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	AOA Research Fellowships

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

 
F01
Determining the Intra-observer Reliability of the Evaluation of Cranial Strain Patterns
K.D. Halma, DO, K.T. Snider, DO, J.C. Johnson, MA, M. Schaun Flaim, DO, B.F. Degenhardt, DO; Dept. of Osteopathic Manipulative Medicine, Kirksville College of Osteopathic Medicine of A.T. Still University of Health Sciences, Kirksville, MO 63501

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Methods: Two board certified Neuromusculoskeletal Medicine/Osteopathic Manipulative Medicine (NMM/OMM) specialists examined 24 subjects each subdivided into three diagnostic groups of eight subjects: those with a history of headaches, with asthma, or with neither (healthy control group). Examiners diagnosed each subject's cranial rhythmic impulse (CRI) rate, cranial strain pattern (CSP), and quadrants of restriction (QOR). To blind the examiners, the subjects were divided into subgroups based on hair length and style. Examiners evaluated four subjects at a time with each subject being evaluated three times per session in a random order. Kappa coefficients () were used to measure intra-observer reliability.

Results: Overall, the cranial strain pattern diagnosis showed the highest reliability (=0.67). Within individual diagnostic groups, the cranial strain pattern diagnosis showed the highest reliability for the healthy group (=0.82), followed by headache (=0.67) and asthma (=0.52) groups. CRI rate showed only fair reliability (=0.23). CRI rate by diagnostic groups, asthma had the lowest reliability (=0.10), while headache and healthy groups had fair reliability (=0.23 and 0.29 respectively). The three of the four quadrants of restriction (QOR) showed moderate overall reliability (=0.44-0.52), while the left posterior quadrant had only fair reliability (=0.33). In both the headache and healthy groups, the left anterior quadrant showed substantial reliability (=0.60 and 0.61 respectively) while the left posterior quadrants showed fair reliability in all three groups.

Comment: There are no previous studies on the intra-observer reliability of CSP. These results indicate good intra-observer reliability can be obtained when evaluating cranial strain patterns. Yet the intra-observer reliability for CRI and QOR were found to be only fair. This finding for intra-observer reliability for CRI was consistent with previous studies. Now that intra-observer reliability has been documented, studies need to be done to establish the inter-observer reliability for QOR, CRI and CSP.

Acknowledgment: Supported through a grant from the AOA (#F03-08).

F02
Intraocular Pressure Correlated With Osteopathic Manipulative Treatment
Z.B. Nye, BA,¹ R.F. Multack, OD, DO,² T. Glonek, PhD³; ¹Midwestern University/CCOM; ²Department of Ophthalmology; ³Department of Osteopathic Manipulative Medicine, Midwestern University/CCOM, Downers Grove, IL

Purpose: To determine if a relationship exists between intraocular pressure (IOP) and osteopathic manipulative treatment (OMT) in patients with and without glaucoma.

Materials and Methods: Patients with primary open angle glaucoma (POAG) (n=76 eyes) and patients without POAG (n=58 eyes) were randomized into a treatment group, a sham-treatment group, and a control group. The treatment and sham-treatment groups had IOP measurements immediately prior to and after OMT, and again one week later. The control group had IOP measurements once, and again one week later. Each pressure measurement for a given patient was performed by the same person who was blinded to the group the patient was assigned. All pressures were measured using a Goldman tonometer.

Results: Using the independent-samples t-test, patients with POAG had a significant difference between treatment and sham groups (treatment (mmHg), 18.30±4.78; sham, 16.34±3.90; P<.013). There was no significant difference between treatment and control groups (treatment, 18.30±4.78; control, 17.20±3.22; P<.193) and sham and control groups (sham, 16.34±3.90; control, 17.20±3.22; P<.255). For patients without POAG, there was a significant difference between treatment and sham groups (treatment, 13.85±2.32; sham, 15.52±1.86; P<.000) and treatment and control groups (treatment, 13.85±2.32; control, 16.25±1.88; P<.000). There was no significant difference between sham and control groups (sham, 15.52±1.86; control, 16.25±1.88; P<.104).

Conclusions: There was a significant difference between treatment and sham-treatment groups for both patients with and without POAG; however, there was no significant difference between treatment and control groups and sham-treatment and control groups for patients with POAG. There was a significant difference between treatment and control groups and sham-treatment and control groups in patients without POAG.

F03
The Role of Osteopathic Manipulative Treatment in the Treatment of Fibromyalgia Syndrome
J.L. Yahnert, R.J. Hartman, OMS IV, P.E. Steward, PhD, M.L. Kuchera, DO; Philadelphia College of Osteopathic Medicine, Philadelphia, PA

Hypotheses: Adding Osteopathic Manipulative Treatment (OMT) to the treatment of Fibromyalgia Syndrome (FMS) would: decrease the effect FMS had on the patient's activity shown by a decreasing Fibromyalgia Impact Questionnaire (FIQ) score; decrease the amount of symptoms and syndromes the patient experienced shown by a decreasing Symptoms and Associated Syndromes Questionnaire (SASQ) score; decrease the amount of time it would take the patient to walk 75 feet; and decrease the amount of pain medication the patient required.

