Vitamin C Supplement for Lumbar Spine Surgery

Study Overview
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Brief Summary
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By doing this study, researchers hope to learn effects of Vit C on lumbar spine surgery outcomes.

Detailed Description
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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.

Official Title
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Vitamin C Supplementation for Lumbar Spine Surgical Patients

Conditions
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Lumbar Spine Surgery

Intervention / Treatment
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* Dietary Supplement: Vitamin C
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 2 groups: placebo and Vitamin C
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Experimental<br>Participants will receive Vit C tablets | Dietary Supplement: Vitamin C<br>* Daily use of Vit C tablets<br>|
| Placebo Comparator: Placebo<br>Participants will receive placebo tablets | Dietary Supplement: Placebo<br>* Daily use of placebo tablets<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment feasibility outcome | The number of participants recruited and enrolled. | up to 7 weeks | 
| Adherence feasibility outcome | Calculate adherence in percentage as subjects enrolled versus completed | up to 7 weeks | 
| Pain intensity: numeric rating pain scale | self reported 0-10 numeric rating pain scale where 0=no pain and 10=most pain imagined | up to 7 weeks | 
| Pain medication consumption | Use of opioids and non-opioids analgesics documented in patients' health records | up to 7 weeks | 
| Function | Gait distance in feet will be obtained during physical therapy visit | up to 7 weeks | 
| Would healing | Surgical incision observation | up to 7 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Beck depression inventory | A standard questionnaire with 1 - 40 points, 1=no depression and 40=extreme depression | up to 7 weeks | 
| Vit C level | Serum level of Vit C in umol/L | up to 7 weeks | 
| Beck anxiety inventory | A standard questionnaire with 21 questions. Scores 0-21=low anxiety, scores 22-35=moderate anxiety and scores 36 and above=potentially concerning level of anxiety | up to 7 weeks | 
| 2011 Fibromyalgia (FM) survey | A standard questionnaire for centralized pain. Scores 3-6 in widespread pain index and 9 or greater in symptom severity suggest widespread pain | up to 7 weeks | 
| fatigue questionnaire | A standard questionnaire with 10 fatigue related questions. Each measured on 1-5 Likert scale. Higher numbers indicate greater fatigue | up to 7 weeks | 
| Pittsburg sleep scale | A standard questionnaires to examine sleep problems. A total of 5 scores or greater indicate poor sleep quality | up to 7 weeks | 
| Pain catastrophizing scale | A standard scale to measure catastrophizing thoughts. Higher numbers indicate greater catastrophizing thoughts | up to 7 weeks |