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	AOA Research Fellowships

Top AOA Research Fellowships Osteopathic Manipulative... Clinical Studies Basic Sciences Medical Education

 
F1
Comparing the Effects of Cranial Manipulation on Heart Rate Variability and Traube-Hering-Mayer Waves
T. Pexton, DO, K. Nelson, DO, T. Glonek, PhD, K. Heinking, DO, R. Kappler, DO, N. Serfueef, DO (France), Dept. of OMM, Midwest University, Chicago College of Osteopathic Medicine, Downers Grove, IL

Hypothesis: It has been shown that the cranial rhythmic impulse (CRI) is simultaneous with a measurable oscillation in blood flow velocity known as the Traube-Hering-Mayer (THM) wave. It has also been shown that the THM wave can be enhanced with cranial manipulation. Based on physiological principles, it is reasonable to expect that heart rate variability (HRV) will similarly be enhanced by cranial manipulation.

Materials and Methods: A heart rate monitor and a laser Doppler flowmeter were used to measure HRV and the THM wave simultaneously. The protocol consisted of a pre-treatment phase, a CV-4 treatment phase and a post-treatment phase. Each phase lasted approximately 5-10 minutes. Subjects remained quietly in the supine position for the duration of the protocol. The following standard HRV measurements were generated: RMSSD; pNN50; Total Power (0-0.4Hz); High Frequency, HF (0.15-0.4Hz); Low Frequency, LF (0.04-0.15 Hz); Very Low Frequency, VLF (0-0.04 Hz); LF/HF; and the ratio of the powers of various frequency ranges to the Total Power. THM wave power spectra were generated with WinDaq Software.

Results: 20 healthy subjects were evaluated. All signed an institutionally approved IRB consent form. Subjects were divided among 3 physicians (N of 3, 4 and 13). For the entire group (N=20), there was no significant change in pre- to post-treatment measurements for any of the standard HRV parameters. For one physician, a significant increase in the Square Root of the Mean of the Squared Differences Between Adjacent Normal RR Intervals (RMSSD) was found pre- to post-treatment [N=4; (mean±SD) pre 51.85±24.33, post 60.7±23.42; P=0.050]. Simultaneous THM wave measurements did not show any significant changes for these subjects [N=4; (mean±SD) pre 1093.3±143.9, post 1079.6±159.1; P=0.601].

Conclusion: An increase in the THM wave following a CV-4 treatment was not demonstrated. However, a significant post-treatment increase in one of the standard HRV measurements was demonstrated. A decreased HRV has been shown to be one of the best predictors of mortality in CHF and post-MI patients. Given the prevalence and mortality associated with heart disease, further research is warranted.

F2
Measuring pressures used by physicians and students for cervical diagnosis of segmental somatic dysfunction using the Iso-TOUCH® Palpation Monitor System
N. T. Jean OMS-III¹, M. L. Kuchera, DO, FAAO¹, B. Schoenfeldt, OMS-III¹, R. T. Dombroski, DO¹, T. Vardy, DO², L. Williams, OMS-III¹, ¹Center of Chronic Disorders of Aging, ¹Philadelphia College of Osteopathic Medicine, Philadelphia, PA, ²Neuromuscular Engineering, Tweed Heads, North South Wales, Australia

For manual medicine (MM) physicians, developing palpatory skills needed to diagnose somatic dysfunction prior to treatment and assess subsequent change is crucial in determining safety and efficacy. Several scientific recording methods have attempted to quantify palpation demonstrated technological limitations.

Hypothesis: It was hypothesized that MM students would use more pressure during cervical spine diagnosis than experienced MM practitioners.

Methods: 10 osteopathic students and 10 osteopathic physicians palpated the cervical spines of volunteers (n=28, 12 by students, 16 by physicians). At each session a student or physician palpated two volunteers and then reported the side-bending/rotational motion characteristics of the perceived "worst segment."

A prototypic Iso-TOUCH® Palpation Monitor System (Neuromuscular Technologies) was developed to provide instrumentation to quantify pressure ranges used by successful practitioners to accurately diagnose (and later, successfully treat) somatic dysfunction. This technology utilizes finger, thumb and palm sensors to measure contact pressures during palpation of a given body region.

Finger pressures over the cervical articular pillars during side-bending and rotation were recorded and graphed by customized Iso-TOUCH® software. They were analyzed using a one-factor analysis of variance test performed by the PCOM statistician. The PCOM Institutional Review Board approved this study.

Results: In comparing all students to physicians, students used an average of 0.82 Lbs more palpatory pressure (p<0.01) than physicians (1.22-2.88 versus 1.03-1.30 Lbs). Additionally, physicians were found to compress the soft tissues prior to motion testing using 0.39 Lbs while students did not compress the tissues at all (p<0.01). Of the 10 students, 7 used more force than any physician palpator. The remaining 3 students used more force than most (7 of 10) of the physicians.

Conclusion: This study tends to confirm the hypothesis that as palpatory skills develop, less pressure is required to accurately diagnose somatic dysfunction. Furthermore, experienced clinicians incorporated loading pressures omitted by students. Based upon these findings, future studies are warranted with this technology to document palpation characteristics. Studies in educational settings are also planned to determine if this real-time feedback system might improve palpatory skills and confidence of future practitioners.

Acknowledgment: This project was partially funded by an AOA Research Fellowship Grant.

F3
Matrix Metalloproteinase-9 Processes Chemokines and Cytokines During Chlamydia Muridarum Urogenital Tract Infection of Mice
J. T. Distelhorst BS¹, M. T. Imtiaz, MD¹, S. R. Lacy, DO¹, J. S. Schripsema, BS¹, I. M. Sigar, PhD¹, J. N. Kasimos, DO², K. H. Ramsey, PhD¹, ¹Microbiology and Immunology Department, ²Pathology Department, Midwestern University-Chicago College of Osteopathic Medicine, Downers Grove, IL

Hypothesis: Matrix metalloproteinase-9 is involved in the pathogenesis of chlamydial infection in a mouse model.

Methods: Mice with a genetic deletion of matrix metalloproteinase-9 (MMP-9 KO) or strain-matched wild type (WT) mice were infected intravaginally with Chlamydia muridarum, mouse pneumonitis biovar (MoPn). Following infection, cervicalvaginal swab samples were collected at 0, 4, 7, 10, 14, 28, 35, and 56 days post-infection for culture confirmation and quantitation of infection. Chlamydial inclusions were enumerated by indirect fluorescence microscopy. At intervals, a subset of mice was euthanized, necropsied, and their urogenital tracts were excised. Some tissues were homogenized in buffer for the assessment of chemokine and cytokine production profiles by antigen capture enzyme-linked absorbent assay (ELISA) as well as antigen capture microarray. Tissue homogenates were also used to assess processing of chemokines by Western blot and to isolate MoPn in the upper genital tract. Lastly, tissues were fixed in buffered formalin, paraffin embedded, sectioned, stained with hematoxylin and eosin and blindly assessed for histopathological parameters. Results: In the lower tract, the infection course remained unchanged as a result of the MMP-9 KO whereas in the upper genital tract, there was a slight reduction in MoPn isolated from the MMP-9 KO mice. Pathological parameters, particularly acute inflammation and hydrosalpinx formation, were significantly reduced in the MMP-9 KO mice when compared to WT controls. Antigen capture ELISA and microarrays yielded quantitative differences in certain chemokines and cytokines and Western blot analysis indicated MMP-9 is involved in the proteolytic cleavage of specific chemokines and cytokines.

Conclusions: MMP-9 (gelatinase B) is a mediator of pathological host responses during Chlamydia muridarum infection in a mouse model. A likely explanation for this is observation is the proteolytic processing of chemokines and cytokines to modulate their activity.

Acknowledgement: Supported by N.I.H. 1 R01 AI49354-05.

F4
Six Etiologies of Low Back Pain Found in the US Army
M. M. Braun, DO, M. L. Kuchera, DO, T. E. Borden, DO, N. Ondrasik, DO, D. E. Jones, DO, G. V. Manco, PhD, M. V. Krueger, DO, Philadelphia College of Osteopathic Medicine, Philadelphia, PA

Objective: To determine the prevalence of six somatic dysfunction diagnoses in the presence or absence of low back pain. These somatic dysfunctions, closely related to six causes of chronic low back pain labeled by Greenman as the "Dirty Half Dozen," include: short-leg syndrome, psoas syndrome, non-neutral sacrum, sacral shear, pubic shear, and non-neutral lumbar dysfunction¹.

Setting: Womack Army Medical Center, Fort Bragg, NC

Methods: Subjects were randomly selected. Subject eligibility was determined by answers to written and oral interview questions. The subjects were evaluated clinically using a standardized osteopathic structural examination for various abnormalities involving the pelvis, sacrum, lumbar spine, and lower extremities. The examining team member was unaware of the patient's low back pain status. Statistical analysis included one-sided T-test for difference in proportions and nonparametric "exact" tests.

Results: 265 subjects were enrolled. Of these, 20 were not eligible to participate based on the initial screening. Of the remaining 245 subjects, 150 (61.1%) interviewed claimed to have back pain issues. 95 patients denied presence of back pain (control group). Of interest, 75% of the subset consisting of all airborne soldiers (n=39) reported back pain. Subjects showing two or more findings exhibited a greater amount of back pain compared to those subjects with 1 or less findings (p=0.046, LCB 95%). Of the "Dirty Half Dozen" diagnoses, subjects exhibiting the following had significant findings with back pain compared to controls: psoas syndrome (p=0.0000009, LCB 95%); non-neutral lumbar dysfunction (p=0.0308, LCB 95%); pubic shear (p=0.00000005, LCB 95%); and non-neutral sacrum (p=0.0185, LCB 95%).

Conclusions: Our study indicates that there is an association between back pain and presence of the "dirty half dozen" physical findings in the U.S. Army. Further study is required to determine if Osteopathic Manipulative Treatment of these dysfunctions can resolve patients' pain and expediently return these soldiers to duty.

