Abstract
Chronic low back pain is a prevalent and debilitating condition, often with limited treatment options. Previous research has shown that a mattress topper containing 'Fibrilium' fibers can effectively reduce chronic low back pain. This study investigated an upgraded fiber, called "Fibranium," with enhanced composition and manufacturing, hypothesized to improve effects for pain reduction and associated parameters. The aim of this study was to evaluate the efficacy of a Fibranium fiber mattress topper for reducing pain intensity and improving function in individuals with chronic low back pain compared to a placebo topper. This prospective, randomized, double-blind, placebo-controlled trial was conducted with 54 patients (aged 40-70 years) with chronic low back pain (≥ 6 weeks, pain intensity ≥ 5/10 on a Numerical Rating Scale). Participants were randomized to a Fibranium topper (n=27) or a placebo topper (n=27) for 4 weeks. The primary outcome was the McGill Pain Questionnaire total score. Secondary outcomes included the Oswestry Disability Index, Linton-Halldén Score, Pittsburgh Sleep Quality Index, Short Form-36. Data were analyzed using linear models, with baseline scores as covariates. The Fibranium group showed significantly greater improvements in McGill total score (p = 0.000002), Oswestry Disability Index (p = 0.000005), Linton-Halldén Score (p = 0.000010), and SF-36 total score (p = 0.000001) compared to the placebo group. All SF-36 subscales except Emotional Wellbeing showed significant improvements. No significant difference was found in the Pittsburgh Sleep Quality Index total score; however, sleep latency (component 2) improved significantly in the Fibranium group (p = 0.000175). The Fibranium fiber mattress topper demonstrated significant efficacy in reducing pain and improving function in individuals with chronic low back pain. These findings support Fibranium as a non-pharmacological intervention for chronic low back pain.