B Vitamin Supplementation to Chiropractic Management of Chronic LBP: Pilot Clinical Trial (VCLBP)

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:

HO: 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.

HA: 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.

Secondary outcomes will be evaluated in the same manner.