References:

¹Kuchera, WA. Lumbar Region. Foundations for Osteopathic Medicine 2nd Ed. 2003; 727-750.

	Osteopathic Manipulative Medicine/Osteopathic Principles and Practice

Top AOA Research Fellowships Osteopathic Manipulative... Clinical Studies Basic Sciences Medical Education

 
P1
A PILOT CLINICAL TRIAL OF OSTEOPATHIC MANIPULATIVE TREATMENT DURING THIRD TRIMESTER PREGNANCY
J. C. Licciardone DO, MS, MBA¹, S. Buchanan, DO², K. Fulda, DrPH², K. Hensel, DO³, H. King, DO, PhD¹, S. T. Stoll, DO, PhD¹, ¹National Osteopathic Research Center, ²Obstetrics and Gynecology, University of North Texas Health Science Center, ³Tarrant County Public Health Department, Ft Worth, TX

Purpose: The primary purpose of this study was to explore the potential therapeutic effects of osteopathic manipulative treatment (OMT) during the third trimester of pregnancy.

Methods: All study procedures were approved by IRB and the study was registered with ClinicalTrials.gov (NCT00298935 [ClinicalTrials.gov] ). Exclusion criteria included either of the following: (1) intent to deliver at a non-designated hospital or (2) high risk pregnancy as determined by the attending obstetrician. Each subject was randomized to one of three treatment groups: (1) usual obstetrical care and OMT (UOBC+OMT); (2) usual obstetrical care and sham ultrasound treatment (UOBC+SUT); or (3) usual obstetrical care only (UOBC only). The UOBC+OMT and UOBC+SUT groups were scheduled to receive treatments at the 30th week (visit 1), 32nd week (visit 2), 34th week (visit 3), 36th week (visit 4), 37th week (visit 5), 38th week (visit 6), and 39th week (visit 7). The primary outcome measures included: (1) an 11-point scale for the typical or average level of back pain; (2) the Roland-Morris Disability Questionnaire; and (3) the SF-12 Version 2 Health Survey (SF-12) scale score for bodily pain and the summary scores for physical health and mental health. All analyses were based on the intention-to-treat principle. Missing data for all primary outcomes were imputed using the carry-forward method. Repeated measures analysis of covariance (ANCOVA) was used to test the hypotheses.

Results: A total of 49, 48, and 49 subjects were randomized to the UOBC+OMT, UOBC+SUT, and UOBC only groups, respectively. Typical or average back pain levels decreased over time in the UOBC+OMT group, remained essentially unchanged in the UOBC+SUT group, and increased in the UOBC only group (ANCOVA treatment group x time interaction, P=.02). The Roland-Morris disability scores increased over time in all three treatment groups; however, the rate of increase was significantly different among the groups (ANCOVA treatment group x time interaction, P<.001). Disability progressed less rapidly in the UOBC+OMT group than in the UOBC only group (P<.001), and there was also a trend toward less rapid progression in the UOBC+OMT group in comparison with the UOBC+SUT group (P=.08).

Conclusion: OMT was associated with favorable disability and pain outcomes during the third trimester of pregnancy. Supported by a grant from the Osteopathic Heritage Foundations.

P2
The Burden of Musculoskeletal Conditions in Ecuador
E. M. Timoshkin BA¹, A. J. Caban-Martinez, MPH¹, E. M. Wallace, DO, MSc¹, G. P. Suciu, PhD, MSPH², ¹Osteopathic Principles and Practice, ²Masters of Public Health Program, Nova Southeastern University-COM, Fort Lauderdale, Fl.

Objective: Understanding and elucidating acute and chronic musculoskeletal somatic dysfunction in regional areas of Ecuador has yet to be ascertained and remains a priority for the World Health Organization. Anecdotal data indicates that developing countries in South America are experiencing increases in work related musculoskeletal disorders. The limited body of literature on musculoskeletal conditions, specific to body region and type of pain are poorly characterized in Ecuador. In the present study, using a musculoskeletal survey, we assessed the proportion of musculoskeletal complaints by body region, at rural and urban Ecuadorian sites.

Methods: A modified 7-item version of a validated musculoskeletal survey was randomly administered to 116 adult patients during the NSU-DOCARE 2007 Ecuador Medical Mission. Descriptive analyses of the 7 selected variables from 100 completed surveys were tabulated using SPSS. Participants were consented prior to participation in the survey and the Nova Southeastern University's institutional review board approved the study.

Results: Among the 100 completed musculoskeletal surveys, adult participant ages ranged from 18-80 years old (mean±SE; 44.1±1.7), height from 48-69 inches (60.3±0.4), weight from 70-206 pounds (137.4±2.3), and BMI from 15.2-46.2 lb/in2 (26.8±0.5). Survey participants most frequently self-reported discomfort of the upper back (65%), knee (63%), and neck (62%) in the past 12-months; and upper back (61%), neck (58%) and low back (58%) body regions with the highest frequency in the past week. Fisher's test performed for site versus musculoskeletal pain location, demonstrated a significant difference for male gender between Baeza and Quito regions of Ecuador for the period of the past week, with a higher proportion of knee pain within Baeza (p=0.024).

Conclusion: Findings from the present study indicate there is a considerable prevalence of musculoskeletal conditions in specific Ecuadorian communities. Individuals residing in more labor intensive communities (Baeza) tend to self report higher levels of knee pain as compared to their urban counterparts. Focused strategies and interventions to ameliorate the current burden among this population are highly warranted.

P3
Student Achievement in a Virtual Reality Test of Palpatory Diagnosis
J. N. Howell, PhD¹, J. M. Burns, DO², D. C. Eland, DO², R. L. Williams, PhD³, R. R. Conatser, MS¹, ¹Dept. of Biomedical Sciences, ²Dept. of Family Medicine, ³Dept. of Mechanical Engineering, Ohio University College of Osteopathic Medicine, Athens, OH

Evaluation of tissue textures is a major part of the palpatory diagnosis of somatic dysfunction. Assessment of tissue textures requires detection of differences in tissue compliance (1/stiffness). In this study the Virtual Haptic Back (VHB) was used to determine the smallest differences in compliance osteopathic medical students could detect. The VHB is a virtual reality, force-feedback simulation of the contour and compliance of the human back, developed as a teaching/learning aid in palpatory diagnosis (JAOA, in press).

Hypothesis: By palpation medical students can detect differences in compliance on the VHB comparable to the 8 to 12% obtained by other investigators, utilizing simpler test algorithms.

Methods: In the fall of 2006, 89 first-year medical students were required, as part of their manipulative skills training, to perform a pre-test, 6 practice sessions, and a post-test on the VHB. The VHB simulation was based on the contours and compliance of the back of a 51 year old female. Programmed into the back were 2.5 x 3 cm regions of abnormally high paravertebral stiffness, which varied randomly from trial to trial as to side (L/R) and vertebral level. The difficulty level was progressively increased by having the difference in compliance between background and abnormal region progressively decrease. The task for the user was to find these abnormal regions by palpation.

Results: As a group, students improved during the practice sessions from being unable to detect differences of less than 28% to detecting differences as little as 14%. Ten students were able to detect differences as little as 7%, which represented achievement 1 standard deviation (SD) above the mean. The performance of these students in the pre-test was not significantly better than the students whose highest achievement during subsequent practice sessions was 1 SD below the mean, but was better (P.05; t-test) in the first practice session. Improvement rates in the remaining sessions did not differ.

Conclusion: Despite the more complex context of the discrimination task, the highest achievers in our sample performed at least as well the 6 subjects tested by De Gersem et al. (2005), although the average for the entire class, 14%, was somewhat poorer. The performance difference between high and low achievers was not apparent in the pre-test, but appeared during first practice session following the pre-test. Supported by the Osteopathic Heritage Foundation, Columbus, OH.

P4
Inter-rater Reliability of Rib Strain-Counterstrain Tenderpoints
J. Hartinger OMS-IV, N. Cloar, OMS-IV, M. Seffinger, DO, Western University of Health Sciences/COMP, Pomona, CA

Objective: The purpose of the study was to assess the reliability between two Osteopathic Manipulative Medicine student teaching fellows palpating a designated set of rib counterstrain tenderpoints.

Methods: After IRB approval, eighty volunteer subjects were recruited from the staff and student body at Western University of Health Sciences. Of the 80, 33 (41%) were randomly selected for the reliability study using an uncharted wrist tenderpoint between the distal radial-ulnar bones. Subjects were included if they were 18 or over, had no current open wounds or fractures in the regions of palpation, and had no tenderness at the uncharted wrist tenderpoints. A total of 14 points were assessed for each subject. Rib tenderpoints, which are on the bony surface of the ribs, consisted of anterior ribs 2-6 and posterior rib 1 bilaterally. The omohyoid tenderpoints (located at the inferior attachment of that muscle on each scapula), were used as non-bony reference points. A 0-10 point verbal pain scale was used upon digital provocation. The pressure applied for palpating the tenderpoints was pre-determined between the examiners to blanch no greater than the first 1/3 of the fingernail bed. Examiner 1 entered the room with the subject supine on a treatment table, assessed all 14 tenderpoints and then left the room. Examiner 2 entered the room within 1 minute, blinded to the results of examiner 1, and instructed the subject to give responses on the 0-10 verbal pain scale independent to the responses given to examiner 1.

Results: Pain scores within a 1-point difference or within a 2-point difference at each tenderpoint were considered as "agreement". Rib scores within 1-point difference: 71% agreement; =0.61; within 2-point difference: 88% agreement; =0.84. For the omohyoid tenderpoint, within 1-point difference: 85% agreement; =0.76; within 2-point difference: 92% agreement; =0.88. There were no significant differences between kappa scores for the rib and muscle tenderpoints (p>.05)

Conclusion: There is good inter-examiner reliability between OMM student teaching fellows at assessing standard rib counterstrain tenderpoints using agreed upon amount of digital pressure. Inter-examiner reliability is comparable between the rib and reference muscle tenderpoints.

