Association Between Serum Beta-Carotene Levels and Lumbar Osteophyte Formation in Adults With Chronic Low Back Pain: A Cross-Sectional Study Protocol
Examining serum beta-carotene concentrations alongside radiographic lumbar osteophytes and relevant lifestyle exposures in adults aged over 50 years.
ARTICLE TYPE | STUDY DESIGN |
SPECIALTY | CATEGORY |
Abstract
Background: Chronic low back pain is common in adults over 50 years of age and may be associated with degenerative changes in the lumbar spine, including osteophyte formation. Beta-carotene is an antioxidant nutrient, and its possible relationship with spinal osteoarthritis and lumbar osteophytes warrants further investigation.
Objective: To assess the association between serum beta-carotene levels and radiographic lumbar osteophyte formation among adults aged over 50 years who have experienced continuous low back pain for more than three months. The protocol also records tobacco use and alcohol intake.
Methods: This cross-sectional study plans to include 153 eligible patients aged over 50 years with chronic low back pain. Participants will undergo clinical assessment, anteroposterior and lateral lumbar spine radiography, and blood sampling for serum beta-carotene measurement using the assay specified in the source protocol. Radiographs will be assessed by a radiologist. The source protocol defines osteophyte-positive status as more than six osteophytes between L1 and S1 and osteophyte-negative status as fewer than six.
Analysis: Data are planned to be analysed using SPSS version 21.0. Categorical variables will be summarized as percentages and assessed using the chi-square test; numeric variables will be summarized as mean and standard deviation and compared using an independent-samples t-test. A p-value below 0.05 will be considered statistically significant.
Protocol status: This article describes a planned study. No study results or conclusions about the presence or direction of an association are available in the supplied synopsis.
Introduction
Chronic low back pain is an important clinical concern among older adults. Degenerative changes in the spine, including spinal osteoarthritis and lumbar osteophyte formation, may contribute to persistent symptoms. The development of these changes is multifactorial, and the role of nutritional and antioxidant factors remains an area of interest.
Beta-carotene is an antioxidant compound that has been studied in relation to osteoarthritis and other inflammatory or metabolic conditions. However, findings related to knee osteoarthritis cannot automatically be applied to the lumbar spine. The association between serum beta-carotene levels and lumbar osteophyte formation in people with chronic low back pain requires direct assessment.
The proposed study will examine serum beta-carotene levels in adults over 50 years of age who report continuous low back pain for more than three months. Lumbar radiographs will be used to assess osteophyte formation, while demographic information and histories of tobacco use and alcohol intake will also be recorded. The study may provide locally relevant observational data, while its cross-sectional design will limit conclusions about causality.
Objective
To assess the association between serum beta-carotene levels and lumbar osteophyte formation among adults aged over 50 years with chronic low back pain lasting more than three months.
Study Design and Methods
Study design: Cross-sectional observational study.
Study setting: A neurosurgical clinical setting. The institution name is omitted from this publication version.
Sample size and sampling: The proposed sample size is 153 patients. The synopsis states that this estimate was calculated using a formula for estimating a population mean with relative precision, based on an expected beta-carotene mean of 0.55, standard deviation of 0.3810, a 5% significance level, and 11% relative precision. The sampling method is not clearly specified in the supplied synopsis.
Inclusion criteria: Adults aged over 50 years who have experienced low back pain continuously for more than three months.
Exclusion criteria: The synopsis lists a history of lumbar spine surgery, trauma, malignancy, osteoporosis, chronic infection, spondylolisthesis, and spinal deformity as exclusion criteria.
Clinical assessment: Eligible patients will be assessed by a consultant neurosurgeon with more than five years of clinical experience. Symptom duration and relevant demographic information will be documented. Histories of tobacco use and alcohol intake will also be recorded according to the definitions described in the source synopsis.
Radiological assessment: Anteroposterior and lateral X-rays of the lumbar spine will be obtained. The source synopsis states that radiographs will be reviewed by a radiologist with more than five years of clinical experience. Osteophytes will be assessed between the L1 and S1 levels. The source definition classifies more than six osteophytes as positive and fewer than six as negative.
Laboratory assessment: A 2 mL blood sample will be collected. After centrifugation, serum will be sent to the biochemistry laboratory for beta-carotene measurement using the ELISA kit specified in the source synopsis (Bioassay Company). The assay units and laboratory reference range are not provided in the supplied document.
Variables and Outcomes
The main variables are serum beta-carotene level and radiographic lumbar osteophyte status. The protocol also records demographic information and histories of tobacco use and alcohol intake. The primary radiographic classification is based on the number of osteophytes described in the source protocol.
For consistent reporting, the research team should confirm the handling of exactly six osteophytes, because the supplied definitions state “more than six” for positive and “less than six” for negative, leaving exactly six unclassified. The synopsis should also specify the planned approach for analysing beta-carotene as a continuous measurement or as categories, if applicable.
Statistical Analysis
The source synopsis specifies SPSS version 21.0 for data analysis. Categorical variables will be summarized using percentages and analysed with the chi-square test. Numeric variables will be summarized as mean and standard deviation, and differences in means will be assessed using the independent-samples t-test. Statistical significance will be set at p < 0.05.
The final analysis plan should clearly identify the principal comparison and specify how serum beta-carotene values will be compared with osteophyte status. Any additional analysis should be prespecified rather than selected after reviewing the results.
Ethical Considerations
The supplied pages do not provide a complete description of ethics approval, informed consent, confidentiality arrangements, or participant-risk management. These details should be confirmed in the approved research synopsis and included in the final protocol before the study begins or the article is submitted for publication.
Expected Significance
The study is intended to explore whether serum beta-carotene levels are associated with radiographic lumbar osteophyte formation in older adults with chronic low back pain. The findings may help clarify whether this relationship merits further investigation in larger or longitudinal studies. As this is a cross-sectional protocol, any observed association would not establish that beta-carotene causes or prevents osteophyte formation.
Limitations
The cross-sectional design can assess associations at a single period but cannot establish temporal sequence or causation. The supplied synopsis does not fully specify the sampling technique, assay units, laboratory reference range, or complete analysis strategy. These items should be clarified before data collection and final publication.
References
1. Imagama S, et al. The effect of β-carotene on lumbar osteophyte formation. Spine. 2011;36(26):2293–2298.
2. Jaypee / JOSS. Assessment of the level of serum beta carotene in chronic low back pain patients and its association with lumbar osteophyte formation. Journal of Spinal Surgery / Jaypee journals. 2019. (Bibliographic details as provided in the source synopsis; verify before publication.)
3. Yen CH, et al. β-Carotene status is associated with inflammation and metabolic syndrome in osteoarthritis patients. Nutrients. 2021. (Additional bibliographic details were not supplied.)
4. Zahan OM, et al. The evaluation of oxidative stress in osteoarthritis. Review. 2020. (Additional bibliographic details were not supplied.)
5. Feng C, et al. Association between different composite dietary antioxidant scores and low back pain: a cross-sectional study. BMC Public Health. 2024. (The source synopsis provides limited bibliographic detail; verify the citation and its relevance to the article before publication.)
Suggested website tags: FCPS; Chronic Low Back Pain; Beta-Carotene; Lumbar Osteophytes; Spinal Osteoarthritis; Cross-Sectional Study; Radiographic Assessment; Tobacco Use; Alcohol Intake