Proposed Research: Role of Matrix Repatterning in improving cardiac function
John H Page MBBS (Hons) MSc ScD
Department of Epidemiology, Harvard University School of Public Health
George Roth BSc DC ND
Matrix Repatterning Center, Aurora, Ontario
1. Specific Aim To evaluate the effect of Matrix Repatterning on B-type natriuretic peptide (BNP) in adults with primary restrictions* involving the heart.
2. Background and Significance
Matrix repatterning is a diagnostic and therapeutic strategy(1) that was developed by Dr George Roth, and has been used for the past 15 years to treat individuals with functional disorders and/or symptoms of pain. Matrix repatterning recognizes that the whole body, including sub-cellular structures, cells, organs, and bone is connected through the cytoskeleton, and connective tissue through the principle of tensegrity (2). It uses the energetic properties of normally functioning hands(3) to detect areas of primary restrictions in the body’s interconnected framework (the matrix), and uses pressure on the tissues to effect structural changes in organs and bones with resultant improvement in health(1). It is thought that these structural changes occur through the effect of pressure on tissues to induce piezoelectricity (3-5).
Clinical Experience with Matrix Repatterning
Matrix repatterning has been successfully used to eliminate various pain syndromes including low-back pain, neck pain, and headaches(1), as well as pain resulting from various injuries. Simultaneous with many of these improvements, individuals have also discovered that other symptoms have improved, including musculoskeletal and athletic performance, hearing loss, gastro-esophageal reflux, numbness, muscle weakness, snoring and apnea, as well as general levels of energy. It has been found that one of the most frequent primary restrictions found in clients is one involving the region of the heart. In some cases, these individuals had clinically apparent murmurs on clinical examination pre-treatment that disappeared after treating the heart using matrix repatterning. Many of these patients have also reported much improved energy levels and improved functioning in their day-to-day activities. We therefore seek to determine the efficacy of matrix repatterning in improving markers of cardiac function in clients with primary restrictions in the region of the heart.
Heart Disease in the North-American population
Heart disease is the number one cause of death in North America(6, 7). The majority of this heart disease is due to coronary artery disease. Congestive heart failure is also common and is the most common cause of hospitalization in individuals aged 65 or over(7). Though less common, valvular heart disease occurs frequently in the North American population(6). One of the most common valvular defects found on examination is mitral valve prolapse, which is often associated with mid-systolic clicks and a systolic murmer on clinical examination. It occurs in as many as 10% of young women and the need for surgical valve repair increases with age and is also more common in men(6). Although there are well-established biological models and prevention strategies for heart disease, its incidence remains high. There have been few studies on the role of trauma in heart disease. However, animal studies suggest that the heart may be a frequent site of injury in motor vehicle accidents(8).
B-type Natriuretic Peptide in the evaluation of heart disease
Brain (B-type) natriuretic peptide (BNP) is a hormone that is released mainly from the left ventricle of the heart in response to stretch of heart cells(9, 10). The biological effects include increased urination (diuresis), vasodilatation, inhibition of renin and aldosterone production and of cardiac and vascular myocyte growth(9). Its concentration in the blood is measured as a marker of cardiac function, and it is now widely used as a biochemical marker of heart failure(11-14). Changes in plasma concentration of BNP is also useful in monitoring adequacy of therapy in heart failure(12). The Triage BNP assay system is a fluorescence immunoassay for quantitative determination in whole blood and plasma specimens(15), and has now been approved by the USA Federal Drug Administration (FDA). The system consists of a Triage BNP Test device that is the size of a Popsicle stick and contains all the reagents sufficient for immunoassay measurements of BNP. EDTA whole blood or plasma is placed on the device, which contains two internal positive controls to indicate that sufficient sample was applied to the device. After a 10-minute incubation the BNP Test device is inserted into the Triage Meter, an instrument the size of a telephone, for reading and result printout. The analytical sensitivity of the Triage BNP Test was < 5 pg/mL (95% confidence interval: 0.2-4.8 pg/mL) and the measurement range is 5 to 5000 pg/mL. The coefficients of variations at mean BNP concentratios of 29.1 pg/ml and 1128 pg/mL were 10.4% and 15.8% respectively(10, 16). BNP concentrations also vary in the normal population. The levels vary according to age (greater with older age), sex (greater in women), physical activity and circadian rhythm(10, 17-19). It is therefore important to focus on intra-individual changes and time of day in measurement.
The effect of matrix repatterning on myocardial stress
Our aim in this study is to determine the effect of matrix repatterning on cardiac stress as measured by B-type natriuretic peptide (BNP) in a randomized clinical trial. The demonstration that matrix repatterning effects changes in this way would improve our understanding of the efficacy of this therapeutic strategy, increase awareness among the wider medical community, and allow a wider cross section of the population to benefit from this therapy. It would also open the door to further clinical and laboratory research of this important technique.
3. Research Design and Methods
We propose to study the role of matrix repatterning in treating myocardial stress by doing a randomized clinical trial.
Clients who present for matrix repatterning at the Matrix Repatterning Center in Aurora, Ontario will be evaluated and those determined to have primary restrictions involving the myocardium will be considered for the study. Full informed consent will be requested. Clients will be randomized (by using random numbers from a computer program, a sequence that the therapist will be “blind” to) for early treatment versus later treatment with matrix repatterning.
All of the patients who consent to the study will have blood samples withdrawn for evaluation of BNP concentration by the Triage BNP Test. The half of the study population randomized to the early therapy arm will be treated immediately after blood sampling. The primary restrictions will be treated in order of importance defined by the evaluation. Re-evaluation of BNP concentration will be repeated at 4 weeks, 8 weeks, and at six months; all done within the same one hour window of the 24 hour clock. Those clients in the delayed therapy arm will have treatment initiated 4 weeks after initial evaluation.
4. Data Management
Clinical (including blood pressure) and demographic data will be entered on standardized forms and later entered into a computer database to facilitate data analysis and optimize patient confidentiality. All records will be kept confidential
6. Data Analysis
The primary outcome for analysis will be change in BNP concentration 4 weeks after therapy. A secondary outcome will be maintenance of BNP change in subsequent weeks (as measured at 8 weeks, and at 6 months). Statistical analysis will be done using random effects multivariate linear regression(20).
7. Human Subjects/Ethical concerns
*Primary Restriction: an area of tissue resistance, representing a clinically significant finding, detectable through the application of a standard Matrix Repatterning evaluation.
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