Utilization of Phase Contrast Magnetic Resonance Imaging to measure Cerebral Hemodynamic Changes
Before and After a NUCCA Atlas Correction - A Case Series
Results of a case study describing a subject diagnosed with migraine headache (without aura) reveal compelling results obtained with Phase Contrast Magnetic Resonance Imaging Angiography (PC MR). The subject was evaluated using the protocol of the National Upper Cervical Chiropractic Association (NUCCA) to determine the presence of an Atlas misalignment. After Atlas correction, a follow up PC MR Study demonstrated changes in cerebral venous outflow. A change in vessel outflow pattern from a jugular to the paravertebral plexus route was discerned. Venous flow rate and vessel pulsatility decreased as well as cerebrospinal flow rate across the Atlas (C-1) vertebra. Most significantly, the imaging procedure measured a distinct decrease in intracranial compliance. The subject obtained relief from migraine headache pain consistent to maintenance of his Atlas correction by the end of thirty days. The PC MR exam continued to show improvement of the hemodynamic parameters measured over the 16-week study period consistent to maintenance of Atlas alignment.
These results coupled with previously documented normalization of blood pressure in a randomized double blind study indicate a casual physiologic and measureable effect occurs after the correction of an Atlas misalignment. Further investigation facilitates elucidation of a physiologic mechanism subsequent to misalignment and its correction. The potential resulting from this study in alleviating migraine pain resultant to an Atlas correction may provide evidence of a viable alternative to usual and customary treatment. A case series, imaging ten subjects diagnosed with migraine headache by a Neurologist is necessary to demonstrate consistency in the cerebral hemodynamic effects previously observed.
- Document the effect of Atlas correction on Cerebral Venous and CSF outflow patterns and velocities, with decreased intracranial compliance, as measured by PC MRA in a case series study of ten migraine (without aura) neurologist diagnosed subjects.
- Observe similarities and differences in a subject’s subjective response to correction and ablation of migraine symptoms, headache pain, in relation to documented changes in PC MRA.
- Demonstrate PC MR measured results and velocities are reproducible, sustained, and consistent over time, after an Atlas correction.
Possible Atlas misalignment interaction with the Trigeminovascular System via decreased intracranial compliance may produce neural influences on cerebral circulation as proposed by Dr. Goadsby providing impetus for further study. This study is significant in bringing a new imaging technology into Canada while offering another research facility to conduct productive investigation in determining a physiologic mechanism underlying the Atlas misalignment and its correction. A case series of ten migraine subjects monitored by PC MR measures cerebral circulatory response to the Atlas correction with a potential to reveal much new information of an underlying physiologic mechanism.
Introduction & Perspective
Throughout the history of the chiropractic profession, there has been a sustained belief that a bone in the spine can become fixed in an abnormal position (subluxated). When the spine is properly adjusted, the bone is corrected to a normal position. Proving this has been the nemesis of scientific investigation and research for all these many years. Even to this day, few chiropractors and researchers are aware of the ability of (orthogonally based) upper cervical chiropractors to objectively 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 not only return a subluxated bone to a defined normal position but to proportionately correct the entire spine and all of the spinal elements to the vertical axis, the normal position defined by gravity itself. In the standing position, this constitutes a minimal stress, minimal energy position for the entire body, thereby serving well as a defined and objectively measurable "normal".
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.
Ongoing Certification Radiograph Inter-examiner Reliability Study
The purpose of a long term x-ray analysis reliability study is to further demonstrate the sustained continued ability of NUCCA Certification examiners to agree on x-ray analysis. The NUCCA Certification program provides an opportunity for collecting data when submitted radiographs are examined for consistency in marking by two different blinded examiners. This ongoing study maintains and increases transparency of the Certification process which provides a demonstrated significance and high standard for the Certified NUCCA Doctor and encouragement for those in the process. Most importantly, it provides a data collection opportunity in demonstrating inter-examiner reliability of the NUCCA radiograph marking and analysis procedure. In addition, it provides an infrastructure to scientifically test new marking and analysis procedures with ease.
A database created with certification records from several years allows for establishing an undisputable record of achievement indicating that Upper Cervical practitioners can analyze films with complete agreement. Statistics used for demonstrating such excellence require many sets of films examined by no more than three assessors over a long study period. The Chair of the Certification Committee is the authority over the two Board certified examiners assessing the submitted film sets. It is the Chair’s analysis that serves as the “Gold Standard” by which the examiners must adhere in their analysis of the films. The Certification Chair approves the selection of no less than three potential Board Certified examiners and ensures they are trained to accomplish the task with moderate agreement before the final trial begins.
To develop a study foundation and test the data collection protocol while adding further significance to the ongoing certification study, an inter-examiner reliability study is underway. This provides baseline data for comparison in tracking ongoing improvements. A five year time line is planned during which a protocol for sustainability is developed then instituted to maintain the infrastructure to research new analysis methods.
