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

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 respective doses of 50 mg, 1.2 mg, and 18 mcg. The targeted number of patients is 48, with 60 recruited to account for dropouts. Inclusion criteria will be (i) ages 18-60, and (ii) chronic inflammatory low back pain experienced constantly or frequently for at least 3 months and screened according to the criteria shown above in TABLE 1, omitting the age criterion. Exclusion criteria will include (i) taking of any antacids, digestive medications, or corticosteroids within the past 30 days, (ii) taking of any of the vitamins B6, B9 (folate), or B12 or a multivitamin capsule containing any of these vitamins within the past 15 days, (iii) not having diagnosed with impaired renal function or chronic kidney disease,1, 2 (iv) currently undergoing therapy for depression or suicidal ideation, (v) the presence of any red flag conditions, such as bowel, bladder, sexual or other dysfunctions; (vi) current involvement with medico-legal proceeding such as workers' compensation claims; or (vii) pregnancy.

Expected outcomes monitored at 2 weeks prior to baseline, at baseline before and after treatment, and at 1, 2, and 3 months after the commencement of treatment will include the Oswestry Disability Index (ODI) as the primary outcome. Secondary outcomes will include (i) the Quadruple Visual Analog Scale (VAS), and (ii) the Short Form Health Survey. Both within-group and between-group comparisons will be made for each chiropractic cohort. A VAS change in the order of 2 units (20 mm) or greater is considered to be of clinical significance in a population low back pain sufferers,3 4 while the minimum clinically important difference for the ODI has been shown to be 6 points, corresponding to 12 percentage points.5, 6

Sample size was previously determined to be 60 participants in treatment and control groups assuming 80% power and α of 0.05 to yield change of ODI of 9 points and SD of 16.29 as previously described.7This is divided among the three participating chiropractors.

For this pilot study, a single chiropractor with a patient cohort of n = 60, randomized into two groups of a minimum 24 each (allowing for dropouts) allocated to placebo or vitamin regimen, will be chosen. We realize that other components in people's diets have ability to produce or suppress inflammation, but our thinking is that (1) the randomization has the capacity to compensate for these effects, and (2) the vitamin supplements have shown a specific ability to significantly suppress homocysteine as a primary inflammatory agent.

After patients agree to participate, they will be further screened with a questionnaire to determine the nature of their back pain, checking off the characteristics that apply to them (Table 1).