[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100353113":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":26,"locations":32,"responsibleParty":250,"collaborators":252,"id":272,"slug":273,"hasResults":274,"nctId":275,"briefTitle":276,"officialTitle":277,"acronym":25,"eligibilityCriteria":278,"healthyVolunteers":274,"sex":279,"minAge":280,"maxAge":25,"enrollmentInfo":281,"targetDuration":25,"studyType":284,"phases":285,"briefSummary":287,"conditions":288,"keywords":290,"overallStatus":35,"whyStopped":25,"lastUpdateSubmitDate":300,"lastUpdatePostDateStruct":301,"startDateStruct":304,"completionDateStruct":306,"leadSponsor":308,"locationsCount":309},{"fullName":5,"class":6},"Curonix LLC","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Interventional","EXPERIMENTAL","Single arm, active stimulation",[13],"Device: Wireless neuromodulation",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","When receiving sham stimulation, devices will be programmed to not actively deliver electrical stimulation but still deplete battery life to maintain blinding. Subjects will have to recharge batteries similar to receiving active stimulation.\n\nSites will not have access to WaveCrest programmer. Study devices can only be programmed by Stimwave representatives.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Wireless neuromodulation","A needle and catheter are carefully inserted near the enervated nerve. The stimulator is then placed through the catheter close to the nerve. The proximal end of the stimulator is then sutured underneath the skin to prevent migration.",[9,15],null,[27],{"name":28,"role":29,"phone":30,"phoneExt":25,"email":31},"Niek Vanquathem, BA","CONTACT","0032 492 69 22 23","niekv@stimwavefreedom.com",[33,56,73,90,106,123,139,156,173,189,205,218,234],{"facility":34,"status":35,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Western Clinical Research","RECRUITING","Placentia","California","92870","United States","US",{"type":42,"coordinates":43},"Point",[44,45],-117.87034,33.87224,{"lat":45,"lon":44},[48,53],{"name":49,"role":29,"phone":50,"phoneExt":51,"email":52},"Jessica Lynch","714-223-7000","124","research@ocpain.net",{"name":54,"role":55,"phone":25,"phoneExt":25,"email":25},"Albert Lai, MD","PRINCIPAL_INVESTIGATOR",{"facility":57,"status":35,"city":58,"state":59,"zip":60,"country":39,"countryCode":40,"cosmosGeoPoint":61,"geoPoint":65,"contacts":66},"Colorado Pain Care, LLC","Denver","Colorado","80222",{"type":42,"coordinates":62},[63,64],-104.9847,39.73915,{"lat":64,"lon":63},[67,71],{"name":68,"role":29,"phone":69,"phoneExt":25,"email":70},"Joe Mitchell","303-756-3245","Joe.Mitchell@coloradopaincare.com",{"name":72,"role":55,"phone":25,"phoneExt":25,"email":25},"Robert Moghim, MD",{"facility":74,"status":35,"city":75,"state":76,"zip":77,"country":39,"countryCode":40,"cosmosGeoPoint":78,"geoPoint":82,"contacts":83},"Holy Cross Hospital, Inc","Fort Lauderdale","Florida","33308",{"type":42,"coordinates":79},[80,81],-80.14338,26.12231,{"lat":81,"lon":80},[84,88],{"name":85,"role":29,"phone":86,"phoneExt":25,"email":87},"Lindita Burba","954-229-7965","lindita.burba@holy-cross.com",{"name":89,"role":55,"phone":25,"phoneExt":25,"email":25},"Paul Wu, MD",{"facility":91,"status":35,"city":92,"state":76,"zip":93,"country":39,"countryCode":40,"cosmosGeoPoint":94,"geoPoint":98,"contacts":99},"Florida Joint Care Institute","Trinity","34655",{"type":42,"coordinates":95},[96,97],-82.68177,28.18085,{"lat":97,"lon":96},[100,104],{"name":101,"role":29,"phone":102,"phoneExt":25,"email":103},"Isabel JC Freeman","7273726637","ifreeman@floridajointcare.com",{"name":105,"role":55,"phone":25,"phoneExt":25,"email":25},"Aaron Mates, DO",{"facility":107,"status":35,"city":108,"state":109,"zip":110,"country":39,"countryCode":40,"cosmosGeoPoint":111,"geoPoint":115,"contacts":116},"Southern Pain and research","Jasper","Georgia","30143",{"type":42,"coordinates":112},[113,114],-84.42909,34.46787,{"lat":114,"lon":113},[117,121],{"name":118,"role":29,"phone":119,"phoneExt":25,"email":120},"Julianna Kirby","(678) 971-4167","jkirby@southernpainandspine.com",{"name":122,"role":55,"phone":25,"phoneExt":25,"email":25},"Jordan Tate, MD",{"facility":124,"status":35,"city":125,"state":109,"zip":126,"country":39,"countryCode":40,"cosmosGeoPoint":127,"geoPoint":131,"contacts":132},"Vista Clinical Research\u002FSummit Spine & Joint