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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if B vitamins can enhance the effects of spinal manipulation therapy for individuals with chronic low back pain. Participants will be divided into two groups: one will receive a daily dose of vitamins B6, B9, and B12, while the other will take placebo pills that appear identical. Both groups will continue their usual chiropractic treatments. The trial seeks individuals who have experienced ongoing low back pain for at least three months.

As an unphased trial, this study offers participants the chance to contribute to valuable research that may improve future treatment options for chronic low back pain.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that B vitamins, such as B6, B9 (folate), and B12, are generally safe when taken in recommended amounts. One study suggested that nerve-related side effects from vitamin B6 are rare and typically occur only with high doses over extended periods. Another study found that vitamin B12 can help with low back pain and is well-tolerated. Folate, also known as folic acid, is safe and supports healthy blood, but it cannot repair nerve damage if vitamin B12 is deficient.

Overall, B vitamins are well-tolerated and safe when taken as recommended. Following dosage instructions reduces the risk of side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the combination of B vitamins and spinal manipulation for low back pain because it offers a potentially natural approach that targets both nutritional and mechanical aspects of pain management. Unlike standard treatments like NSAIDs or physical therapy, this approach uses vitamins B6, B12, and folic acid, which may support nerve health and reduce inflammation. The addition of spinal manipulation aims to enhance mobility and relieve pain, possibly providing a more holistic and side-effect-free alternative to existing treatments. This dual-action strategy could offer a complementary solution for those seeking non-pharmacological options.

What evidence suggests that this trial's treatments could be effective for low back pain?

Research has shown that B vitamins, such as B6, B9, and B12, can help reduce low back pain and improve quality of life. Studies have found that Vitamin B12, in particular, may lessen pain and disability related to low back pain. Other research suggests that B vitamins as a group can significantly reduce the severity of pain. These vitamins might help by supporting nerve health and lowering inflammation. Although the data is somewhat limited, existing evidence is promising for their role in managing back pain. In this trial, one group of participants will receive B Vitamin Supplementation alongside chiropractic intervention, while another group will receive placebo pills with the same chiropractic intervention. ^{3 4 6 7 8}

Are You a Good Fit for This Trial?

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

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

Pregnancy

I have serious issues like problems with bowel movements, urination, or sexual function.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9339724/

Effect of vitamin B complex administration on pain and ... This study aimed to evaluate the effect of vitamin B complex supplementation on pain and sensory problems following mandibular implant placement surgery.

2. europeanreview.org europeanreview.org/wp/wp-content/uploads/200.pdf

Vitamin B12 in low back pain: a randomised, double-blind, ... Conclusions: The efficacy and safety of par- enteral Vitamin B12 in alleviating low back pain and related disability and in decreasing the con- sumption of ...

3. researchgate.net researchgate.net/publication/330980377_The_role_of_B_vitamins_in_the_treatment_of_back_pain

The role of B vitamins in the treatment of back pain The results of various clinical studies on the use of the B complex of vitamins showed a significant decrease in the severity of the pain ...

4. painphysicianjournal.com painphysicianjournal.com/current/pdf?article=NjAxNQ%3D%3D&journal=116

Vitamin B12 as a Treatment for Pain Clinical trials provide evidence for the effectiveness of vitamin B12 for the treatment of low back pain and neuralgia, although data is still fairly limited ...

5. academic.oup.com academic.oup.com/painmedicine/article/21/4/766/5570552

Effect of Combined Diclofenac and B Vitamins (Thiamine ... EM. Results of a double-blind study of diclofenac + vitamin B1, B6, B12 versus diclofenac in patients with acute pain of the lumbar vertebrae.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7764703/

Update on Safety Profiles of Vitamins B1, B6, and B12 We consider that neurological side effects due to vitamin B6 intake are rare and only occur with high daily doses and/or longer treatment duration.

7. aetna.com aetna.com/cpb/medical/data/500_599/0536.html

Vitamin B-12 Therapy - Medical Clinical Policy Bulletins The authors cited evidence that demonstrates, however, that oral vitamin B-12 has been shown to have an efficacy equal to that of injections in the treatment of ...

8. mayoclinic.org mayoclinic.org/drugs-supplements-folate/art-20364625

Folate (folic acid) Taking folic acid supplements can help correct low blood counts, but it won't repair nerve damage from not having enough vitamin B-12. Taking a ...