Ninth Annual Vertebral Subluxation Research Conference

October 13-14, 2001
Spartanburg, SC

The principal concerns of the IRB are scientific merit of the protocol, subject selection, informed consent, risk/benefit ratio, documentation and protocol compliance. If the proposal does not have scientific merit, the subjects will be subjected to risk with no potential of benefit. The IRB looks very closely at the informed consent document, to insure that it is understandable to the subject and explicitly details what they are volunteering to do and the potential risks associated with the project. Special considerations are applied to vulnerable populations, e.g., children, pregnant women and prisoners. Audit procedures are implemented to verify protocol compliance. Understanding what the IRB is looking for can greatly increase the probability of getting speedy approval of a proposal and decrease the frustration that investigators sometimes feel when dealing with the IRB.

This presentation has the specific aim to increase the knowledge and skills of chiropractic students, faculty and field doctors in performing the necessary steps to accomplish a published case study. This guide is intended to answer questions and provide a format for planning and proposing prospective case studies or reviewing cases and preparing to write the retrospective case study for publication.

The literature search makes use of the many resources available to help the field doctor define a specific condition or define a specific question, and then answer whether or not this finding or idea is something new. Further, it must be determined if this information has any value to patients and colleagues.

Searching the literature can be done with online tools such as Pubmed, MANTIS, CINAHL, ICL or Internet Search Engines. Reference Libraries have the online tools in addition to ICL, CRAC, Books/Monographs and Journals. Once the literature search has been done, the evidence must be evaluated for methodological quality and based on the types of articles that were found, a critical appraisal should be applied. The outcome of the literature review determines if the investigator should continue his or her efforts. Validating evidence that provides a solid knowledge based indicates no further study is needed. If there is a lack of strong evidence, then new research is needed in the area of interest.

In 1979, a group of biomedical journal editors determined a need to standardize the format for articles and proposals in writing research reports called the Vancouver Style. The case report must also follow the guidelines, which can be found in the rear section of all indexed journals or online. As a learning tool, each section of the research article will be discussed using examples from the literature.

A brief review of the experimental evidence relating to chiropractic subluxations reveals three distinct approaches [misalignments, aberrations of movement integrity, and changes in physiological functions]. Each perspective contains significant drawbacks; however, when taken in concert, they function as a three-legged stool in advancing our attempts to explain those instances in which chiropractic spinal manipulation is found to be efficacious and effective. Just as we have come to peaceful terms with what appear to be conflicting concepts in physics and chemistry, so we need to embrace the discordant notes sounded by what we have observed to date regarding chiropractic subluxations--taking care to neither reject nor adopt without question or qualification those models of subluxations which have thus far been presented.

These questions will be explored in an interactive format, with input from the audience as well as a group of distinguished researchers.

Methods: A survey was produced which includes much of the same information from the above-mentioned studies, but it also includes questions specific to the qualities of an orthogonally-based upper cervical doctor and his/her practice. The survey is broken down into the following categories: Doctor Information, Office Environment, Types of Patients/Conditions, and Case Management. This survey was mailed or presented to ~500 upper cervical doctors. The techniques included the following: Grostic Procedure, Orthospinology, NUCCA, Atlas Orthogonality and SONAR.

Results: Data results will be reviewed which was obtained from ~100 completed upper cervical surveys.

Conclusion: This information will aid in determining if upper cervical patient case management is any different from the average chiropractor. This data will be a stand-alone project, but it will also be used in many future research studies.

Methods: A longitudinal study has been conducted over a period of 34 months. Every new case, 21 years of age and older, admitted into this private office setting was included in this study, provided they followed their doctor-directed schedule of care. 33 subjects fit the criteria set for inclusion in this study. Bone mineral density was assessed on each subject via the accuDEXA BMD assessment system. The accuDEXA device from Schick Technologies, Inc. is a bone densitometer that estimates bone mineral density (BMD) of the middle finger of the non-dominant hand. Finger BMD is a relative indicator of bone density in other parts of the body. It is a self-contained, table-top unit, employing dual energy X-ray absorptiometry (DEXA) technology.

Each subject was examined via accuDEXA BMD assessment system prior to receiving his or her first upper cervical adjustment. Follow-up examinations were performed in 4 weeks, 6 months and 1 year post initiation of upper cervical chiropractic care.

In addition, each patient completed a SF-36 Rand Health Survey coinciding with each BMD examination.

Results and Conclusions: Significant positive changes in BMD were noted in the majority of cases following one year of upper cervical chiropractic care. 3 cases that presented with a BMD lower than what is considered normal moved into the normal range on their one-year follow-up examination. BMD changes observed 4 weeks and 6 months following the initiation of upper cervical chiropractic care do not appear significant. The SF-36 Rand Health Survey demonstrated positive responses in each of the follow-up examinations. This study suggests that upper cervical chiropractic care may positively influence bone mineral density.