Materials and Methods: Nine possible subjects were recruited. Of these nine, five were enrolled. Of the five enrolled subjects, four completed the protocol. One subject dropped out for personal reasons. Each subject was evaluated and treated for 8 weeks. Each week, the patient filled out the FIQ and the SASQ and recorded their medication use in a diary. On weeks one and eight, the amount of time it took the subject to walk 75 feet was recorded. Osteopathy in the Cranial Field (OCF) treatment was given weekly. The OMT protocol was designed to address somatic dysfunction in the sphenobasilar synchondrosis, occipital-atlantal and atlantal-axial joints, 2nd cervical vertebrae and sacrum. The clinical endpoint of the model was improved symmetry, amplitude, vitality, and rate of the Cranial Rhythmic Impulse. All findings were recorded.

Results: Two of the four subjects had decreases in their FIQ scores from 28 to 14 and from 80 to 23. All four subjects had decreases in their SASQ scores from 29 to 25, from 31 to 29, from 37 to 30, and from 42 to 30. All four subjects also decreased the amount of time it took them to walk 75 feet with the decrease ranging from 1.5s to 10.1s. One subject showed a dramatic decrease in pain medication use going from using 2 medications to not using any medication. The remaining subjects varied in medication use.

Conclusion: This study supported the hypotheses, by showing a reduction in all proposed categories, but due to the small number of subjects, statistical significance cannot be properly assessed. The results suggest that OCF may be of benefit for patients with FMS. Expanding this study over a longer period of time, with a larger subject pool will provide definitive answers as to the benefit of OMT in FMS.

F04
Immediate Effects of Osteopathic Manipulative Treatments on Immune Function in a Healthy Population: A Pilot Study
J.T. John, OMS IV; Texas College of Osteopathic Medicine, Fort Worth, TX

Objectives: The purpose of this pilot study was to investigate the immediate effects of Osteopathic Manipulative Treatment (OMT) on immune function in a healthy population.

Methods: This was a prospective, randomized, blinded and controlled clinical trial. Fifty healthy individuals, ages 18 to 40, were recruited primarily from the UNTHSC campus. Exclusion criteria included any disease, treatment or habit that influences immune function and any condition for which OMT is contraindicated. Subjects were randomly assigned to one of two groups: OMT or Rest (control). Blood and saliva samples were collected pre- and post-intervention (thirty minutes of OMT or Rest). Samples were analyzed for a complete blood count (CBC) with a differential using a Coulter Counter, salivary IgA using ELISA, and B-lymphocyte percentages, and T-lymphocyte sub-population concentrations: CD4, CD8 and natural killer cells using flow cytometry.

Results: Fifty subjects were recruited, 25 in each group. This study demonstrated the feasibility of this protocol. Additionally, strong relationships for future collaborations were developed. No statistically significant differences in outcome measures were identified between the two groups, nor were any apparent trends identified.

Conclusion: Although this study proved the feasibility of this protocol and established a solid framework for future research, further studies must be conducted. It is imperative that the efficacy of OMT in acute and chronic infection, chronic pain, and immunocompromised populations continued to be studied. Animal studies have proven to be insightful, and should continue to provide valuable information on the mechanism of action of OMT. In addition, the long term results of osteopathic manipulative treatments over a longer period of time should be examined. This pilot study offers valuable information that should direct future studies.

Acknowledgment: This study was funded by the Osteopathic Research Center and approved by the UNTHSC Institutional Board.

	Osteopathic Manipulative Medicine/Osteopathic Principles and Practice

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

 
P01
The Effect of CV-4 Upon Cutaneous Bloodflow Velocity
K.E. Nelson, DO, N. Sergueef, DO, T. Glonek, PhD; Dept. of Osteopathic Manipulative Medicine, Midwestern University/Chicago College of Osteopathic Medicine, Downers Grove, IL

