Study protocol: an observational study of distress, immune function and persistent pain in HIV.
HIV & AIDS
IMMUNOLOGY
MENTAL HEALTH
NEUROLOGY
PAIN MANAGEMENT
Journal
BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874
Informations de publication
Date de publication:
03 06 2022
03 06 2022
Historique:
entrez:
24
1
2023
pubmed:
25
1
2023
medline:
26
1
2023
Statut:
epublish
Résumé
Many people with HIV report both distress and pain. The relationship between distress and pain is bidirectional, but the mechanisms by which distress exacerbates pain are unclear. The inflammatory response to challenge (inflammatory reactivity, IR) may be a partial mediator, given that neuroimmune interactions provide a substrate for IR to also influence neurological reactivity and, thus, pain-related neural signalling. This prospective, observational, case-control study will characterise the relationships between distress, IR, pain-related signalling as captured by induced secondary hyperalgesia (SH), and pain, in people with HIV who report persistent pain (PP) (cases) or no pain (controls). One hundred people with suppressed HIV, reporting either PP or no pain, will be assessed two or four times over 6 months. The primary outcomes are distress (Hopkins 25-item symptom checklist), IR (multiplex assay after LPS challenge), and PP (Brief Pain Inventory), assessed at the baseline timepoint, although each will also be assessed at follow-up time points. Induced SH will be assessed in a subsample of 60 participants (baseline timepoint only). To test the hypothesis that IR partly mediates the relationship between distress and pain, mediation analysis will use the baseline data from the PP group to estimate direct and indirect contributions of distress and IR to pain. To test the hypothesis that IR is positively associated with SH, data from the subsample will be analysed with generalised mixed effects models to estimate the association between IR and group membership, with SH as the dependent variable. Information obtained from this study will be published in peer-reviewed journals and presented at scientific meetings. The study has been approved by the Human Research Ethics Committee of the University of Cape Town (approval number: 764/2019) and the City of Cape Town (ref: 24699). NCT04757987.
Identifiants
pubmed: 36691234
pii: bmjopen-2021-059723
doi: 10.1136/bmjopen-2021-059723
pmc: PMC9171212
doi:
Banques de données
ClinicalTrials.gov
['NCT04757987']
Types de publication
Journal Article
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
e059723Subventions
Organisme : FIC NIH HHS
ID : K43 TW011442
Pays : United States
Organisme : FIC NIH HHS
ID : K43 TW011178
Pays : United States
Organisme : NIDDK NIH HHS
ID : R01 DK123164
Pays : United States
Organisme : NCCIH NIH HHS
ID : R01 AT010381
Pays : United States
Organisme : NIAMS NIH HHS
ID : R01 AR077418
Pays : United States
Organisme : NIAMS NIH HHS
ID : U19 AR076734
Pays : United States
Organisme : NINDS NIH HHS
ID : K24 NS126570
Pays : United States
Informations de copyright
© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
Déclaration de conflit d'intérêts
Competing interests: VJM, GJB and RP receive payment for lectures on pain and rehabilitation. JAJ has received once-off payments from Prudential Africa and SANOFI for work unrelated to this study. All authors declare no conflicts of interest related to this work.
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