P5
The Effect of Cranial Osteopathic Treatment on Visual Function
A. Caban-Martinez, MPH¹, E. Timoshkin, BA¹, M. E. Sand-house, DO¹, D. Shechtman, OD, FAAO², G. Fecho, OD, FAAO², A. Snyder, DO¹, M. Patterson, PhD¹, J. Shallo-Hoffmann, PhD², P. Hardigan, PhD³, ¹Dept. of Osteopathic Principles and Practice, Nova Southeastern University COM, ²College of Optometry, Nova Southeastern University COO, ³Statistical Support Center, Nova Southeastern University Health Prof Division, Fort Lauderdale, FL.

Objective: The effects of cranial osteopathy on visual function, particularly on changes of the visual field, and the binocular alignment of the eyes, are limited in the literature. Anecdotal evidence indicates that patients who undergo cranial osteopathic manipulation claim to experience an improvement in visual performance. A pilot study recently conducted by the authors demonstrated that a single treatment using cranial osteopathic manipulation produced statistically significant differences (p<0.05) within groups for multiple optometric parameters. In the present full study three important issues were addressed and included in the design of this study: increasing sample size, measuring the cumulative effects of multiple treatments, and measuring the temporal permanence of these effects.

Methods: Using a randomized, double-blind, placebo-controlled protocol, we assessed for a change in visual function following cranial manipulation among a sample of healthy adults with cranial asymmetry. 113 adults (18-35 years old), who were free of active ocular or systemic disease, were consented prior to and entered into the study. The Nova Southeastern University's institutional review board approved the study. Following a battery of optometric examinations, all participants were evaluated for cranial dysfunction. The treatment group received cranial osteopathic manipulation to correct cranial dysfunctions, while the control group had a light pressure of a few ounces of force applied to their cranium without the use of osteopathic manipulation. All subjects were re-evaluated for cranial dysfunction after the intervention, and then all optometric parameters were re-measured. This was repeated for a total of 8 visits, followed by another 8 visits during which only the optometric measurements were performed.

Results: 89 subjects completed the trial, 42 in the control group and 47 in the treatment group. A two-way ANOVA revealed statistically significant differences within groups in seven of the twelve parameters measured, and between groups in Pupillary size measured under bright illumination OS (p<0.05) and Near Point of Convergence break measurement (p<0.04).

Conclusion: The changes in both groups suggest that active motion testing of the sphenobasilar synchondrosis (SBS) may alter the cranial system to a sufficient extent as to alter visual function.

P6
Evaluation of the Effects of Heel and Forefoot Lifts on Body Weight Distribution, Center of Mass, and Muscle Activity in the Lumbar Region
K. Quinones BS¹, E. Shamus, PhD¹, M. Fernandez, PhD², C. Sheehan, MS³, M. Akin, BS², ¹College of Osteopathic Medicine, ²Department of Public Health, ³Center for Psychological Studies, ¹Nova Southeastern University, Fort Lauderdale, FL The ability to symmetrically distribute body weight has been reported to be essential to normal balance and to the ability to perform daily activities. Therefore, decreasing asymmetry and enhancing dynamic stability are important therapeutic goals. Postural instability is a growing problem in the older population, leading to falls that may result in major health problems. Even in the younger population, a number of physical problems have been associated with unbalanced weight distribution. In this study we are using the quadruple postural scale to measure body weight distribution and the Surface Electromyogram (SEMG) to measure muscle activity while wearing different heel and forefoot lifts. Results from this study may lead towards understanding if certain footwear can be helpful in treating postural asymmetries and preventing associated pathologies.

Hypothesis: Varying the heights of heel and forefoot lifts will have an effect on anterior/posterior weight distribution and muscle activity in the lumbar spine.

Materials and Methods: Fifty female NSU students ages 18 to 35 are being recruited to participate in this study. The quadruple postural scale measures the participants' weight distribution under five conditions: 1)barefoot, 2)1 inch heel lifts, 3)2 inch heel lifts, 4)^[] inch forefoot lift, and 5)1 inch fore-foot lifts. While the SEMG records muscle activity in the lumbar spine while under the five conditions. To control for order effects, the order of presentation of the conditions is determined randomly. Procedures have been approved by the HPD Research Committee and the NSU IRB.

Results and Conclusion: Preliminary (N=9) results have shown a significant movement towards balance of weight distribution in participants with an initially posterior stance when wearing 2 inch heel lifts (p=0.013). SEMG results have shown significant decrease in muscle activity in both the right and left lumbar region when wearing 1 inch heel (left: p=0.027; right: p=0.045), 2 inch heel (left: p=0.029), and 1 inch forefoot lifts (left: p=0.022; right: p=0.029) when compared to baseline (bare-foot). The results from the 50 participants will be presented at the meeting.

P7
Reproducibility Assessment of the Response to CV4 as Measured by the Laser Doppler Flowmeter and Electrocardiogram
K. K. Guinn, OMS-III¹, C. Rodriguez, BS², D. Bucheli, BS², R. L. Alsip, OMS-II², M. A. Seffinger, DO², M. L. Smith, PhD¹, ¹UNTHSC, Fort Worth, TX, ²Western University Health Science Center COMP, Pomona, CA

Background: Osteopathic manipulation techniques, such as Compression of Fourth Ventricle (CV4), have been shown to influence autonomic balance as measured by Laser Doppler Flowmeter (LDF) and electrocardiogram (EKG). In this study, authors assess reproducibility of a subject's response to CV4, measured by LDF and EKG.

Objective: Assess reproducibility of subject's response (change in autonomic variability) to CV4 by an alternate operator as compared to response elicited by reference standard operator.

Methods: 22 healthy volunteers were enrolled in IRB approved project. Simultaneous LDF and EKG readings were obtained before, during, after CV4 in 7min segments. Five minutes of data with least amount of noise were selected from each segment for analysis. Each subject underwent this protocol on 2 different occasions, once each with reference standard operator and an alternate operator. All operators were trained in CV4 technique. Timed periods were compared using WINDAQ and BIOPAC software for LDF and Heart Rate Variability (HRV) software used for EKG. Spectral analyses were performed using Discrete Fourier Transformation and areas under the curve of the low frequency Traube-Hering wave (TH) (0.8-.15 Hz) were measured. Results were analyzed using a paired samples t-test in SPSS. Duration of change in area under curve of TH wave during CV4 performed by each operator was compared using a paired samples correlation in SPSS.

Results: Paired samples t-test (SPSS) demonstrated significant (p<.05) decrease in autonomic variability from baseline for all subjects measured by LDF and EKG, regardless of the operator. Results of alternate operator were compared with results of primary investigator for each subject. Overall, there was no significant difference (p>.2) in the subject's response to CV4. Comparison of duration (seconds) of change, determined by a 40% decrease from baseline in area under curve (TH) during CV4 revealed correlation of .777 p=.001.

Conclusion: Decreased autonomic variability and length of its duration during CV4 are reproducible in same subject by an alternate operator as compared to response elicited by reference operator. This response to CV4 as measured by LDF was mirrored in changes seen in HRV, as obtained from EKG. Any potential therapeutic effects of CV4 are undetermined at this time, it is recommended that LDF or EKG be used in clinical outcomes studies to investigate efficacy of CV4 in select patient populations.

P8
Prolonged Effects of Maximal Effort Exercise (with Valsalva) and Osteopathic Manipulative Treatment in Women with Multiple Sclerosis
M. L. Kuchera DO, FAAO¹, T. C. Vardy, DO², H. Yates, DO³, B. Stouch, PhD¹, J. C. Johnson, MA³, CCDA, ¹Human Performance & Biomechanics Lab, Philadelphia College of Osteopathic Medicine, Philadelphia, PA, ²Neuromuscular Clinic, Tweed Heads, North South Wales, Australia, ³Kirksville College of Osteopathic Medicine, Kirksville, MO

Benefits gained through most exercise programs typically diminish shortly after discontinuing the program. This study investigates the effect over time of discontinuing a uniquely structured machine-assisted exercise and manual medicine protocol that previously demonstrated short-term benefits (JAOA, May 2002). The exercise previously used employed isometric and eccentric vertical leg presses as well as isometric semi-erect whole body lunges. Each exercise had been performed for an average of 6 seconds duration with Valsalva and 3-5 repetitions of each exercise was performed on specialized equipment (IsoPUMP®, Neuromuscular Technologies). OMT had been integrated to reduce coexisting somatic dysfunction each session and to help prepare the subject for exercise.

Hypothesis: We hypothesized that previously reported improvement in strength, endurance, fatigue, coordination, and ambulation in females with Multiple Sclerosis (MS) as a result of a twelve-week physical intervention protocol combining machine-assisted MEE and OMT would be maintained for at least nine months after discontinuing the protocol.

Materials and Methods: Strength (isometric lunge, isometric and eccentric leg press), ambulatory ability (Timed 25-foot Walk) and coordination (Block-and-Box Test, BBT) were measured at 3 and 6 months post-intervention (n=7) and at 9 months (n=6). Repeated-measures ANOVAs were used to determine whether outcomes previously reported as a consequence of the MEE/OMT protocol were maintained after discontinuing the treatment. This study was approved by the KCOM Institutional Review Board where all data had been gathered.

Results: Significant increases in strength during isometric lunge (P<0.001) and BBT (P<0.001) as well as reductions in Timed 25-foot Walk (P=0.007) due to the MEE/OMT protocol were maintained at 3-, 6-, and 9-month follow-up. Gains in strength during isometric leg press were lower at six months than immediately post-intervention, but still retained significance above baseline at all three follow-up times (P<0.001).

Conclusion: Prolonged positive effects, including increased strength, ambulatory ability, and coordination, results from a combined MEE/OMT protocol in women with mild-moderate MS impairment. Measurable benefits in walking and strength still existed nine months after discontinuing the twelve-week protocol.

