B Vitamins + Spinal Manipulation for Low Back Pain
(VCLBP Trial)
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.12345Why 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.34678
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Participants complete baseline questionnaires and are randomized into treatment groups
Treatment
Participants receive chiropractic care and either vitamin or placebo pills for 3 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
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?
2
Treatment groups
Experimental Treatment
Placebo Group
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 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
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Western States
Lead Sponsor
Published Research Related to This Trial
Citations
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.
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_painThe 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 ...
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 ...
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.
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.
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 ...
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 ...
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