The CV-4 procedure purports to affect the cranial rhythmic impulse, a phenomenon that has been shown to be concomitant with the low-frequency Traube-Hering (TH) oscillation in blood flow velocity. This study examines the affect of the CV-4 upon blood flow velocity. Fourier-transform spectra were extracted from laser-Doppler flowmetry of each of three component parts of the experimental CV-4 procedure (Control, Treatment, Response). The component spectra are compared statistically in each of three low-frequency and four high-frequency spectral parameters derived therefrom. Also included in the analysis are the mean frequency of the dominant flowmetry (TH) wave, and the mean duration of the CV-4 procedure. Human subjects (informed consent obtained) were paired with 28 individual physicians for the performance of the CV-4 procedure. Flowmetry records (Transonic® Laser-Doppler; BLF21, Ithaca, NY) were obtained tracking the course of the procedure, 20 of which were useable for inter-group comparisons. Fourier transform difference spectra were compared statistically using the One-Way ANOVA (SPSS Inc, Chicago, IL). The mean frequency of the TH waveform visible in the blood flowmetry record was 7.10±2.07 cpm. The mean CV-4 procedure length was 4.43±2.22 minutes. The CV-4 procedure was shown specifically to affect the low-frequency oscillations in blood flow velocity. Following its application, the amplitude of the TH wave increased [0.10 Hz frequency relative area units: control minus treatment (0.08010 units) compared with control minus response (–0.03358 units), P=0.011]. It is concluded that cranial manipulation affects the autonomic nervous system because the TH waves have been demonstrated to be mediated through autonomic activity (Akselrod et al, 1985). Since palpation alone does not greatly effect blood flow velocity oscillations, there is a quantifiable difference between palpation alone and cranial treatment utilizing the CV-4 procedure. It can be said that the practitioners of cranial manipulation who participated in this study affected their subjects in a quantifiable manner with the CV-4 procedure.

[Akselrod S, Gordon D, Madwed JB, Snidman NC, Shannon DC, Cohen RJ. Hemodynamic regulation: investigation by spectral analysis. Am J Physiol. 1985;249(4 pt 2):H867–H875.]

P02
Osteopathic Manipulative Medicine for Carpal Tunnel Syndrome: Changes in Nerve Conduction
H.D White, DO,¹ S.T. Stoll, DO, PhD,² D. Cruser, PhD,² R. Whitesell, MPH,³ H.H. King, DO, PhD²; ¹University of North Texas Health Science Center at Fort Worth; ²Osteopathic Manipulative Medicine/Osteopathic Research Center, UNTHSC; ³University of Texas San Antonio Medical School

Purpose: The goal of this clinical trial was to assess for physiologic and anatomic changes in CTS in response to OMT.

Methods: This prospective, randomized, controlled, clinical trial (RCT) included two experimental groups, OMT and placebo sub-therapeutic ultrasound. Adults were enrolled who were between 21 and 70 with a clinical diagnosis of CTS and increased conduction latency (slowed conduction) of the median nerve. Outcome measures were changes in median motor and sensory distal latencies measured by Nerve Conduction Studies (NCS). Subjects receive six treatments. NCS were taken at entry to the study (baseline), midpoint, and endpoint.

Results: Thirty-seven of a planned 50 subjects were randomized to groups. Thirty-one subjects were included in the final data analysis. Preliminary analysis found no significant difference in NCS values over the three testing intervals. Analysis of 15 subjects with a single treatment provider found significant improvements in some NCS for the OMT group.

Conclusions: The results of this study indicate possibility for improvement of CTS with OMT, but no conclusive statements about the efficacy of OMT can be made. This preliminary study enabled us to identify multiple areas in the research design and methodology that could be improved, and provides the framework for future studies. This study contributed to achieving a 3-year NIH-NCCAM R21 to study OMT for CTS in a larger number of subjects.

P03
Operator Differences in the Use of Thoracic Lymphatic Pump Technique in Persons With COPD
D.R. Noll, DO,¹ J. Johnson, MA,² E. Snider, DO³; ¹Kirksville College of Osteopathic Medicine; ²A.T. Still Research Institute/KCOM; ³Dept. of OMM, KCOM

Hypothesis: There will be no significant difference between operators using a thoracic lymphatic pump technique in persons with COPD.

Methods: A standard description of the thoracic lymphatic pump technique was developed. Operators A and B reviewed and practiced the protocol several times together at the onset of a study testing the effects of manipulation techniques on pulmonary function parameters in persons with COPD. Pulmonary function parameters were measured at baseline and 30 minutes after a five-minute session in which this standardized thoracic lymphatic pump technique was applied. Subjects were randomly assigned.

Results: Each operator treated 12 subjects. The mean residual volume (RV) decreased by 243 ml ±281 (standard deviation) for operator A, but increased by 144 ml ±455 for operator B, P=0.0094. The mean total gas volume (TGV) decreased by 214 ml ±150 for operator A and increased by 88 ml ±391 for operator B, P=0.0193. The mean total lung capacity (TLC) decreased by 258 ml ±256 for operator A, and increased by 99 ml ±376 for operator B, P=0.0153. The mean forced expiratory volume in one second (FEV1) decreased by 85 ml ±0.11 for operator A and decreased by 20 ml ±97 for operator B, P=0.0458. Post study review found differences in how operators A and B interpreted and used the protocol technique during the study. Operator A used progressive compressive forces on exhalation, with slow release on inhalation, while operator B used steady pumping throughout, without compressive forces.

Conclusion: The "compressive" operator A version of the technique reduced lung volumes in persons with COPD, while version B did not. Differences in how techniques are applied can lead to significant differences in physiologic effects. This highlights the need for stricter protocol standardization in research, and the need to study different versions and applications of osteopathic techniques. Lines of research organized in this manner will begin to sort out how to perform OMT in order to maximize physiological effects.

