Keywords: chronic low back pain, placebo-control, randomised clinical trial, natural minerals, siliconised fibre, nanotechnology, silicon, anti-ageing therapy,
Lower back pain (low back pain, shooting pain, a feeling of aching or pulling in the lumbar region) is a common complaint of patients when going to the doctor. According to international medical statistics, at least 70 per cent of the population experience such symptoms at least once in their lifetime. In 10 per cent of cases, low back pain attacks become chronic.
If the pain lasts up to 4 weeks, it is called acute, from 4 to 12 weeks – subacute, over 12 weeks – chronic.
The most common causes of lumbar pain (90 to 95%) are disorders of the musculoskeletal apparatus of the back. Such pain is called lumbalgia. In this form, the source of pain can be localised in the area of:
– muscles and ligaments of the back (myofascial pain syndrome),
– the joints of the vertebrae (facet syndrome),
– the sacroiliac joint,
– intervertebral discs (intervertebral disc protrusion, extrusion).
The pattern of symptomatology is as follows:
80-85 % – non-specific low back pain. The symptoms subside within a few weeks;
10-15% – spinal stenosis, radiculopathy causing nerve root compression;
1-2% – a specific syndrome caused by oncopathology, diseases of internal organs.
Low back pain ranks second in duration and third in frequency of causes of temporary disability among all diseases. Low back pain is one of the most significant medical problems worldwide and is difficult to treat.
Many years of scientific research and randomised clinical trials conducted by IFIBR specialists have been devoted to solving the problem of chronic lumbar pain caused by disorders of the musculoskeletal apparatus of the back.
Taking into account the recommendations of the World Health Organisation, which discourage the use of medication in chronic patients and recommend active treatments such as exercise, which, however, have only a small or moderate effect, and the fact that although prevention is possible through regular movement and exercise, the effect is not always visible and not for everyone, the IFIBR specialists focused on finding a safe treatment that could also be used for prevention.
The result of this work was the appearance on the market of an innovative product – the IFIBR model 1 therapeutic mattress pad.
It is a cotton mat with 30% content of silicon fibres, the source of which is a healing earth extracted in South Korea containing a special type of silicon crystals. Fibre containing silicon interacts with the muscles of the body, so the mattress cover from the manufacturer “IFIBR” creates ideal conditions for a healthy sleep.
Silicon fibre is able to restore the flow of energy in the body. It has its own radiation, thus ensuring stabilisation of the body’s energy balance. This allows a person to sleep better, feel more energetic and concentrate better in everyday life, without the need to exert effort. Thus, the use of “IFIBR” products can help to improve health and well-being.
The effectiveness of “IFIBR model 1” was demonstrated in a clinical study by Dr Michael Ofner. In 2019, Dr Ofner received the “ITALIAN HEALTH AWARD 2019” for his achievements in health promotion and regeneration research, thus confirming the success of the technology.
The so-called fibrilium is woven into a cotton mat (30% fibrilium, 70% organic cotton), which is then used as a mat to cover a conventional sleeping mattress to sleep on at night. The hypothesis that this fabric reflects infrared and near-infrared body radiation (wavelength 4-14 nm) was confirmed by an in-depth laboratory study.
In addition, three parallel blind and placebo-controlled randomised studies in patients with chronic low back pain, premenstrual syndrome and arthralgic pain, 50 patients in each study , conducted in accordance with GCP and in compliance with the Declaration of Helsinki, were conducted. The study was submitted and approved by the ethics committee in Carinthia with registration number: A35/16.
The study confirmed a very strong clinical effect in this strictly blind and placebo-controlled study over 4 weeks in patients with chronic low back pain.
Despite the apparent success of the development and widespread popularity of the IFIBR model 1 mattress pad, the company has continued to research for improvements in the therapeutic and consumer properties of the product.
This year a new mattress cover – “IFIBR – FIBRANIUM” – was launched on the market.
In addition to the idea of using silicon crystals, the development of “IFIBR FIBRANIUM” is based on the discovery in nature of a set of minerals capable of propelling the silicon towards incredible performance, i.e. natural chemical compounds and their mechanical mixtures with high biogenicity, or the ability to ensure interaction between biosubstrates during metabolic reactions at the cellular, organ and system level. Their origin is the Western spurs of the highest mountain systems of the planet Earth, the Himalayas and African countries.
