Study protocol: an observational study of distress, immune function and persistent pain in HIV
Introduction 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...
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BMJ Publishing Group
2022-06-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/12/6/e059723.full |
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| author | John A Joska Mark R Hutchinson Maia Lesosky Victoria J Madden Ncumisa Msolo Luyanduthando Mqadi Gillian J Bedwell Jonathan Grant Peter Romy Parker Andrew Schrepf Robert R Edwards |
| author_facet | John A Joska Mark R Hutchinson Maia Lesosky Victoria J Madden Ncumisa Msolo Luyanduthando Mqadi Gillian J Bedwell Jonathan Grant Peter Romy Parker Andrew Schrepf Robert R Edwards |
| author_sort | John A Joska |
| collection | DOAJ |
| description | Introduction 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).Methods and analysis 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.Ethics and dissemination 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).Trial registration number NCT04757987. |
| format | Article |
| id | doaj-art-440c0289fe50422f9987763fabf3c0c2 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2022-06-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-440c0289fe50422f9987763fabf3c0c22025-01-24T21:00:10ZengBMJ Publishing GroupBMJ Open2044-60552022-06-0112610.1136/bmjopen-2021-059723Study protocol: an observational study of distress, immune function and persistent pain in HIVJohn A Joska0Mark R Hutchinson1Maia Lesosky2Victoria J Madden3Ncumisa Msolo4Luyanduthando Mqadi5Gillian J Bedwell6Jonathan Grant Peter7Romy Parker8Andrew Schrepf9Robert R Edwards10HIV Mental Health Research Unit, Department of Psychiatry and Mental Health, Neuroscience Institute, University of Cape Town, Cape Town, South AfricaCentre of Excellence for Nanoscale BioPhotonics, The University of Adelaide, Adelaide, South Australia, AustraliaNational Heart and Lung Institute, Imperial College London, London, UKPain Research Team, Department of Anaesthesia and Perioperative Medicine, Neuroscience Institute, University of Cape Town, Cape Town, South AfricaPain Research Team, Department of Anaesthesia and Perioperative Medicine, Neuroscience Institute, University of Cape Town, Cape Town, South AfricaPain Research Team, Department of Anaesthesia and Perioperative Medicine, Neuroscience Institute, University of Cape Town, Cape Town, South AfricaPain Research Team, Department of Anaesthesia and Perioperative Medicine, Neuroscience Institute, University of Cape Town, Cape Town, South AfricaDivision of Allergy and Clinical Immunology, Department of Medicine, Groote Schuur Hospital, University of Cape Town, Rondebosch, South AfricaPain Research Team, Department of Anaesthesia and Perioperative Medicine, Neuroscience Institute, University of Cape Town, Cape Town, South AfricaChronic Pain and Fatigue Research Center, Department of Anesthesiology, Michigan Medicine, University of Michigan, Ann Arbor, Michigan, USADepartment of Anesthesiology, Perioperative, and Pain Medicine, Harvard Medical School, Boston, Massachusetts, USAIntroduction 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).Methods and analysis 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.Ethics and dissemination 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).Trial registration number NCT04757987.https://bmjopen.bmj.com/content/12/6/e059723.full |
| spellingShingle | John A Joska Mark R Hutchinson Maia Lesosky Victoria J Madden Ncumisa Msolo Luyanduthando Mqadi Gillian J Bedwell Jonathan Grant Peter Romy Parker Andrew Schrepf Robert R Edwards Study protocol: an observational study of distress, immune function and persistent pain in HIV BMJ Open |
| title | Study protocol: an observational study of distress, immune function and persistent pain in HIV |
| title_full | Study protocol: an observational study of distress, immune function and persistent pain in HIV |
| title_fullStr | Study protocol: an observational study of distress, immune function and persistent pain in HIV |
| title_full_unstemmed | Study protocol: an observational study of distress, immune function and persistent pain in HIV |
| title_short | Study protocol: an observational study of distress, immune function and persistent pain in HIV |
| title_sort | study protocol an observational study of distress immune function and persistent pain in hiv |
| url | https://bmjopen.bmj.com/content/12/6/e059723.full |
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