B Vitamins + Spinal Manipulation for Low Back Pain

(VCLBP Trial)

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Western States

Must not be taking: B vitamins, Multivitamins

Disqualifiers: Renal impairment, Depression, Pregnancy, others

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

60 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you've taken B6, B12, or folic acid in the past 15 days.

Is spinal manipulation generally safe for humans?

Spinal manipulation is generally safe, with about half of patients experiencing mild and short-term side effects like extra pain. Serious side effects are rare, but more research is needed to understand their frequency. ^{1 2 3 4 5}

How does the treatment of B Vitamins + Spinal Manipulation for Low Back Pain differ from other treatments?

This treatment is unique because it combines B vitamins, which have been shown to enhance pain relief and reduce the need for NSAIDs (nonsteroidal anti-inflammatory drugs), with spinal manipulation, a physical therapy technique. This dual approach may offer a more comprehensive solution by addressing both nutritional and mechanical aspects of low back pain. ^{6 7 8 9 10}

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for individuals experiencing chronic low back pain. Participants must be willing to undergo spinal manipulation therapy and take B vitamin supplements or a placebo daily. Specific eligibility criteria are not provided, but typically participants would need to meet certain health conditions.

Exclusion Criteria

My kidney function is normal.

I am currently receiving treatment for depression or thoughts of harming myself.

Current involvement with medico-legal proceeding such as workers' compensation or claims

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Baseline Assessment

Participants complete baseline questionnaires and are randomized into treatment groups

1 day

1 visit (in-person)

Treatment

Participants receive chiropractic care and either vitamin or placebo pills for 3 months

12 weeks

Regular visits as needed (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

Treatment Details

Interventions

• B Vitamin Supplementation

Trial Overview The study is testing if adding B vitamins (B6, B9, and B12) enhances the effectiveness of spinal manipulation in treating chronic low back pain over 12 weeks. Patients will either receive these vitamins or a placebo while continuing their regular chiropractic treatments.

Participant Groups

Group I: Vitamin Administration Experimental Treatment 1 Intervention

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

Group II: Placebo Administration Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

University of Western States

Lead Sponsor

Trials

5

Recruited

980+

Findings from Research

A systematic review of five studies on spinal manipulation (SM) found that about half of patients experience mild and transient adverse events after treatment, indicating that while side effects are common, they are generally not severe.

There is currently no reliable data on the incidence of serious adverse events related to spinal manipulation, suggesting that while they are likely rare, further research is needed to better understand their frequency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective investigations into the safety of spinal manipulation. Ernst, E.[2019]

References

1. Scotland pubmed.ncbi.nlm.nih.gov

A perspective for considering the risks and benefits of spinal manipulation in patients with low back pain. [2006]

2. England pubmed.ncbi.nlm.nih.gov

Reporting of adverse events associated with spinal manipulation in randomised clinical trials: an updated systematic review. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Adverse effects of spinal manipulation. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Prospective investigations into the safety of spinal manipulation. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Adverse effects of spinal manipulation: a systematic review. [2023]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Nucleotides Cytidine and Uridine Associated with Vitamin B12 vs B-Complex Vitamins in the Treatment of Low Back Pain: The NUBES Study. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

High Prevalence of Hypovitaminosis D in Patients with Low Back Pain: Evidence from Meta-Analysis. [2019]

8. Germany pubmed.ncbi.nlm.nih.gov

[Shortening diclofenac therapy by B vitamins. Results of a randomized double-blind study, diclofenac 50 mg versus diclofenac 50 mg plus B vitamins, in painful spinal diseases with degenerative changes]. [2013]

9. Germany pubmed.ncbi.nlm.nih.gov

Vitamin D supplementation attenuates oxidative stress in paraspinal skeletal muscles in patients with low back pain. [2021]

10. Germany pubmed.ncbi.nlm.nih.gov

[Reduced diclofenac administration by B vitamins: results of a randomized double-blind study with reduced daily doses of diclofenac (75 mg diclofenac versus 75 mg diclofenac plus B vitamins) in acute lumbar vertebral syndromes]. [2019]