Among the mineral salts dispersed in the lithosphere, which were subject to clinical and pharmacological study in this study, the most valuable are: native silver with an admixture of gold; the family of platinum metals (platinum and its permanent companions: iridium, osmium, palladium, ruthenium, radium); beryl and its varieties – aquamarine and emerald; corundum with an admixture of chromium – ruby, with an admixture of iron and titanium – sapphire; halogens (bromine, fluorine, chromium, iodine); chalcogenes (sulphur, selenium); alkali (lithium, sodium, potassium) and alkaline-earth metals (magnesium, calcium, barium, beryllium); iron family.
The technology applied in the manufacture of the product “IFIBR – FIBRANIUM” meets the requirements of novelty and is used to realise the potential of artificially unreproducible natural minerals.
Application of the technology with the use of silicon crystals in combination with groups of natural minerals allowed to achieve a significant increase and expansion of therapeutic and prophylactic and consumer properties of the product “IFIBR FIBRANIUM“. The table of comparative characteristics of “IFIBR model 1” and “IFIBR FIBRANIUM” is given below.
For independent expertise and preparation for further certification of the products “IFIBR model 1” and “IFIBR FIBRANIUM” were submitted to the Research laboratory of Integrative Medicine of the International University of Fundamental Learning, St. Petersburg, Russia, INTER-UNIVERSITI HIGHER ACADEMIC COUNCIL, Paris, France and TARPTAUTINIS FUNDAMENTALIŲ STUDIJŲ UNIVERSITETAS, Vilnius, Lithuania.
The aim of the study was to create a system of complex assessment and compensation of the effects of IFIBR model 1 and IFIBR FIBRANIUM on the condition of subjects experiencing pain or discomfort in the lumbar region for a long period of time.
The aim was achieved by fulfilling the following objectives:
To investigate the effects of using the products “IFIBR model 1” and “IFIBR FIBRANIUM” and a placebo product on the functional state of the subjects;
a system of diagnostics, analysis and accounting of the dynamics of the functional state of the subjects in a 4-week observation cycle was developed;
regular dynamic examinations of the subjects during the use of “IFIBR model 1″ and “IFIBR FIBRANIUM” products were carried out.
Scientific novelty and practical significance:
For the first time in persons experiencing pain or discomfort in the lumbar region, using the products “IFIBR model 1″, “IFIBR FIBRANIUM” and placebo products during 4 weeks dynamic medical observation of the state of health and basic physiological systems of the organism was carried out.
The developed system of diagnostics of psychophysiological and somatic status of the research participants was based on the totality of modern methods of examination, diagnostics and treatment accepted in physiology of labour, in outpatient and clinical medical practice; including research of the state of analyzers, immune and hormonal systems, cardiovascular system, hematopoiesis, etc.
Based on the objectives of the study, we applied methods of assessing physical performance, functional state of cardiovascular and respiratory systems, vegetative and psychological status, determination of functional reserves of the organism and neurophysiological studies.
It was shown that using the products “IFIBR model 1“, “IFIBR FIBRANIUM” there was a clear reduction in the intensity of pain or discomfort in the lumbar region, improved quality of sleep and increased psychological and emotional background of the subjects. IFIBR model 1” and “IFIBR FIBRANIUM” showed a clear decrease in the intensity of pain or discomfort in the lumbar region, improved the quality of sleep and increased the psycho-emotional background of the subjects.
However, in addition to the above-mentioned effects, the persons using the “IFIBR FIBRANIUM” product also showed correction of metabolic disorders, vegetative-vascular dysfunctions, normalisation of sympatho-adrenal and parasympathetic system reactivity caused by influence on biologically active points.
When ‘IFIBR FIBRANIUM’ is used, the skin receptors are stimulated and, as a result of the hypothalamic reaction, the smooth muscles of the blood vessels relax, resulting in dilation of the blood vessels.
Furthermore, ‘IFIBR FIBRANIUM’ has a relaxing and sedative effect, promotes wound healing, the reabsorption of haematomas, and inhibits the growth of unhealthy cells. It can be used in weight loss programmes, in the treatment of cellulite (expansion of fat cells and release of water), promotes natural sweating, which facilitates the work of the kidneys.