Acknowledgment: Supported by the KCOM Strategic Research Initiative.

P9
Foot Ankle Biomechanics: Effects of Manipulative Intervention on Plantar Fasciitis Subjects
A. L. Morton BS¹, A. McGrew, BS¹, J. M. Burns, DO¹, E. Karodogan, MS², R. Conatser, MS¹, J. N. Howell, PhD¹, ¹Biomedical Science, ²Engineering, OUCOM-IINR, Athens, OH Counterstrain (CS), an Osteopathic Manipulative Medicine (OMM) technique that involves passively shortening painful tissues, significantly reduced plantar fasciitis (PF) pain in a prior OUCOM study (Wynne, et. al., JAOA Sep 2006; 106:547-556). Triceps surae peak force (Torque) production as well as time needed to reach peak force increased in both PF and control subjects without altered muscle spindle gain (H-reflex). This lack of a neuroreflexive explanation prompts possible involvement of passive mechanical tissue properties of the foot/ankle complex.

In order to isolate these properties, force production was measured on the same apparatus, and the ankle was dorsiflexed the same number of repetitions and degrees as the former study; but slow enough to prevent eliciting an Achilles tendon reflex. Non-therapeutic passive 90 second shortening represented a sham for CS.

Hypotheses: Alteration of passive mechanical tissue properties of the foot/ankle complex by stretching or shortening the plantar surface of the foot will result in: 1. Increased force production and time to reach peak force, 2. Decreased PF pain.

Methods: Case-control study following informed consent per OU IRB.

Cohort: 12 subjects with plantar fasciitis, 5 controls. Force against the foot plate of a motor driven apparatus was recorded in supine subjects while the ankle was dorsiflexed (5° over 500 msec) 10 times followed by a 30 second rest then repeated 10 times. This was done at baseline and after two manipulative interventions: 1) a 90 second hold of the plantar fascia in a shortened position and 2) a 90 second stretch of the plantar fascia. Subjects were randomized to receive either stretching or shortening first.

Results: RMANOVA statistical analysis showed no difference, following either intervention, in peak force production or time needed to reach peak force (p 0.05). Plantar fasciitis subjects reported no change in foot pain following either or both interventions.

Conclusion: If the decrease in pain or increases in peak force production and in time needed to reach peak force seen in the previous experiment resulted primarily from an alteration in the passive biomechanical components of the foot-ankle complex, similar results would be expected in this study. This was not the case. Force generation under the ball of the foot may also be influenced by reflex activity of intrinsic foot muscles and is the subject of future study. Further research into the mechanisms of CS is warranted.

P10
Developing technology and protocols to measure pressure characteristics used by physicians and students for diagnosis and treatment of cervical somatic dysfunction
M. L. Kuchera, DO, FAAO¹, N. T. Jean, OMS-III², B. Schoenfeldt, OMS-III², L. Williams, OMS-III², T. Vardi, DO³, R. T. Dombroski, DO², ¹CCDA, Human Performance & Biomechanics Lab, ²Philadelphia College of Osteopathic Medicine, Philadelphia, PA, ³Neuromuscular Engineering, Tweed Heads, North South Wales

Risk-to-benefit data concerning cervical spinal manipulation (CSM) provokes great interest among manual medicine (MM) practitioners whose concern extends to safety-efficacy issues performing and teaching CSM.

Hypotheses: A protocol for a prototypic Iso-TOUCH® palpation system (Iso Technologies) was developed to quantify and provide feedback concerning cervical pressure used in diagnosis and CSM. It is hypothesized that this protocol and equipment would be sensitive enough to differentiate student from physician pressures used to palpate and perform CSM. Also that data gathered would demonstrate intra-examiner consistency and suggest adequate sample sizes for future studies.

Methods: Osteopathic physicians (n=10) and students (n=10) wore pressure sensors over thumbs, index fingertips, and thenar eminences. The system was tared to compensate for finger size. Customized software converted electrical sensor signals into pounds using pre-determined calibration curves. Palpators applied articular pillar pressure to diagnose cervical somatic dysfunction. Each provided self-selected thrust, muscle energy, or balanced tension CSM to the "worst" dysfunction. Individually "stacking" each barrier (side-bending, rotation, and flexion/extension) prior to applying activating forces helped measure individual and total barrier engagement and isolated CSM pressure and duration. Between trials, taring limited sensor deformation drift.

Results: Individual palpators' pressures used in diagnosis were internally consistent from cervical segment-to-segment. Sampling rates captured beginning and end treatment forces even in thrust activations of short duration. Data documented that students use more pressure than physicians in both diagnosis (1.22-2.88 versus 1.03-1.30 Lbs) and CSM (1.87-11.61 lbs versus 0.87-11.42 lbs). The data suggests future cervical trials should use 0.5 -15.0 pound calibrations (creating a sensitivity range of +/- 0.1-0.2 pounds). Protocols to detect physician-student differences should involve each palpating the same 16 subjects or 29 unique subjects (n=58).

Conclusions: Carefully described protocols using calibrated digital and manual sensors could provide reliable, reproducible data needed to quantify pressure characteristics used by MM physicians and students in cervical diagnosis and CSM. The protocol could be further enhanced by using a scale to create customized sensor calibration curves for each palpator.

	Clinical Studies

Top AOA Research Fellowships Osteopathic Manipulative... Clinical Studies Basic Sciences Medical Education

 
C1
Free Serum Acrolein Levels in Several Disease States Associated with Oxidative Stress or Inflammation
A. Gugliucci MD, PhD¹, C. Hathuc, OMS-III², J. Schulze, BS², S. Kimura, MD³, ¹Dept. of Biochemistry, Touro University-CA, ²Glycation, Dept. of Oxidation and Disease Laboratory, Touro University-CA, Vallejo, CA, ³Dept. of Laboratory Medicine, Showa University, Northern Yokohama Hospital, Yokohama, Japan

We tested the hypothesis that free serum acrolein levels are increased in conditions associated with increased oxidative stress and inflammation: renal failure, stroke, infection and diabetes, as well as in liver disease by impaired metabolism. We performed a nested case-control study with 35 chronic liver disease patients; 40 chronic renal failure (CRF) patients undergoing dialysis; 22 type 2 diabetic patients (mean HbA1c 10%); 15 stroke (CVA) patients; 10 acute pneumonia patients and 40 age-matched controls. Fasting blood samples were analyzed for acrolein using a fluorometric method. Serum acrolein levels were 312±76 nmol/l for control subjects; 914±210 nmol/l for CRF patients; 404±96 for diabetic patients; 300±89 for chronic liver disease patients; 330±91 for CVA patients and 1212±210 for pneumonia patients. The differences between controls and diabetes, CRF, and pneumonia patients are significant with a p<0.01; 0.001 and 0.001, respectively. In diabetes patients, acrolein correlates with fasting glycemia and HbA1c (r=0.5 and 0.41 respectively, p<0.05). We failed to see a difference in acrolein levels in liver disease, suggesting that liver metabolism is not a major player in the circulating acrolein pool. Acrolein levels are extremely high in pneumonia, suggesting it as a potential marker of infection and/or damage by inflammation. This new finding also lends mechanistic support to the synthesis of acrolein from threonine by phagocytes MPO as a major source of acrolein in vivo.

C2
PROVIDER OPINIONS AND PRACTICES IN MANAGING POSTPARTUM DEPRESSION
J. L. Drowos DO, MPH¹, A. Alonso, MD, MPH², G. P. Suciu, MSPH, PhD³, R. D. Lovinger, MD⁴, ¹Dept. of Family Practice Residency, Broward General Medical Center, PBCHD, NSU-COM, ³Public Health Program, NSU-COM, Davie FL, ²Palm Beach County Health Department, ⁴Preventive Medicine Residency Palm Beach County Health Department, West Palm Beach, FL

Purpose: Despite the availability of effective screening tools for postpartum depression this condition remains largely under-diagnosed in the United States. We performed a pilot study to survey attitudes and practices among healthcare providers in diagnosing and treating postpartum depression.

Methods: A cross-sectional analysis was performed based on a 21 item questionnaire. Questions were based on prior screening studies for evaluating attitudes and practices for post partum depression. All healthcare providers serving new mothers and newborns at the Palm Beach County Health Department clinic locations received copies of the survey for participation. This included family physicians, pediatricians, obstetricians, physician assistants and nurse practitioners. Parameters were evaluated independently using the SAS statistical computer package for contingency table analysis, using Chi-square test of independence and the corresponding p-values to determine the significance between particular variables.

Results: 24 providers (50% response rate) completed questionnaires for inclusion in the data analysis. Trends were apparent including a number of providers (7 or 29.2%) who reported they had never received training pertaining to postpartum depression. Significant relationships were found between variables including provider gender and general beliefs about postpartum depression, as well as between specialty practiced and personal attitudes toward postpartum depression.

Conclusions: Trends in managing postpartum depression related to provider characteristics can be understood. Surveys can uncover providers who have not received training on the subject, and to identify those who feel uncomfortable with their knowledge base. Identifying those specific providers who are most likely to care for affected patients and who are unfamiliar with screening and treatment measures can facilitate designing educational interventions and policies for Palm Beach County Health Department clinicians.

C3
Withdrawn at the Author's Request

C4
BREAST CANCER AND MAMMOGRAPHY: HOW KNOWLEDGEABLE ARE WOMEN OF THE RECOMMENDATIONS?
S. K. Desai, BS, BA¹, J. V. Davis III, DO², A. Gnanadev, MD³, D. T. Wong, MD³, ¹WesternU-COMP, ²Dept. of Surgery, WesternU-COMP/ARMC/OPTI, Pomona, CA, ³Dept. of Surgery, Arrowhead Regional Medical Center, Colton, CA

Background: Several randomized trials have shown that screening mammography decreases Breast Cancer mortality specifically, in women 50 and older. Significant protection has also been demonstrated in women who begin screening at 40 years of age. The estimate for reduction of Breast Cancer mortality attributable to mammogram screening in the U.S. is approximately 10%. The American Cancer Society, American College of Radiology, National Cancer Institute, and the American College of Obstetrics and Gynecology all recommend routine screening at age 40.