Acknowledgment: Supported by an Osteopathic Heritage Foundation grant.

P04
The Immediate Effects of the Splenic Pump Technique on Blood Cell Counts in Normal Adults
C.M. Harpenau, OMS III,¹ A. Inoue, OMS III,¹ J.C. Johnson, MA,² N.R. Chamberlain,³ E. Jadoon-Khamash,⁴ D.R. Noll, DO⁴; ¹Kirksville College of Osteopathic Medicine; ²Office of Research Support; ³Department of Microbiology/Immunology; ⁴Department of Internal Medicine, ATSU-KCOM, Kirksville, MO

Hypothesis: The splenic pump technique will alter blood cell counts in healthy adults at 30 and 60 minutes posttreatment relative to a sham treatment. The technique will increase leukocyte and reticulocyte counts, decrease hemoglobin, hematocrit, erythrocyte and platelet counts, and change differential cell counts, but not change blood cell indices.

Materials and Methods: This was an unblinded IRB-approved study in which normal adults (age 20–67, n=107) were randomized to receive a splenic pump (n=52) or sham treatment (n=55). The treatment group received 100 repetitions of the splenic pump over a five-minute period. The sham group received light touch for five minutes. Blood for CBC and reticulocyte counts was drawn before treatment and at 30 and 60 minutes posttreatment. Analysis consisted of non-parametric ANCOVA.

Results: Compared to the sham group, the treatment group demonstrated lower MCVs at 30 minutes posttreatment [treatment median (1st quartile, 3rd quartile) 88.1 fL (86.3, 91.7); sham 88.7 fL (86.4, 91.0); P=0.01] and higher neutrophil counts at 30 minutes posttreatment [treatment 3.7x10³ cells/mm³ (2.9, 4.6); sham 3.2x10³ cells/mm³ (2.4, 4.2); P=0.02]. At 60 minutes posttreatment, the treatment group had higher neutrophil percents [treatment 58.1% (53.8, 61.6); sham 54.1% (48.9, 60.2); P=0.02], lower lymphocyte percent [treatment 31.3% (28.1, 35.5); sham 34.3% (28.9, 40.4); P=0.01], and higher basophil counts (all medians and quartiles 0 cells/mm³; treatment mean ± standard deviation 0.02±0.04x10³ cells/mm³; sham 0.01±0.02x10³ cells/mm³; P=0.05). There were no other statistically significant differences between the groups.

Conclusions: In normal healthy adults, the splenic pump did not alter leukocyte, reticulocyte, erythrocyte or platelet counts, hemoglobin or hematocrit levels as hypothesized. There were statistically significant differences in MCV, neutrophil percents and counts, lymphocyte percents and the basophil counts, but these modest changes may not constitute clinically meaningful differences in a healthy population. Subsequent studies with the splenic pump in a non-healthy population would enhance our understanding of the clinical relevance of the technique.

Acknowledgment: Supported by the ATSU Strategic Research Initiative, A.T. Still Research Institute.

P05
The Immediate Effects of the Splenic Pump on Serum Level of C-reactive Protein in Normal Adults
A. Inoue, OMS III,¹ C.M. Harpenau, OMS III,¹ N.R. Chamberlain,² J.C. Johnson, MA,³ E. Jadoon-Khamash,⁴ D.R. Noll, DO⁴; ¹Kirksville College of Osteopathic Medicine; ²Department of Microbiology/Immunology; ³Office of Research Support; ⁴Department of Internal Medicine, ATSU-KCOM, Kirksville, MO

Hypothesis: Splenic pump technique will cause increased serum C-reactive protein (CRP) levels in normal adults when compared to sham treatment.

Materials and Methods: In this IRB-approved unblinded study, normal adults (age 20–67, n=107) were randomized to receive the splenic pump technique (n=52) or light touch (n=55) for five minutes. The splenic pump consisted of 100 bimanual compressions and relaxations of tissues overlying the spleen. The serum level of CRP was measured at baseline, and at 30 and 60 minutes posttreatment. A non-parametric ANCOVA was used to test for statistical differences between the groups, and Friedman's tests were used for within-group comparisons.

Results: The median (first quartile, third quartile) CRP levels in the treatment group were 0.428 mg/L (0.192, 1.956) at baseline, 0.512 mg/L (0.180, 1.943) at 30 minutes post-treatment, and 0.460 mg/L (0.182, 1.766) at 60 minutes post-treatment. The corresponding medians in the sham group were 0.440 mg/L (0.150, 2.040), 0.480 mg/L (0.142, 2.025), and 0.446 mg/L (0.140, 2.195). The changes within the treatment group and the sham group were not significant (P=0.30 and P=0.06, respectively). There was no statistically significant difference in the median serum levels of CRP between the treatment group and the sham group (P=0.46 and P=0.80 at 30 minutes and 60 minutes, respectively).

Conclusions: The splenic pump technique does not appear to change the level of C-reactive protein at 30 or 60 minutes post-treatment compared to sham treatment.

