Vitamin C Supplementation for Lumbar Spine Surgical Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 55
- Locations
- 2
- Primary Endpoint
- Adherence feasibility outcome
Study Overview
Brief Summary
By doing this study, researchers hope to learn effects of Vit C on lumbar spine surgery outcomes.
Detailed Description
Lumbar spine surgeries are common procedures for management of low back pain and their prevalence is increasing. However, their outcomes are less than optimal.
An effective and inexpensive solution to minimizing surgical complications and expediting recovery following lumbar spine surgery could be supplementation using high doses of vitamin C, also known as ascorbic acid. Vit C can help reduce oxidative stress and inflammation and improve immune system and body's own chemicals to fight pain.
The researchers want to examine if Vit C is effective in decreasing pain and pain medications and improving function. Gaining a better understanding of effects of Vit C on patient recovery may lead to improved outcomes.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description
Blinded pilot randomized control trial
Eligibility Criteria
- Ages
- 45 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients scheduled to have a lumbar spine fusion
- •Can read and understand the English language
- •BMI 35 or less
Exclusion Criteria
- •Patients taking certain medications
- •lumbar spine laminectomy or discectomy
- •taking a Vit C supplement
- •pregnancy
- •Cauda equine syndrome or spinal tumor
- •neurological, neurodegenerative or cognitive issues
- •renal pathology
- •sickle cell anemia
- •iron metabolism disorder
Outcomes
Primary Outcomes
Adherence feasibility outcome
Time Frame: up to 7 weeks
Calculate adherence in percentage as subjects enrolled versus completed
Function
Time Frame: up to 7 weeks
Gait distance in feet will be obtained during physical therapy visit
Would healing
Time Frame: up to 7 weeks
Surgical incision observation
Pain intensity: numeric rating pain scale
Time Frame: up to 7 weeks
self reported 0-10 numeric rating pain scale where 0=no pain and 10=most pain imagined
Pain medication consumption
Time Frame: up to 7 weeks
Use of opioids and non-opioids analgesics documented in patients' health records
Recruitment feasibility outcome
Time Frame: up to 7 weeks
The number of participants recruited and enrolled.
Secondary Outcomes
- Vit C level(up to 7 weeks)
- Beck depression inventory(up to 7 weeks)
- Beck anxiety inventory(up to 7 weeks)
- 2011 Fibromyalgia (FM) survey(up to 7 weeks)
- fatigue questionnaire(up to 7 weeks)
- Pittsburg sleep scale(up to 7 weeks)
- Pain catastrophizing scale(up to 7 weeks)