Journal of Orthopedics
Fibromyalgia and therapeutic integration: role of quantum medicine
*Giovanni Barassi1, Alì Younes2, Antonella Di Iulio3, Sergio Guerri4,Vito Guglielmi4,Franco Della Rovere4, Angelo Di Iorio5
- Physiotherapy Center for Rehabilitation and Reeducation (Ce.Fi.R.R.) venue “G. d’Annunzio University” Chieti-Pescara.
- Sector of clinical evaluation and diagnosis: Ce.Fi.R.R. venue “G. d’Annunzio” University-Chieti Pescara- Clinical Manager International Association for Fibromyalgia Research
- UOC Thoracic Surgery. Hospital “Santo Spirito” Pescara (PE) – ASL Pescara
- Sector of clinical evaluation and diagnosis: Ce.Fi.R.R. venue “G. d’Annunzio” University-Chieti Pescara
- Department of Aging Sciences – “G. Annunzio” University Chieti-Pescara
Physiotherapy Center for Rehabilitation and Reeducation (Ce.Fi.R.R.) venue “G. d’Annunzio University” Chieti-Pescara.Viale Abruzzo, 322 Chieti Scalo c/o Centro Universitario di Fisioterapia e Riabilitazione c/o G. d’Annunzio University, Chieti, 66100, Italy
Fibromyalgia is a mutifactorial pathology that requires complex multidisciplinary collaboration.
The aim of this single-blind randomized controlled clinical trial was to evaluate the therapeutic integration of manual neuromuscular therapy, rhythmic electric frequency modulation therapy (FREMS) and cyclotronic bioresonance (QPS1), in fibromyalgia syndrome (FMS).
There were statistically significant improvements in the two groups for pain, disability and muscle rheological values.
The parameters of elasticity, stiffness and muscle tone improve during the three months of the study in a variable percentage that varies from 20 to 60%. We can observe that in the group undergoing bioresonance therapy (QPS1) improves the accounting of muscle performance by a quarter to half of the total variation.
The integration of therapies in patients with FMS has been shown to be effective, using quantum bioresonance therapy which tends to restore the functionality of the organism and its regulatory systems.
According to the American College of Rheumatology, fibromyalgia syndrome (FMS) is a common health problem characterized by widespread pain and tenderness (1). Patients with FMS suffer from fatigue and often have sleep disturbances. FMS is estimated to affect 2 to 4 percent of the general population .(2)
FMS is estimated to affect 2%–8% of the adult population and is the most common cause of generalized, musculoskeletal pain in women between the ages of 20 and 55 years. (3)
Manual therapy, as one of the complementary and alternative treatments, has been widely used for FM. (4)
However, the conclusions of massage therapy for FM are inconsistent, although many studies have provided beneficial evidence for the use of manual therapy in the treatment of FM. (5)
Changes in the amplitude of Hoffmann reflex (H-reflex) may reflect variations in the characteristics of the largely monosynaptic circuitry that is explored and are a possible target for physical therapeutic intervention. Previous workers applied fixed frequency in the low- (2-5 Hz) or in the high- (100 Hz) field, but they did not attempt to vary frequency and/or impulse duration in time.
H-reflex amplitude was substantially decreased (-50%) during FREMS (Frequency Rhythmic Electrical Modulation System) and H-reflex amplitude variations were influenced by w/f variation in time during FREMS subphase C in a predictable way (r(2)=0.43; P<0.001). This study suggests an effective ability of FREMS to modulate H reflex amplitude. (6)
The aim of this study is to evaluate the effectiveness of a new integrated therapeutic approach: the cyclotron ion resonance (Quech Phisis1 which identifies the cyclotron apparatus and resonance technology in a concentrated field)(7) associated with FREMS (Frequency Rhythmic Electrical Modulation System) and manual therapy for patients with FMS to reduce the nociceptive impact with consequent improvement of symptoms and quality of life and muscle tissue, establishing the integration of therapy as a safe and effective intervention for FMS.
MATERIALS AND METHODS
The patients were recruited at the physiotherapy, rehabilitation and re-education center (CeFiRR) venue of the University of Chieti-Pescara to allow interested parties to assess their suitability.
The trial was conducted between December 2019 and February 2020.
The study was conducted according to common standard guidelines for clinical studies:
all participants signed the informed consent for the experimental procedure, which complies with the latest revision of the Helsinki Declaration and with the procedures defined by the ISO 9001-2015 standards for “Research and Experimentation”; this procedure also protects the privacy of subjects participating in biomedical research.
Patients who met the inclusion criteria were invited for evaluation in which detailed information on the written study was provided; and their written informed consent has been obtained.
The physician verified the patient’s medical history, examined their physical health and checked the patient’s medical records. If patients met the inclusion criteria and did not meet any exclusion criteria, they were included.
The study participants were aged between 18 and 75 and fibromyalgia syndrome was diagnosed by specialists in rheumatology and pain therapy.
Patients also had to report at least moderate pain of 45mm or greater on an analog visual scale (VAS), with 100mm described as “worst imaginable pain” (8).