Numerous toxic substances are released from the body with sweat. It is necessary to emphasise the fact that 77% of the test subjects had a clear therapeutic effect as early as 5-10 minutes (!) after starting to use the IFIBR FIBRANIUM mattress cover. Whereas with the “IFIBR model 1” product such an effect is usually observed only after 3 to 4 weeks.
It should be emphasised that the pathological anatomy, pathogenesis and morphogenesis of changes with the use of the IFIBR FIBRANIUM product remain insufficiently studied and disclosed and require further in-depth studies.
Table 01
Comparative assessment IFIBR (Table 1)
Characteristics | IFIBR model 1 | IFIBR FIBRANIUM |
Type
Coating
Filler
Indications for use
Average time to therapeutic effect
Usage
Age restrictions
Wear resistance
Shelf life |
Orthopaedic
Cotton
Fibrilium nanofibre, silicon fibre
Chronic low back pain, sleep disorders
4 – 6 weeks
As a bed cover
From 18 years of age
Medium
5 years Not identified |
Orthopaedic
Lyocell / Wool
special silicon fibre with the addition of 38 types of natural minerals Chronic low back pain, sleep disorders, psycho-emotional overstrain, as a component of anti-ageing therapy
from 5/10 minutes
As a sleeping seat cover, work chair cover, resting place or vehicle seat cover
Not available. Particularly indicated for older and elderly patients
High
Not limited not identified |
Type.
Both mattress covers belong to orthopaedic therapeutic and preventive products designed to alleviate the condition of chronic patients or prevent the development of diseases.
Coating.
When manufacturing the covering of the mattress covers “IFIBR model 1” and “IFIBR FIBRANIUM” strictly 100% natural fabrics was used, which ensures good heat exchange, hygiene and hypoallergenic properties.
Filler.
Whereas only silicon nanofibre were used in the manufacture of IFIBR model 1 mattress covers, the IFIBRFIBRANIUM filler is a high-tech combination of silicon crystals and 38 natural minerals, which gives the product much higher therapeutic, preventive and consumer properties.
Indications for use.
IFIBR model 1 mattress cover has proven its effectiveness as a therapeutic and preventive product used for chronic lumbar pain, sleep disorders, neuro-psychic fatigue.
The range of indications for the use of the IFIBR – FIBRANIUM mattress cover is much wider. In addition to relieving chronic lumbar pain, normalising sleep, relieving neuropsychic tension, the product contributes to the normalisation of energy-information processes in the body and can be successfully used as an element of anti-ageing programmes. The use of “IFIBR FIBRANIUM” is especially indicated for elderly and old people, contributing to their recovery and significant improvement of the quality of life.
Average time of therapeutic effect manifestation.
While the proven average time of the therapeutic effect of the IFIBR model 1 is 4 weeks, the IFIBR FIBRANIUMhas a clear therapeutic effect on the patient after 5-10 minutes in some cases.
Usage.
The “IFIBR model 1” is used almost exclusively as a cover for the patient’s resting (sleeping) place. At the same time, the IFIBR FIBRANIUM mattress cover can also be used in a wide variety of situations: to cover a working chair, in transport – cars, trains, airplanes – where movement is restricted for long periods of time.
Wear resistance.
Unlike IFIBR model 1 and the vast majority of similar products, IFIBR FIBRANIUM is exceptionally wear-resistant. During the tests, the IFIBR FIBRANIUM mattress cover retained its therapeutic properties under rough mechanical impact (e.g. being run over by a car) and could be successfully used in the future for its intended purpose. IFIBR mattress covers, due to the use of wool and lyocell, it must be washed in the laundry or by hand at low temperatures, to maintain a high level of aesthetics.
Shelf life.
The shelf life of the product “IFIBR model 1” is declared by the manufacturer up to 10 years, while the mattress cover “IFIBR FIBRANIUM” has an unlimited period of use and can literally “pass from generation to generation”.
CONCLUSIONS
IFIBR mattress pads are a new and very important word in the industry of healthy sleep, treatment and prevention of chronic lumbar pain and anti-ageing therapy. With the introduction of the “IFIBR FIBRANIUM” product on the market, many people have not only solved their health problems but also significantly improved their quality of life.
Research Institutes.
IUHAC Inter-University Higher Academic Council, Paris
TFSU Research Laboratory of Integrative Medicine, Lithuania
IUFS Research lab – International University of Fundamental Studies, Moscow
IHAC International Higher Academic Council, St.Petersburg