[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100581078":3},{"organization":4,"outcomesModule":7,"designInfo":36,"detailedDescription":35,"studyPopulation":35,"armGroups":43,"interventions":50,"overallOfficials":35,"centralContacts":35,"locations":55,"responsibleParty":79,"collaborators":81,"id":84,"slug":35,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":35,"eligibilityCriteria":89,"healthyVolunteers":85,"sex":90,"minAge":91,"maxAge":35,"enrollmentInfo":92,"targetDuration":35,"studyType":95,"phases":96,"briefSummary":97,"conditions":98,"keywords":100,"overallStatus":58,"whyStopped":35,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"Curonix LLC","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":35},[9],{"measure":10,"description":11,"timeFrame":12},"Pain scores","A text description of the subject's pain location(s) and severity will be recorded to correlate with subject feedback. The VRS will be used to measure severity.","12 months",[14,17,20,23,26,29,32],{"measure":15,"description":16,"timeFrame":12},"Opioids","Each subject's opioid medication type, dose, frequency, and method of administration will be recorded at baseline and follow-up visit.",{"measure":18,"description":19,"timeFrame":12},"Work status","Work history and status will be evaluated based on a subject's self-reported questionnaire(s) completed at screening\u002Fbaseline and all follow up visits.",{"measure":21,"description":22,"timeFrame":12},"GPES","Subject satisfaction with the implant will be measured by assessing global perceived effects (GPES) on a 7-point scale (1 = worst and 7 = best)",{"measure":24,"description":25,"timeFrame":12},"Amount of sleep","Average hours of sleep per night will be evaluated at baseline and all follow-up visits",{"measure":27,"description":28,"timeFrame":12},"Sleep disturbances","The amount of sleep disturbances (awakenings) per night to track quality of sleep",{"measure":30,"description":31,"timeFrame":12},"EQ-5D-5L","The European Quality of Life - 5 Dimension - 5L (EQ-5D-5L) is a standardized instrument for use as a measure of health outcome.",{"measure":33,"description":34,"timeFrame":12},"Claims data","The value of claims data at the site will be measured from 1 year before and up to the date of implant and compared to the claims value up to 1 year after implant. The number of appointments will be collected together with the CPT codes used for pain interventions.",null,{"allocation":37,"interventionModel":38,"interventionModelDescription":39,"primaryPurpose":40,"observationalModel":35,"timePerspective":35,"maskingInfo":41},"NA","SINGLE_GROUP","Retrospective\u002FProspective","OTHER",{"masking":42,"maskingDescription":35,"whoMasked":35},"NONE",[44],{"label":45,"type":46,"description":47,"interventionNames":48},"Observational","EXPERIMENTAL","observational",[49],"Device: PNS device, observational study, no intervention during study",[51],{"type":52,"name":53,"description":53,"armGroupLabels":54,"otherNames":35},"DEVICE","PNS device, observational study, no intervention during study",[45],[56],{"facility":57,"status":58,"city":59,"state":60,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"The Metrohealth System","RECRUITING","Cleveland","Ohio","44109","United States","US",{"type":65,"coordinates":66},"Point",[67,68],-81.69541,41.4995,{"lat":68,"lon":67},[71,76],{"name":72,"role":73,"phone":74,"phoneExt":35,"email":75},"Samantha Pope","CONTACT","216-778-1270","Spope1@metrohealth.org",{"name":77,"role":78,"phone":35,"phoneExt":35,"email":35},"Brendan Astley, MD","PRINCIPAL_INVESTIGATOR",{"type":80,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR",[82],{"name":83,"class":40},"MetroHealth System, Ohio","100581078",false,"NCT06845631","Retrospective-Prospective PNS Study","Retrospective-Prospective Clinical Trial Investigating the Treatment of Chronic Pain With the Freedom Peripheral Nerve Stimulation System","Inclusion Criteria:\n\nA. Subject is ≥ 18 years of age at time permanent implant; B. Subject has been implanted with the Freedom PNS system; C. Subject is willing to attend visit as scheduled, and comply with the study requirements (if prospective); D. Patient is capable of giving informed consent.\n\nExclusion Criteria:\n\nA. Subject is currently enrolled in or plans to enroll in any concurrent drug and\u002For device study while participating in this study (if prospective); B. Any additional active implanted devices for the treatment of chronic pain in addition to the Freedom PNS system.","ALL","18 Years",{"count":93,"type":94},40,"ESTIMATED","INTERVENTIONAL",[37],"This is a retrospective-prospective study in which 40 patients have received a permanent Freedom PNS System. Subjects presented with chronic, intractable pain of peripheral nerve origin refractory to standard medical and\u002For surgical treatment.\n\nA retrospective chart review will be conducted to assess baseline and follow-up parameters in patients who have received a permanent implant with the Freedom PNS system for at least 12 months. Missing data might be collected after informed consent.",[99],"Chronic Pain",[101],"chronic pain, PNS, Retrospective, prospective","2025-02-24",{"date":104,"type":105},"2025-02-25","ACTUAL",{"date":107,"type":105},"2024-07-01",{"date":109,"type":94},"2026-12-01",{"name":5,"class":6},1]