Research Publications and Presentations
- The Effect of Frequency of Treatment on Patient Response to Multiple Impulse Therapy for Low-back Pain
- The Efficiency of Multiple Impulse Therapy for Musculoskeletal Complaints
- Pilot Study of The Effectiveness of Multiple Impulse Therapy for Musculoskeletal Complaints
- Pilot Data: Passive Cervical End Range Stiffness Contralateral to Side of PulStar Measured Compliance in Acute Neck Pain Patients
- Estimating the Efficiency and Effectiveness of Techniques of Musculoskeletal Therapy
- Introduction to the Use of Kaplan-Meier Survival Analysis for the Evaluation of Musculoskeletal Therapy
- Differential Compliance Instrument in the Treatment of Infantile Colic: A Report of Two Cases
- PulStar Differential Spinal Compliance Instrument:
- The Minimum Energy Hypothesis: A Unified Model Of Fixation Resolution
- Similarities and Differences Between X-ray Analysis And Computerized Fixation Imaging of the Cervical Spine
- The Clinical Application of Differential Compliance Methodology to Joint Fixation Identification and Resolution Using the PulStarFRAS™
- Differential Compliance Measured by the Function Recording and Analysis System in the Assessment of Vertebral Subluxation
- Pilot Study of the Repeatability of the PulStarFRAS™
The Effect of Frequency of Treatment on Patient Response to Multiple Impulse Therapy for Low-back Pain
ABSTRACT
Study Design. Prospective, controlled, blinded time series analysis of the effect of a change in clinic policy thatresulted in an increase in the frequency of patient visits
Objectives.
To document the effect of an increased frequency of patient treatment (increase in dose) on the response of patients treated for low-back pain with multiple impulse therapy provided by the PulStarFRAS™.
Summary of Background Data.
Results of an initial pilot study of multiple impulse therapy showed rapid patient response rates judged to be faster than estimates of the natural history of low-back pain. It was hypothesized that increasing the frequency of treatment would further improve response rates to therapy for low-back pain if the therapy were effective.
Method.
The effect of visit frequency on the treatment time and number of visits necessary to achieve a pain-free state using multiple impulse therapy provided by the PulStarFRAS was analyzed using survival analysis. During the first phase of the study, patients were scheduled by the normal clinic routine i.e. the patient was referred to the “front desk” for assignment to an open appointment as close as possible to the time for the return visit specified by the clinician. During the second phase, the clinician changed the practice of patient scheduling to decrease the average time between visits by a few days resulting in an increase in the frequency of patient visits. Survival analysis was used to examine the relationship between visit frequency, days required for symptom resolution and total visits for patients treated under two separate protocols which differed only in the frequency of patient treatment.
Results.
Two hypotheses were tested in the study. The first hypothesis was that increases in the frequency of patient visits would result in shorter times to symptom resolution. This hypothesis was supported. The second hypothesis was that increasing the frequency of patient visits would increase the number of visits required for the resolution of patient symptoms. This hypothesis was not supported. The number of patient visits required for symptom resolution did not change when visit frequency was increased.
Conclusion.
The results of this study supported the hypothesis that increasing the dose of multiple impulse therapy increased the rate of patient response to therapy with no increase in the cost of therapy.
Key Words:
musculoskeletal,manipulation, effectiveness, visit frequency, dose, pain-free, impulse, time trial, PulStarFRAS, emerging technology, low-back.
topThe Efficiency of Multiple Impulse Therapy for Musculoskeletal Complaints
ABSTRACT
Objective:
To document the response of patients to multiple impulse therapy for a variety of musculoskeletal complaints encountered in clinical practice. This study presents the treatment results of 249 patients using multiple impulse therapy provided by the PulStarFRAS™.
Setting:
A single practitioner in a private clinic setting provided the therapy.
Methodology:
Survival analysis was used to plot probability of pain versus the days required for symptom resolution for each of eight patient complaints. Analysis of variance was used to examine the influence of covariates such as age, gender, body mass index and chronicity.
Results:
Findings of the study include: 1) the average number of visits required to achieve a pain-free state for each of eight patient symptoms; 2) the half-life for response to multiple impulse therapy using the PulStarFRAS for each of eight patient symptoms; 3) comparison of the results to published studies of low-back and neck pain and comparison to an estimate of the natural course of low-back pain.
