Efficacy of a Novel Fibranium Fiber Mattress Topper for Reducing Chronic Low Back Pain: A Randomized, Double-Blind, Placebo-Controlled Trial

Article Sidebar

PDF
Published Apr 30, 2025
DOI: https://doi.org/10.18103/mra.v13i4.6494

Downloads

Download data is not yet available.

Submit your own article

Register as an author to reserve your spot in the next issue of the Medical Research Archives.

Author Registration

Join the Society

The European Society of Medicine is more than a professional association. We are a community. Our members work in countries across the globe, yet are united by a common goal: to promote health and health equity, around the world.

Join Europe’s leading medical society and discover the many advantages of membership, including free article publication.

Membership

Main Article Content

Michael Ofner
Department of Pathophysiology and Immunology, Medical University Graz, Austria;  Medyco International, Dubai, United Arab Emirates
Martin Liebhauser
ImPuls Institut, Klagenfurt, Austria
Harald Walach
Kazimieras Simonavicius University, Vilnius, Lithuania ; CHS-Institut, Basel, Switzerland

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.

Keywords: chronic low back pain, Fibranium, mattress topper, randomized controlled trial, pain management, non-pharmacological intervention, infrared radiation

Article Details

How to Cite
OFNER, Michael; LIEBHAUSER, Martin; WALACH, Harald. Efficacy of a Novel Fibranium Fiber Mattress Topper for Reducing Chronic Low Back Pain: A Randomized, Double-Blind, Placebo-Controlled Trial. Medical Research Archives, [S.l.], v. 13, n. 4, apr. 2025. ISSN 2375-1924. Available at: <https://esmed.org/MRA/mra/article/view/6494>. Date accessed: 15 may 2025. doi: https://doi.org/10.18103/mra.v13i4.6494.
ABNT APA BibTeX CBE EndNote - EndNote format (Macintosh & Windows) MLA ProCite - RIS format (Macintosh & Windows) RefWorks Reference Manager - RIS format (Windows only) Turabian
Issue
Vol 13 No 4 (2025): Vol.13, Issue 4, April 2025
Section
Research Articles

The Medical Research Archives grants authors the right to publish and reproduce the unrevised contribution in whole or in part at any time and in any form for any scholarly non-commercial purpose with the condition that all publications of the contribution include a full citation to the journal as published by the Medical Research Archives.

 