Acknowledgment: Funded by ATSU Strategic Research Initiative, A.T. Still Research Institute.

P06
CV-4 Induced Physiological Change as Measured by Transcutaneous Laser Doppler Flowmeter
K. Guinn, MA, Seffinger, DO; Dept. of Osteopathic Manipulative Medicine, Western University Health Sciences/COMP, Pomona, CA

Background: Osteopathic manipulation techniques, such as Compression of the Fourth Ventricle (CV4), influence autonomic balance. Prior studies demonstrate that laser Doppler flowmeter (LDF) accurately measures autonomic balance by measuring the Traube-Hering (TH) wave (.08-.15 Hz) of peripheral blood flow velocity. Authors investigated the ability of CV4 technique to alter autonomic balance.

Objective: To evaluate whether the CV4 technique alters autonomic balance as measured by the LDF in comparison to rest and touch (sham) only.

Methods: 25 healthy subjects (convenience sample) gave informed consent to participate. LDF measured skin blood flow velocity before, during and after the CV4 technique. 18/25 subjects experienced both a sham and a CV4 technique, 7 experienced a CV4 only. Lying horizontal, a five min. baseline was recorded, followed by a five min. sham procedure, five min. resting interval, five min. CV4 technique and a final five min. post technique resting period. Three minutes of data were selected from each time frame. A spectral analysis was performed using DFT for each time frame and compared to other time frames using a paired sample t-test.

Results: There is a significant difference in autonomic balance during the CV4 (P<.000). There is no significant difference between the baseline and post technique autonomic balance (P<.645), nor between baseline and the sham procedure (P<.727), or between the sham procedure and post technique (P<.630). The 08-.15 Hz component of blood flow velocity greatly decreased in amplitude in 24/25 subjects during a CV4 technique. The duration of altered autonomic balance during the CV4 was also longer than any change in autonomic balance measured at rest, during sham, or after the interventions (P<.000). Mean time frame of decreased amplitude of TH wave during CV4 is 64.6 seconds, compared to 11.68 seconds during rest and 14.92 seconds for sham.

Conclusion: Decreased autonomic balance and its duration during CV4 are measurable and distinctly related to the technique. The LDF can quantify the therapeutic intervention known as the CV4 technique and differentiate its characteristic physiologic effect from resting state and sham interventions.

P07
Validation of Transcutaneous Laser Doppler Flowmeter in Measuring Autonomic Balance
K. Guinn, MA,¹ Seffinger, DO,¹ H. Ali,¹ T. Glonek, PhD²; ¹Dept. of Osteopathic Manipulative Medicine, Western University of Health Science/COMP, Pomona, CA; ²Dept. of Osteopathic Manipulative Medicine, Midwestern University/CCOM, Downers Grove, IL

Background: Transcutaneous Laser Doppler Flowmeter (LDF) is a non-invasive device to measure the Traube-Hering (TH) wave and heart rate. TH component represents baroreceptor activity; changes in TH reflect changes in autonomic balance. Heart rate variability (HRV) measured by EKG is the "gold standard" for measuring autonomic balance. To evaluate the validity of LDF as a device for measuring autonomic balance, it needs to be compared to the gold standard.

Objective: Evaluate LDF's sensitivity and specificity in measuring autonomic balance.

Methods: Blood flow velocity obtained from LDF and RRI from EKG were recorded from 22 healthy individuals (convenience sample) before, during, after provocative procedures. Head-Up Tilt Test and Cold Pressor Test were employed as standard provocative autonomic procedures. While supine, a five min. baseline recording was taken prior to tilt test. Subjects were passively raised 80° for five min. recording, and passively returned to supine for five min. recording. Cold Pressor Test was performed: immersion of subject's hand in cold water (10°C) for 60 sec. A five min. post provocation recording followed. HRV was analyzed from RRI using Fourier Transform. The spectral analyses from EKG were compared to spectral analyses of autonomic (TH) component of LDF wave. Subjects signed IRB approved informed consent prior to participation.

Results: Calculation software packages were used to quantify data gathered from spectral analyses. Using a paired-samples T-test, HRV calculated from EKG and cardiac component of LDF wave demonstrated a correlation of .97 (P<.00); this reflects LDF's ability to detect RRI with accuracy. TH component of LDF wave (.08-.15Hz) when compared with low frequency component of EKG/HRV (.08-.15Hz) demonstrated a correlation of .712 (P=.00); this reflects simultaneous changes between TH component of LDF wave and HRV. LDF is 95.45% sensitive and 90.91% specific in detecting changes in autonomic balance.

Conclusion: LDF is sensitive and specific in detecting autonomic balance changes. Cardiac and autonomic (TH) components of LDF wave accurately assess and quantify changes in autonomic balance.

