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De klinische studie NCT06576739 (VCLBP) voor Terugkerende lage rugpijn is nog niet rekruterend. Bekijk de kaartweergave van de Klinische Studies Radar en de AI-ontdekkingstools voor alle details. Of stel hier een vraag.
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B Vitamin Supplementation to Chiropractic Management of Chronic LBP: Pilot Clinical Trial (VCLBP) 60

Nog niet rekruterend
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De klinische studie NCT06576739 (VCLBP) is een interventioneel studie bij Terugkerende lage rugpijn met de status nog niet rekruterend. De inclusie van 60 deelnemers start op 15 november 2024. De studie wordt geleid door University of Western States en de voltooiing is gepland op 1 oktober 2025. Laatste update op ClinicalTrials.gov: 29 augustus 2024.
Beknopte samenvatting
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 Sc...Toon meer
Uitgebreide beschrijving
As groundwork for a randomized controlled trial, this investigation proposes a pilot study in the management of chronic inflammatory low back pain in patient cohorts under the routine chiropractic care of a given physician, at the same time ingesting daily doses at the same hour each day over a period of 3 months after being randomized to either placebo or a combination of vitamins B6, B9 (folate), and B12 in respect...Toon meer
Officiële titel

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

Aandoeningen
Terugkerende lage rugpijn
Publicaties
Wetenschappelijke artikelen en onderzoekspapers gepubliceerd over deze klinische studie:
Andere studie-ID's
  • VCLBP
  • SP Vitamin LBP
NCT-ID
NCT06576739
Startdatum (Werkelijk)
2024-11-15
Laatste update geplaatst
2024-08-29
Verwachte einddatum
2025-10-01
Inschrijving (Geschat)
60
Studietype
Interventioneel
FASE
N.v.t.
Status
Nog niet rekruterend
Primaire doel
Behandeling
Toewijzing
Gerandomiseerd
Interventiemodel
Parallel
Blindering
Drievoudig blind
Armen / Interventies
Deelnemersgroep/StudiearmInterventie/Behandeling
ExperimenteelVitamin Administration
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
Spinale manipulatie
Daily administration of combination of vitamin B6,,vitamin B12, and folic acid
Placebo-comparatorPlacebo Administration
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
Spinale manipulatie
Daily administration of combination of vitamin B6,,vitamin B12, and folic acid
Primaire uitkomst
UitkomstmaatBeschrijving van de uitkomstmaatTijdsbestek
Oswestry Disability Index
Validated paper questionnaire
2 weeks prior to basel;ne, at baseline; time 0 immediately after first chiropractic treatment; 30 days, 60 days, and 90 days immediately after chiropractic treatment
Secundaire uitkomst
UitkomstmaatBeschrijving van de uitkomstmaatTijdsbestek
Quadruple Visual Analog Scale
Validated paper questionnaire
2 weeks prior to baseline; at baseline; time 0 immediately after first chiropractic treatment; 30 days, 60 days, amnd 90 days after chiropractic treatment
Short Form (SF-36) Health Survey
Validated paper questionnaire
2 weeks prior to baseline; at baseline; time 0 immediately after first chiropractic treatment; 30 days, 60 days, and 90 days after chiropractic treatment
Deelname-assistent
Geschiktheidscriteria

Leeftijd van deelnemers
Volwassene
Minimumleeftijd
18 Years
Geslachten die in aanmerking komen voor de studie
Allen
  • Ages 18-60 Chronic inflammatory low back pain experienced constantly or frequently for at least 3 months

  • 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
University of Western States logoUniversity of Western States
Verantwoordelijke instantie
Anthony Rosner, Hoofdonderzoeker, Research Director, University of Western States
Geen contactgegevens beschikbaar
1 Studielocaties in 1 landen

Oregon

University of Western States, Portland, Oregon, 97230, United States
Anthony L Rosner, Ph.D., Contact, 617-794-1372, [email protected]
Heather Zwickey, Ph.D., Contact, 503-552-1751, [email protected]