The first project year develops and refines a sound data collection protocol to assure data quality and to troubleshoot difficulties as they arise. A manuscript will be written documenting the first year project development and refining the research procedure report of the reliability outcomes of the first year pilot study. Year one and two are a Development Phase in which the procedure is perfected. Data is collected continuously for a minimum of one year. Upon conclusion of the first year of data collection, sometime early in year two, analysis of the study procedure and data collected will yield a paper for the indexed literature. Needed changes will be introduced with consideration to include Part Two Certification into the investigational process. Feasibility and the procedure of this are explored in Year One of the Development. Years Four and Five involve a two year data collection and sustainability phase. At the end of five years, the pooled dataset is analyzed and reliability of the examiners reported for the indexed literature.
As radiographs are submitted for review, the NUCCA Certification Chair inspects incoming films to determine acceptability for further examination and inclusion into certification study. The Chair analyzes the film set, sending the data sheet to the study Coordinator for database entry. This record becomes the ‘standard’ by which examiners must agree in their analysis. All pre-existing lines are removed to maintain blinding for the Examiners who analyze the films according to the established protocol. The Administrator is blinded to the identity of the Certification Candidate. The Examiners have the option to reject films based on their experience at which time are returned to the Certification Chair who returns them to the Certification candidate.
The Administrator sends the films to Examiner One who records the findings on a data sheet, returning films and completed sheet to the Coordinator. A copy of the datasheet is also sent to the Certification Director to compare against the ‘standard’, then determining if the film set passes for Certification. The Administrator inspects the returned film sets for identifiers, removed if found, and sent to Examiner Two according to a pre-established randomization rubric. All data from the examiner datasheets is double entered, verified into the study database contracted data entry personnel. As a Web Based Data Entry Platform is developed, data entry can occur via that resource. Once both Examiners have reviewed the film set, the film set and copies of the data sheet are sent to the Certification Examiner who determines if radiographs have passed the Certification requirement.
With our ongoing dedication to the excellence of the care we continue we provide our patients, we continue to refine , study and validate our clinical / practice procedures.
Full Scale SLC Inter-examiner Reliability Study
Initial investigation into the reliability of NUCCA assessments returned much success with the Supine Leg Check (SLC) Pilot study. Donor contributions allowed for:
- Initiation of the study;
- Presentation of results at two conferences;
- Chiropractic Research Agenda Conference (ACC-RAC 2011),
- 3rd North American Congress of Epidemiology,
- Publication of results to two indexed peer reviewed journals;
- Journal of Manipulative and Physical Therapeutics (JMPT - May 2011)
- Epidemiologic Perspectives & Innovations
Protocols for data analysis and interpretation were developed for all future NUCCA assessment reliability studies. Funding the SLC Pilot Study allowed for important team building and infrastructure development to handle data and employ a biostatistician necessary to proceed to a full scale SLC reliability study.
Results from the pilot have allowed for sample size calculations to produce statically significant outcomes as well as the ability to fine tune the original pilot protocol to demonstrate overall increased reliability in performing the SLC. Sample size requirements depend on the question being asked and the underlying assumptions. Using assumptions of an underlying kappa (κ) of 0.45, a margin of error of .10, requires 358 observations, compensating for a 15% non-inclusion rate. Four hundred subjects are to be recruited to produce statistically significant results.
Inter-examiner reliability may be assumed to increase when the population is symptomatic and leg length inequalities exceed ¼-inch. Subjects with headaches, neck and back pain will be recruited. Inter-examiner reliability is also highly dependent on the threshold set for defining leg length inequality. Strict definitions for examiner decision making thresholds will be established and refined.
Prevalence of leg length inequality (LLI) in the general populations has yet to be addressed. The potential of the full scale SLC study is putting to rest issues surrounding the SLC reliability.
Two Board Certified NUCCA practitioners will examine 100 subjects every other weekend for approximately two months. Fifty subjects are examined on Saturday then fifty subjects on Sunday, until four hundred subjects are seen. A study location has been secured in Seattle, WA to capitalize on the diverse population present in the city. Subjects volunteering must be between the ages of 18 and 65 years of age. An ideal demographic of subjects would consist of the following:
The study protocol is centered on lessons learned from the SLC Pilot study to decrease examiner variability in their observations thereby increasing their ability to agree on the amount of LLI seen. Use of bowling shoes reduces the chance that foot wear changes examiner agreement. Shoes will be marked with a “L” for left and “R” for right to eliminate any likelihood of human error. Exam tables are identified as right or left as well. The data collection protocol developed for the pilot study will be used to assure solid collection and protection of the examiner’s data.
Publication of study results in indexed peer review journals will profoundly impact the credibility and effectiveness of the NUCCA correction.
NUCCA Practice Based Research Network (PBRN)
Drs. Jeff Scholten and Mikael Reney demonstrated a stellar performance in establishing the current PBRN on a shoestring budget which they personally funded. We now need to take this valuable infrastructure to the next stage. Below is a flow chart of possibilities. These preliminary ideas require refinement with proposed budgets to become a reality.