Purpose: To determine how frequently women diagnosed with Breast Cancer at Arrowhead Regional Medical Center (ARMC) obtained a mammogram the year before their most recent mammogram leading to their diagnosis.

Methods: We conducted a retrospective study with 87 female patients diagnosed with Breast Cancer between Jan 2005-March 2006. We reviewed ARMC Tumor Registry charts to obtain demographic, staging, and diagnostic information.

Results: 70 out of 87 (80.5%) Breast Cancer patients did not complete a mammogram one year prior to their diagnosis. Of these 70 patients, 16 were categorized with Stage I, 22 with Stage II, 16 with Stage III, and 15 with Stage IV Breast Cancer. The average age of patients was 51.7±10.6. Of the 70 females who did not have a mammogram one year prior to their diagnosis, 59 (84%) were age 40 and above.

Conclusion: The recommendation of routine screening in women over 50 years of age is well established. Though it is controversial between 40 and 50 years of age. Our data indicates that the vast majority of women at our county facility have not received timely and appropriate mammographic evaluations prior to their diagnosis. This is unfortunate because it has been shown that women who have had one screening mammogram in the previous 2 years were less likely to be stage II B or higher. There may be a lack of understanding, or a failure to follow through even when knowledgeable. Also, it may be an inability to access resources that prevents them from obtaining care. Among our patients, it may be a communication or cultural issue as well. Better cultural and language instruction for non-English speaking patients may improve compliance.

C5
The Safety and Efficacy of Duloxetine Hydrochloride for the Treatment of Fibromyalgia: Results from a 6-month Randomized, Double-Blind, Placebo-Controlled, Fixed-Dosed Trial
M. Wohlreich, MD¹, J. Russell, MD, PhD², P. Mease, MD³, T. Smith, MD⁴, D. Kajdasz, PhD¹, D. Walker, PhD¹, F. Lewis, DO⁵, A. Chappell, MD¹, ¹Eli Lilly and Company, Indianapolis, IN, ²University of Texas Health Science Center, San Antonio, TX, ³University of Washington School of Medicine, Seattle, WA, ⁴Mercy Health Research, Chesterfield, MO, ⁵Global Therapeutic Development in Neurology and Ps, Weston, FL

Objectives: The primary objective was to determine whether treatment with duloxetine [DLX] 120 mg/d for 3 months was effective in reducing pain severity in patients with fibromyalgia syndrome [FMS].

Methods: DLX60 mg/d, DLX120 mg/d, and placebo [PBO] were compared during 6 months of treatment in adults with American College of Rheumatology-defined primary FMS. Coprimary efficacy measures included the Brief Pain Inventory Average Pain Score [APS], and the Patient's Global Impressions of Improvement [PGI-I] questionnaire. Safety and tolerability were assessed.

Results: At 3 months, patients treated with DLX120 mg/d showed greater improvement in change from baseline in APS score [-2.31 vs. -1.38, P<0.001] and endpoint PGI-I score [2.89 vs. 3.39, P=0.004] vs. PBO-treated patients. At 6 months, the DLX120 mg/d group still exhibited greater improvement in APS change [-2.25 vs. -1.42, P=0.003] and PGI-I [2.93 vs. 3.37, P=0.012]. The DLX60 mg/d group showed significant improvement compared with PBO on both measures at 3 months and on APS change at 6 months. At 6 months, response, defined as 50% reduction from baseline in APS, was greater with DLX120 mg/d [35.9%, P0.01] and DLX60 mg/d [32.6%, P0.05] vs. PBO [21.6%]. DLX was similarly efficacious in patients with [N=122] or without [N=375] major depressive disorder [MDD] with regard to both co-primaries. Discontinuation rates over 6 months were similar among the groups (DLX60 mg/d 45.3%, DLX120 mg/d 46.3%, PBO 50.0%). Adverse event-related discontinuation was significantly higher in the DLX120 mg/d [25.9%, P=.009] but not in the DLX60 mg/d [15.3%, P=0.400] group compared with the PBO (11.8%) group.

Conclusions: DLX60 and DLX120 mg/d are efficacious and safe treatment options for pain associated with FMS, whether or not MDD is present

C6
Minimally Invasive Posterior Lumbar Interbody Fusion after Treatment with Recombinant Human Bone Morphogenic Protein-2 Added to Bioresorbable Implants: Surgical Technique, Clinical Results, and Review of the Literature
A. J. Scumpia, OMS-IV¹, K. O. Colle, DO², A. C. Mapley, OMS-IV¹, M. C. Overby, MD², M. B. Eisenberg, MD², M. E. Levine, MD², P. H. Hollis, MD², ¹Dept. of Neuroscience, New York College of Osteopathic Medicine/NYIT, Old Westbury, NY, ²Dept. of Neurosurgery, North Shore University Hospital-LIJ Health System, Manhasset, NY

Hypothesis: The purpose of this study is to evaluate the clinical suitability of combining recombinant human bone morphogenic protein-2 (rhBMP-2) to bioresorbable implants as interbody spacers in spinal lumbar fusion surgery, via the minimally invasive posterior lumbar interbody fusion (PLIF) technique.

Materials and Methods: This is a retrospective study of 40 consecutive patients who underwent the minimally invasive PLIF procedure after treatment with rhBMP-2 added to bioresorbable implants as interbody spacers in single and multi-level applications for various lumbar spine pathologies. This study assessed the use of combining rhBMP-2 to bioresorbable implants in forty consecutive patients with at least two years of follow-up who underwent the minimally invasive PLIF for various spinal pathologies, particularly spondylolisthesis, herniated nucleus pulposis, and degenerative disc disease.

Results: At the nine month post-operative follow-up, 38 (95%) were found to have solid fusions. Independent neuroradialogists' evaluations of CT scans with reconstructions were obtained at 3, 6, 9, 12, and 24 months respectively.

Conclusions: The minimally invasive PLIF procedure utilizing bioresorbable implants in conjunction with rhBMP-2 can achieve successful lumbar fusion safely and effectively, for a variety of common lumbar spine pathologies.

C7
Dyslipidemia among Stroke Patients in a Large, Urban Tertiary Care Center
A. N. Russman DO, D. R. Nerenz, PhD, Henry Ford Hospital, Detroit, Michigan

Hypothesis: Dyslipidemia is an important modifiable risk factor in patients with ischemic stroke. Prior to a first stroke, the current NCEP III guidelines suggest maintenance of low-density lipoprotein (LDL) less than 130 and high-density lipoprotein (HDL) greater than 40. Clinicians will need to address dyslipidemic management during the initial admission.

Methods: Following IRB approval, we queried the Henry Ford Hospital database for single-payer HMO patients with an admission and an ICD-9 code for ischemic stroke during the period from 01/01/2001 to 06/30/2006. Medical records were reviewed and data collected on demographics, lipid studies, and length of stay (LOS).

Results: We identified 944 patients, 51% women, mean age of 66 years (range 27-97). Average fasting lipid values were cholesterol 183, triglycerides 143, LDL 110, and HDL 46. The average LOS was 5.4 days. Using LOS as a proxy for disease severity, patients with LDL greater than 130 tended to have a lower average LOS (5.0 versus 5.5 days, p=0.24) compared to those with levels less than 130. In addition, patients with HDL less than 40 tended to have a higher average LOS (5.7 versus 5.1 days, p=0.14) compared to those with an HDL greater than 40. Women were more likely to have a higher LDL (115 versus 104, p<0.001), and HDL (50 versus 42, p<0.001) than men. Patients over the age of 65 were more likely to have LDL less than 130 (34% versus 26%, p=0.01) and HDL levels greater than 40 (43% versus 35%, p=0.02). However, LOS was higher for patients over the age of 65 (5.8 versus 4.8 days, p=0.006) compared to those under 65.

Conclusion: Among our urban population, younger patients tended to have a less favorable profile of high LDL and low HDL. Women were more likely to have an intermediate risk profile with higher serum LDL and HDL. Low serum HDL may be a risk factor for longer length of stay and possibly disease severity. Our data suggest that studies are needed to better characterize the relationship between ischemic stroke severity and dyslipidemia.

C8
Influence of Customized Proprioceptive Foot Orthotics in Posture, Balance and Pain
V. A. Cohen MS, OMS-I, M. L. Kuchera, DO, FAAO, P. E. Stewart, PhD, CCDA, Human Performance & Biomechanics Laboratory, Philadelphia College of Osteopathic Medicine, Philadelphia, PA

Background: The adult body constantly receives information from proprioceptors throughout the body, including the soles of the feet. The CNS integrates this proprioceptive information with visual and vestibular information. The input integrated from these 3 systems is important in homeostatic maintenance of balance and posture from moment to moment as the body ages.

Hypothesis: Custom-fitted foot orthotics working through the proprioceptive system will provide a greater level of pain relief, range-of-motion (ROM), and postural balance than sham foot orthotics.

Methods: 22 subjects with low back pain were randomized into treatment (n=11) or placebo/sham (n=11) insole groups, with 13 subjects (7 treatment, 6 placebo/sham) completing the entire study. All subjects completed an Oswestry Disability Questionnaire (ODQ), pain VAS, balance test, and ROM evaluation during the 1st visit. Additionally, each participant received a "body balance check" (according to Vabena protocol) that dictated the specific prescription for customized insoles. Upon receiving their insoles, balance and ROM tests were rechecked. During the 3rd and 4th visit, all surveys and tests were repeated. Additionally, at the 4th and final visit, a post treatment body balance check was conducted and randomization was revealed.

