Establishing Reliability of the Supine Leg Check (SLC)
Establish X-ray Reliability - Certification Process X-ray Reliability
Practice Based Research – Web Based Data Collection – The Insight Study
Establishing Reliability of the Supine Leg Check (SLC)
The first step begins in demonstrating reliability of the Supine Leg Check. During this phase, an opportunity to establish a Biostatistics Team and Data Computational Center to collect and safeguard quality data exists. Orthogonal based Upper Cervical practitioners have used the Supine Leg Check (SLC) for over 40 years as a screening tool for Atlas misalignment to determine need for posture assessment and radiographic exam. The study published in the May 2007 Journal of Human Hypertension used the SLC to screen for potential subjects. There is interest in using the SLC as a screening tool to determine prevalence of Atlas misalignment in the US population, especially for those with hypertension. Screening tests require a high degree of precision and accuracy with examiner performance ability crucial in duplicating results for every exam.
To confirm the high standard of SLC reliability required necessitates using a large population of subjects examined through rigorous and controlled investigation. Before the resubmission of the SLC validity protocol to the NIH, SLC reproducibility and concordance must be undeniably demonstrated. A high caliber protocol developed to reduce confounding bias and assure quality data collection for analysis is pilot tested determining if any difficulty encountered challenges study integrity. The Data Collection Pilot Study allows fine-tuning of the protocol to further increase the likelihood for success.
The primary research objective is demonstrating examiner agreement of 90% + 4% for categorization of even vs. right short leg vs. left short leg. A Kappa of 0.65 + 0.10 is specified for the secondary research objective, quantifying the magnitude of LLI categorized by LLI = 0; < 0.25 in.; between 0.25 in. and 0.75 in.; or > 0.75 in. A sample size of approximately 3000 subjects is estimated currently to demonstrate these high standards. Upon conclusion of the pilot study, the statistician reevaluates sample size calculations, adjusting for the number needed to complete the trial. Immediate support for conducting this study is a priority.
Data quality and safety must be assured to prevent undue criticism of data embellishment if standard research protocol is not followed. This requires personnel handling the data that have no direct benefit resulting from a favorable outcome or NUCCA association. This study provides an opportunity to establish a Statistical team by a modest financial commitment with more benefits than if the same services were obtained by contractual hiring of one biostatistician. Currently, LCCW pays $250 an hour for Statistical services. Consultations regarding protocol development have a large cost associated with them. By contracting the described support, team reduces costs that are eventually passed onto the Research Sponsor's costs. Funding this team begins development of necessary infrastructure to conduct the high quality research required for a self-sustaining research effort for NUCCA. Costs for statistical support are reduced using the team approach as work is allocated to personnel who are paid appropriately for their skill level. Development of a Data Computational Center to maintain data safety and quality assurance of data collection are necessary for attracting NIH and other governmental agencies financial support. Receiving support from a PhD graduate student from a nearby institution opens many collaborative possibilities.
A modular approach has been developed to assemble the needed study team and subjects required to establish reliability. Each module is budgeted separately allowing the process to begin while arranging further funding resources for completion. The first module is conducted at Life Chiropractic College West (LCCW) and then at various cities across the US and Canada where Certified NUCCA Practitioners practice. Upon completion of each module consisting of three weekends or six study days, 300 subjects will have objectively been studied by two NUCCA Doctors. With an established research team in place, 600 subjects could easily be tested depending on the interest of the examining doctors. The value of this approach is the statistical assessment is stronger for two examiners checking more subjects. Presently, it is estimated six modules are required to approach the sample size required for statistical significance. The flow chart below outlines the Modular approach to SLC reliability study.
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It is imperative to conduct the Data Collection Pilot Study to allow a calculation to refine the sample size and then budgetary requirements for success. This allows a means to determine exactly how to proceed and how much it could cost. The reliability issue regarding doctors utilizing the SLC to screen patients for Atlas misalignment will be adequately addressed with statistical confirmation to validate the observed outcome. A study of this scale demonstrates the ability of NUCCA and LCCW to conduct a multi-site study using a sound data collection protocol assuring data quality and safety. It addresses in one study the many deficiencies outlined in the NIH SLC validity protocol and goes a long way to answer the critics following the standards of established scientific inquiry.
Establish X-ray Reliability - Certification Process X-ray Reliability
The NUCCA Certification program provides an opportunity for collecting data when submitted radiographs are examined for consistency in marking by two different assessors. The ongoing study maintains transparency to the Certification process as Assessors are blinded to the Candidate submitting films. This provides quality to the certification process demonstrating high standards and significance in support of the Certified NUCCA Doctor. Most importantly, it provides a data collection opportunity to demonstrate inter-examiner reliability of the NUCCA Radiograph marking and analysis. Statistics used for demonstrating such excellence require many sets of films examined by no more than three assessors over a long study period. A manuscript documenting the first year development establishing the procedure can report reliability outcomes of the pilot study. The second and third year provide pooled data for statistical analysis and another manuscript.
The first project year develops and refines a sound data collection protocol to assure data quality and troubleshoot difficulties as they arise. To prevent miscommunication glitches in the fine tuning process between the Coordinator and Administrator, the first year duties of both are performed by the Administrator. As radiographs are submitted for review, the NUCCA Radiograph Certification Examiner inspects incoming films to determine acceptability for further examination and inclusion into certification study. After removing markings by which the Candidate can be identified, the Certification Examiner then sends the films to the Coordinator. All lines are removed to maintain blinding for the Assessors who will mark and measure the films according to the established protocol. The Coordinator is blinded to the identity of the Certification Candidate. The Assessors have the option to reject films based on their experience at which time are returned to the Certification Examiner who returns them to the Certification Candidate.
The Coordinator sends the films to Assessor One who records the findings on a data sheet, returning films and completed sheet to the Coordinator. The films are inspected for identifiers, removed if found, and sent to Assessor Two. All data is entered into the study database by the coordinator from the Assessor datasheets. As the Web Based Data Entry Platform is developed, data entry will occur via that resource. Once both Assessors have reviewed the film set, the film set and copies of the data sheet are sent to the Certification Examiner who determines if the radiographs have passed the Certification requirement and notifies the Candidate of the outcome.
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Changes in Cerebral Blood Flow Patterns and Velocities of Migraine Subjects Following an Atlas Correction
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.
Specific Aims
- 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.
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Practice Based Research – Web Based Data Collection – The Insight Study
NUCCA has developed a web based data collection platform that can be viewed at: http://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 begins 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 NIH’s 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 a 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). 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 NUCCA practitioners in Research Methods. Basic Research and Data Handling classes are offered as a course of instruction at the NUCCA biennial Conferences, eventually to an online instructional platform under consideration. 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 that 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 NUCCA care began. This allows for development of sound follow up data collection that can be difficult to attempt successfully. 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, like the NUCCA Correction, commonly used in effectiveness investigations. This data is observationally compared to changes in NUCCA assessments recorded by the participating practitioner. An attempt to associate the outcomes of both will be attempted. 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. This study provides insight into the NUCCA Procedure while documenting patient’s outcome to care on a daily basis.
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.
Research Goals
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.
Modeling Technique
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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Principal Investigators/Credentials
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.
Chiropractic Liaison
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.