The first project would develop a database designed to answer specific questions regarding why a patient seeks care compared with practices located in a different locale, i.e. Calgary vs. Seattle vs. Montreal. Another question to possibly be addressed is why patients may seek different types of upper cervical care and how we can track the effectiveness of the various techniques.
The next project involves Quality of Life data (QOL) data using the NIH “Gold Standard” PROMIS. We can begin piloting this limiting data collection to a select few practices to refine the procedure and troubleshoot challenges. Drawing on experience gained and lessons learned, it may now be time to initiate a pilot study.
These preliminary studies provide team building opportunities in establishing motivated practitioners as dedicated researchers that can be used for clinical trials. A multi-practice Practice Based Research Network (PBRN) hypertension study may also be conducted as a result of these foundation building research infrastructure measures.
NUCCA Practice Based Research Update
Committee Co-Chairs – Dr. Jeff Scholten, Dr. Mikaël Reney
Research Advisors/Participants – Dr. Chuck Woodfield, Jim Palmer, Dr. Marja Verhoef, Ania Kania
Vision – Establish an understanding for upper cervical doctors and the general public as to why and when the upper cervical chiropractic procedures work optimally.
Mission – Develop a clinical outcomes database allowing for retrospective analysis and prospective evaluation to determine and understand the efficacy of upper cervical chiropractic approaches enabling intra- and inter-professional dialogue to support the mission of the Upper Cervical Research Foundation.
2011 Goal - 100 upper cervical chiropractors actively engaged by putting their new patient’s data into nuccaforms.com; Acquire funding to move project to Phase 2
Practice Based Research – Web Based Data Collection – The Insight Study
NUCCA has developed a web based data collection platform that can be viewed at: nuccaforms.com
Phase One has been recently completed at the cost of $5,000.00 and several hundred man hours of volunteer labor. The following was completed in Phase One: Database structuring, Basic web structure, Layout for 1st form (initial patient history). It began Beta testing February 2010. Once this endeavor is funded, the remaining development Phases are completed and tested, launching a viable web based data collection platform. The major attraction to this platform is collecting and mining data the patients introduce to the database as part of a usual and customary visit to a NUCCA Doctor. As the patient enters most of the data themselves, there is less likelihood in breach of security to allow for data tampering. The patient can complete patient outcomes measures that can track their outcome to NUCCA care. Plans have been made to interface with the National Institutes of Health’s (NIH) PROMIS (Patient Reported Outcome Measurement Information System) allowing for comparative effectiveness study with various traditional and CAM treatments. With a large enough dataset, coupled with NUCCA Assessment Measures, an association can be made between changes in assessment measures and changes in patient outcomes. This can occur after completion of Phase 4 of the development plan. The potential impact of mining this planned database is endless. However before these plans are realized, the preceding development phases require funding and testing to assure the process produces data of high quality and is adequately safeguarded.
These phases include:
Phase 2: Add to the web structure to include other initial forms (SF-36, Oswestry, Neck Pain Disability) and a reevaluation protocol using these forms. The layout for these forms is time consuming and laborious costing $10,000.00
Phase 3: Changes the layout to be dynamic, i.e., changes as someone enters data, including details of health complaints to allow specific forms to their condition to be displayed. Developing the algorithms is labor intensive costing $10,000.00.
Phase 4: Redesigns the platform to add daily SOAP notes (recording subjective, VAS linked to each symptom, leg length inequality, Anatometer®/postural measurements and radiographic data, and paraspinal thermography). This data is vital to this research effort estimated at $30,000.00. Funding for this development is requested when the Phase 2 and 3 are completed and tested, allowing the platform to prove useful for its designed intention.
In the meantime, the Practice Based Research process must begin by recruiting and training volunteer practitioners in Research Methods. For the initial development of the first participating practitioners, training is held in interested doctor’s offices teaching basics of data collection and safeguarding. Following procedures to collect quality data is emphasized to reduce confounding bias that may result negating the data collection effort. The development of this Quality Assurance is vital to the PBR effort. The first study planned involves Examiners who volunteered for the Supine Leg Check Validity Study Protocol recently submitted to the NIH. This project demonstrates the ability of these doctors to work as a research team and accomplish tasks required for completing a successful study. Doctors collect data from all new patients for thirty days and again in thirty days from when upper cervical care began. Patients will complete basic demographic forms and Quality of Life (QOL) forms using the SF-36. The SF-36 is the health care industry standard used to determine significant changes in QOL as a result of an intervention, commonly used in effectiveness investigations. This data is observationally compared to changes in assessments recorded by the participating practitioner. Once completed, a minimum of two manuscripts can be written for publication; one, describing the process of establishing PBR, reporting solutions to problems encountered; and two, reporting observed results of the collected outcomes and associations if they are present. When the time is appropriate, the established team is linked with the Data Collection Platform for a concentrated research effort to begin.