Key terms: Meniere's disease, vertigo, dizziness, upper cervical specific chiropractic, subluxation

Data Collection: Online searches were performed using non-medical, chiropractic research links available on the Sherman College of Straight Chiropractic Website including, Chiro-Access, Mantis, and journal specific websites such as JMPT, JVSR, and CRJ. Despite these technologies, a majority of articles were obtained directly from the bound journals of the Palmer College of Chiropractic library in Davenport, IA and the Sherman College of Straight Chiropractic library in Spartanburg, SC. Data demonstrating subjective measurements, such as those utilizing self-rated patient surveys, were excluded from this analysis.

Results: The search revealed 20 peer-reviewed, published studies that specifically involved "asymptomatic," "healthy," or "normal" subjects. Health Benefits of some kind were observed in all twenty studies. Fourteen additional studies demonstrated measurable health benefits in subjects to which no symptoms or pathology were described. This could mean that subjects may or may not have been asymptomatic. Nonetheless, these studies are significant because they demonstrate how the patient's symptomatic presentation is not necessarily relevant to administration of chiropractic adjustments and any subsequent health benefit. Health benefits in these studies include but are not limited to improvements in the respiratory system, cardiovascular system, immune system, muscular strength, visual acuity, cortical processing or mental functioning, the limbic system, the endocrine system, as well as overall health and wellness. The data presented here are of varying methodologies; several studies are controlled trials, some with randomization and some with single and double blinding. Others are retrospective studies, pilot studies, and still some are case series.

Conclusion: The notion that there is no evidence of chiropractic care being of benefit to individuals without musculoskeletal complaints is erroneous. Despite the opinions of some critics, the data reviewed lend support to the contention that chiropractic adjustments, often for the purpose of correcting vertebral subluxations, confer health benefits to people regardless of the presence or absence of symptoms. Though limited, there is an increasing body of evidence to support the contention that individuals presenting without symptoms can benefit markedly from chiropractic care. Improved function can be objectively measured in asymptomatic individuals following chiropractic adjustments/care, in a number of body systems, often by relatively non-invasive means. The data are encouraging and a more concerted effort should be made to conduct research on healthy, asymptomatic individuals to document the health benefits derived from chiropractic adjustments.

The purpose of the project will be as follows:

• to demonstrate a quantitative and reproducible basis for diagnosing, adjusting and evaluating patients presenting with cervical dysfunction
• to share our results with other chiropractors and health providers
• to provide evidence to insurance companies and employers of how effective AO adjusting is for cervical dysfunction
• to suggest a possible alternative to drug therapy to the military and high risk industry who require "down time" for personnel who must take prescription drugs for cervical pain.

We have hired Dr. Lasca Hospers, PhD in Anatomy, to present these case studies to the National Institutes of Health for a Federal Research Grant. Our target date is October 2001. The conference presentation will show the data collection forms and discuss the proposed methods and data collection strategy.

References

• Nuygen HT, Resnick, DN, Caldwell, SG et al. Interexaminer reliability of activator methods' relative leg length evaluation in the prone extended position. J. Manipulative Physio. Ther. 1999, 22(9): 565-569.
• Hinson, R, Brown, SH. supine leg length differential estimation: an inter- and intra-examiner reliability study. Chiro. Res. J. 1998; 5(1): 17-22.
• Jansen RD; Cooperstein R. Measurement of soft tissue strain in response to consecutively increased compressive and distractive loads on a friction-based test bed. Journal of Manipulative and Physiological Therapeutics 1998 Jan; 21(1): 19-26.
• Knutson GA. Rapid elimination of chronic back pain and suspected long-term postural distortion with upper cervical vectored manipulation: a novel hypothesis for chronic subluxation/joint dysfunction. Chiropractic Research Journal 1999 Fall; 6(2): 57-64.

Design: To compare Health Locus of Control scores in approximately 50 people who are under regular chiropractic care to about 50 people from the same socioeconomic-cultural backgrounds who are not under regular chiropractic care.

Participants: The chiropractic patients will be obtained via chiropractic offices in the Newberry, SC area; the non-chiropractic subjects will be obtained via churches also in the Newberry area.

Study Duration: One college quarter of 11 weeks

Outcome Measures: The Health Attribution Test by Achterberg and Lawlis, 1990.

Expected Results: To find that chiropractic patients will score significantly higher on Intrinsic Control Scales than will non-chiropractic subjects. To find that people who do not go to chiropractors, or another type of "alternative" practitioner will score significantly lower on the Intrinsic Health Locus of Control Scales.

Key Words: Locus of Control, alternative medicine, chiropractic

The advent of hand-held digital infrared scanners has enabled more sophisticated and objective analysis of paraspinal thermal skin patterns. We developed specialized analysis software that computes congruence factors between any two thermograms as a way to judge their similarity. This software is being use in short-term and longer-term studies to assess the changes that occur over time. In the first study, two different doctors scanned 30 student subjects 4 times in rapid succession.

