An Interventional Response Phenotyping Study in Chronic Low Back Pain: Protocol for a Mechanistic Randomized Controlled Trial.
Journal
Pain medicine (Malden, Mass.)
ISSN: 1526-4637
Titre abrégé: Pain Med
Pays: England
ID NLM: 100894201
Informations de publication
Date de publication:
04 08 2023
04 08 2023
Historique:
received:
30
09
2022
revised:
20
12
2022
accepted:
17
01
2023
medline:
7
8
2023
pubmed:
29
1
2023
entrez:
28
1
2023
Statut:
ppublish
Résumé
Evidence-based treatments for chronic low back pain (cLBP) typically work well in only a fraction of patients, and at present there is little guidance regarding what treatment should be used in which patients. Our central hypothesis is that an interventional response phenotyping study can identify individuals with different underlying mechanisms for their pain who thus respond differentially to evidence-based treatments for cLBP. Thus, we will conduct a randomized controlled Sequential, Multiple Assessment, Randomized Trial (SMART) design study in cLBP with the following three aims. Aim 1: Perform an interventional response phenotyping study in a cohort of cLBP patients (n = 400), who will receive a sequence of interventions known to be effective in cLBP. For 4 weeks, all cLBP participants will receive a web-based pain self-management program as part of a run-in period, then individuals who report no or minimal improvement will be randomized to: a) mindfulness-based stress reduction, b) physical therapy and exercise, c) acupressure self-management, and d) duloxetine. After 8 weeks, individuals who remain symptomatic will be re-randomized to a different treatment for an additional 8 weeks. Using those data, we will identify the subsets of participants that respond to each treatment. In Aim 2, we will show that currently available, clinically derived measures, can predict differential responsiveness to the treatments. In Aim 3, a subset of participants will receive deeper phenotyping (n = 160), to identify new experimental measures that predict differential responsiveness to the treatments, as well as to infer mechanisms of action. Deep phenotyping will include functional neuroimaging, quantitative sensory testing, measures of inflammation, and measures of autonomic tone.
Identifiants
pubmed: 36708026
pii: 7008338
doi: 10.1093/pm/pnad005
pmc: PMC10403311
doi:
Substances chimiques
Duloxetine Hydrochloride
9044SC542W
Types de publication
Clinical Trial Protocol
Journal Article
Research Support, N.I.H., Extramural
Langues
eng
Sous-ensembles de citation
IM
Pagination
S126-S138Subventions
Organisme : NIAMS NIH HHS
ID : U19 AR076734
Pays : United States
Informations de copyright
© The Author(s) 2023. Published by Oxford University Press on behalf of the American Academy of Pain Medicine.
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