Pain Relief with Integrative Medicine (PRIMEe)?: Feasibility Trial of Acupuncture for LongCOVID
Project Number1R34AT012679-01
Contact PI/Project LeaderGENTILE, NIKKI
Awardee OrganizationUNIVERSITY OF WASHINGTON
Description
Abstract Text
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.
Public Health Relevance Statement
Project Narrative
A substantial number of people infected with COVID-19 experience persistent debilitating symptoms for months or years after the initial infection, consistent with post-acute sequelae of COVID-19 (PASC). There is an urgent need for research that identifies effective treatment strategies for the growing number of patients with PASC, about half of whom have persistent pain. This feasibility study will lay the foundation for a large trial of acupuncture, which has been found effective for chronic pain but has not yet been studied for persons with PASC.
NIH Spending Category
No NIH Spending Category available.
Project Terms
Acupuncture TherapyAddressAdherenceAffectAreaBody SystemCOVID-19 impactCaringChinese Traditional MedicineClinicClinical TrialsCommunicationComplexEffectivenessExclusionFeasibility StudiesFoundationsHealthcare SystemsIndividualInfectionInflammationIntegrative MedicineInterventionInterviewLanguageLearningLongCOVIDManualsMedicalNational Center for Complementary and Integrative HealthPainParticipantPatient-Focused OutcomesPatientsPersistent painPersonsPost-Acute Sequelae of SARS-CoV-2 InfectionProceduresProtocols documentationQuality of lifeQuestionnairesRandomizedRecoveryRehabilitation therapyReportingResearchSARS-CoV-2 infectionSample SizeSiteSpecific qualifier valueSuggestionSymptomsTreatment ProtocolsUniversitiesWashingtonWorkarmcare seekingchronic paincommon symptomdaily functioningdebilitating symptomearly phase clinical trialeffective therapyeffectiveness evaluationexperiencefeasibility trialfollow-upfunctional improvementimprovedimproved outcomeinnovationinstrumentmind/bodyoperationpain reductionpain reliefparticipant retentionpilot testpost-COVID-19pragmatic randomized trialprimary care clinicrandomized, clinical trialsrecruitresponsesuccesstooltreatment armtreatment as usualtreatment strategytrial comparingwhole health
National Center for Complementary and Integrative Health
CFDA Code
213
DUNS Number
605799469
UEI
HD1WMN6945W6
Project Start Date
26-February-2024
Project End Date
31-January-2027
Budget Start Date
26-February-2024
Budget End Date
31-January-2027
Project Funding Information for 2024
Total Funding
$656,157
Direct Costs
$421,966
Indirect Costs
$234,191
Year
Funding IC
FY Total Cost by IC
2024
National Center for Complementary and Integrative Health
$656,157
Year
Funding IC
FY Total Cost by IC
Sub Projects
No Sub Projects information available for 1R34AT012679-01
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Clinical Studies
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