December 17, 2007

Proposed Research: Efficacy of Matrix Repatterning in promoting health

Proposed Research: Efficacy of Matrix Repatterning in promoting Health

Prepared by:

John H Page MBBS(Hons) MSc ScD Diplomate ABIM

Internist, Epidemiologist, Biostatistician

Harvard University School of Public Health

Outline of Research Proposal

1. Specific Aims

Specific Aim 1: To validate the measurements to be used in evaluating Matrix Repatterning. This includes measures of ranges of motion at joints, size of organs, length and width of bone measures, biomarkers, other clinical measurements, and a measure of overall well-being

Specific Aim 2: To collect case reports and compare outcomes to what would have been expected with the standard of routine medical care

Specific Aim 3: To evaluate before and after clinical outcomes in an unselected group of clients

Specific Aim 4: To evaluate the efficacy of matrix repatterning in a controlled clinical trial

2. Background and Significance

Definition of Matrix Repatterning

Clinical Experience with Matrix Repatterning

Alternatives to Matrix Repatterning

Evaluation of select organ function:

Heart: N-terminal prohormone brain natriuretic peptide

Liver: Gamma glutamyl transpeptidase (GGT), C-reactive protein

Kidney: Serum Creatinine, Creatinine Clearance

Blood vessel: Blood pressure

The matrix: Range of motion at joints, muscle tone

3. Research Design and Methods

There is hierarchy of research methods that are used in evaluating the usefulness of any therapy

i) Case reports

ii) Case series

iii) A comparison of a series of patients to expected outcomes in a similar group of patients

iv) Non-randomized controlled clinical trial

v) Randomized clinical trial

We need to determine our exact goals for this research, and appropriately choose the research methods that will best answer our questions, while not being disruptive of patient care.

We also need to determine the appropriate intervals for follow-up as well as the length of follow-up in order to establish how lasting clinical changes are.

It is important to establish objectivity of clinical measurements. It may not be feasible to “blind” evaluators of clinical response to the kind of therapy being offered. There are other ways to establish objectivity of clinical measurements, e.g. training and testing of evaluators.

4. Data Management

We will need to develop a system of recording clinical data into standardized forms and or computer database to facilitate data analysis and optimize patient confidentiality.

5. Quality Control

6. Data Analysis

i) Evaluation of reliability and validity of measures by estimating kappa, intraclass correlation coefficients. This will involve the use of random effects regression models

ii) Multivariate linear regression

iii) Multiple logistic regression

7. Human Subjects/Ethical concerns

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Proposed Research: Efficacy of Matrix Repatterning in promoting Health Prepared by: John H Page MBBS(Hons) MSc ScD Diplomate ABIM Internist, Epidemiologist, Biostatistician Harvard University School of Public Health Outline of Research Proposal 1. Specific Aims Specific Aim 1: To validate...

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