[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100560407":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":27,"locations":28,"responsibleParty":51,"collaborators":27,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":57,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":27,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":27,"overallStatus":75,"whyStopped":27,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"University of Western States","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Vitamin Administration","EXPERIMENTAL","Vitamins B6, B12, and folic acid will be administered orally between 8:30 am - 10:30 am on day of chiropractic manipulation Chiropractic intervention will be applied Number of patients in arm anticipated: 30",[13],"Procedure: Spinal Manipulation",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo Administration","PLACEBO_COMPARATOR","Placebo pills equal in number and appearance to the B vitamins will be administered orally between 8:30 am - 10:30 am on day of chiropractic intervention Chiropractic intervention will be applied Number of patients in arm anticipated: 30",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Spinal Manipulation","Daily administration of combination of vitamin B6,,vitamin B12, and folic acid",[15,9],[26],"B vitamin supplementation",null,[29],{"facility":5,"status":27,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"Portland","Oregon","97230","United States","US",{"type":36,"coordinates":37},"Point",[38,39],-122.67621,45.52345,{"lat":39,"lon":38},[42,47],{"name":43,"role":44,"phone":45,"phoneExt":27,"email":46},"Anthony L Rosner, Ph.D.","CONTACT","617-794-1372","arosner@uws.edu",{"name":48,"role":44,"phone":49,"phoneExt":27,"email":50},"Heather Zwickey, Ph.D.","503-552-1751","hzwickey@nunm.edu",{"type":52,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"PRINCIPAL_INVESTIGATOR","Anthony Rosner","Research Director","100560407","b-vitamin-supplementation-to-chiropractic-management-of-chronic-lbp-pilot-clinical-trial-vclbp-100560407",false,"NCT06576739","B Vitamin Supplementation to Chiropractic Management of Chronic LBP: Pilot Clinical Trial (VCLBP)","Efficacy and Duration of Chiropractic Spinal Manipulation in Chronic Back Pain With the Inclusion of Vitamins B6, B9, and B12: A Pilot, Placebo-Controlled, Double Blinded Randomized Controlled Trial","VCLBP","Inclusion Criteria:\n\n* Ages 18-60 Chronic inflammatory low back pain experienced constantly or frequently for at least 3 months\n\nExclusion Criteria:\n\n* Taking any of the vitamins B6, B12, or folic acid or a multivitamin capsule containing any of these vitamins within the past 15 days Not having been diagnosed with impaired renal function or impaired kidney disease Currently undergoing therapy for depression or suicidal ideation Presence of any red flag conditions, such as bowel, bladder, sexual or other dysfunctions Current involvement with medico-legal proceeding such as workers' compensation or claims Pregnancy","ALL","18 Years","60 Years",{"count":67,"type":68},60,"ESTIMATED","INTERVENTIONAL",[71],"NA","The purpose of this investigation is to assess the effects of a combination of B vitamins (B6 \\[pyridoxine\\],, B9 \\[folate\\], and B12 \\[cyanocobalamin\\] upon the efficacy and duration of spinal manipulation in its treatment of chronic low back pain. Outcome measures over a 12-week period include disability (the Oswestry Disability Index), pain (the Quadruple Visual Analog Scale), and quality of life (Short Form 36 Scale). A total of 60 patients are to be recruited by a single practicing chiropractor who will randomize consenting patients into two groups of 30, one of which will take 3 tablets of the Standard Process folic acid B12 and one tablet of Standard Process B6 Niacinamide between 8:30 - 10:30 am each day and the other 4 tablets of placebo fabricated by Standard Process. Both groups will receive treatments from their chiropractor in the manner they would normally experience as patients. Outcomes will be measured 2 weeks prior to commencing the protocol (baseline), at baseline, immediately upon commencing the protocol, and at one, 2, and 3 months following.. Hypotheses are as follows:\n\nHO: Differences in the Oswestry Disability Index (primary outcome) between the experimental and placebo groups will not be clinically and statistically significant at 3 months of treatment.\n\nHA: Differences in the Oswestry Disability Index (primary outcome) between the experimental and placebo groups will be clinically and statistically significant at 3 months of treatment.\n\nSecondary outcomes will be evaluated in the same manner.",[74],"Recurrent Low Back Pain","NOT_YET_RECRUITING","2024-08-26",{"date":78,"type":79},"2024-08-29","ACTUAL",{"date":81,"type":68},"2024-11-15",{"date":83,"type":68},"2025-10-01",{"name":5,"class":6},1]