[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100609381":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":36,"centralContacts":40,"locations":50,"responsibleParty":72,"collaborators":45,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":77,"sex":83,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":45,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":96,"overallStatus":99,"whyStopped":45,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Loma Linda University","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"INF® Therapy Only Group","EXPERIMENTAL","INF® therapy is a manual technique designed to improve neural circulation by using a series of manual holds administered by a trained practitioner. Participants will receive 60-minute sessions, 2-3 times per week, for a total of 8 sessions.",[13],"Other: INF® Therapy",{"label":15,"type":10,"description":16,"interventionNames":17},"NVIf Only Group","NVIf, is a dietary intervention that uses a patented ultrasound technology to assess vascular responses to food allergens. By identifying foods that exacerbate inflammation and restrict circulation, the intervention guides patients to eliminate these foods, thereby improving nerve health. Those in this group will participate in follow-up for food elimination adherence, including daily tracking of foods ingested. Week 1-2: 4 x NVI food guided-elimination visits. Week 2-5 complete weekly Likert scale inquiring about food eliminations and weekly phone call check-in attempts will be made by research staff.",[18],"Other: NVIf",{"label":20,"type":10,"description":21,"interventionNames":22},"INF® Therapy + NVIf Group","INF® therapy and NVI Food-Guided Elimination Group: Week 1-2: 4 x NVI food guided-elimination visits. Participants will receive 60-minute sessions, 2-3 times per week, for a total of 8 sessions. As well as participate in NVIf, which is a dietary intervention that uses a patented ultrasound technology to assess vascular responses to food allergens. By identifying foods that exacerbate inflammation and restrict circulation, the intervention guides patients to eliminate these foods, thereby improving nerve health. Those in this group will participate in follow-up for food elimination adherence, including daily tracking of foods ingested. Week 2-5 complete weekly Likert scale inquiring about food eliminations and weekly phone call check-in attempts will be made by research staff as well as INF® therapy for 60-minute sessions, 2-3 times per week, for a total of 8 sessions.",[13,18],[24,30],{"type":6,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"INF® Therapy","INF® therapy is a manual technique designed to improve neural circulation by using a series of manual holds administered by a trained practitioner,",[20,9],[29],"Intranerual Facilitation",{"type":6,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"NVIf","NVIf is a dietary intervention that uses a patented ultrasound technology to assess vascular responses to food allergens",[20,15],[35],"Neuro vascular index food-guided elimination",[37],{"name":38,"affiliation":5,"role":39},"Kyan Sahba, PhD","PRINCIPAL_INVESTIGATOR",[41,47],{"name":42,"role":43,"phone":44,"phoneExt":45,"email":46},"Kyan Sahba, Post Doctoral Fellow, PhD","CONTACT","9095586799",null,"kyansahba@llu.edu",{"name":48,"role":43,"phone":44,"phoneExt":45,"email":49},"Mark Bussell, Clinical Director, DPT","mbussell@llu.edu",[51],{"facility":52,"status":45,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Neuropathic Therapy Center","Loma Linda","California","92354-0200","United States","US",{"type":59,"coordinates":60},"Point",[61,62],-117.26115,34.04835,{"lat":62,"lon":61},[65,68,71],{"name":66,"role":43,"phone":67,"phoneExt":45,"email":49},"Mark Bussell, DPT","909-558-6799",{"name":69,"role":43,"phone":70,"phoneExt":45,"email":46},"Kyan Z Sahba, PhD","7142350087",{"name":38,"role":39,"phone":45,"phoneExt":45,"email":45},{"type":39,"investigatorFullName":73,"investigatorTitle":74,"investigatorAffiliation":5,"oldNameTitle":45,"oldOrganization":45},"Kyan Sahba","Principal Invetigator","100609381","combined-circulatory-and-dietary-interventions-for-neuropathy-100609381",false,"NCT07213843","Combined Circulatory and Dietary Interventions for Neuropathy","Combined Circulatory and Dietary Interventions for Neuropathy (CDIN)","CDIN","Inclusion Criteria\n\n* Confirmed diagnosis of peripheral neuropathy in the lower extremities by a physician\n* Lower Extremity Functional Scale (LEFS) score between 0-60 (indicating moderate to significant difficulty in lower extremity function)\n* Ability to speak and understand English\n* Ability to provide appropriate written informed consent\n* Willingness to participate in all study procedures, including the intervention and follow-up visits\n* Ability to ambulate independently with or without an assistive device\n\nExclusion Criteria\n\n* Any medical condition suggesting potential decline in function over the next 6 months (e.g., ongoing chemotherapy, radiation therapy, or dialysis)\n* Active alcohol or drug misuse\n* End-stage renal failure\n* Uncontrolled hypertension\n* Severe dyslipidemia\n* Chronic liver disease\n* Autoimmune disease\n* Advanced chronic obstructive pulmonary disease (COPD)\n* Active inflammation\n* Shingles-related neuropathy\n* Presence of any lower extremity amputations or significant wounds\n* Severe chronic medical conditions requiring active treatment that could interfere with study outcomes\n* Morbid obesity\n* Concomitant use of medications or devices that may interfere with study results or are not allowed per protocol\n* Inability to comprehend or provide informed consent\n* Inability to speak or understand English\n* Pregnancy, breastfeeding, or planning pregnancy during the study period (female participants)\n* Inability or unwillingness to adhere to study procedures, including dietary guidelines or follow-up visits\n* Inability to complete all required study assessments, including follow-up appointments and questionnaires","ALL","35 Years","85 Years",{"count":87,"type":88},60,"ESTIMATED","INTERVENTIONAL",[91],"NA","The purpose of this study is to evaluate the effectiveness of three different interventions in improving neuropathy symptoms in individuals aged 35-85 with moderate to severe neuropathy. The study will compare three treatment groups: Intraneural Facilitation® (INF®) therapy alone, INF® therapy combined with Neuro vascular index (NVI) food-guided elimination (NVIf), and NVIf alone. The aim is to determine which treatment results in the greatest improvement in neuropathy symptoms, including quality of life, sensory and pain improvements, and functional outcomes.",[94,95],"Diabete Type 2","Neuropathy, Painful",[97,98],"neuropathy","diabetes type 2","NOT_YET_RECRUITING","2025-10-07",{"date":102,"type":103},"2025-10-09","ACTUAL",{"date":105,"type":88},"2026-10-01",{"date":107,"type":88},"2028-12-01",{"name":5,"class":6},1]