Results: A clinical importance measure was demonstrated in this study. The treatment group achieved the ODQ mean clinically important difference (MCID?6%) at both 3rd and 4th (11.04%, 10.86%) visits. Additionally, a 2-tailed fisher's exact test detected a significant difference (p=0.0344) in the proportion of treatment to placebo subjects clinically improving between first and last visits. Aside from a suggested significant baseline difference in ODQ (p=0.063) between the treatment and placebo groups, ANOVA and univariate statistics showed no statistically significant pain, balance, or postural differences between or within treatment and placebo groups. However, upon reviewing subject compliance, those who most regularly wore their insoles demonstrated the greatest decrease in their ODQ score.

Discussion: This study demonstrated that systematic proprioceptive stimulation using neuromuscular proceptor soles (Vabena protocol) may be clinically beneficial in decreasing patient pain perception. Larger trials, controlled for compliance, however are warranted to fully understand the impact of these insoles in treating patient posture, balance, and chronic back pain.

C9
Ropinirole CR Extended Release Reduces Mood Disturbance in Patients with Moderate-to-Severe Primary Restless Legs Syndrome (RLS): Results from a 12-Week Pivotal Trial
R. B. Ziman MD, FACP¹, J. S. Gitt, DO², M. Castiglia, PharmD³, N. Williams, MSc⁴, ¹Northridge Neurological Center, Norridge, CA, ²Hope Research Institute, Phoenix, AZ, ³GlaxoSmithKline, ⁴Research Triangle Park, NC, GlaxoSmithKline, Harlow, Essex

HYPOTHESIS: Patients with Restless Legs Syndrome (RLS) may report comorbid symptoms of depression and/or anxiety. A 14-hour extended-release formulation - ropinirole CR - was developed to provide symptom coverage in patients with primary RLS who experience symptoms that occur in the late afternoon/early evening and during the night. The effect of treatment with ropinirole CR on mood in patients with moderate-to-severe RLS was assessed.

MATERIALS AND METHODS: In a 12-week pivotal study (protocol 101468/205), patients with moderate-to-severe primary RLS experiencing symptoms in the evening and at nighttime were randomized to ropinirole CR (n=189), 0.5-6.0 mg/day, or placebo (n=195), titrated as needed and tolerated, taken once daily (4pm or later) 1-2 hours before the usual onset of RLS symptoms. Effect on mood was assessed by mean changes from baseline in the Hospital Anxiety and Depression (HADS) subscale scores (in symptomatic sub-populations defined by a baseline score 8) and in the Profile of Mood State (POMS) scale six domain scores and total mood disturbance score at Week 12 last observation carried forward (LOCF). The primary endpoint for the study was mean change from baseline in International Restless Legs Scale (IRLS) total score at Week 12 LOCF.

RESULTS: Greater improvements from baseline (reductions) in mean HADS anxiety and HADS depression subscale scores were observed at Week 12 LOCF for ropinirole CR vs. placebo, with a statistically significantly greater improvement seen for the HADS depression subscale (adjusted mean treatment difference [AMTD]: -2.3; p<0.01). The AMTD for the HADS anxiety subscale was -1.3 (p=0.13). In addition, a greater improvement in each domain and the total mood disturbance score of the POMS scale was observed with ropinirole CR vs. placebo at Week 12 LOCF (not tested). For the primary endpoint, a significantly greater improvement (reduction) in IRLS total score was seen for ropinirole CR vs. placebo (AMTD: -5.9; p<0.001).

CONCLUSIONS: Ropinirole CR reduces RLS severity and depressive mood symptoms associated with RLS in patients with moderate-to-severe primary RLS.

SUPPORTED BY: GlaxoSmithKline Research and Development.

C10
Ropinirole CR Extended-Release Treatment Improves Both the Symptoms and the Impact of Restless Legs Syndrome
R. B. Ziman MD, FACP¹, J. S. Gitt, DO², N. Williams, MSc³, ¹Northridge Neurological Center, Norridge, CA, ²Hope Research Institute, Phoenix, AZ, ³GlaxoSmithKline, Harlow, Essex, UK

HYPOTHESIS: Restless Legs Syndrome (RLS) is a chronic neurological disorder. The International Restless Legs Scale (IRLS) is a validated, disease-specific, 10-item scale for assessing RLS symptoms, from which two subscales can be derived: the Symptoms subscale (items 1, 2, 4, 6, 7, and 8, which relate to the severity/frequency of core symptoms and sleep disturbance [the primary morbidity of RLS]), and the Symptoms Impact subscale (items 5, 9, and 10, relating to the impact of core symptoms on daytime sleepiness, daily functioning, and mood). Ropinirole CR, a novel 14-hour extended-release formulation, was developed to provide extended coverage of RLS symptoms. The effect of ropinirole CR treatment on the core RLS symptoms and impact of symptoms was assessed using IRLS subscale data from a pivotal study in patients with moderate-to-severe primary RLS.

MATERIALS AND METHODS: In this 12-week, doubleblind, placebo-controlled study (protocol 101468/205), patients with moderate-to-severe primary RLS were randomized to ropinirole CR (n=189), 0.5-6.0 mg/day, or placebo (n=195), titrated as needed and tolerated, taken once daily (4pm), 1-2 hours before usual onset of RLS symptoms. The effect of treatment on the core RLS symptoms and impact of symptoms was evaluated by post-hoc analysis of mean changes from baseline in IRLS Symptoms and Symptoms Impact subscale scores (ranges 0-24 and 0-12, respectively) at Week 12 last observation carried forward (LOCF). The primary endpoint was mean change from baseline in IRLS total score (range 0-40) at Week 12 LOCF.

RESULTS: At baseline, mean IRLS subscale and total scores were similar between treatment groups. At Week 12 LOCF, statistically significant treatment benefits were seen for ropinirole CR, compared with placebo, for improvements (decreases) in the IRLS Symptoms and Symptoms Impact subscale mean scores (adjusted mean treatment difference [AMTD]: -3.8 and -1.6, respectively; both p<0.001). Ropinirole CR also significantly improved (decreased from baseline) mean IRLS total score at Week 12 LOCF compared with placebo (AMTD: -5.9; p<0.001).

CONCLUSIONS: Ropinirole CR extended release improves the core symptoms of RLS and the impact of these symptoms in patients with moderate-to-severe primary RLS.

SUPPORTED BY: GlaxoSmithKline Research and Development.

C11
Efficacy Comparison of Albendazol and Ivermectin in Treatment of Ascariasis in Children
A. Moradi M.D., MPH & TM, P. Mortazavi, PharmD, R. Nassiri, DSc, Department of Pharmacology and Public Health LECOM College of Osteopathic Medicine, Bradenton, FL

Abstract: Ascariasis is an intestinal infection caused by the parasitic roundworm Ascaris lumbricoides. It is the most common of intestinal helminthes infection which is limited to humans. The infection can be seen in all age groups but the highest morbidity appears to be in children.

Objective: To evaluate the high efficacy of albendazole in comparison to ivermectin for the treatment of intestinal infection caused by parasitic roundworm ascaris.

Material and Method: The treatments used in this study were a single dose of oral Albendazole 400mg and a single dose of oral Ivermectin 200mcg/kg. We tested the efficacy of both medications in two control trial groups of 105 school children during a light infection stage (early stage) with ascaris in Bahamas. This study clearly demonstrated that the treatment efficacy in children with a single dose of albendazoloe considerably differs than a second group with a single dose of ivermectin.

Result: The treatment with a single dose of albendazole in first group of children produced cure rates of over 93%. On the other hand a single dose of ivermectine in the second group of children had only produced a 75% cure rate initially and needed an additional dose given at a 7 days interval to archive a 95% cure rate.

Conclusion: Our result suggests that single dose oral albendazole has higher efficacy against light ascaris infection than ivermectin in a similar condition. These findings are of major public health relevance in cost-effectiveness in treating school age children with very effective therapy and no need for further doses to be given at interval time.

C12
Tolerability with No Loss of Efficacy after Overnight Conversion to a Novel Extended-Release Formulation, Ropinirole CR, in Primary Restless Legs Syndrome (RLS)
A. L. Ellenbogan DO¹, MPH, M. Castiglia, PharmD², R. A. Hodge, MSc³, ¹Quest Research Institute, Bingham Farms, MI, ²GlaxoSmithKline, Research Triangle Park, NC, ³GlaxoSmithKline, Harlow, Essex, UK

HYPOTHESIS: Many patients with moderate-to-severe primary Restless Legs Syndrome (RLS) experience symptoms that occur in the late afternoon/early evening and at night, and may benefit from an extended-duration treatment. Safety and tolerability were assessed after overnight conversion from the current formulation of ropinirole (ropinirole IR) to a new, once-daily, 14-hour, and extended-release formulation - ropinirole CR - in patients with primary RLS.

MATERIALS AND METHODS: In a randomized, double-blind, three-cohort study (protocol 101468/805), patients currently treated with ropinirole IR for RLS entered one of three cohorts (A, B, or C) based on their stable dose of ropinirole IR (1mg, 2mg, or 4mg, respectively). Patients were then randomized (1:1) to one of two dosing groups within each cohort and entered a 4-week treatment phase. At one of two pre-identified clinic visits, patients were converted overnight to ropinirole CR for 1 week (2mg, 3mg, and 6mg in cohorts A, B, and C, respectively). To allow for comparison between groups in each cohort and to maintain the blind, at each conversion time-point one group underwent an actual conversion to ropinirole CR, while the second group underwent a "dummy" conversion. Primary endpoint was incidence of post-conversion-emergent adverse events (AEs), defined as first occurrence, new episode, or increase in severity of an ongoing AE. Efficacy was assessed by pre- to post-conversion change in International Restless Legs Scale (IRLS) total score.