Conclusion:
Response of patients in the study sample to multiple impulse therapy for symptoms of low-back and neck pain appeared to be considerably faster than that obtained in three recent studies. The use of multiple impulse therapy for the treatment of low-back pain was judged to be effective when compared to an independent reference standard representing the best estimate of the course of low-back pain without manipulative treatment. The results of this study support the continued use and study of multiple impulse therapy provided by the PulStarFRAS as a means of resolving musculoskeletal symptoms. These results compare favorably with published studies of techniques of musculoskeletal therapy.Key Words:
musculoskeletal,manipulation, effectiveness, pain-free, impulse, Kaplan-Meier, survival analysis, PulStarFRAS.
topPilot Study of The Effectiveness of Multiple Impulse Therapy for Musculoskeletal Complaints
ABSTRACT
Study Design:
This study presents the results of treatment of 50 patients using multiple impulse therapy provided by the PulStarFRAS™. The study consisted of a randomized retrospective analysis of patient files to determine symptomatic improvement over the course of treatment for a variety of musculoskeletal complaints that were encountered in clinical practice. The multiple impulse therapy was supplemented, at the discretion of the practitioner, with manual adjustments. The manual adjustments consisted of HVLA (high velocity low amplitude) and drop table and were administered to fewer than 5% of the patients.
Objective:
The objective of this study was to document the effectiveness of the multiple impulse therapy provided by the PulStarFRAS for a variety of musculoskeletal symptoms encountered in clinical practice.
Setting:
The therapy was provided by a single practitioner in a private clinic setting. Results: Important findings of the study include: 1) All patients expressed improvement in symptoms immediately after the first visit (average improvement in subjective pain rating scale of 41%). 2) Patient symptoms improved between the first and second visits for 70% of patients (average improvement in subjective pain scale for all patients was 58%). 3) No patients expressed a negative result to therapy. 4) The majority of patients achieved complete resolution of symptoms between the 3rd and 4th visits. 5) Maximum benefit for all patients across all symptoms required an average of 4.2 visits. 6) The half-life for response to multiple impulse therapy using the PulStarFRAS for all symptoms was 17 to 26 days. 7) The half-life for response to multiple impulse therapy using the PulStarFRAS for low back pain was 9 to 16 days.
Conclusion:
The results of this study support the use of multiple impulse therapy provided by the PulStarFRAS as a means of resolving musculoskeletal symptoms. These results compare favorably with published studies of techniques of musculoskeletal therapy.
topPilot Data: Passive Cervical End Range Stiffness Contralateral to Side of PulStar Measured Compliance in Acute Neck Pain Patients
In a preliminary effort to develop a clinical protocol using the computer assisted PulStar device as a purported mediating variable for subluxation complex, a convenience sample of 25 patients presenting with acute neck pain were evaluated before and after upper cervical diversified adjustments. In blinded assessments end range asymmetries were evaluated using the Nansel (1991) protocol, and compared with PulStar compliance measures taken separately, while the patient actively hyperextended the neck to the right and left while sitting upright. In 18 of 25 subjects, PulStar compliance was significantly increased contralateral to the side of end range motion restriction. Further, in subjects with VAS pain scores >4, 12 of 15 exhibited this contralateral stiffness finding.
Subsequent diversified technique was used only at the side and at the level predicted by the passive end range motion restriction (again after Nansel, 1991: upper right, upper left, lower right, or lower left cervical spine adjustment), in the subjects with contralateral stiffness (PulStar prediction). Of these 18 subjects, 6 of 9 with lateral bending restrictions, and 8 of 9 with rotational restrictions had significant improvement in L/R asymmetry post treatment as measured by PulStar. For all 25 subjects, upper cervical asymmetries improved 77% of the time, and lower cervical asymmetries improved 72% of the time after a single neck adjustment directed to the side and level predicted by passive end range motion assessments.
Data appear to support the findings of Nansel, that there are side and level specific adjustments that will best ameliorate end range motion restrictions. Further blinded research is necessary to correlate these findings with clinical outcomes, and determine whether PulStar measures may serve as a predictor/mediating variable of subluxation complex. Currently planning is underway for a RCT.