P08
Inhibitory Rib-Raising With Direct Sympathetic Nervous System Measurement
D.W. Kinzler, J. Siu, M. Smith, PhD; Dept. of Integrative Physiology, Texas College of Osteopathic Medicine, Fort Worth, TX The systematic evaluation of osteopathic manipulative therapy (OMT) on sympathetic neural activity (SNA) is limited. A specific OMT technique (inhibitory sympathetic rib-raising) has been theorized to regulate autonomic imbalance by applying direct pressure to the head of the rib near the sympathetic ganglion. This technique has historically been described to initially produce sympathoexcitation followed by a sympatholysis, yet no work has been published documenting this effect. An initial study in our lab found no change in SNA in healthy individuals who had low basal SNA. We hypothesized that rib-raising applied while SNA is elevated will effectively modulate SNA.

Methods: We used a cold stimulus to produce a pain-mediated elevation of the SNA which allowed us to determine whether OMT can directly reduce a state of elevated SNA. Fifteen healthy subjects by history and physical examination who were naïve to OMT techniques and proposed effects were recruited. IRB approval was obtained. SNA was assessed using standard microneurography. Data were recorded continuously on a computer analysis system. After instrumentation and an initial 20 min period of rest, subjects were exposed to a two-minute cold stimulus (CS) by submersion of the hand in water randomized at 2°C, 10°C and 18°C. During each stimulus sustained inhibitory rib-raising or sham OMT was applied. The sustained inhibitory rib-raising OMT was performed for 2 min in an attempt to affect the thoracic sympathetic chain ganglia. Sham OMT was performed by placing the hands in the same position without the concurrent anterolateral force. Data recording began two-minutes prior to the stimulus, during the stimulus and for a four-minute recovery period. All data were reduced post hoc via a customized digital data acquisition system.

Results and Conclusions: There was no significant difference between the treatment groups (P>0.05) suggesting that the OMT did not directly affect sympathetic nervous system activity. However, there was a trend towards an initial sympathoexcitation (P<0.11) during the 10° cold-pressor stimulus. Additional subject recruitment to complete the study is currently ongoing and will achieve appropriate statistical power.

P09
Examiners Prioritize Displacement Over Pressure and Force Measurements When Diagnosing Rotational Thoracic Vertebral Motion
B.F. Degenhardt, DO, Q. Yang, MS, J.C. Johnson, MA; A.T. Still Research Institute, Kirksville College of Osteopathic Medicine, Kirksville, MO

Objectives: To quantify rotational vertebral motion testing and to determine how these measurements correlate with examiners' diagnoses.

Methods: Twenty examiners evaluated multiple thoracic vertebrae for rotational motion preference on one of seventeen subjects. Motion testing occurred through a pressure sensing pad used to obtain maximum pressure (kg/cm2) and force (Newtons) generated. Simultaneously from the head of the examination table, digital video imaging was collected so that reference points on the palpating thumbs could be seen throughout the motion testing process and used to determine the displacement (mm) of the thumbs relative to baseline. Examiners' thumbs identified the transverse processes of randomly chosen thoracic vertebrae. Anterior pressure with the right and then left thumbs were applied in an alternating fashion for two trials on each transverse process. Baseline and peak pressures and forces generated by each thumb were determined, synchronized with displacement measurements, and compared to examiners' observations.

Results: Maximum pressure, force, and displacement were determined for both thumbs individually and for the first and second trials per segment. The overall mean maximum pressure and force were 0.52 kg/cm2 (95% CI: 0.37–0.66) and 24.6 N (95% CI: 16.7–32.6). There was no statistically significant difference between the thumbs on the pressure or force applied (P=0.53 and P=0.15, respectively) or when comparing first and second trials (P=0.28 and P=0.43, respectively). The overall mean for displacement was 8.3 mm (95% CI: 6.8–9.8). There were statistically significant differences in displacement between the two thumbs (1.2 mm; P<0.001) with the side of least displacement corresponding to the clinical diagnosis. There also was a statistically significant increase in displacement on both sides between trial 1 and 2 (0.9 mm; P<0.001).

Conclusions: The results indicate that when osteopathic clinicians are evaluating segmental vertebral rotational motion, they tend to maintain similar thumb force and pressure during testing and focus on the secondary degree of displacement to determine diagnosis.

P10
The Effects of OMT on Median Nerve Size and Function in Patients with Carpal Tunnel Syndrome
T.A. Feathers, OMS, W.M. Foley, DO, J. Panzone, J.B. Lyons, P.E. Stewart, PhD, M.L. Kuchera, DO; Human Performance and Biomechanics Laboratory, Philadelphia College of Osteopathic Medicine, Philadelphia, PA

Carpal Tunnel Syndrome (CTS) is the most common entrapment neuropathy. Conservative treatment includes NSAIDs, wrist splints, and exercises. Diagnosis can be made by using nerve conduction studies (NCS), or by showing median nerve swelling with ultrasound (US). In numerous studies OMT improved pain and Phalen tests, and was linked in pilot projects to trends in NCS improvement and decreased median nerve swelling.