References

1. Global Burden of Disease Collaborative Network. Global Burden of Disease Study (GBD 2019) Results. Seattle, United States: Institute for Health Metrics and Evaluation (IHME);2020.
2. Qaseem A, Wilt TJ, McLean RM, Forciea M, Physicians; ftCGCotACo. Noninvasive treatments for acute, subacute, and chronic low back pain: A clinical practice guideline from the american college of physicians. Annals of Internal Medicine. 2017;166(7):514-530.
3. Savigny P, Kuntze S, Watson P, et al. Low Back Pain: early management of persistent non-specific low back pain. London: National Collaborating Centre for Primary Care and Royal College of General Practitioners; 2009.
4. Chou R, Deyo R, Friedly J, et al. Nonpharmacologic Therapies for Low Back Pain: A Systematic Review for an American College of Physicians Clinical Practice Guideline. Ann Intern Med. 2017;166(7):493-505.
5. Ofner M, Treven M, Walach H. A new nano-fibre mat has a strong benefit for chronic low-back pain patiens - Results of a double-blind randomised trial. Clinical Research and Trials. 2019;5:1-6.
6. Tonelli MR. Optische Kennzeichnung der Proben von Cafissi in dem Spektralbereich von 4-14 um [Optical characterisation of probes of "cafissi" in the spectral range of 4 - 14 micrometer]. Pisa: CNRNano: Istituto Nanoscienze - Consiglio Nazionale di Ricerche; 2013.
7. Tsai S-R, Hamblin MR. Biological effects and medical applications of infrared radiation. Journal of Photochemistry and Photobiology B: Biology. 2017;170:197-207.
8. Vatansever F, Hamblin MR. Far infrared radiation (FIR): Its biological effects and medical applications [Ferne Infrarotstrahlung: Biologische Effekte und medizinische Anwendungen]. Photonics & Lasers in Medicine. 2012;1(4):255-266.
9. Hammerschlag R, Levin M, McCraty R, et al. Biofield physiology: A framework for an emerging discipline. Global Advances in Health and Medicine. 2015;4(suppl):35-41.
10. Ives JA, van Wijk EPA, Bat N, et al. Ultraweak Photon Emission as a Non-Invasive Health Assessment: A Systematic Review. PLoS ONE. 2014;9(2):e87401.
11. van Wijk R, van Wijk EPA, Wiegant FAC, Ives J. Free radicals and low-level photon emission in human pathogenesis: State of the art. Indian Journal of Experimental Biology. 2008;46:273-309.
12. Popp FA. Biophoton emission. Experientia. 1988;44:443-444.
13. Zarkeshian P, Kergan T, Ghobadi R, Wilten N, Simon C. Photons guided by axons may enable backpropagation-based learning in the brain. . 2022;12(1):20720. PMID: 36456619. Scientific Reports. 2022;12(1):20720.
14. Pollack GH. The Fourth Phase of Water: Beyond Solid, Liquid, and Vapour. Seattle: Ebner & Sons; 2013.
15. Bordoni B, Marelli F. Emotions in motion: myofascial interoception. Complementary Medicine Research. 2017;24:110-113.
16. Langevin HM, Keely P, Mao J, et al. Connecting (t)issues: How research in fascia biology can impact integrative oncology. Cancer Research. 2016;76(21):6159-6162.
17. Tozzi P. A unifying neuro-fasciagenic model of somatic dysfunction - underlying mechanisms and treatment - part I. . Journal of Bodywork and Movement Therapies. 2015;19:310-326.
18. Tozzi P. A unifying neuro-fasciagenic model of somatic dysfunction - underlying mechanisms and treatment - Part 2. Journal of Bodywork and Movement Therapies. 2015;19:526-543.
19. Ofner M, Walach H. The Vegetative Receptor-Vascular Reflex (VRVR) – A New Key to Regeneration. Frontiers in Physiology - Autonomic Neuroscience. 2020;11:547526.
20. Dworkin RH, Turk DC, Farrar JT, et al. Core outcome measures for chronic pain clinical trials: IMMPACT recommentatioins. Pain. 2005;113:9-19.
21. Kiss I, Müller H, Abel M. The McGill Pain Questionnaire - German version. A study on cancer pain. Pain. 1987;29(2):195-207.
22. Melzack R, ed Pain. Measurement and Assessment. New York: Raven Press; 1983.
23. Mannion AF, Junge A, Fairbank JC, Dvorak J, Grob D. Development of a German version of the Oswestry Disability Index. Part 1: cross-cultural adaptation, reliability, and validity. European Spine Journal. 2006;15:55-65.
24. Fairbank J, Davies J, Couper J, al. e. The Oswestry low back pain disability questionnare. Physiotherapy. 1980;66:271-273.
25. Linton SJ, Halldén K. Can we screen for problematic back pain? A screening questionnaire for acute and subacute back pain. Clinical Journal of Pain. 1998;14(3):209-215.
26. Backhaus J, Junghanns K, Broocks A, Riemann D, Hohagen F. Test-retest reliability and validity of the Pittsburgh Sleep Quality Index in primary insomnia. Journal of Psychosomatic Research. 2002;53(3):737-740.
27. Buysse D, Reynolds C, Monk T, Berman S, Kupfer D. The Pittsburgh Sleep Quality Index: A new instrument for psychiatric practice and research. Psychiatry Research. 1989;28:193-213.
28. Bullinger M, Kirchberger I. Der SF-36 Fragebogen zum Gesundheitszustand (SF-36). Handbuch für die deutschsprachige Fragebogenversion. Göttingen: Hogrefe; 1998.
29. Popp F-A. Biophotons - Background, experimental reuslts, theoretical approach and applications. Frontier Perspectives. 2002;11(1):16-28.
30. Sandkühler J. Learning and memory in pain pathways. Pain. 2000;88:113-118.
31. Bordoni B, Marelli F, Morabito B, Castagna R, Sacconi B, Mazzucco P. New proposal to define the fascial system. Complementary Medicine Research. 2018;25:257-262.
32. Schleip R, Findley TW, Chaitow L, Huijing PA, eds. Fascia: The Tensional Network of the Human Body. London: Churchill Livingstone/Elsevier; 2012.
33. Schleip R. Fascia as an organ of communication. In: Schleip R, Findley TW, Chaitow L, Huijing PA, eds. Fascia: The Tensional Network of the Human Body. London: Churchill Livingstone; 2012:77-79.
34. Pomeranz B. Acupuncture analgesia - basic research. In: Stux G, Hammerschlag R, eds. Clinical Acupuncture. Scientific Basis. Heidelberg: Springer; 2001:1-28.
35. Bergholdt K, Fabricius RN, Bendix T. Better backs by better beds? Spine (Phila Pa 1976). 2008;33(7):703-708.
36. Kovacs FM, Abraira V, Peña A, et al. Effect of firmness of mattress on chronic non-specific low-back pain: randomised, double-blind, controlled, multicentre trial. The Lancet. 2003;362(9396):1599-1604.
37. Alfano AP, Taylor AG, Foresman PA, et al. Static magnetic fields for treatment of fibromyalgia: A randomized controlled trial. Journal of Alternative and Complementary Medicine. 2001;7:53-64.
38. Caggiari G, Talesa GR, Toro G, Jannelli E, Monteleone G, Puddu L. What type of mattress should be chosen to avoid back pain and improve sleep quality? Review of the literature. Journal of orthopaedics and traumatology : official journal of the Italian Society of Orthopaedics and Traumatology. 2021;22(1):51.
39. Ervolino F, Gazze R. Far infrared wavelength treatment for low back pain: Evaluation of a non-invasive device. Work (Reading, Mass). 2015;53(1):157-162.
40. Oosterveld FG, Rasker JJ, Floors M, et al. Infrared sauna in patients with rheumatoid arthritis and ankylosing spondylitis. A pilot study showing good tolerance, short-term improvement of pain and stiffness, and a trend towards long-term beneficial effects. Clin Rheumatol. 2009;28(1):29-34.
41. York RM, Gordon IL. Effect of optically modified polyethylene terephthalate fiber socks on chronic foot pain. BMC Complement Altern Med. 2009;9:10.
42. Gale GD, Rothbart PJ, Li Y. Infrared therapy for chronic low back pain: a randomized, controlled trial. Pain research & management. 2006;11(3):193-196.
43. Masuda A, Koga Y, Hattanmaru M, Minagoe S, Tei C. The effects of repeated thermal therapy for patients with chronic pain. Psychother Psychosom. 2005;74(5):288-294.