CURRENT & ONGOING RESEARCH PROJECTS
Introduction & Perspective
Throughout the history of the chiropractic profession, the belief that a bone in the spine is fixed in an abnormal position (subluxated) and when the spine is adjusted, the bone is corrected to a normal position. This has been the nemesis of scientific investigation and research for years. Even to this day few chiropractors and researchers have been aware of the ability of upper cervical chiropractors to measure misalignments of the cervical spine using angular (rotatory) relationships. Fewer still are aware of the ability of upper cervical chiropractors to apply the correction principle and return a “subluxated bone (joint)” to a normal position.
During early chiropractic investigations and education, the focus of care was on the upper cervical spine. Over time, this focus shifted to the entire spine creating a shift in belief systems between upper cervical and “full-spine” or “segmental” chiropractors. Few resources have been dedicated to research to test the upper cervical proposition that spinal misalignments (abnormal position) create mechanical distress that has a global affect on the nervous system, body posture, and normal physiology.
Chiropractic research has been focused on the effectiveness of spinal manipulation therapy regarding the outcomes of a wide range of symptoms, pain relief, and increasing the mechanical range of motion. This has been practiced to the near exclusion of determining what is biomechanically and neurologically normal. This also includes identifying what forces should be used to correct spinal misalignments and what forces produce common spinal misalignments. There are no studies showing the negative health effects of chronic spinal misalignments.
The Spinal Model project specifically addresses what is biomechanically normal. Once a biomechanical normal is established, then measurements become less relative, more absolute and scientifically acceptable. After biomechanical normal is established, we will assess the effects of misalignments/mal-position of both cervical vertebra and head-neck relationships, as well as the effect of forces the head-cervical spine and forces producing malposition of both cervical vertebra and head–neck relationships.
The stress strain relationships, material behavior, geometry, loads and constraints on any structural component can be represented by a set of equations. However, as the complexity of the geometry (i.e., the shape of the component), loading conditions and the constraints in an engineering problem increase, it becomes impossible to find an exact solution to this set of equations. Finite element analysis is a numerical technique that is used to find an approximate solution to this set of equations.
The engineering-problem in finite element analysis is represented by what is called a finite element model. In a finite element model, the geometry of the structural component is divided into small parts/mesh. Each of these small parts is called an “element” and the points where these small parts connect to each other is called a “node”. Appropriate material properties are assigned to each element. Therefore, intuitively, as the size of the element becomes smaller, the model more closely represents the actual material continuity that exists. As the mesh is refined, the model shape will match more closely to the actual shape.
The University of Toledo Spine Research Laboratory’s ABAQUS software is used for finite element analysis. Previously, 3-D finite element models have been made of the lumbar, thoracic, and cervical spinal segments. These models incorporated all the details of the segment including the ligaments, facet joints, the intervertebral discs, vertebral bodies, etc. The material properties of various tissues have been adapted from the literature and from in-house data.
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The principal investigator of this project is Dr. Vijay K. Goel, McMaster-Gardner Professor of Orthopedic Bioengineering, Co-Director Engineering Center for Orthopaedic Research Excellence (E-CORE) at the University of Toledo. Dr. Goel holds appoints in the Departments of Bioengineering and Orthopaedic Surgery in the Colleges of Engineering and Medicine. His specialty is in orthopedic and dental biomechanics, especially spine biomechanics and spinal discs. Dr. Goel is a recipient of the University of Toledo’s 2005-2006 Outstanding Faculty Researcher Award and is internationally renowned for his work on spinal implants. In 2003 he received the H.R. Lissner Award from the American Society of Mechanical Engineers for his work on spinal implants. Between 2000 and 2006 he has published 56 peer-reviewed manuscripts, several book chapters, and more than 130 abstracts.
The principle chiropractic liaison on this project is Jim Palmer, Professor of Physics at the University of Toledo, who is the UCRF Director of Research. He is also the editor of The Upper Cervical Monograph and a long-time contributor to this in-house publication. Chiropractors Dr. K. Denton and Dr. T. Palmer are also assisting as chiropractic liaisons.
2 post docs at $60K/year ......... $120,000/year
2 graduate students @ $21,000/year/student....... $42,000/year
3 computers............ $15,000
Abacus software license........$2,000/year
Total Estimated Expense
$228,000 per year plus 25% University expenses.........$283,000/year
Demonstrating Relevance of the Atlas Correction
Introduction and Perspective
The Upper Cervical Research Foundation (UCRF) understands the wisdom and necessity of establishing practice-based research (PBR) to provide relevant data to produce research and publications for use by both the biomedical community and the policy makers that influence services provided and compensation for those services. PBR can contribute to the clinical and health services knowledge base on usual and customary clinical practices, particularly in terms of data on practice and patient characteristics that may modify treatment outcomes.
Our major concerns with establishing a research network are for developing infrastructure that will support practitioners’ data collection efforts without intruding on their practice activities or compromising patient care while collecting high-quality data regarding their patient populations.
NUCCA practice-based research will make important contributions, distinct from those of clinical trials, in investigating ways to improve health and health care. The current health care marketplace, in which quality assurance and practice guidelines are increasingly important, the ability of PBR to gather data on practice and patient characteristics is particularly valuable. Neither the individual researcher in an academic center nor the busy practicing NUCCA practitioner can undertake meaningful research efforts of this kind.
The goal of this project is to develop systematic methods of describing patients and measuring their health outcomes in an actual NUCCA chiropractic practice. The data yielded includes various types and proportions of patients seen in chiropractic practice and describes features that correlate with other factors (such as region, age, education, type of technique employed, practice philosophy, etc.). In addition, the effectiveness of NUCCA chiropractic care (outcomes) for a variety of conditions seen in actual practice can be assessed. Variables would include quality of life and patient satisfaction. It may be possible to establish correlations between variations in chiropractic technique, frequency, and duration of care on patient outcomes.
Finally, through PBR training, some practitioners will develop dependable, solid research skills. It is the network of these doctors that Randomized Controlled Clinical Trials can be conducted. Of particular importance is training and planning for a Phase Three clinical trial in the investigation of Hypertension and the NUCCA correction. A Phase Three clinical trial has never been funded or performed in the history of chiropractic research
Institutions and Administrator
Life Chiropractic College West in Hayward, California will provide the institutional infrastructure and support for NUCCA PBR to include; the institutional review board, for the data collection, quality assurance and management. Chuck Woodfield, DC, RPh, with more than fifteen years of research experience in the chiropractic field will be the administrator for the NUCCA Practice-based Research Network.
Estimated Costs to Establish NUCCA PBR (First Year)
Introduction and Perspective
One of the research objectives of the Upper Cervical Research Foundation is to determine the percentage of the American population influenced by the Atlas Subluxation Complex (ASC). It is simply not enough to determine the biomechanics, the mechanisms and the relationship to symptoms, conditions and diseases.
Misalignment of the atlas vertebra is hypothesized to disrupt neural traffic of brain stem nuclei in the medulla oblongata. The misalignment results in postural imbalance or “spastic contracture” of the extensor muscles which is observed as unequal leg length when examined with the patient in a supine position. It is reported that an atlas misaligned to a very small degree has a resultant leg length inequality (differential). A difference in the leg length of more than one quarter of an inch is an indication of the presence of the ASC
The recent association of the atlas misalignment with elevated blood pressure in double blind placebo controlled study in Stage 1 hypertensive patients was initially assessed using the Supine Leg Length Check (SLC) test. The SLC checks for an apparent “short leg” or leg length inequality (LLI) or physiologic LLI. The use of a validated screening test would identify people with hypertension and atlas misalignment who could reduce their pill burden while further reducing their blood pressure.
Of utmost importance to fund and complete this study is the National Health and Nutrition Examination Survey(NHANE) National Institutes of Health (NIH) initiative that ‘measures’ communities health status. NHANE can field test the SLC and obtain important atlas misalignment (ASC) prevalence data. There is discussion for medical doctors to adopt the SLC to screen their patients to refer to a NUCCA practitioner to determine the status of atlas alignment.
Background and Significance
General chiropractic testing for LLI occurs with the patient in the prone position. Multiple investigations of intra-and inter- examiner reliability in implementation of the prone test procedure has been well documented. While the apparent leg length differences have acceptable reliability, the validity of this test is still questionable.
There has been little funding or interest to provide a unified, valid and reliable method to assess functional LLI indicating Atlas misalignment. One recent study, however reports the SLC may have clinical validity as a stand-alone test for recurring back pain. Validating the SLC test could also have ramifications for identifying people with Atlas misalignment and correcting it to reduce arterial pressure. Further research will establish a unified method by which to assess atlas misalignment.
The broad objective of this proposal is to evaluate the sensitivity and specificity of the SLC test to define the presence of atlas misalignment. Additionally, the study will assess examiner reliability by using a variety of practitioners. The underlying hypothesis of this study is that the use of the standardized SLC procedure reliably detects a misaligned atlas vertebra.
The true prevalence of atlas misalignment in the general population is unknown. This research proposal provides a plan to validate the Supine Leg Length Check (SLC) and provide reliable data for the SLC test leading to standardization. With validation, it could become an effective screening and referral tool for use by the general medical community.
The SLC test requires validation in a broad spectrum of the population especially those most vulnerable to co-morbidities resulting from uncontrolled hypertension, i.e. Black Americans. To evaluate a diverse population demography, the Pacific Northwest has been chosen to perform the assessments. These sites also provide quality examiners experienced in following research protocol. The validity examiner (VE) is a licensed chiropractor; NUCCA certified having at least 10 years of practice experience. To assure quality and standardization of the SLC, each examiner is required to participate in certification training before enrolling patients.
Physician Certification for SLC
All Study Site Examiners must participate in a 6-hour training and certification course to assure consistency and repeatability of the SLC procedure. Instruction occurs at the biannual NUCCA conventions. The Examiner must demonstrate the ability to reliably and accurately determine a difference in LLI of ¼ in, 80% of the time and 3/8 inch 95% of the time to become certified. The literature describes that “inter-examiner reliability of manual diagnosis in the examination of the cervical spine should be improved by standardizing the examination process and setting guidelines for documentation and evaluation criteria. Controlled and frequently repeated training sessions also contribute to the reproducibility of findings from manual examinations.
Certification requirements include: a) repeatable, accurate subject placement avoiding procedural errors that can skew results; b) repeatable, accurate examiner body positioning to provide accurate checks; c) repeatable accuracy of examiner hand placement, and procedure of actual check; d) ability to determine an apparent short leg with 100% agreement of peer examiners; e) ability to determine a ¼ inch 80% of the time and 3/8 inch difference 100% of the time.
Visit 1: Initial Assessment
The initial visit following enrollment primarily explains the protocol, confirms inclusion criteria allowing for an informed consent signature. The candidate is not pressured and may return at a later date. All required demographic forms including a complete health history are completed. The subject is randomized, determining further advancement to the SLC reliability examination. Appointments are made with the other examiner offices for the follow up leg checks. If scheduling permits, the initial Validity Examination could occur. The subject is scheduled for visit 2.
Visits 2&3: Validity Examination
The subject is treated like a ‘new patient’ maintaining office ‘flow’ preventing disruption. During this visit the subject’s leg length will be checked per protocol and results recorded. The standardized SLC procedure as described by Gregory(5), currently used by NUCCA, Orthospinology, Grostic, and Atlas Orthogonal practitioners, is described in the Appendix.
The subject completes the normal office paperwork as required for new patient visits. The VE examines the subject according to standardized NUCCA protocol by performing the SLC. For study purposes, the equal finding does not preclude participation in further examination. Data is recorded on the form supplied. The practitioner records LLI reading greater than ¼ inch, yes for LLI and no for equal and estimates the difference in inches. Equality is assessed on head rotation and results recorded describing the original short leg as either ‘going long’ or ‘going short.
Posture is assessed using the Anatometer. The Anatometer quantifies body distortion, measures the degree of vertical pelvic tilt, pelvic rotation in the horizontal plane, and lean of the spinal column at the shoulder level (fixed point). It measures subject's weight bearing on each foot, reported in percentage of total weight.
As the final step, an orthogonal radiographic exam is conducted according to NUCCA protocol. After recording the atlas alignment ‘listing’ results on the provided collection form, all markings from atlas alignment analysis are removed. The coordinator packages and sends the films to the X-ray reading
Visit 4: Follow-Up Visit
During this visit the participant, based on their randomization at the beginning of the study, will return to the chiropractor’s office and have a SLC recheck either by the same practitioner or another one in the local area to ensure reproducibility of the procedure.
All data are sent to a central UCRF Data Coordinating Center for final statistical analysis.
The study will be under the direction of the Co-Principal Investigators, Charles Woodfield, R.Ph., D.C. at Life West Chiropractic College and George Bakris, M.D. at the University of Chicago School of Medicine. Theodore Karrison, Ph.D. will head the Data Coordinating Center and provide statistical support for the trial.
George Bakris, MD
Professor of Medicine, University of Chicago
Director, Hypertension Center
Dr. George Bakris specializes in the diagnosis and reduction of high blood pressure, particularly in complicated or refractory cases. His internship and residency was at the Mayo Clinic where he specialized in Clinical Trial Research Design. He is the author of over 340 journal articles. He served on the 2003 the Joint National Committee on Blood Pressure and Hypertension setting guidelines for classification and treatment of hypertension. Dr. Bakris contributed his expertise to the NUCCA hypertension study.
Charles Woodfield, D.C., R.Ph.
Life Chiropractic College West
Dr. Woodfield received his training at UNC-Chapel Hill School of Pharmacy and Palmer College of Chiropractic. While a student at Palmer, he conducted a clinical trial remaining after graduation conducting other trials in chronic neck pain. He was instrumental in establishing the Practice Based Research Network. He has conducted NUCCA upper cervical chiropractic research since 1996 in conjunction with Dr. Dickholtz, Sr. and Dr. Bruce Bell. He was the primary developer of the NUCCA hypertension study protocol and major contributor to the final published paper.
Dr. Karrison has extensive coordinating experience and has participated in dozen of clinical trials providing statistical and database support for more than 25 years.
Personnel: $252, 500.00
Total: $424, 500.00
Confirmation of Orthogonal Radiographic Procedure Establishing Atlas Misalignment
Introduction and Perspective
Numerous chiropractic theories and hypotheses have been used to describe the misalignment of bones in the spine and their impact on human health and quality of life. Many of these ideas have not held up to scientific scrutiny. Using gravity as a constant, the capability of establishing a normal position on a vertical axis for the position of the pelvis, spinal vertebrae and skull has led to the discovery of a normal position for the atlas vertebra and the body skeleton.
The three words used for caring for spinal misalignments have been manipulation, adjustment and more recently, correction. The word correction has been used in connection with a segment of the chiropractic profession known as upper cervical chiropractic. Of the major systems of upper cervical chiropractic several of them have used measurements on X-rays based on an orthogonal axis. The orthogonal axis is the intersection of the three cardinal planes, the frontal, transverse and sagital.
X-rays of the skull and cervical spine are taken from three perspectives: lateral, vertex and nasium. These three views form the basis for the orthogonal axis. A line analysis is used to measure the angular relationships between the atlas and skull (rotation) on the vertex view representing the transverse plane. Measurements are made between the atlas and skull (laterality) and the atlas and the cervical spine representing the frontal plane on the nasium view.
Years of clinical investigation and thousands of pre and post X-rays taken by doctors practicing the NUCCA procedure and doctors using other upper cervical procedures have given rise to the biomechanical analysis of the misalignment and the establishment of the vectors necessary to correct deviations of the structures to their normal position on both the vertical and orthogonal axis.
Previous studies have been conducted by practitioners who do not have adequate experience or do not have certification in positioning patients for the X-rays or have not demonstrated competency in identifying structures or drawing lines for angular measurements.
This study will be research investigating the work of Board Certified NUCCA practitioners who have demonstrated both competency and proficiency. It is designed to help overcome the bias that remains from earlier theories and hypotheses suggesting that misalignment of spinal vertebrae are not measurable on X-ray.
The validity of orthogonal X-ray analysis sets a standard for the evaluation of the use of manipulation, adjustment or correction in treating spinal and spine related conditions. The confirmation of an orthogonal radiographic procedure helps establish the misalignment of the atlas vertebra as predictable and reproducible phenomena for further investigation. This study is also fundamental for investigating the incidence and prevalence of the Atlas Subluxation Complex in our society with its postural distortion and resulting leg length inequality.
The specific aim of the study is to demonstrate that NUCCA Board Certified practitioners can mark and measure x-rays used to determine atlas misalignment with-in ½ degree, in laterality and rotation, with 90% agreement and to determine atlas misalignment and subsequent correction after adjustment procedure.
Inter- and Intra- Examiner Reliability Marking and Measuring NUCCA Radiographs
The NUCCA organization has a three-year three-part certification program designed to evaluate the competency and proficiency of doctors practicing the NUCCA procedure. Radiographs accepted and being considered for Part III certification are screened for quality and sent to study coordinator.
X-rays sets composed of lateral, nasium and vertex pre radiograph views and nasium and vertex post radiographs are assigned to a randomized rubric to determine which set is examined for inter-examiner and then intra-examiner reliability. Four examining doctors will each read twenty sets initially.
Each of the four examiners will read five previously read sets to determine intra examiner reliability. An additional ten sets that have been previously read by other examiners will be re-read by two additional examiners to determine inter examiner reliability. Once each examiner has checked the 45 sets, the study is completed.
The following data will be collected: atlas laterality, atlas rotation, atlas/ cervical spine angle, rotation of axis, achievement of proportional reduction, listing and subluxation type.
Data is analyzed using an ANOVA as described by Haas, outlining methods in determining reliability. A statistician consultation will substantiate the most useable method and to determine accurate sample sizes, randomization rubric and analysis of data collected for reliability measures. The coordinator prepares a manuscript for publication in the Journal of Manipulative and Physiological Therapeutics (JMPT) or similar publication.
Marshall Dickholtz, Jr., DC is a NUCCA certified practitioner, chairman of the NUCCA Certification program and an authority on the diagnosis and treatment of adults and children with headaches, musculoskeletal conditions, spinal disc syndrome, back and neck pain, and other neurologically based conditions.
Russell Friedman, DC is a lifetime member of the Upper Cervical Research Foundation board of directors, a board certified NUCCA doctor, and a NUCCA instructor.
Michael Zabelin, DC is a board certified NUCCA practitioner with seventeen years of experience serving as an international aligned x-ray equipment consultant. He is a member of the NUCCA board of directors and former chairman of its education committee.
Keith Denton, DC is President of the Upper Cervical Research Foundation Board of Directors. Dr. Denton has authored and contributed to a number of publications including the NUCCA Standards of Care and Practice Guidelines and NUCCA Protocols and Perspectives: A Textbook for The National Upper Cervical Chiropractic Association. He also is one of the few people to have co-authored with Dr. Gregory. Dr. Denton has been a lead instructor for NUCCA since 1982 and a member of the Upper Cervical Research Foundation (formerly NUCCRA) board for twenty-six years.
Chuck Woodfield, DC was instrumental in establishing the Practice Based Research Network. He has conducted NUCCA upper cervical chiropractic research since 1996 in conjunction with Dr. Dickholtz, Sr. and Dr. Bruce Bell. He was the primary developer of the NUCCA hypertension study protocol and major contributor to the final published paper.
NUCCA Examiners (4) ……$18,000.00
Total estimated Cost: $101,875.00
Introduction and Perspective
Chiropractic and dental literature suggest an association between Temporal Mandibular Disorders, commonly called TMJ or TMD, and cervical chiropractic. One study in Cranio (April 2005, Vol 23, No. 2 pp119-129) showed the production of scoliosis in rats as a result of experimentally-induced malocclusion. All of the rats with scoliosis exhibited a tilt of the atlas or what the Upper Cervical Research Foundation would call Atlas Laterality.
Dr. Marshall Dickholtz Sr. has conducted preliminary studies with Chicago area neuro-muscular dentists who are members of the International College of Cranio-mandibular Orthopaedics (ICCMO) on approximately 8 patients with TMD/TMJ in preparation for designing the protocol used in this project. This protocol has been submitted for approval to an institutional review board. All of the preliminary subjects with TMJ have responded to upper cervical misalignment correction. Earlier data from the office of Dr. Dickholtz Sr. supports the effects of chiropractic on pain associated with TMJ. There are a number of NUCCA doctors and UCRF board members who have been working with dentists and dental researchers for more than fifteen years.
This project is designed to provide an understanding of the interconnections between TMD and malposition of the atlas. In addition to providing an understanding between TMD and atlas malposition, this project is expected to determine the optimal way in which dentists and upper cervical chiropractors can work together for the benefit of the patient. The question to be answered is, “Does a malposition of the upper cervical spine change the dental occlusion or bite? For example, if the atlas is corrected and not malpositioned, does that decrease the number of adjustments needed on dental occlusion and appliances? Clinical observations to date support the view that increased spinal stability and dental function are seen with patients using an integrated approach to dental care. The cervical spine-jaw-head modeling at the University of Toledo will be used to interpret what is seen dentally and chiropractically and will provide a biomechanical model relating TMD and misaligned cervical vertebrae.
Principal Investigators/ Credentials
Dr. Marshall Dickholtz Sr. will be the lead chiropractor and the other investigators will be announced once an Institutional Review Board has approved the project. The involved University faculty has yet to be finalized.
Dental organizations are providing $200,000 for their share in this joint project. UCRF is responsible for $185,000 of the projected cost. This covers $100,000 for chiropractic services, and $85,000 for data management, writing of research results, writing/organization of IRB (Institutional Review Board) proposal and additional involvement with University.
Introduction & Perspective
The NUCCA approach to atlas correction presents many opportunities to collect data and conduct scientific study. As part of this process, compelling findings must be documented and published to ensure validation and further research. Publication of research findings allows for scientific discussion and exchange of ideas which assist in the reduction of errors, improved methods of investigation, and interpretation of results. The potential value of such academic publication assures NUCCA a position to attract other science and health care professionals to assist in these investigations and to ultimately improve the quality of life and optimal health and well-being for the public at large. The vision of investigating the NUCCA correction using a large sample of diverse populations provides evidence that will help establish the successful demonstration of the positive impact on health the NUCCA correction may offer. The Upper Cervical Research Foundation is currently committed to the academic publication of the three research projects described as follows:
Mechanisms in Cerebrovascular Blood Flow Following Atlas Realignment
As a result of the Hypertension study published in Journal of Human Hypertension, May 2007, the investigation for a mechanism explaining how the NUCCA atlas correction exerts the effect on the autonomic nervous system is in progress. This involves an examination of changes in cerebral blood flow pre and post correction, and describes a case reporting the results of an imaging study of the vasculature of the brain stem region using cutting edge imaging tools that allow for the most accurate study of this phenomena to date. Professionals involved in the research include: Terry Lichtor, PhD; MD, Noam Alperin, PhD; Bruce Bell, MD; Charles Woodfield, RPh, DC.
Estimated Timeline and Expense
Publication of the Blood Flow study requires $6,000.00 for literature review and manuscript preparation to be completed by June, 2008.
Hypertension Study Data Report
Unpublished data from the hypertension study showing the effect of the NUCCA correction on blood pressure levels which was published May, 2007 in the Journal of Human Hypertension is described in this update. Quality of life results from the SF-36 quality of life survey, Pain Scales from the VAS, and the end of study questionnaire and quality of life measures are presented and discussed. Authors from the hypertension study include G. Bakris, MD; M. Dickholtz, Sr. DC; P.M. Meyer; G. Kravitz; E. Avery; M. Miller; J. Brown, DC; C. Woodfield, RPh; B. Bell, MD.
Estimated Timeline and Expense
The Hypertension paper requires $8,000.00 total: literature review and manuscript preparation, $6,000.00; Data entry, $500.00; Biostatistician consultation, $1,500.00. Completion scheduled for July, 2008.
Atlas Misalignment and Chronic Fatigue Syndrome
A case series of 19 subjects medically diagnosed with Chronic Fatigue Syndrome according to the Center for Disease Control’s differential diagnosis criteria, were studied pre and post NUCCA atlas adjustment. Multiple diagnostic tests and outcome measures were used including the SF-36 survey and Pittsburgh Sleep Quality Index. The study shows improvement in SF-36 quality of life descriptors indicating that the NUCCA correction may help ease the suffering of those diagnosed with Chronic Fatigue Syndrome. The final manuscript reports on a case series of patients suffering from chronic fatigue syndrome and how the correction improved their quality of life and several immune markers over a 6 month study period. Participating professionals include: Charles Woodfield, RPh, DC; Leo Jacobs, MD; Bruce Bell, MD; Marshall Dickholtz, Sr.
Estimated Timeline and Expense
The Chronic Fatigue manuscript requires $6,000.00 for literature review and manuscript preparation to be completed by August, 2008
Dr. Charles Woodfield began his chiropractic research career at Palmer Center for Chiropractic Research and was the architect of the Chronic Fatigue Case Series using the SF-36 as the primary outcome to NUCCA care. The hypertension study was based on a protocol of his design with input from the other investigators.