Vitamin C Supplement for Lumbar Spine Surgery

Lumbar Spine Surgery Clinical Trial

Official title:

Vitamin C Supplementation for Lumbar Spine Surgical Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03918694
• Other study ID #: STUDY00143319
• Status: Recruiting
• Phase: N/A
• Start date: April 24, 2019
• Est. completion date: January 2021

Study information

• Verified date: January 2020
• Source: University of Kansas Medical Center
• Contact: Neena Sharma, PT, PhD, CMPT
• Phone: 913 588-4566
• Email: nsharma[@]kumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 2021
• Est. primary completion date: January 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Lumbar Spine Surgery

Intervention

Dietary Supplement:
• Vitamin C
Daily use of Vit C tablets
• Placebo
Daily use of placebo tablets

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment feasibility outcome	The number of participants recruited and enrolled.	up to 7 weeks
Primary	Adherence feasibility outcome	Calculate adherence in percentage as subjects enrolled versus completed	up to 7 weeks
Primary	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
Primary	Pain medication consumption	Use of opioids and non-opioids analgesics documented in patients' health records	up to 7 weeks
Primary	Function	Gait distance in feet will be obtained during physical therapy visit	up to 7 weeks
Primary	Would healing	Surgical incision observation	up to 7 weeks
Secondary	Beck depression inventory	A standard questionnaire with 1 - 40 points, 1=no depression and 40=extreme depression	up to 7 weeks
Secondary	Vit C level	Serum level of Vit C in umol/L	up to 7 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Pain catastrophizing scale	A standard scale to measure catastrophizing thoughts. Higher numbers indicate greater catastrophizing thoughts	up to 7 weeks