Document text
Principal Investigator: Nikki Gentile
Organization: UNIVERSITY OF WASHINGTON
Fiscal Year: 2024
Award: $656,157
Funding agency: National Center for Complementary and Integrative Health
Project Summary/Abstract
Post-acute sequelae of COVID-19 (PASC), or “Long-COVID” has negatively impacted millions of individuals with regard to quality of life, daily functioning, and ability to work, and has placed enormous demands on the healthcare system. Pain-related symptoms are reported by almost half of all patients with PASC, and yet pain is still not consistently addressed in work-ups or treatment options. Thus, we have chosen to study acupuncture for improving pain, quality of life, and function in individuals experiencing PASC-related pain. These treatments have been successful in treating various types of chronic pain and should lend themselves to similar results with PASC-related pain. Furthermore, acupuncture focuses on treating the whole patient, which makes it uniquely well-suited for a complex condition like PASC that affects multiple body systems.
We propose an initial study to determine the feasibility of successfully conducting a subsequent fully-powered pragmatic randomized trial evaluating the effectiveness of Traditional Chinese Medicine acupuncture for persistent pain problems experienced by persons with PASC. Acupuncture is a physical treatment that aims to correct imbalances in the body (including inflammation and pain) within a Chinese Medicine paradigm. This study will occur through the University of Washington Post-COVID Rehabilitation and Recovery Clinic at the Northgate Primary Care Clinic site. Our specific aims are to (1) assess the feasibility of conducting a randomized clinical trial comparing acupuncture with usual care alone for reducing pain in patients with PASC; (2) evaluate the overall patient experience with participation in the feasibility trial and solicit suggestions about how the study procedures, documents, and treatment protocols could be improved to facilitate participation and better meet participants’ needs; and (3) revise study procedures, protocols, and instruments to prepare for a fully-powered pragmatic randomized trial.
Our study is innovative because it focuses on treatments that address whole person health rather than individual symptoms. We believe whole-person-oriented treatments can improve outcomes for patients with PASC when used as adjuncts to usual medical care. This study has the potential to help patients with PASC improve function and quality of life, and to provide PASC clinicians with more tools to effectively respond to their patients’ needs.
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Outcomes><Patients><Persistent pain><Persons><Post Acute Sequelae of COVID19><Post Acute Sequelae of SARS-CoV-2><Post Acute Sequelae of SARS-CoV2><Post Acute Sequelae of severe acute respiratory syndrome coronavirus 2><Post-Acute Sequelae of SARS-CoV-2 Infection><Procedures><Protocol><Protocols documentation><QOL><Quality of life><Questionnaires><Randomized><Recovery><Rehabilitation><Rehabilitation therapy><Reporting><Research><SARS-CoV-2 infection><SARS-CoV2 infection><Sample Size><Severe acute respiratory syndrome coronavirus 2 infection><Site><Specific qualifier value><Specified><Suggestion><Symptoms><Treatment Protocols><Treatment Regimen><Treatment Schedule><Universities><Washington><Work><Zhong Yi Xue><active followup><acupuncture><adverse sequelae of COVID><adverse sequelae of COVID-19><adverse sequelae of coronavirus disease><adverse sequelae of coronavirus disease 2019><arm><assess effectiveness><care as usual><care seeking><chronic COVID><chronic COVID-19><chronic COVID-19 sequelae><chronic novel coronavirus disease 2019><chronic pain><common symptom><constant pain><coronavirus disease 2019 consequence><coronavirus disease 2019 effect><coronavirus disease 2019 impact><coronavirus disease 2019 infection><coronavirus disease-19 impact><daily functioning><debilitating symptom><determine effectiveness><early clinical trial><early phase clinical trial><effective therapy><effective treatment><effectiveness assessment><effectiveness evaluation><evaluate effectiveness><examine effectiveness><experience><feasibility trial><follow up><follow-up><followed up><followup><functional improvement><improve function><improved><improved functional outcomes><improved outcome><infected with COVID-19><infected with COVID19><infected with SARS-CoV-2><infected with SARS-CoV2><infected with coronavirus disease 2019><infected with severe acute respiratory syndrome coronavirus 2><innovate><innovation><innovative><instrument><integrative healing><integrative health><intervention arm><interventional strategy><lasting pain><long haul COVID><long haul COVID-19><long haul coronavirus disease><long haul coronavirus disease 2019><long haul sequelae of COVID-19><long haul sequelae of coronavirus disease 2019><long-hauler COVID><long-hauler COVID-19><long-hauler coronavirus disease 2019><long-hauler syndrome><long-term COVID><long-term COVID-19><long-term coronavirus disease><long-term coronavirus disease 2019><long-term sequelae of COVID-19><long-term sequelae of SARS-CoV-2><long-term sequelae of coronavirus disease 2019><long-term sequelae of severe acute respiratory syndrome coronavirus 2><longterm COVID><longterm COVID-19><longterm coronavirus disease><longterm coronavirus disease 2019><mind/body><on-going pain><ongoing pain><operation><operations><pain reduction><pain relief><participant retention><patient oriented outcomes><persistent COVID-19><pilot test><post COVID syndrome><post COVID-19 sequelae><post COVID-19 syndrome><post acute COVID syndrome><post acute COVID-19><post acute COVID-19 syndrome><post acute SARS-CoV-2><post acute coronavirus disease 2019><post acute coronavirus disease 2019 syndrome><post acute coronavirus disease syndrome><post acute sequelae following COVID-19><post acute severe acute respiratory syndrome coronavirus 2><post coronavirus disease 2019 syndrome><post coronavirus disease syndrome><post-COVID><post-COVID-19><post-acute phases of COVID-19><post-acute sequelae following SARS-CoV-2 infection><post-acute sequelae of COVID-19><post-acute sequelae of acute COVID infection><post-acute sequelae of coronavirus disease 2019><post-coronavirus disease 2019><pragmatic randomized trial><primary care clinic><prolonged COVID-19 symptoms><randomisation><randomization><randomized, clinical trials><randomly assigned><recruit><reduce pain><rehab therapy><rehabilitative><rehabilitative therapy><relieve pain><response><success><tool><treatment arm><treatment as usual><treatment strategy><trial comparing><usual care><whole health><whole person health>