RESULTS: Baseline demographics and characteristics were similar between groups. Emergent AEs (any) following actual vs. dummy conversion occurred in 37% vs. 43%, 33% vs. 37%, and 46% vs. 36% of patients in cohorts A, B, and C, respectively. The most common AE following actual conversion in each cohort was nausea (A and B) and somnolence (C). No patients discontinued due to AEs in cohorts A or C; 2 patients (1 IR, 1 CR) discontinued in cohort B. Overall, conversion to ropinirole CR did not lead to a loss of efficacy based on mean change from pre- to post-conversion in IRLS total score.

CONCLUSIONS: Overnight conversion from ropinirole IR to the longer-acting ropinirole CR extended release was generally well tolerated, with no loss of efficacy.

SUPPORTED BY: GlaxoSmithKline Research and Development.

C13
Bipolar Depression: Diagnosis, Recognition, and Treatment Experience with Quetiapine
S. D. Levy DO, West Chester Psychiatric Associates, West Chester, PA

Hypothesis: Bipolar disorder is a complex illness with episodes of mania, hypomania, depression, or mixed states alternating with euthymia. Bipolar depression is now recognized to be an extremely common and disabling part of the illness and is often misdiagnosed as major depression¹. For appropriate management, it is important that primary care physicians also be involved in the accurate diagnosis and recognition of bipolar disorder. Currently available atypical antipsychotics (olanzapine, quetiapine, risperidone, aripiprazole and ziprasidone) have demonstrated efficacy in treating bipolar mania as monotherapy but only quetiapine monotherapy has received approval in the US for treating bipolar depression^2,3.

Materials and Methods: A post hoc evaluation of outpatients with DSM-IV bipolar disorder experiencing depressive episodes combined from two similarly designed, 8-week, double-blind, randomized, placebo-controlled trials of quetiapine monotherapy (fixed doses, 300 or 600 mg/d once daily; BOLDER I & II). The primary efficacy endpoint was mean change from baseline to Week 8 in MADRS total score (ANCOVA/LOCF analysis).

Results: Combined data from these trials (n=1045) showed that quetiapine monotherapy (300 or 600 mg/d) significantly (P<0.001) improved MADRS total score from Day 7 to Day 56 (effect size: 300 mg/d 0.65; 600 mg/d 0.69), and significantly improved HAM-D, HAM-A, CGI-S, and YMRS scores, compared with placebo. All individual MADRS items were significantly (P<0.001) improved, by week 8 of treatment compared with placebo, with 7 of the items being significant from Week 1 through Week 8.Quetiapine monotherapy also significantly (P<0.001) improved patients health-related quality of life. Quetiapine was generally well tolerated in both studies, with low and similar incidences of treatment-emergent mania in quetiapine and placebo groups.

Conclusions: Quetiapine is the first of the currently available treatments to demonstrate substantial clinical efficacy as monotherapy (likely optimal dose: 300 mg/d) for treating depressive episodes for both bipolar and bipolar II disorder. Moreover, unlike antidepressants, quetiapine monotherapy did not appear to increase the risk for switching into hypomanic or manic states.

References

¹Post RM. J Clin Psychiatry. 2005;66 Suppl 5:5-10.

²Calabrese JR, et al. Am J Psychiatry 2005; 162:1351-60.

³Thase ME, et al. J Clin Psychopharmacol 2006; 26:600-9.

Supported by funding from AstraZeneca Pharmaceuticals LP.

C14
Higher Levels of Ischemia-Modified Albumin in Acute Cerebrovascular Accidents: A Pilot Study
A. Gugliucci MD, PhD¹, S. Kimura, MD², T. Menini, MD, MS³, ¹Dept. of Biochemistry, Touro University-CA, Vallejo, CA, ²Laboratory Medicine, Showa University, Yokohama, Yokohama, Japan, ³Dept. of Basic Sciences, Touro University-CA, Vallejo, CA

Ischemia modified albumin (IMA) could become a triage tool in acute coronary syndrome patients. It does not appear to be very tissue or clinically specific and might also find utility in stroke. In this pilot study we set out to confirm this contention and to test the hypothesis that IMA levels raise even more in subsequent days after the acute episode.

We studied 12 consecutive patients presenting within 6 h of the onset of an acute neurological deficit as well as 40 age-matched controls. Serum samples were obtained for all patients at initial presentation and repeated only in patients with stroke at 2, 4 and 6 days. IMA was measured by the albumin-cobalt-binding test and expressed as absorbance arbitrary units. The intra-assay CV was 5%. The initial IMA was 0.57±0.08 AU for stroke patients vs. 0.55±0.09 AU for control subjects, showing no significant differences (p<0.2). At 2-4 days IMA levels raised to 0.69±0.1 AU (p<0.001 vs. day 0). IMA levels not only do not return to control levels in 2 or 4 days but continue to rise and, in some cases, remain elevated for more than a week (0.7±0.03, n=3). Even with the limitations of small n, this is the first study to serially measure IMA levels in stroke patients after 24h post-episode, and the data are consistent with a persistent elevation of IMA levels beyond the first day, suggesting this marker is sensitive to changes in brain tissue resulting from ischemic injury and its oxidative stress consequences.

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Diabetes Self Care: Unrealistic Expectations?
J. Shubrook DO¹, G. Klein, OMS 1², F. L. Schwartz, MD³, A. Wapner, DO⁴, ¹ Dept. of Family Medicine, ²Dept. of Student Services, ³Dept. of Specialty Services, ⁴Dept. of Pediatrics, OUCOM, Athens, OH

Background: It has been estimated that 90% of diabetes self-care falls on the patient. Diabetes educators are critical providers to help patients learn the skills and habits necessary to successfully manage their diabetes. A previous study by Russell, Suh, and Safford showed in focus groups with diabetes educators that time demands for diabetes self-management were substantial if patients followed educators' recommendations. A pilot study by the lead author found that self-care for people with type 2 diabetes (DM) can require up to 3 hours a day. In this study, the authors quantified the necessary time needed to complete all of the tasks for self-management in a national sample of diabetes educators.

Methods: The prototypical patient for this study was an adult with chronic type 2 diabetes on oral medications alone. Questionnaires were administered to a national list of diabetes educators. The questionnaire addressed the estimates of time demands for self-care as directed by the ADA guidelines. This study was approved by the Ohio University Institutional Review Board.

Results: At the time of submission 674 questionnaires have been analyzed. The time needed for the required elements for a person with type 2 DM was 234 minutes (3 hours and 54 minutes). There was substantial variation in the estimates of each component of self-care. In addition, recommendations varied by the training of the educator and their previous experience with diabetes.

Conclusions: The recommendations for DM self-care are likely too time intensive for most people to successfully complete. Despite national guidelines explaining the components for self-care the actual recommendations vary greatly. These differences should be evaluated and addressed.

C16
KCUMB DOCARE: A Service Oriented, Educational, and Research Outreach Program in Guatemala
G. J. Desai DO¹, D. L. McCandless, PharmD², A. G. Glaros, PhD³, D. Dyck, DO³, R. Magie, DO⁵, R. Ogden, DO⁶, ¹Dept. of Medical Affairs, Family Medicine, ²Dept. of Pharmacology, ³Dept. of Basic Medical Sciences, ⁴Dept. of Family Medicine, ⁵Dept. of Pediatrics, ⁶Dept. of Family Medicine, KCUMB, Kansas City, MO

Hypothesis The investigators conducted a medical mission in February 2007, in conjunction with DOCARE International, in Guatemala, C.A. Prior missions resulted in clinical impressions that the most common diagnoses were gastroesophageal reflux disease (GERD), headache, cough and upper respiratory symptoms, musculoskeletal pain, and gastroenteritis (GE). Based on past experience, the investigators also felt it likely that most of the patients would be women and children. Our goal in this year's project was to continue to provide screening and educational services and to assess the accuracy of prior clinical impressions using a structured, data collection form.

Materials and Methods With IRB approval, patients seen during the 2-week mission had their non-identifiable data gathered in a computer-readable sheet that was used as the encounter form. All individuals screened during this visit lived in rural areas several hours distant from the capital, Guatemala City.

Results Proportions of valid, non-missing data include 1477 patients, 70% female, and 28% male. Age ranges most represented were 1-4 (10% of total pts), 5-11 (24%), 18-39 (29%), and 40-64 (19%), Diagnoses most often made were GERD (17%), headache (17%), rhinitis (8%), GE (8%), and arthropathy (8%). The most commonly dispensed medications were acetaminophen (24% of visits), children's multivitamins (23%), adult multivitamins (19%), H2 - blockers (17%), and ibuprofen (16%).

Conclusions The most commonly seen diagnoses correlated to an earlier study, as well as previous missions. The majority of patients were women and children, confirming earlier clinical impressions. We don't have data on why the proportion of men was so low. We hope to increase the number of men seen in the future. Infectious diseases often affect the health of rural Guatemalans, and development of public health programs emphasizing general hygiene may have a positive impact. Some data may be skewed as medication supplies affect dispensing habits, and we often deplete the entire stock of medication. The international rotation served to improve health of Guatemalans, and served as an eye-opening experience for medical students, faculty and staff, with extremely positive subjective feedback from participants and patients. The data will be used to better understand the population served and provide an empirical basis for planning for future missions.

C17
Barriers to Effective Chronic Pain Management: Perceptions of Prescribers in Rural Appalachia
E. N. Remster OMS-IV, T. L. Marx, DO, CMD, Department of Family Medicine

OUCOM, Athens, OH

Context: Chronic pain is a significant cause of morbidity among adults worldwide. Previous research indicates "prescriber reluctance to prescribe Opioid" and "inadequate knowledge of appropriate pain management" as major barriers to effective management of chronic pain. Few studies have evaluated the opinions of prescribers working with the unique patient population in rural Appalachia regarding pain management.

Hypothesis: Prescribers in rural Appalachian Ohio encounter the same barriers as prescribers elsewhere in providing effective management of chronic pain.