Hypothesis: The addition of OMT to standard medical therapy for CTS will: decrease median nerve cross-sectional area (CSA), decrease Symptom Severity Scale (SSS) scores, and decrease Functional Status Scale (FSS) scores.

Methods: 23 patients with mild-to-moderate CTS diagnosed by NCS in 39 wrists were randomized into OMT (n=21) or sham laser (n=18) groups. US measurements of all median nerves were obtained, and all patients completed SSS and FSS prior to treatment. These subjects were provided eight weekly sessions of OMT (MFR/BLT) or sham laser. All patients were provided wrist splints, exercises, and ibuprofen if not contraindicated. Survey data on pain level, medication use, splint wearing, and exercises were recorded weekly. NCS, US, SSS, and FSS data were collected after the last treatment.

Results: There was a positive correlation between US measurements of the median nerve CSA and the severity of CTS as diagnosed by NCS (P=0.012). Comparison of pre-, post-, and post- minus pre-treatment groups revealed no significant difference in median nerve CSA. Regression analysis of the US measurements and SSS and FSS scores showed an increase in median nerve CSA was related to an increase in SSS in the laser post-treatment group (P=0.007). There were no significant changes in the OMT group. Head to head analysis of the post-treatment groups showed significantly higher SSS scores (P=0.013) and FSS scores (P=0.005) in the sham laser group.

Conclusions: While US was shown to correlate with the diagnosis of CTS, it did not detect any significant change in median nerve CSA in patients receiving OMT or sham laser after eight treatments. Weekly OMT was shown to slow, if not halt, the progression of symptoms and the decline in function in patients with CTS, while those receiving sham laser treatments had more symptoms and worse function.

P11
Effect of OMT on Myofascial Somatic Dysfunction and Objective Parameters of Severity in Patients with Carpal Tunnel Syndrome
W.M. Foley, DO,¹ M.L. Kuchera, DO,¹ J.B. Lyons,¹ J. Panzone,² J. Yahnert,¹ P.E. Stewart, PhD¹; ¹Philadelphia College of Osteopathic Medicine, Philadelphia, PA; ²Lake Erie College of Osteopathic Medicine, Erie, PA

Background: Carpal Tunnel Syndrome (CTS) is a common entrapment neuropathy. Current conservative treatments are NSAIDs, wrist splints, and exercises. Myofascial trigger points (MTrPs), painful hyperirritable areas in skeletal muscles that can refer pain, decrease range of motion, and cause altered neural-vascular-lymphatic function, have been associated with CTS. In numerous studies, osteopathic manipulative treatment (OMT) has improved pain and Phalen's test measures. OMT has also been linked to decreased median nerve swelling and to trends in nerve conduction study (NCS) improvement.

Methods: Patients with mild-to-moderate CTS diagnosed by NCS were randomized into OMT (n=14 wrists) or sham laser (n=14 wrists) groups. Ultrasound measurements of the median nerve were obtained from all subjects. The subjects were provided 8 weekly treatments of pan-corporeal OMT (myofascial release/balanced ligamentous tension) or forearm sham laser. All patients were provided wrist splints, hand exercises, and ibuprofen if not contraindicated. At the time of the NCS, MTrPs common in CTS were recorded and scored (0=none; 1=inactive; 2=latent MTrP; 3=active MTrP) at baseline and 1 week after final treatment. Survey data on pain level, NSAIDs and splint use and exercises were recorded weekly throughout.

Results: There were 29 hands with a positive NCS (14 in OMT group, 14 in sham group, 1 excluded for severe CTS rating). There were also 12 symptomatic hands with negative NCS. There was no difference in total MTrP load in subjects with (n=29) or without (n=12) a positive NCS (P=0.23). A statistically significant reduction in total MTrP load was achieved in the OMT group (P<0.01). Conversely, conservative+sham care resulted in more myofascial dysfunction with "no myofascial activity" shifting towards more inactive (P=0.01) and latent (P=0.001) MTrPs. The adductor pollicis is the most abundant MTrP (P<0.01). Individual patient analysis was highly suggestive (P=0.06) of a trend towards MTrP reduction in those treated with OMT compared to the individual treated with sham laser.

Conclusion: OMT is successful in reducing MTrP load while those receiving standard care alone got significantly worse. This study suggests addition of OMT would benefit standard conservative care for mild-to-moderate CTS.

P12
Effectiveness of Osteopathic Manipulative Treatment for Parkinson Disease
T.C. Snider, OMS III, C. La Croix, DO, T. Nunnley, DO, S. Colwell, OMS IV, L. Jones, B. Wilde, OMS IV, K. Lodge, PA,¹ A. Will, DO,² D. Shoup, DO,² W. Devine, DO,² N. Wechsler, MA,¹ K. Cooper, PhD,¹ W.P. Baker, PhD¹; ¹Biomedical Department, Midwestern University/AZCOM, Glendale AZ; ²OMM Department, Midwestern University/AZCOM, Glendale AZ

Hypotheses: We predict a significant difference in Unified Parkinson Disease Rating Scale (UPDRS) and Quality of Life Inventory (QLI) scores in favor of Parkinson Disease patients who receive OMT.

