Abstract

Background: Axial low back pain (LBP) is a leading cause of disability worldwide, affecting 65-80% of US adults throughout their lifetime. Lumbar facet joint arthritis (FJA) is a primary cause of LBP, with patients experiencing loss of cartilage, joint space, and ultimately, painful inflammation of surrounding tissues. First-line treatment includes use of NSAIDs; however, chronic anti-inflammatory use often leads to GI and renal toxicity side effects. Cetylated Fatty Acids (CFAs), defined as fatty acids esterified with cetyl alcohol, have likewise been shown to decrease production of inflammatory mediators (i.e. B4, IL-6, TNF-a), with limited documented side effects. The purpose of this study is to evaluate CFA supplementation, consisting of an oral gel with transdermal patch system, on FJA-related low back pain. We hypothesize CFA supplementation will reduce patient outcomes of both LBP and reported disability, with minimal adverse effects. Methods: A total of 28 patients (17 male, 11 female) were recruited to the study, with an average age of 61.8 (±17.2) years and BMI of 24.7 kg/m2(±3.9). All patients over 21 years of age with the following inclusion criteria were enrolled: axial back pain from facet degenerative joint disease (>3 months of duration). Exclusion criteria included: patients on narcotic pain medication, current use of pain patch (lidocaine), pregnancy or breastfeeding, and LBP from traumatic injury. Subjects were given a 4-week supply of CFA intervention, consisting of an oral supplement gel twice per day with 8-hr transdermal patch. The primary outcome was to measure patient physical disability using pre- and post-RMDQ scores. Secondary outcomes included pain, using NPRS scale, adverse effects, and reported outcomes. Results: After four weeks of supplementation, preliminary analysis determined a statistically significant reduction in both RMDQ Disability scores (p-value=0.002) and NPRS Reported Pain values (p-value=0.04) (Table I). Notably, 21.4% of patients reported skin irritation to the transdermal patch and 10.7% of patients reported general GI upset or diarrhea over the trial period. Four patients were excluded from the study, two patients due to non-compliance and two patients due to unrelated hospitalization, and therefore not included in the final analysis. Conclusion: The study found that a combined 4-week oral and transdermal CFA system did significantly reduce patient reported disability and pain outcomes. Interestingly, over 25% of patients experienced mild to moderate GI and skin irritation side effects from intervention. While necessary follow-up studies, including a larger cohort and control group, are to be pursued, CFA supplementation shows potential in improving LBP and overall function for patients.

Keywords

low back pain, facet joint arthritis, cetylated fatty acids, clinical outcomes, disability