Reference:
Nansel D, Peneff A, Quitoriano J. Effectiveness of upper vx. Lower cervical adjustments with respect to the amelioration of passive rotational vs. lateral-flexion end-range asymmetries in otherwise asymptomatic subjects. Proc 1991 International Conference Spinal Manipulation, April 12-13, 1991:21-25. topEstimating the Efficiency and Effectiveness of Techniques of Musculoskeletal Therapy
ABSTRACT
Introduction:
Assessing the relative effectiveness of musculoskeletal manipulation techniques is difficult and controversial. This study proposes a numerical method for comparing the results of trials of musculoskeletal therapy as an alternative to ranking literature by experts in the field. The method is based on the observation that, in general, the course of recovery of patients with musculoskeletal complaints can be approximated by an exponential function.
Methods:
Using data from published studies,a simple exponential model was used as the basis for estimating thehalf-life (the time necessary for half of the patients in a study to express relief of pain) of various techniques of musculoskeletal therapy.
Results:
The half-life of the techniques used in the study varied from 6 to 195 days. The majority of studies had estimated half-lives of 22 to 83 days.
Conclusion:
The results suggest that studies of most techniques of chiropractic and osteopathic therapy exhibit similar half-lives and in that sense similar efficiency. One possible explanation for this result is that, especially in the early course of patient treatment, the natural healing process dominates the results and therefore differences in treatment techniques and protocols are unlikely to be discerned until the majority of patients have finished the course of treatment. In other words, differences in treatment efficiency and effectiveness are unlikely to be observed using relatively short treatment times and/or small subject sizes.
topIntroduction to the Use of Kaplan-Meier Survival Analysis for the Evaluation of Musculoskeletal Therapy
ABSTRACT
Introduction: Survival analysis is seldom used in studies of the effectiveness of musculoskeletal therapy. The reasons for this are unclear given the simplicity and power of the procedure and its use for a wide variety of problems in other fields of medical research. Under the assumption that the neglect of this method of analysis is due at least in part to unfamiliarity on the part of researchers, this work describes the analysis and discusses examples of its use in musculoskeletal research.
Discussion:
Survival analysis is the calculation of the probability of the occurrence of an event (becoming pain free) in the patient population under study. The mathematical underpinning of the method is described and the use of the results is illustrated with two case studies drawn from the current literature.
Conclusion:
Survival analysis is a powerful analysis technique that offers the researcher a clear and unambiguous method of presenting the results of studies of the effectiveness of musculoskeletal therapy and comparing the results to other studies.
topDifferential Compliance Instrument in the Treatment of Infantile Colic: A Report of Two Cases
ABSTRACT
Objective:
To report on a novel use for a computer assisted adjusting device as a potentially safe method for treatment of infantile colic.
Clinical Features:
Two pediatrician-diagnosed cases of infantile colic, characterized by signs of distress, uncontrolled crying, with brief episodes of screaming, were otherwise associated with normal growth (despite low birth weight in the second case) and no other abnormalities.Intervention and Outcome:
A PulStar Function Recording and Analysis System (PulStarFRASTM) device was used to administer light impulses (viz. @1.7 joules which produced a 3 to 4 lb. Force) at each segmental level throughout the dorsal spine using probe tips spaced 2 cm apart, straddling the spinous processes. Crying was reduced by 50% after a single session of instrumented adjusting in a 6-week old female and after four sessions in a 9-week old male, according to colic diaries kept prospectively by the mothers. Uninterrupted daily sleep increased from 3.5 to 6.5 average hours after a single session. Within 10 days (5 and 8 sessions respectively) colicky behavior disappeared and total daily sleep improved to 14.5 average hours (up from 4.5 average previously); results continued over a 30-day follow-up. The treatment was well tolerated, with only mild temporary observed discomfort. These initial findings using a low force instrumented procedure mirror results from controlled trials of manual adjustments for colic.Conclusion:
The PulStar mechanical adjusting device appears to have been well tolerated and beneficial in two cases of infantile colic. Further research will be necessary to determine if this device can enhance the safety and/or effectiveness of chiropractic treatment in infants with colic. topPulStar Differential Spinal Compliance Instrument:
A Blinded Randomized Inter- and Intra-Examiner Reliability Study
ABSTRACT
Objective:
To provide an entry-level, new-technology reliability assessment of the PulStar computer assisted, differential spinal compliance instrument.Subjects:
Eighteen college students (9 males and 9 females) were recruited by announcements and personal contacts.Methods:
Inclusion criteria included subjects aged only in the 18 to 25 range, of normal weight (obesity defined by World Health Organization criteria), and who denied any prior history of significant spinal problems or treatment. Following approval of the consent process by the institutional review board of Mississippi State University, a PulStar Function Recording and Analysis System (PulStarFRAS™) device was evaluated for clinical reliability. Two blinded examiners used the instrument in random order on individual subjects lying prone with their backs exposed, to administer light impulses (vis. ul. 7 joules which produced a 3 to 4 lb. force) at each segmental level throughout the cervical, dorsal, and lumbar spine using probe tips spaced 3 cm apart, straddling the spinous processes, while a computer recorded the findings (resistance to thrust on a scale of 0 to 255 joules).Results:
Data were analyzed by Exploratory Data Analysis (EDA) with ANOVA testing, and by use of the Intraclass Correlation Coefficient (ICC). In addition, a means test (ANOVA) was conducted to determine if a trend in variation occurred as a result of repeated light thrusts to the spine, independent of variance explained by different examiners. Using EDA analysis and ANOVA intra-examiner reliability for the two practitioners was very high but not perfect. This was confirmed by ICC statistics demonstrating good to excellent reliability for both practitioners (0.89 for the experienced practitioner, 0.78 for the newly trained practitioner). Inter-examiner reliability of PulStar was similarly very high but not perfect based upon EDA/ANOVA analysis, and good to excellent (ICC = 0.87). Means testing with ANOVA did not explain variance between examinations which might have been expected due to any biological effect of repeated measurements with the device set to analysis mode. A fatigue effect was observed with the newly trained practitioner’s reliability decreasing over time during the trial.Conclusion:
the PulStar mechanical adjusting device set to analysis mode appears to have good to excellent reliability when used by either an experienced or a novice (but trained) examiner. In addition, as a measure for spinal resistance to a light thrust, or spinal compliance, reliability was similarly good to excellent between the two doctors using the PulStar instrument. This initial study does not address the validity or clinical significant of the measurement method. Further research will be necessary using greater numbers and a wider variety of subjects, and more diverse examiners, to verify these findings and fully understand the generalizability of these results. topThe Minimum Energy Hypothesis: A Unified Model Of Fixation Resolution
ABSTRACT
Objective:
To present a new theoretical construct, the Minimum Energy hypothesis, which explains structural changes observed in the spine concomitant to spinal joint fixation resolution in initial investigations.
Design:
Theoretical analysis.Hypothesis:
A unified theory of manipulative effectiveness is proposed which integrates the fixation and sensory tonus models of manipulation. The theory is based on the fact that the spine will assume a position of minimum internal energy when mechanical equilibrium is achieved. Using a simple mathematical model, it is shown that the fixation model and the sensory tonus models are two different aspects of the same theoretical construct. The Minimum Energy hypothesis predicts that the spine will seek an optimal minimum energy configuration, if the constraints preventing it from doing so are removed. Constraints are hypothesized to be joint fixations caused by inflammation in and about the spine and its sequella, muscle spasm, fibroadipose and scar tissue, and ultimately degeneration. It is further hypothesized that use of a computerized mechanical manipulative device may resolve such fixations, an example of which is radiographically demonstrable cervical hypolordosis.
Conclusion:
A unified theory of manipulative effectiveness based on the concept of minimum energy to attain mechanical equilibrium is brought forward to explain the results of initial investigations.
topSimilarities and Differences Between X-ray Analysis And Computerized Fixation Imaging of the Cervical Spine
ABSTRACT
This paper presents a comparative study of the results of x-ray analysis and Computerized Fixation Imaging (CFI) analysis of the cervical spine. Twenty-five patients seeking chiropractic care at a private clinic were randomly selected to participate in the study.
This study was undertaken to answer questions from clinicians using the Sense Technology PulStarFRAS (Function Recording and Analysis System). These questions arise regarding the findings of a mature and widely used method of spinal analysis (x-ray) and this new and rapidly evolving method of objective instrumented palpation (CFI).