Centers","Newnan","30265",{"type":42,"coordinates":128},[129,130],-84.79966,33.38067,{"lat":130,"lon":129},[133,137],{"name":134,"role":29,"phone":135,"phoneExt":25,"email":136},"Debra Helton","770-755-6914","dhelton@vistaclinresearch.com",{"name":138,"role":55,"phone":25,"phoneExt":25,"email":25},"Sandeep Vaid, DO",{"facility":140,"status":35,"city":141,"state":142,"zip":143,"country":39,"countryCode":40,"cosmosGeoPoint":144,"geoPoint":148,"contacts":149},"Desert Orthopaedic Center","Las Vegas","Nevada","89149",{"type":42,"coordinates":145},[146,147],-115.13722,36.17497,{"lat":147,"lon":146},[150,154],{"name":151,"role":29,"phone":152,"phoneExt":25,"email":153},"Paul Gastelum","725-706-7860","pgastelum@doclv.com",{"name":155,"role":55,"phone":25,"phoneExt":25,"email":25},"Sungkook park, MD",{"facility":157,"status":35,"city":158,"state":159,"zip":160,"country":39,"countryCode":40,"cosmosGeoPoint":161,"geoPoint":165,"contacts":166},"Orthopedic Associates of Southwest Ohio","Dayton","Ohio","45459",{"type":42,"coordinates":162},[163,164],-84.19161,39.75895,{"lat":164,"lon":163},[167,171],{"name":168,"role":29,"phone":169,"phoneExt":25,"email":170},"Laura Peterson","937-439-6483","lpeterson@oaswo.com",{"name":172,"role":55,"phone":25,"phoneExt":25,"email":25},"Jonathan Silverman, MD",{"facility":174,"status":35,"city":175,"state":159,"zip":176,"country":39,"countryCode":40,"cosmosGeoPoint":177,"geoPoint":181,"contacts":182},"Premier Pain Treatment","Loveland","45140",{"type":42,"coordinates":178},[179,180],-84.26383,39.26895,{"lat":180,"lon":179},[183,187],{"name":184,"role":29,"phone":185,"phoneExt":25,"email":186},"Kathy P White","5134547246","kwhite@premierpaintreatment.com",{"name":188,"role":55,"phone":25,"phoneExt":25,"email":25},"Michael Danko, MD",{"facility":190,"status":35,"city":191,"state":159,"zip":192,"country":39,"countryCode":40,"cosmosGeoPoint":193,"geoPoint":197,"contacts":198},"Kettering Health","Miamisburg","45429",{"type":42,"coordinates":194},[195,196],-84.28661,39.64284,{"lat":196,"lon":195},[199,203],{"name":200,"role":29,"phone":201,"phoneExt":25,"email":202},"Machelle Gonzalez","9373844511","machelle.gonzalez@ketteringhealth.org",{"name":204,"role":55,"phone":25,"phoneExt":25,"email":25},"Nirmala Abraham, MD",{"facility":206,"status":35,"city":207,"state":208,"zip":209,"country":39,"countryCode":40,"cosmosGeoPoint":210,"geoPoint":214,"contacts":215},"Austin Orthopedic Institute","Austin","Texas","78759",{"type":42,"coordinates":211},[212,213],-97.74306,30.26715,{"lat":213,"lon":212},[216],{"name":217,"role":55,"phone":25,"phoneExt":25,"email":25},"Earl Kilbride, DO",{"facility":219,"status":35,"city":220,"state":208,"zip":221,"country":39,"countryCode":40,"cosmosGeoPoint":222,"geoPoint":226,"contacts":227},"Performance pain and sports medicine","Houston","77027",{"type":42,"coordinates":223},[224,225],-95.36327,29.76328,{"lat":225,"lon":224},[228,232],{"name":229,"role":29,"phone":230,"phoneExt":25,"email":231},"Amber Pulis","346-217-1111","apulis@performancepainhouston.com",{"name":233,"role":55,"phone":25,"phoneExt":25,"email":25},"Matthias Wiederholz, MD",{"facility":235,"status":35,"city":236,"state":208,"zip":237,"country":39,"countryCode":40,"cosmosGeoPoint":238,"geoPoint":242,"contacts":243},"Advanced Spine and Pain Center","San Antonio","78240",{"type":42,"coordinates":239},[240,241],-98.49363,29.42412,{"lat":241,"lon":240},[244,248],{"name":245,"role":29,"phone":246,"phoneExt":25,"email":247},"Sofia Sued","210-690-0777","sofia.sued@gmail.com",{"name":249,"role":55,"phone":25,"phoneExt":25,"email":25},"Ellen Lin, MD",{"type":251,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[253,256,258,259,261,263,265,267,268,270,271],{"name":254,"class":255},"Texas Institute for Pain and spine","UNKNOWN",{"name":257,"class":255},"Performance Pain and Sports Medicine PLLC",{"name":74,"class":255},{"name":260,"class":255},"Colorado pain Care, LLC",{"name":262,"class":255},"Advanced Spine and Pain",{"name":264,"class":255},"Desert Orthopaedic Institute",{"name":266,"class":255},"Vista Clinical Research",{"name":174,"class":255},{"name":269,"class":255},"Florida Joint Pain Institute",{"name":206,"class":255},{"name":190,"class":255},"100353113","freedom-1-study-for-chronic-knee-pain-100353113",false,"NCT03877653","Freedom-1 Study for Chronic Knee Pain","Double-Blinded Randomized Control Trial of Knee Pain Utilizing Sub-Threshold Peripheral Nerve Stimulation","Inclusion Criteria:\n\ni. Subject is over 18 years of age; ii. Subjects with a history of