Exclusion criteria from the study included pain due to inflammatory rheumatic disorder, any serious psychiatric disorder, severe depression or substance abuse, any severe comorbidity such as cancer or neurological disorders, recently started or changed drug treatment, previous injections or acupuncture (previously 3 months or during the study), treatment with opioids or steroid painkillers.
Drugs such as nonsteroidal anti-inflammatory or antidepressants were allowed if the dosage was kept constant during the study. Finally, pregnant or lactating women or patients who took part in other clinical studies were excluded. A total of 20 women with an average age of 42 were hired for the study.
Patients were assigned to one of two groups in sequential order by adopting a computer-generated layered block randomization (Random Allocation Software, version 1.0.0) with random-sized blocks.
Group A: 10 patients assigned to group “A” performed peripheral sensorineural stimulation therapy three times a week in this order:
Manual neuromuscular therapy
Group B: 10 patients assigned to group “B” performed peripheral sensorineural stimulation therapy three times a week in this order:
Neuromuscular manual therapy
Therapy of the rhythmic frequency electric modulation system (FREMS), based on the administration of pulsed, negative, asymmetric single-phase pulsed electric fields generated by a neurostimulator with characteristics of low variable frequency, high voltage and very low pulse duration.
Manual neuromuscular therapy:
it consisted of joint treatment, balanced ligament tension / joint ligament tension treatment, anti-stretch treatment, direct treatment, muscle energy treatment, soft tissue treatment (ST) and visceral manipulative treatment.
The QUEC PHISIS system emits ultra-weak electromagnetic waves which, by calculating the cyclotronic resonance of the ions in the sectors of water coherence, excite the ions themselves making them “bioavailable”.
FIQR: was developed in response to known shortcomings of the FIQ. The FIQR has the same 3 domains as the FIQ (i.e. function, overall impact and symptoms). All questions are ranked on a 0-10 numerical scale.
VAS: is typically presented as a horizontal line.
Passive muscle stiffness, tone and elasticity were measured in a relaxed state using a portable myotonometric device, MyotonPRO (Myoton AS, Tallinn, Estonia).
Two muscle sites were selected for myometric measurement: lumbar paravertebral (L3 level) and upper trapezius. At each site, the mean value of two sets of five consecutive measurements was used for analysis. The same tester performed all myometric measurements. (9)
In the comparison between the enrolled groups, no statistically significant differences were found, at baseline in: rheological properties (elasticity,stiffness and muscle tone)
and in the evaluation of the FMS clinical score (VAS and FIQR) (Table 1, column p -value 1).
The rehabilitation intervention in the three months of the study induced a significant reduction of almost all the markers evaluated, regardless of the type of intervention (table 1, p value 2).
Both VAS and FIQR were statistically significant reduced in the comparison between the two times. In the FIQR score almost 80.8% of the variation within the person is associated with linear time, while in the SEA this association was 73.4%.
Muscle tone assessment was statistically significantly reduced in all study groups, regardless of the treatment group (table 1 column p-value 2); the left trapezius seems to be affected only modestly by the interventions (p value for time = 0.17). In addition, the proportional reduction of the level 1 variance component ranges from 49.5% for the right trapezius to 62.4% for the right paraspinal.
The elasticity parameter increased, and the stiffness decreased, between the two times of the study, statistically significant in the overall enrolled population, both for the Trapezius and Paraspinal muscles regardless of the dimensions considered (table p column 1 value 2). The proportional reduction of the level 1 person variance component per time ranged from 17.8% for rigidity of the right trapezius to 60.0% of the elastic property of the right paraspinal.
No significant differences were found in the interaction between time and treatment group, with the exception of muscle tone, stiffness and the elasticity parameter for the paraspinal muscles bilaterally (p-value of column 1 of table 1). Interestingly, the percentage in total variation is linearly associated with treatment group B, and in detail, it represented 25.3% (right paraspinal muscle) and 47.4% (left paraspinal muscle) for muscle tone; 29.1% (left paraspinal muscle) for rigidity; 51.7% (right paraspinal muscle) and 40.9% (left paraspinal muscle) for elastic properties.
|Table 1: Mixed Model analysis, comparison between treatments and times of the study. Values were reported as mean±S.E.; Paraspinal muscles were assessed at L3 level.
|Baseline||Follow-up||Baseline||Follow-up||p-value 1||R2ε||p-value 2||p-value 3|
|FIQR= Fibromyalgia Impact Questionnaire Revised; V.A.S.: Visuo Analogic Scale;
p-value 1: statistical test for the comparison between treatment at the baseline;
p-value 2: statistical test for the comparison between time independently of group of treatment;
R2ε = Proportional reduction in the Level-1 variance component for time;
p-value 3: statistical test for the comparison between treatment and time (interaction term)
The diagnosis of FMS has changed in the last 10 years, but objective criteria do not yet exist: diagnosis and therapy can be complex and require the collaboration of many specialists. Rheumatologists often diagnose and differentiate FMS with other disorders from the rheumatoid group. (10) (11).
