CURRENT & ONGOING RESEARCH PROJECTS
Changes in Intracranial Compliance and Quality of Life in Migraine Subjects Receiving an Atlas Intervention
Utilization of Phase Contrast Magnetic Resonance Imaging to measure Cerebral Hemodynamic Changes
Before and After a NUCCA Atlas Correction - A Case Series
HC. Woodfield (1), WJ. Becker (2), DG. Hasick (3), MS. Rose (4), JN. Scott (5)
(1) Upper Cervical Research Foundation (UCRF), Minneapolis, MN;
(2) University of Calgary and Alberta Health Services, Foothills Hospital, Calgary, AB;
(3) Britannia Clinic, Calgary, AB;
(4) Rho Sigma Scientific Consultants, Calgary, AB;
(5) Departments of Diagnostic Imaging and Clinical Neurosciences, University of Calgary, Calgary, AB;
Background: Following a National Upper Cervical Chiropractic Association (NUCCA) atlas vertebrae intervention, previous case study revealed a significant decrease in migraine symptoms with accompanying increased intracranial compliance (ICCI) and venous pulsatility decrease.
Objective: To measure using Phase Contrast Magnetic Resonance Imaging (PC-MRI), changes in ICCI from baseline to week-four, and eight, following a NUCCA intervention of neurologist screened migraine subjects. Secondary outcomes comprised several Health Related Quality of Life (HRQoL) measures used specifically in documenting patient perceived changes in migraine status.
Methods: After screening, candidates signed a consent form, completed baseline migraine-specific quality of life measures, then returned after 30-days with a baseline headache diary. Determining need for NUCCA care confirmed inclusion, allowing subjects to obtain baseline PC-MRI measures. Using a 1.5-Tesla GE 360 Optima MRI scanner to acquire flow data, analyses were completed using proprietary software, MRICP, version 1.4.35. Subjects received eight weeks of NUCCA care.
Results: Eight females, and three males, average age 41 years, met inclusion criteria. At baseline, mean subject ICCI was 6.39(SD = 3.15); 6.25(SD = 1.76), at week-four and 7.32(SD = 3.59) by week-eight. Baseline Headache Impact Test-6 was 64.2, decreasing to 55.2(95% CI 4.7, 13.1) at week-four, to 53.8(95% CI 4.7, 13.1) by week-eight. Migraine Disability Assessment Test at baseline, 46.7(SD=27.7) decreased to 14.6(95% CI 13.2, 51.0) at week-twelve. 24-hours after intervention, ten subjects reported mild neck discomfort.
Conclusion: One study limitation is lack of a control group for comparison of observed changes. HRQoL measures seemed to indicate resolution of many migraine symptoms in conjunction with a slight increase in ICCI.
The Phase Contrast Magnetic Resonance Imaging (PCMRI) Migraine study was a multidisciplinary project that created ongoing partnerships between NUCCA, University of Calgary Neurology and Elliot-Fong-Wallace (EFW) Radiology. It brought to Calgary new state-of-the-art, dynamic MRI technology to determine how the brain’s vascular system and brain function respond to an optimal NUCCA correction. Subjects reported positive results regarding migraine quality of life with no adverse reactions to care.
This study looked at the correlation of quality-of-life measures and physiological changes as measured from the PC-MRI (dynamic) evaluation, pre and post correction NUCCA x-ray evaluations and measured postural changes. Whereas many studies have a lot of patients with a few specific outcome measures, this pilot study had a few patients and a lot of data to scrutinize for the linked relationships. The cross references of data from x-ray, posture, MRI and Quality of Life measures was very revealing. The study manuscript has been published by BioMed Research International .
Spinal Modeling Project
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.
Click on the play button to view video
Click on the play button to view video
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.
Drs. Keith Denton, Teresa Palmer and Mr. Jim Palmer provided valuable support and guidance for this study.
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)
Initiating the development a chiropractic practice based research network: Evaluating the feasibility of using online software to collect patient information
J. Scholten (1), A. Kania-Richmond (2), L. Weeks
(1) The Vital Posture Clinic - A NUCCA Practice
(2) University of Calgary
Background: Two Canadian National Upper Cervical Chiropractic Association (NUCCA) practitioners have initiated the development of a practice based research network (PBRN). The function of the NUCCA-PBRN will be to collect and evaluate patient information to inform clinical decision-making and conduct practice-based research.
Purpose: To assess the feasibility of using online software to collect quality patient information for the purposes of the NUCCA-PBRN.
Methods: We conducted a feasibility study with two phases: 1) Assessment of the quality of information provided using online software through a standardized form completed by clinicians and administrative staff; and 2) Exploration of patients’ perspectives and experiences regarding online information provision through semi-structured interviews with patients. Data analysis was descriptive, in the first phase using frequencies and means and in the second phase using qualitative content analysis techniques.
Findings: Based on a sample of 36 consecutive new patients at one NUCCA office, online forms were submitted on time 86% of the time and always completed by an appropriate individual. Eighteen errors were identified for 11 participants. We interviewed 22 patients. Overall, patients expressed a preference for using online over paper forms. The majority reported that the forms were easily accessed, clear, and secure. Most felt completing forms online and on their own time was efficient and conducive to providing reliable answers. Problems related to technical difficulties and standardized response options.
Conclusions: Collection of personal and health information using online software is preferred by patients and feasible for the purposes of the NUCCA-PBRN.
Practice Based Research – Web Based Data Collection – The Insight Study
NUCCA has developed a web based data collection platform that can be viewed at: mycondition.info
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.
Phase 1: Database structuring, Basic web structure, Layout for 1st form (initial patient history).
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.
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.
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). 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.
Relationship Between Cranio-Cervical Orientation and Centre of Force of Occlusion in Adults.
J. Scholten (1), C. Westersund (2), RJ. Turner (3)
(1) Private Practice, Suite 104-4600 Crowchild Trail NW, Calgary, AB
(2) Private Practice, 801 6 St SW, Calgary, AB
(3) Dept of Biological Sciences, University of Calgary.
Background: The integration of care between chiropractors focused on treating disorders of the cranial cervical junction (CCJ) and dentists treating dysfunction of the temporomandibular joint (TMD) has developed as clinicians seek novel and effective integrative patient management strategies for solutions for patients with TMD. Clinical observation and anecdotal reports suggest changes to the dental occlusion following an adjustment to the CCJ using the procedure developed by The National Upper Cervical Chiropractic Association (NUCCA).
Purpose: To investigate whether there is there is a change in occlusion that can be measured using a dental force plate following a NUCCA adjustment to the CCJ.
Methods: A pre-post case series wherein patients served as their own controls by being assessed twice prior to and twice following an intervention. Active patients at a private NUCCA clinic, with occlusal imbalances, were invited to participate and eleven volunteered. All eleven patients received one NUCCA intervention. Data were collected twice prior to the NUCCA intervention and twice following the intervention. Measures collected were leg length, postural position, and cervical paraspinal thermographic evaluation (by a NUCCA team member); and occlusion was evaluated with a dental occlusal analysis system, the T-Scan (by the dental team member). Patient outcomes were observed for consistency between pre-pre and post-post measurements as compared to pre-post measurements. Standard deviations of the mean and t-test of the data is used to compare the measures taken before and after the NUCCA adjustment and between patients.
Results and Conclusions: Findings obtained in this first study of its kind demonstrate that changes in both posture and occlusion can be observed after the NUCCA chiropractic procedure. However, we found that patients tend to have unique responses with some showing a shift in initial occlusal contact and others lending to a more balance contact pattern. Our findings demonstrate further the interconnectivity of the CCJ and an individual’s bite and related discomfort.