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

NCT06576739 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-08-29

No results posted yet for this study

Summary

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.

Conditions

  • Recurrent Low Back Pain

Interventions

PROCEDURE

Spinal Manipulation

Daily administration of combination of vitamin B6,,vitamin B12, and folic acid

Sponsors & Collaborators

  • University of Western States

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-15
Primary Completion
2025-04-01
Completion
2025-10-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06576739 on ClinicalTrials.gov