[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100526869":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":40,"responsibleParty":85,"collaborators":26,"id":87,"slug":88,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":26,"eligibilityCriteria":93,"healthyVolunteers":89,"sex":94,"minAge":95,"maxAge":26,"enrollmentInfo":96,"targetDuration":26,"studyType":99,"phases":100,"briefSummary":102,"conditions":103,"keywords":26,"overallStatus":59,"whyStopped":26,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"University of Minnesota","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental group","EXPERIMENTAL","adults with SCI-related neuropathic pain with at least 50% from diverse groups randomized to experimental group",[13],"Behavioral: Qigong",{"label":15,"type":16,"description":17,"interventionNames":18},"Active comparison group","ACTIVE_COMPARATOR","adults with SCI-related neuropathic pain with at least 50% from diverse groups randomized to active comparator group",[19],"Behavioral: Daily 2 min pain management survey",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","Qigong","a Qigong introduction class and a 12-week remote Qigong intervention, with a 6-month follow-up",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Daily 2 min pain management survey","Completing one short survey (2 min) daily through your phone or computer (you will get a survey link through email or text), with a 6-month follow-up.",[15],[32],{"name":33,"affiliation":5,"role":34},"Ann Van de Winckel, PhD, MSPT, PT","PRINCIPAL_INVESTIGATOR",[36],{"name":33,"role":37,"phone":38,"phoneExt":26,"email":39},"CONTACT","612-625-1191","avandewi@umn.edu",[41,58,71],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"University of Miami","NOT_YET_RECRUITING","Miami","Florida","33124","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-80.19366,25.77427,{"lat":53,"lon":52},[56],{"name":57,"role":37,"phone":26,"phoneExt":26,"email":26},"Leslie Morse",{"facility":5,"status":59,"city":60,"state":61,"zip":62,"country":47,"countryCode":48,"cosmosGeoPoint":63,"geoPoint":67,"contacts":68},"RECRUITING","Minneapolis","Minnesota","55414",{"type":50,"coordinates":64},[65,66],-93.26384,44.97997,{"lat":66,"lon":65},[69],{"name":70,"role":37,"phone":26,"phoneExt":26,"email":26},"Van De Winckel Van",{"facility":72,"status":43,"city":73,"state":74,"zip":75,"country":47,"countryCode":48,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"University of Texas - Rio Grande Valley","Harlingen","Texas","78539",{"type":50,"coordinates":77},[78,79],-97.6961,26.19063,{"lat":79,"lon":78},[82],{"name":83,"role":37,"phone":26,"phoneExt":26,"email":84},"Kelsey Baker","kelsey.baker@utrgv.edu",{"type":86,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100526869","happiness-changing-the-perceived-pain-intensity-in-populations-with-spinal-cord-injury-and-with-health-disparities-a-feasibility-study-100526869",false,"NCT06140355","cHAnging the Perceived Pain INtensity in divErSe Populations With Spinal Cord Injury","HAPPINESS: cHAnging the Perceived Pain INtEnSity in Populations With Spinal Cord Injury and With Health Disparities: A Feasibility Study","Inclusion Criteria:\n\n* 18+ years old\n* medically stable\n* with neuropathic pain 4 or above on the numeric pain rating scale + screened with painDETECT\n* willing to participate in a remote Qigong intervention (from any location with internet connection)\n* fluent in English or Spanish\n* access to the internet and a computer\u002FiPad or smartphone\n\nExclusion Criteria:\n\n* uncontrolled seizure disorder\n* cognitive impairment and\u002For communicative disability (e.g., due to brain injury) preventing them from following directions or from learning\n* ventilator dependency\n* major medical complications\n* pressure ulcers hindering prolonged sitting or lying down\n* (planning to become) pregnant or planning a major surgery during the study (given study duration, regular Qigong practice, and frequent check-ins)\n* regular Tai Chi or Qigong practice in the past 6 months (3x\u002Fweek or more)\n* currently engaged in other rehabilitation programs that would influence outcomes","ALL","18 Years",{"count":97,"type":98},40,"ESTIMATED","INTERVENTIONAL",[101],"NA","Chronic neuropathic pain affects 69% of adults with spinal cord injury (SCI). Current treatment options are limited (primarily pain medications) with insufficient benefits and significant risks for addiction and adverse effects. Of the available mind and body approaches, Qigong is the most accessible for adults with SCI with evidence for effectiveness in reducing pain, but there is insufficient evidence to make recommendations for adults with SCI. Thus, the feasibility of Qigong in SCI needs to be established.\n\nTo support our feasibility study, we investigated a 12-week remote Qigong program in adults with SCI and neuropathic pain. We recruited 23 adults with SCI, 18 completed the study, and 12 completed the 1-year follow-up. They practiced Qigong 138% of the required intensity (which was, at least 3x\u002Fweek with Qigong video through the internet). Their pain was reduced by 44% after 12 weeks of Qigong practice and was still reduced at the 6-week and 1-year follow-up. However, three key elements need to be addressed before performing a larger effectiveness study: (1) feasibility\u002Facceptability of Qigong from adults with SCI of diverse backgrounds; (2) feasibility of the study design with control group); and (3) objective outcome measures.\n\nThis R34 feasibility study, the HAPPINESS trial (cHAnging the Perceived Pain INtensity in divErSe populations with Spinal cord injury), will expand on our prior study to consolidate feasibility with a rigorous protocol. We will address the following aims: AIM 1. Identify the facilitators\u002Fbarriers to participating in a Qigong study through focus groups\u002Finterviews with stakeholders from diverse backgrounds, defined as Hispanics, veterans, and adults living in rural, underserved areas. AIM 2. Establish the feasibility of study design\u002Fmethods of the HAPPINESS trial in adults with SCI (at least 50% of diverse backgrounds) through pre-specified targets for recruitment\u002Fenrollment, feasibility, and acceptability of design and outcomes. Using a Phase I randomized controlled trial design, 40 adults with SCI-related neuropathic pain will be randomized to 12-week remote Qigong intervention OR a short daily pain management survey that can be completed on phone\u002FiPad\u002Fcomputer + 6-month follow-up. The study results will facilitate a rigorous structure to design larger effectiveness studies and facilitate a clear pathway for researchers to investigate Qigong and other mind-body approaches for whole-person health in diverse groups of adults with chronic\u002Fneurological disorders.",[104],"Spinal Cord Injuries","2026-08-17",{"date":107,"type":108},"2026-08-19","ACTUAL",{"date":110,"type":108},"2024-08-20",{"date":112,"type":98},"2027-01-31",{"name":5,"class":6},3]