Significant major findings were:
- A Kendall coefficient of concordance of .74 was obtained between the results of x-ray analysis and the results of CFI analysis.
- A Kendall coefficient of concordance of .74 was obtained between x-ray findings of arthritic joint involvement and CFI analysis and
- A Kendall coefficient of concordance of .76 was obtained between x-ray findings of discontinuities of cervical spine curvature and CFI analysis.
These results show that there is a high degree of correlation between x-ray analysis and CFI in findings of discontinuities of spinal structure and in observation of evidence of osteo-arthritis.
topThe Clinical Application of Differential Compliance Methodology to Joint Fixation Identification and Resolution Using the PulStarFRAS™
ABSTRACT
This Paper describes a single subject case study designed to evaluate the clinical usefulness of Differential Compliance Methodology employing the PulStarFRAS instrumentation. The results of the study illustrate the effectiveness of multiple impulse percussive force application in the release of fixations of spinal joints, where the fixations were identified by compliance readings obtained with the PulStarFRAS. Over a progression of three weeks, the patient experienced a change in cervical curvature from a radius of 150 cm to 15 cm, as well as resolution of presenting symptoms. Moreover, a restoration of normal cervical hard tissue compliance was recorded. Based on the results of the study, Differential Compliance Methodology including multiple impulse force application using the PulStarFRAS can be considered to have been an effective intervention in the care of the patient studied, who exhibited signs of spinal fixation with accompanying musculoskeletal dysfunction and other symptoms.
topDifferential Compliance Measured by the Function Recording and Analysis System in the Assessment of Vertebral Subluxation
Joseph M. Evans Ph.D. Journal of Vertebral Subluxation Research, Vol. 2, No. 1, 1998
ABSTRACT
This study presents the theory of differential compliance and the clinical application of instrumentation designed for its detection in the clinical setting. The engineering principle of using a mechanical impulse to excite a structure coupled to sensors to measure the response, has been employed in the design of the Function Recording and Analysis System (FRAS). This system, linked to software which analyzes input data, is further designed to graphically display relative differences in vertebral compliance. The present study employed assessment of a region of the spine encompassing the occiput to the third thoracic vertebra as a model to demonstrate how compliance measurements can be obtained, graphically displayed, and interpreted. The reliability of the instrumentation to accurately and consistently measure different levels of compliance was tested on three artificial substrates of varying “stiffness” and three human tissue locations exhibiting different “Stiffness’ including the heel, palm, and finger tip. Moreover, intra- and inter-examiner reliability in the use of the system has also been reported. Statistical evaluation of repeated measures for each of these categories included analysis by chi-square, Pearson product moment correlation, and intraclass correlation coefficients (ICC). Results indicated a high level of consistency of the instrument in measuring substrates of varying compliance. Moreover, strong intra-examiner reliability (ICC ³ 0.90), and inter-examiner reliability (ICC = 0.65) suggest a consistent use of the instrument among and between practitioners. These findings indicate a useful role for the FRAS in the characterization of vertebral subluxation, as well as serving as one means of assessing changes in flexibility of the spine following the chiropractic adjustment.
topPilot Study of the Repeatability of the PulStarFRAS™
ABSTRACT
Objective:
The objective of this study was to document the repeatability of computerized method of instrumented palpation of the spinal musculoskeletal system in three positions of analysis: prone, sitting and standing.
Clinical Setting:
Private chiropractic office.
Results:
The spines of ten patients (7,200 observations) were analyzed by four investigators following a repeated measures design. Each subject’s spinal structure was analyzed in the prone, sitting and standing positions. The measured compliance of the spine was observed to vary smoothly along the spine with the exception of T2 where a discontinuity was observed. Four clinical users of the PulStarFRAS with different levels of experience with the PulStarFRAS were able to reproduce their findings on ten chiropractic patients with remarkable consistency (R+.83 for experienced users; .73-.75 for less experienced users). Inter-examiner results were also high. The positional analysis showed that the prone position produced the highest repeatability.
Conclusion:
This study contributes to the understanding of the musculoskeletal system’s response to low energy dynamic impulses, but more research is needed before the results can be extended to the general patient population. The study results indicate that instrumented palpation with the PulStarFRAS has the potential of exceeding the repeatability of any other method of clinical assessment of the musculoskeletal system in general use.