chronic, function-limiting (m-MPS \\>6\u002F10) knee pain from osteoarthritis of at least three months in duration with or without prior surgeries; iii. Subject has been diagnosed with Kellgren-Lawrence Grade II or III knee osteoarthritis, confirmed by X-ray studies conducted in the last year; iv. Subject has been examined and has been deemed to be an appropriate candidate for the procedure, including chronic knee pain in patients post total knee replacement (TKR); v. Subjects who are able to understand this investigation, and give voluntary, written informed consent to participate in this study; vi. Subjects who are able to co-operate with the study procedures and are willing to return to the center for all the required post-operative follow-ups; vii. Documented failure of at least two less invasive treatment modalities including physical therapy, intra-articular steroids and\u002For oral NSAIDS; viii. Subject has not had recent invasive surgical procedures of the knee within the following intervals in relation to the time of signing Informed Consent:- 2 weeks for steroid injection - 4 weeks for radiofrequency, cryoablation or hyaluronic acid (HA) injection ix. Subject noted good (\\> 75%) but only temporary relief for at least 2 hours from an infrapatellar saphenous nerve injection with local anesthetic; x. Subject is deemed to be neuro-psycho-socially appropriate for implantation therapies based of assessment of a Clinical Psychologist.\n\nExclusion Criteria:\n\nxi. Significant contralateral knee pain that would influence their level of activity greater to 6 on the modified-Mankosky Pain Scale; xii. Hip or foot pain greater than knee pain; xiii. Neurogenic or vascular claudication; xiv. Subject has been diagnosed with Kellgren-Lawrence Grade IV knee osteoarthritis, confirmed by X-ray studies conducted in the last year; xv. Uncontrolled major depression or uncontrolled psychiatric disorders; xvi. Uncontrolled or acute medical illnesses including coagulopathy, renal insufficiency, chronic liver dysfunction, progressive neurological deficit, infection, unstable angina, and severe chronic obstructive pulmonary disease; xvii. Chronic severe conditions that could interfere with the interpretations of the outcome assessments for pain and bodily function (eg. Rheumatoid arthritis, severe spinal stenosis, activity-limiting cardiac disease); xviii. Women who are pregnant or planning to become pregnant, lactating; xix. Body mass index (BMI) greater than 40 (morbid obesity); xx. Subjects with multiple complaints involving concomitant knee, foot, or ankle pathology or radiculopathy, that will not be amenable to study due to the overlap of pain complaints; xxi. Subject has been examined and has been deemed to be inappropriate for the procedure based on anatomical restrictions; xxii. Lymphedema or stasis ulcers or other conditions that would compromise the surgical site; xxiii. History of adverse reaction to local anesthetic drugs; xxiv. Worker's compensation claimants; xxv. Incarcerated or has an ankle position locator; xxvi. Documented allergy to device material components; xxvii. Known or suspected substance abuse within the last 2 years; xxviii. Pacemaker or implanted defibrillator; xxix. Participation in another clinical study that could confound the results of this study; xxx. Based on the opinion of the investigator any legal or medical concerns that would preclude his\u002Fher enrollment in the study or potentially confound the results; xxxi. Any other implanted active medical devices in the same site.","ALL","18 Years",{"count":282,"type":283},100,"ESTIMATED","INTERVENTIONAL",[286],"NA","To demonstrate the potential benefits and risk of active sub-threshold stimulation in the treatment of chronic knee pain as compared to subjects that did not have active stimulation. Improvement will be assessed in relation to the clinical outcome measures of pain, with primary endpoint; Pain relief rate as measured by the number of subjects with greater or equal to a 50% decrease in pain on the visual analog scale, comparing baseline to the 1-month follow-up.",[289],"Osteoarthritic Knee Pain",[291,292,293,294,295,296,297,298,299],"PNS","Chronic","Pain","Wireless","Neuromodulation","knee","osteoarthritic","peripheral nerve stimulation","infra patellar saphenous","2025-02-11",{"date":302,"type":303},"2025-02-13","ACTUAL",{"date":305,"type":303},"2021-09-01",{"date":307,"type":283},"2027-06",{"name":5,"class":6},13]