A new nano-fibre mat has a strong benefit for chronic low back pain patients – Results of a double-blind randomised trial

Abstract

Background: Chronic low back pain is one of the most debilitating medical problems worldwide and difficult to treat. New methods are wanted. A cotton mat with 30% silica fibres produced from traditional Korean clay by nano-technology, fibrilium, has shown very good informal results in practice. We tested this mat for clinical effectiveness. Methods and Findings: Randomized, placebo-controlled, blinded clinical trial in 50 chronic low back pain patients (median duration of illness 10 years; pain severity > 5 on a 10 point scale); 2 patients withdrew, 48 were analyzed. The study was fully blinded. Intervention was sleeping on a fibrilium mat on top of a normal matrace for 4 weeks or on a mat with only cotton fibres. Outcomes were functional scores (Oswestry Disability Score, Linton-Halldén Score, McGill Pain Questionnaire), sleep quality (Pittsburgh Sleep Quality Index), generic quality of life (SF 36), clinical ratings (pain, wellbeing), and physiological measures (skin conductance, heart rate, breathing frequency). All 5 multivariate linear models with baseline scores as covariates showed significant differences between groups in all measures (p < .038 to p < .0.0002), with large effect sizes for the functional scores between d = 0.8 and d = 1.4. We observed no negative effects. The trial’s main limitation is its short observation period. Conclusion: Sleeping on a fibrilium mat that contains 30% fibres made from silica containing clay using nano-technology has a strong therapeutic effect on chronic low back pain. *Correspondence to: Harald Walach, Change Health Science Institute, Schönwalder Str. 17D – 13347, Berlin, Germany, E-mail: hwalac@gmail.com