:
27
7
2024
Statut:
epublish
Résumé
Physiotherapeutic management is the first-line intervention for patients with entrapment neuropathies such as carpal tunnel syndrome (CTS). As part of physiotherapy, neurodynamic interventions are often used to treat people with peripheral nerve involvement, but their mechanisms of action are yet to be fully understood. The MONET (mechanisms of neurodynamic treatment) study aims to investigate the mechanisms of action of neurodynamic exercise intervention on nerve structure, and function. This mechanistic, randomised, single-blind, controlled trial will include 78 people with electrodiagnostically confirmed mild or moderate CTS and 30 healthy participants (N = 108). Patients will be randomly assigned into (1) a 6-week progressive home-based neurodynamic exercise intervention (n = 26), (2) a steroid injection (= 26), or (3) advice (n = 26) group. The primary outcome measure is fractional anisotropy of the median nerve at the wrist using advanced magnetic resonance neuroimaging. Secondary outcome measures include neuroimaging markers at the wrist, quantitative sensory testing, electrodiagnostics, and patient reported outcome measures. Exploratory outcomes include neuroimaging markers at the cervical spine, inflammatory and axonal integrity markers in serial blood samples and biopsies of median nerve innervated skin. We will evaluate outcome measures at baseline and at the end of the 6-week intervention period. We will repeat questionnaires at 6-months. Two-way repeated measures ANCOVAs, followed by posthoc testing will be performed to identify differences in outcome measures among groups and over time. This study will advance our understanding of the mechanisms of action underpinning neurodynamic exercises, which will ultimately help clinicians to better target these treatments to those patients who may benefit from them. The inclusion of a positive control group (steroid injection) and a negative control group (advice) will strengthen the interpretation of our results. NCT05859412, 20/4/2023.
Sections du résumé
BACKGROUND
BACKGROUND
Physiotherapeutic management is the first-line intervention for patients with entrapment neuropathies such as carpal tunnel syndrome (CTS). As part of physiotherapy, neurodynamic interventions are often used to treat people with peripheral nerve involvement, but their mechanisms of action are yet to be fully understood. The MONET (mechanisms of neurodynamic treatment) study aims to investigate the mechanisms of action of neurodynamic exercise intervention on nerve structure, and function.
METHODS
METHODS
This mechanistic, randomised, single-blind, controlled trial will include 78 people with electrodiagnostically confirmed mild or moderate CTS and 30 healthy participants (N = 108). Patients will be randomly assigned into (1) a 6-week progressive home-based neurodynamic exercise intervention (n = 26), (2) a steroid injection (= 26), or (3) advice (n = 26) group. The primary outcome measure is fractional anisotropy of the median nerve at the wrist using advanced magnetic resonance neuroimaging. Secondary outcome measures include neuroimaging markers at the wrist, quantitative sensory testing, electrodiagnostics, and patient reported outcome measures. Exploratory outcomes include neuroimaging markers at the cervical spine, inflammatory and axonal integrity markers in serial blood samples and biopsies of median nerve innervated skin. We will evaluate outcome measures at baseline and at the end of the 6-week intervention period. We will repeat questionnaires at 6-months. Two-way repeated measures ANCOVAs, followed by posthoc testing will be performed to identify differences in outcome measures among groups and over time.
DISCUSSION
CONCLUSIONS
This study will advance our understanding of the mechanisms of action underpinning neurodynamic exercises, which will ultimately help clinicians to better target these treatments to those patients who may benefit from them. The inclusion of a positive control group (steroid injection) and a negative control group (advice) will strengthen the interpretation of our results.
TRIAL REGISTRATION
BACKGROUND
NCT05859412, 20/4/2023.
Identifiants
pubmed: 39068435
doi: 10.1186/s12891-024-07713-6
pii: 10.1186/s12891-024-07713-6
doi:
Banques de données
ClinicalTrials.gov
['NCT05859412']
Types de publication
Journal Article
Clinical Trial Protocol
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
590Subventions
Organisme : Wellcome Trust
ID : 222101/Z/20/Z
Pays : United Kingdom
Organisme : Wellcome Trust
ID : 203139/Z/16/Z
Pays : United Kingdom
Organisme : Wellcome Trust
ID : 223149/Z/21/Z
Pays : United Kingdom
Organisme : Wellcome Trust
ID : 222101/Z/20/Z
Pays : United Kingdom
Organisme : Advanced Pain Discovery Platform
ID : MR/W002388/1
Organisme : European Commission Horizon 2020
ID : ID633491
Organisme : European Union's Seventh Framework Program
ID : FP7/2007-2013
Organisme : Novo Nordisk Foundation Challenge Program grant
ID : NNF14OC0011633
Organisme : Diabetes UK
ID : 19/0005984
Pays : United Kingdom
Organisme : MRC and Versus Arthritis
ID : MR/W002388/1
Informations de copyright
© 2024. The Author(s).
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