Materials and Methods: This IRB-approved prospective study was designed to evaluate prescriber opinions of chronic pain management in rural Appalachian Ohio. The investigators developed a 30-item questionnaire and distributed it to physicians and nurse practitioners attending a CME conference on pain management. Demographics and aspects of pain management were assessed and participants were asked to rank a list of twelve perceived barriers to effective chronic pain management.

Results: Thirty-six questionnaires were distributed, 22 were returned (response rate of 61.1%). All participants reported practicing in rural Appalachian Ohio; fifteen practice primary care (family medicine, internal medicine and geriatrics) and 7 reported other disciplines. Overall, participants were male physicians with a mean age of 50. Most participants were involved with chronic pain management "several times each week" or more; fifteen participants reported that they wrote prescriptions for Opioid medications "several times each week" or more. A calculation of mean was used to identify whether participants ranked barriers as "more significant" or "less significant". The most significant barriers were 1) prescriber reluctance to prescribe Opioid; 2) inadequate access to health care due to financial burden; and 3) inadequate access to pain specialists.

Conclusions: Prescribers in rural Appalachian Ohio did identify the same top barrier to effective chronic pain management as prescribers elsewhere, but also identified issues of health care accessibility as significant barriers. The researchers intend to use these preliminary study results to direct a larger, more comprehensive study involving all physicians in Appalachian Ohio.

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Patient Reported Effectiveness and Tolerability of Frovatriptan in a Large Population Previously Taking Other Triptans for Acute Migraine Treatment: An Open-Label, German Postmarketing Surveillance Study
B. L. Peterlin DO¹, S. Barlas, PhD², B. A. Jones, PhD², J. Campbell, BSc², ¹Department of Neurology Drexel University College of Medicine, Philadelphia, PA, ²Medical Affairs, Endo Pharmaceuticals Inc., Chadds Ford, PA

Hypothesis: Migraineurs who are not effectively treated with one triptan may respond to another (Dodick D. Headache. 2005;45(2):156-162). In this retrospective sub-analysis of a large migraine postmarketing surveillance study, we examined the hypothesis that patients would report frovatriptan to be an effective and well-tolerated acute migraine treatment in migraineurs who had previously taken another triptan.

Materials and Methods: Among 7107 German patients initiated on frovatriptan in a post marketing observational study for acute treatment of migraine, 2437 were identified as previous triptan (other than frovatriptan) users. Baseline data included previous migraine characteristics, and effectiveness and tolerability with previous therapies which were assessed categorically as Poor, Satisfactory, Good, or Very Good. Ordinal data were described as both the absolute number and as the percentage of the overall cohort. Intrapatient change in ratings was evaluated by McNemar's test of agreement.

Results: The mean±SD age was 44 ±11 years, and 85% were women. Fifty-four percent of triptan-experienced patients had 3 attacks per month; 34% reported attacks lasting >24 hours when untreated. Patients rating their treatment effectiveness as Good or Very Good improved from 39% with their previous triptan to 84% with frovatriptan. Similarly, 60% rated the tolerability of their previous triptan Good to Very Good compared with 93% with frovatriptan. Intrapatient comparison showed that 51% rated their previous triptan as Satisfactory to Poor and improved to Very Good or Good on frovatriptan (P<0.001). After switching to frovatriptan, patients' ratings of efficacy and tolerability were 8.2 times and 15.8 times more likely to improve to Good or Very Good than to decrease to Satisfactory or Poor (P<0.001). At the conclusion of the study, 85% of patients indicated they would continue treatment with frovatriptan.

Conclusion: Patients who reported less than Good efficacy and/or Good tolerability with their previous triptan reported clinically meaningful improvements in acute migraine treatment after switching to frovatriptan.

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Immediate and Prolonged Effects of a 10-Week Maximal Effort Exercise (with Valsalva) Protocol on Cognition in Men and Women with Multiple Sclerosis: A Multi-Center Study
M. L. Kuchera, DO, FAAO¹, R. T. Dombroski, DO², T. Vardy, DO³, F. Thomas, MD, PhD⁴, P. Yagnik, MD, PhD⁵, K. Wenzel, MA⁶, S. Stoll, DO⁷, PhD, B. Stouch, PhD², M. T. Wallin, MD, PhD⁸, ¹CCDA, Human Performance & Biomechanics Lab, ²PCOM, ³Dept. of Neuromuscular Engineering, Tweed Heads, North South Wales, Australia, ⁴Saint Louis VAMC, St. Louis, MI, ⁵Philadelphia VAMC, Philadelphia, PA, ⁶Rocky Mountain Multiple Sclerosis Center, Denver, Colorado, ⁷UNTH-SCFW-Texas College of Osteopathic Medicine, Fort Worth, TX, ⁸Washington VAMC, Washington D.C.

Half of all Multiple Sclerosis (MS) patients develop cognitive dysfunction (CogD) with slowed ability to reason, concentrate, or remember. While 5-10% develop problems interfering with activities-of-daily living, mild CogD decreases quality-of-life and contributes to depression. CogD, 1 of 3 MS Functional Composite measures, can be seen early but is more common in long-term MS.

Hypothesis: We hypothesized that adding a 10-week protocol of twice-weekly progressive maximal effort exercise (MEE) would improve scores on a standardized CogD test, the Paced Auditory Serial Addition Test (PASAT). We also hypothesized that benefits would be retained when rechecked at 6 and 12 weeks.

Methods: 68 subjects (60% female; median age 50 years) with mild-to-moderate MS participated in an adjunctive, standardized, multicenter 10-week twice-weekly non-fatiguing progressive MEE protocol. During MEE, isometric and eccentric vertical leg presses and semi-erect whole body (lunge) exercises (4 seconds each with Valsalva) were repeated 3-5X on specialized exercise and strength-sensing equipment (IsoP-UMP®, Neuromuscular Engineering).

PASAT-3, a 3-minute, validated instrument requiring concentration, short-term memory, and simple addition skills (numbers electronically spoken every 3 seconds) was performed at baseline; twice during the 10-week intervention; and at 6- and 12-week rechecks. One research coordinator scored all subjects.

The Institutional Review Boards (IRB) of Philadelphia College of Osteopathic Medicine (lead site), Texas College of Osteopathic Medicine and Veterans Administration Medical Centers of Philadelphia, St. Louis, Denver, and Washington all approved this study.

Results: Where perfect=60, PASAT-3 correct scores at base-line averaged 41.16 (range 12-60; 39.62-44.70 [95%CI]); 48.00 after 10-weeks MEE (range 18-60; 45.02-50.98 [95%CI]); and 49.06 three-months after discontinuing exercise (range 20-60; 46.08-52.03 [95%CI]). Significant change (12%) from baseline correct was noted during the exercise period (+3.44 at week 6, p<0.001) and increased thereafter: end-MEE (+5.04, p<0.0001) and 12-week post-MEE (+6.64, p<0.0001).

Conclusions: Integration of a progressive, non-fatiguing IsoP-UMP® MEE protocol twice weekly for ten-weeks results in improved cognition lasting at least 3 months post-MEE (p<0.0001).

Acknowledgment: Supported by joint civilian - Veterans Affair Project

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Immediate and Prolonged Effects of a 10-Week Non-Fatiguing Maximal Effort Exercise Protocol on Strength in Deconditioned Men and Women with Multiple Sclerosis: A Multi-Center Study
M. L. Kuchera, DO, FAAO¹, R. T. Dombroski, DO², T. Vardy, DO³, F. Thomas, MD, PhD⁴, S. O'Brien, MD, PT⁹, P. Yagnik, MD, PhD⁵, K. Wenzel, MA⁶, S. Stoll, DO⁷, PhD, B. Stouch, PhD², M. T. Wallin, MD, PhD⁸, ¹CCDA, Human Performance & Biomechanics Lab, ²PCOM, ³Dept. of Neuromuscular Engineering, Tweed Heads, North South Wales, Australia, ⁴Saint Louis VAMC, St. Louis, MI, ⁵Philadelphia VAMC, Philadelphia, PA, ⁶Rocky Mountain Multiple Sclerosis Center, Denver, Colorado, ⁷UNTHSCFW-Texas College of Osteopathic Medicine, Fort Worth, TX, ⁸Washington VAMC, Washington D.C., ⁹Colorado Multiple Institutional Review Board, Denver, CO

Multiple Sclerosis (MS) patients become deconditioned and weak; poorly tolerating aerobic exercise or fatigue. Pilot data (JAOA 102(5):267-275; 2002) showed significant strength improvement after a 12-week program combining maximal effort exercise (MEE) with osteopathic manipulative treatment (OMT).

Hypothesis: In MS subjects, 20 2x-weekly MEE sessions will result in proximate and prolonged increases in isometric and eccentric strength measures above baseline.

Methods: 68 MS subjects (60% female; ageave=50 yrs) participated in a multicenter 10-week 2x-weekly progressive MEE protocol (without OMT) with rechecks at 6 & 12 weeks. MEE consisted of isometric & eccentric leg presses (IsoLP, EccLP) and total body lunges (IsoTBL, EccTBL) performed maximally (4 secs, 3-5 reps). MS Functional Composite, fatigability, and quality-of-life measures were followed longitudinally along with IsoPUMP® (Neuromuscular Engineering) strength measures. All college and VA IRBs approved the protocol.

Results: IsoLPave strengths maximally improved by week 6 (p<0.0041) and most retained increases 3-months post-protocol. Immediate post-MEE strengths increased 67 Lbs (range IsoL-Pave=21-113, p=0.005), a 13% increase. (Ave IsoLPmax=492 Lbs). At both post-exercise points, IsoLPave remained +52 Lbs (+8%) overall; some retaining +100 Lbs improvement (6-weeks post-MEE, p=0.024; 12-weeks post-MEE, p=0.045). EccLPave strength +46 Lbs (range=16-77, p=0.004) during exercise becoming insignificant by 6-weeks post-MEE.

IsoTBL strength was compared for 3 matched leg positions. Subjects gained considerable (p<0.01) strength in all positions at 6-weeks ME