Health TrialsbyHealthPanel

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

ConditionRecurrent Low Back Pain
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorUniversity of Western States

About 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 does not accept healthy volunteers

Qualifiers

Ages 18-60 Chronic inflammatory low back pain experienced constantly or frequently for at least 3 months

Disqualifiers

Taking any of the vitamins B6, B12, or folic acid or a multivitamin capsule containing any of these vitamins within the past 15 days Not having been diagnosed with impaired renal function or impaired kidney disease Currently undergoing therapy for depression or suicidal ideation Presence of any red flag conditions, such as bowel, bladder, sexual or other dysfunctions Current involvement with medico-legal proceeding such as workers' compensation or claims Pregnancy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Spinal Manipulation

    Procedure/Surgery

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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Vitamin AdministrationExperimental treatment 1 intervention
Group B: Placebo AdministrationPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Oswestry Disability Index

Validated paper questionnaire

Time frame
2 weeks prior to basel;ne, at baseline; time 0 immediately after first chiropractic treatment; 30 days, 60 days, and 90 days immediately after chiropractic treatment

Secondary outcomes

1

Quadruple Visual Analog Scale

Validated paper questionnaire

Time frame
2 weeks prior to baseline; at baseline; time 0 immediately after first chiropractic treatment; 30 days, 60 days, amnd 90 days after chiropractic treatment
2

Short Form (SF-36) Health Survey

Validated paper questionnaire

Time frame
2 weeks prior to baseline; at baseline; time 0 immediately after first chiropractic treatment; 30 days, 60 days, and 90 days after chiropractic treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Western States

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: