CURRENT & ONGOING RESEARCH PROJECTS

NUCCA Practice-Based Research Initiative

Inter & Intra Examiner X-ray Reliability Study

Manuscript Preparation of Completed Research for Publication

 

NUCCA Practice-Based Research Initiative

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.

Research Goals

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

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Inter & Intra Examiner X-ray Reliability Study

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.

Research Goals

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.

Study Design

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.

Principle Investigators

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.

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Manuscript Preparation of Completed Research for Publication

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.

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.

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.

Liaison

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.