Lumbar Spine Surgery
Conditions
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.
Interventions
DIETARY_SUPPLEMENTVitamin C
Daily use of Vit C tablets
DIETARY_SUPPLEMENTPlacebo
Daily use of placebo tablets
Sponsors
University of Kansas Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
Blinded pilot randomized control trial
Intervention model description
2 groups: placebo and Vitamin C
Eligibility
Sex/Gender
ALL
Age
45 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment feasibility outcome | up to 7 weeks | The number of participants recruited and enrolled. |
| Adherence feasibility outcome | up to 7 weeks | Calculate adherence in percentage as subjects enrolled versus completed |
| Pain intensity: numeric rating pain scale | up to 7 weeks | self reported 0-10 numeric rating pain scale where 0=no pain and 10=most pain imagined |
| Pain medication consumption | up to 7 weeks | Use of opioids and non-opioids analgesics documented in patients' health records |
| Function | up to 7 weeks | Gait distance in feet will be obtained during physical therapy visit |
| Would healing | up to 7 weeks | Surgical incision observation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Beck depression inventory | up to 7 weeks | A standard questionnaire with 1 - 40 points, 1=no depression and 40=extreme depression |
| Pain catastrophizing scale | up to 7 weeks | A standard scale to measure catastrophizing thoughts. Higher numbers indicate greater catastrophizing thoughts |
| Vit C level | up to 7 weeks | Serum level of Vit C in umol/L |
| Beck anxiety inventory | up to 7 weeks | 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 |
| 2011 Fibromyalgia (FM) survey | up to 7 weeks | A standard questionnaire for centralized pain. Scores 3-6 in widespread pain index and 9 or greater in symptom severity suggest widespread pain |
| fatigue questionnaire | up to 7 weeks | A standard questionnaire with 10 fatigue related questions. Each measured on 1-5 Likert scale. Higher numbers indicate greater fatigue |
| Pittsburg sleep scale | up to 7 weeks | A standard questionnaires to examine sleep problems. A total of 5 scores or greater indicate poor sleep quality |
Countries
United States
Outcome results
None listed