Study protocol: an observational study of distress, immune function and persistent pain in HIV.

Journal: BMJ open

Volume: 12

Issue: 6

Year of Publication: 2023

Affiliated Institutions:  Pain Research Team, Department of Anaesthesia and Perioperative Medicine, Neuroscience Institute, University of Cape Town, Cape Town, South Africa torymadden@gmail.com. Pain Research Team, Department of Anaesthesia and Perioperative Medicine, Neuroscience Institute, University of Cape Town, Cape Town, South Africa. Division of Epidemiology & Biostatistics, School of Public Health and Family Medicine, University of Cape Town, Cape Town, South Africa. Adelaide Medical School, The University of Adelaide, Adelaide, South Australia, Australia. Division of Allergy and Clinical Immunology, Department of Medicine, Groote Schuur Hospital, University of Cape Town, Rondebosch, South Africa. Chronic Pain and Fatigue Research Center, Department of Anesthesiology, Michigan Medicine, University of Michigan, Ann Arbor, Michigan, USA. Department of Anesthesiology, Perioperative, and Pain Medicine, Harvard Medical School, Boston, Massachusetts, USA. HIV Mental Health Research Unit, Department of Psychiatry and Mental Health, Neuroscience Institute, University of Cape Town, Cape Town, South Africa.

Abstract summary 

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.

Authors & Co-authors:  Madden Victoria J VJ Msolo Ncumisa N Mqadi Luyanduthando L Lesosky Maia M Bedwell Gillian J GJ Hutchinson Mark R MR Peter Jonathan Grant JG Parker Romy R Schrepf Andrew A Edwards Robert R RR Joska John A JA

Study Outcome 

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Statistics
Citations :  Parker R, Stein DJ, Jelsma J. Pain in people living with HIV/AIDS: a systematic review. J Int AIDS Soc 2014;17:18719. 10.7448/IAS.17.1.18719
Authors :  11
Identifiers
Doi : e059723
SSN : 2044-6055
Study Population
Male,Female
Mesh Terms
Humans
Other Terms
HIV & AIDS;IMMUNOLOGY;MENTAL HEALTH;NEUROLOGY;PAIN MANAGEMENT
Study Design
Cross Sectional Study
Study Approach
Mixed Methods
Country of Study
Publication Country
England