B Vitamin Supplementation to Chiropractic Management of Chronic LBP: Pilot Clinical Trial (VCLBP)
Unknown statusNot applicableNCT06576739
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- 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
- Conditions
- Recurrent Low Back Pain
- Interventions
- Sponsor
- University of Western States
- Start date
- 2024-11-15
- Primary completion
- 2025-04-01
- Sex
- All
- Age range
- from 18 Years to 60 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Ages 18-60 Chronic inflammatory low back pain experienced constantly or frequently for at least 3 months Exclusion Criteria: * 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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06576739