In order to evaluate the function of the endogenous mechanisms that modulate somatosensory input in the FMS, the effect of vibratory stimulation, the heterotopic harmful stimulation of conditioning on the perception of various somatosensory modalities and the transcutaneous electrical nerve stimulation were evaluated. (12)
Only in recent decades, biophysical studies have shown that with the ionic resonance of the cyclotron it is possible to stimulate the passage of ions through the cell membranes of living beings, modifying their permeability and thus improving the ion exchange on both sides of the membrane itself. Cellular DNA emits very low frequency waves.
The failure of this “interval” compromises the balance of the cell, with consequent onset of pathological manifestations. The increase in the bioavailability of the essential ions increases the efficiency of the cell itself by adding its correct metabolism (13).
In this study, the main results showed that the integration of rehabilitation ensured a subjective improvement in both groups as by means of an objectively instrumental assessment, regardless of the type of intervention.
Both manual somatic stimulation (14) and FREMS therapy(15) contributed to the reduction of pain and the increase in quality of life in the two groups.
The parameters of elasticity, stiffness and muscle tone improve during the three months of the study in a variable percentage that varies from 20 to 60%. We can say that in the group that has undergone bioresonance therapy (QPS1) improves the accounting of muscle performance by a quarter to half of the total variation.
The results confirmed the advantages of the protocol to reduce the nociceptive impact with consequent improvement of symptoms, quality of life and muscle tissue, establishing the integration of therapies in patients with FMS, using quantum bioresonance therapy which tends to restore the functionality of the organism and its regulation systems.
- Schmidt-Wilcke T, Clauw DJ:Fibromyalgia: from pathophysiology to therapy.Nat Rev Rheumatol. 2011 Jul 19; 7(9):518-27. Review
- Review Clauw DJ, Arnold LM, McCarberg BH :The science of fibromyalgia. Mayo Clin Proc. 2011 Sep; 86(9):907-11
- Branco JC, Bannwarth B, Failde I, Abello Carbonell J, Blotman F, Spaeth M, Saraiva F, Nacci F, Thomas E, Caubère JP, Le Lay K, Taieb C, Matucci-Cerinic M. Prevalence of fibromyalgia: a survey in five European countries.
- Arnold LM, Fan J, Russell IJ, Yunus MB, Khan MA, Kushner I, Olson JM, Iyengar SK. The fibromyalgia family study: a genome-wide linkage scan study. Arthritis Rheum. 2013 Apr; 65(4):1122-8.
- Kalichman L. Massage therapy for fibromyalgia symptoms. Review
Rheumatol Int. 2010 Jul; 30(9):1151-7.
- Barrella M1, Toscano R, Goldoni M, Bevilacqua M. Frequency rhythmic electrical modulation system (FREMS) on H-reflex amplitudes in healthy subjects. Eura Medicophys. 2007 Mar;43(1):37-47. Epub 2006 Dec 12.
- Corbellini E, Corbellini M, Licciardello O, Marotta F. – Modulating biological events by biophysics: an innovative molecular methodology using ion cyclotron resonance–a pilot study. – Epub 2014 Apr 8
- Jensen M. P., Chen C. & Brugger A. M. Interpretation of visual analog scale ratings and change scores: a reanalysis of two clinical trials of postoperative pain. J Pain 4, 407–414, doi: 10.1016/S1526-5900(03)00716-8 (2003).
- Bizzini M, Mannion AF.Reliability of a new, hand-held device for assessing skeletal muscle stiffness.Clin Biomech (Bristol, Avon). 2003 Jun;18(5):459-61.
- Wolfe F, Walitt B.Culture, science and the changing nature of fibromyalgia. Nat Rev Rheumatol. Review 2013 Dec; 9(12):751-5.
- Sprott H, Salemi S, Gay RE, Bradley LA, Alarcon GS, Oh SJ, et al. Increased DNA fragmentation and ultrastructural changes in fibromyalgic muscle fibres. Ann Rheum Dis 2004; 63: 245–51.
- Kosek E, Hansson P. Modulatory influence on somatosensory perception from vibration and heterotopic noxious conditioning stimulation (HNCS) in fibromyalgia patients and healthy subjects. Pain. 1997;70:41–51.
- Luc Montagnier, Emilio Del Giudice, Jamal Aïssa, Claude Lavallee, at all: “Transduction of DNA information through water and electromagnetic waves” – Electromagnetic Biology and Medicine 2015.34:106-112
- Barassi G, Bellomo RG, Di Giulio C, Giannuzzo G, Irace G, Barbato C, Saggini R. Effects of Manual Somatic Stimulation on the Autonomic Nervous System and Posture.Adv Exp Med Biol. 2018;1070:97-109. doi: 10.1007/5584_2018_153.
- Farina S, Casarotto M, Benelle M, Tinazzi M, Fiaschi A, Goldoni M, Smania N. A randomized controlled study on the effect of two different treatments (FREMS AND TENS) in myofascial pain syndrome.Eura Medicophys. 2004 Dec;40(4):293-301.