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B Vitamins + Spinal Manipulation for Low Back Pain (VCLBP Trial)

N/A
Waitlist Available
Research Sponsored by University of Western States
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ages 18-60 with chronic inflammatory low back pain experienced constantly or frequently for at least 3 months
Be between 18 and 65 years old
Must not have
Not having been diagnosed with impaired renal function or impaired kidney disease
Currently undergoing therapy for depression or suicidal ideation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks prior to baseline; at baseline; time 0 immediately after first chiropractic treatment; 30 days, 60 days, amnd 90 days after chiropractic treatment
Awards & highlights

Summary

This trial is looking at how a combination of B vitamins (B6, B9, and B12) affects the effectiveness and duration of spinal manipulation in treating chronic low back pain. They will assess

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While side effects are not explicitly mentioned for this trial, common side effects from taking high doses of B vitamins can include nerve damage, nausea, diarrhea, and increased risk of heart disease among others.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 60 years old and have had constant or frequent low back pain for at least 3 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My kidney function is normal.
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I am currently receiving treatment for depression or thoughts of harming myself.
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I have serious issues like problems with bowel movements, urination, or sexual function.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks prior to baseline; at baseline; time 0 immediately after first chiropractic treatment; 30 days, 60 days, and 90 days after chiropractic treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks prior to baseline; at baseline; time 0 immediately after first chiropractic treatment; 30 days, 60 days, and 90 days after chiropractic treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Oswestry Disability Index
Secondary study objectives
Quadruple Visual Analog Scale
Short Form (SF-36) Health Survey

Side effects data

From 2015 Phase 1 trial • 10 Patients • NCT02213094
20%
Renal failure
20%
Elevated LFTs
100%
80%
60%
40%
20%
0%
Study treatment Arm
Nicotinamide 500 mg
Nicotinamide 1000 mg

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Vitamin AdministrationExperimental Treatment1 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 AdministrationPlacebo Group1 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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Spinal Manipulation
2014
Completed Phase 3
~1840

Find a Location

Who is running the clinical trial?

University of Western StatesLead Sponsor
4 Previous Clinical Trials
921 Total Patients Enrolled
2 Trials studying Low Back Pain
585 Patients Enrolled for Low Back Pain
~40 spots leftby Apr 2025
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