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

Conditions

• Recurrent Low Back Pain

Eligibility Criteria

Sex

ALL

Age

18 Years - 60 Years

Healthy Volunteers

Not accepted

Interventions

• Spinal Manipulation — PROCEDURE
  Daily administration of combination of vitamin B6,,vitamin B12, and folic acid

Study Details

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.

Key Dates

Start date

Nov 15, 2024

Status verified

Aug 2024

Primary completion

Apr 1, 2025

Completion

Oct 1, 2025

Study Design

Enrollment

60 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Vitamin 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
• Placebo Comparator: Placebo 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

Primary Outcome Measure

Oswestry Disability Index [ Time Frame: 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 ]

Locations (1)

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