With 4 scans for each patient, there are 6 unique comparisons of pairs of thermograms. The pattern analysis software calculates a set of 15 congruence factors for each of the 6 comparisons. While data analysis has been straightforward, sifting through the mountain of calculated factors to find some meaning has been a challenge. The presentation will show the approach to data synthesis and the results of the short-term reliability study.

Owens (2) conducted a study that is quite similar to the one proposed here. In the Owens study Visi-Therm II readings were taken on 25 subjects every 3 minutes over a 33 minute period. This study showed that there was an ongoing cooling-off period during the equilibration time with the patterns of the heat readings stabilizing after 12 minutes.

The purpose of the present study is to re-visit the question of heat pattern stability using the Pattern Calculator - a recently developed software program that will give a percent similarity between any two digitized line readings (3-4). Computer-aided analysis of paraspinal heat differentials was a theory developed by Stewart et al (5) in 1989. Analysis of paraspinal heat patterns assists the chiropractor in determining if neurological adaptability has been compromised due to vertebral subluxation (6-7). The study began in June 2001 and the data will be ready for presentation by conference time (October 2001).

Methods

Five students will be recruited and scanned by the author. Each subject will receive an initial reading about 10 seconds after the shirt is off. The next reading will be taken after 1 minute, followed by a reading every 5 minutes to the 20 minute mark for a total of 6 readings. The author will analyze the readings via the Pattern Calculator. Each of the 6 readings will be compared to each other (i.e. reading #1 with the other 5, reading #2 with the other 5, etc) in the Pattern Calculator. Each comparison will result in a percentage of similarity between any two readings compared. The highest and lowest percentages will be identified so that a possible conclusion can be made regarding the effect of equilibration on the stability of the patterns. These results will assist the chiropractor in deciding which time interval, if any, tends to produce the most repeatable/reliable reading.

References

• Rein, H. Thermographic evidence of soft tissue injuries. Shepard's/McGraw-Hill, Colorado Springs, CO, 1987. [cited in the Owens reference, #2 below].
• Owens EF. Equilibration times for digitized thermographic evaluation. In proceedings of the Chiropractic Centennial Foundation, Washington, D.C. July 6-8, 1995.
• Owens E, Penrod M, Stein T. Thermographic pattern analysis using objective numeric methods. [abstract] Chiropractic Research Journal 1999; 6(2):78-79.
• Owens EF, Stein T. Computer-aided analysis of paraspinal thermographic patterns: a technical report. Chiropr Res J 2000; 7(2):65-69.
• Stewart MS, Riffle DW, Boone WR. Computer-aided pattern analysis of temperature differentials. Journal of Manipulative and Physiological Therapeutics 1989;12(5):345-352.
• Kessinger R. Boneva D. Vertigo, tinnitus, and hearing loss in the geriatric patient. Journal of Manipulative and Physiological Therapeutics 2000; 23(5):359-360.
• Owens EF, Pennacchio VS. Operational definitions of vertebral subluxation: A case study. Topics in Clinical Chiropractic 2001;8(1):40-48.

The data showed that 51% of volunteers examined (n=74) in the general (non-clinical) population had supine fLLI. Those with fLLI has a significantly (p=0.04) lower score on the mental component of the SF-12 general health survey than those without. There was a moderate correlation between supine fLLI and recurrent back pain (K=0.51). Pain intensity on a visual analogue scale of those demonstrating supine fLLA was significantly higher (p<0.001) than those without fLLA. The validity of the supine postural leg check showed an acceptable (p<0.001) level for sensitivity (87%), specificity (84%), and positive (73%) predictive value. Findings also indicate a high incidence (85%) of supine fLLA in subjects with chronic back pain.

These results show that subjects with fLLI - a sign of subluxation - had a statistically significant decrease in a measure of general well-being, increased pain intensity and likelihood of recurrent back pain. Given these results, along with established inter- and intra-examiner reliability, the supine leg length alignment check should be considered a valid clinical test.

Traditionally, posture is seen as a form of biomechanical linkage of body segments, the purpose being to keep the center of mass over the base of support. Smart and Smith (2001) have recently redefined posture as a behavior whose purpose is to facilitate other behaviors through the maintenance of a given coordination of segments that are biomechanically viable (i.e. goal is achieved without loss of balance) and efficient (energy expenditure is minimized).

Taking a behavioral approach to examining posture offers additional methods of assessment for the chiropractor. In lieu of being able to study the nervous system directly in relation to energy expenditure, stability and regulation, the behavioral approach, which emphasizes the study and quantification of global system dynamics is an attractive measure to investigate the system indirectly. In this presentation i review important concepts of postural control that are relevant to chiropractic practice and research. Pilot data will be presented (from patients) on postural control with chiropractic adjustments when the primary goal is to maintain balance on different surfaces in the absence of any perturbation. Implications of this form of investigation to the chiropractor and researcher will be discussed.

REFERENCE:
Smart, L. J., & Smith, D. L. (2001). Postural dynamics: Clinical and empirical implications. Journal of Manipulative and Physiological Therapeutics, in press.