Methods: We used a randomized, single blind, IRB approved, placebo-controlled parallel-group design. Twenty-seven PD patients were randomized with 14 placed in the treatment and 13 in the placebo (sham) group. All participants were given the same pretest measures of symptoms (UPDRS) and quality of life (QLI). Experimental participants received standardized OMT that included soft-tissue articulatory and muscle energy techniques. Sessions were 30 minutes 1 day per week for 6 weeks. The control group received a sham treatment consisting of standard OMT diagnostic techniques alone. All participants were re-administered the same pretest measures to assess effectiveness of OMT at the end of the study.

Results: Mean pretest UPDRS scores were 27 (n=14, SD=9) for the treatment group and 36 (n=11, SD=17.8) for the control group. Mean posttest UPDRS scores for the treatment group were 24 (n=14, SD=8.6) and 32 (n=11, SD=18.4) for the control group. Pre-post UPDRS scores were not statistically significant by ANCOVA, F(2,24)=0.183, P=.834. Pre-post estimated marginal means for the UPDRS treatment group were 3 (n=14) and 4 (n=11) for the control group. Mean pretest QLI scores were 65 (n=14, SD=18) for the treatment group and 78 (n=11, SD=28) for the control group. Mean QLI posttest scores for the treatment group were 61 (n=14, SD=17) and 72 (n=11, SD=26) for the control group. QLI pre-post scores were not statistically significant by ANCOVA, F(2,24)=0.702, P=.506. Pre-post estimated marginal means (EMMs) for the QLI treatment group were 2 (n=14) and 7 (n=11) for the control group. Mean likert scores on the outgoing patient survey for the control group was 25 and 34 for the treatment group.

Conclusions: EMMs reveal a trend towards improvement that is clinically significant and will inform treatment. Comments often revealed that participants found OMT most useful for increased mobility. This medical benefit derived from the OMT appeared to be retained and transferred to other ADLs. Future studies will examine this in greater detail using a larger sample size and greater demographic heterogeneity.

	Clinical Studies

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

 
C01
Tai Chi and Low Impact Exercise Reduce Functional Limitations in the Elderly
R.A. Pruchno, PhD, B.R. Frye, PhD, S.M. Scheinthal, T. Kemerskaya, M.A. Cavalieri, T. Lin; New Jersey Institute for Successful Aging, University of Medicine and Dentistry of New Jersey–School of Osteopathic Medicine, Stratford, NJ

Introduction: The Nagi Model of Disablement suggests that active pathology leads to physiological impairment, then to functional limitations and finally to disability. However, recent data suggest that physical inactivity is on par with chronic disease as a cause of disability, and that increased physical activity is associated with higher levels of functional mobility. Studies show that increased physical activity, even when begun late in life, results in improved physical fitness and functional ability.

Methods: Baseline assessments on 84 community-dwelling individuals over the age of 50 were conducted. The physical assessment consisted of the following tests: grip dynamometer (upper body strength), chair stand (lower body strength), sit-and-reach (flexibility), up-and-go (dynamic balance and agility) and the two minute step (endurance). Participants also completed a self report questionnaire on functional limitations. After the assessment, participants were randomized into one of three groups: tai chi (31), low impact (30), or control (23). Participants assigned to exercise groups were expected to attend three one-hour classes per week over the 12 week intervention. 12 people withdrew (14.3%), most for medical reasons unrelated to the study. After week 12, all physical measures were repeated on the 72 remaining participants.

Result: Better grip strength, balance, lower body strength, endurance, and less difficulty carrying heavy items were evident in the low-impact group compared to the Tai Chi group. Participants in the Tai Chi group reported higher subjective health and more energy. Both exercise groups performed better than the controls on most measures of functional limitations.

Conclusion: Compared with the control group, both low-impact exercise and Tai Chi are safe and cost-effective ways to reduce both self-reported and performance-based measures of functional limitations.

C02
Diastolic Dysfunction: Congestive Renal Failure?
M.D. Purcell, DO,¹ T. Logan, DO,² J. Kaiser, DO³; ¹Dept. of Internal Medicine; ²Dept. of Cardiology; ³Dept. of Nephrology, Mt. Clemens General Hospital, Mt. Clemens, MI

Background: The majority of cases of volume overload arise from heart failure (HF), which represents one of the leading causes of hospitalizations among the elderly in the United States. When patients have normal ejection fraction and evidence of left ventricular hypertrophy (LVH) on echocardiogram, they are commonly labeled as having diastolic dysfunction. We evaluated the prevalence of chronic kidney disease (CKD) among patients with presumed diastolic dysfunction. It was our hypothesis that patients with diastolic dysfunction had CKD and dysregulation of the renin-angiotensin-aldosterone system (RAAS) as the cause of their fluid overload and LVH.

Methods: The trial included 116 subjects at a community-based hospital with presumed diastolic dysfunction on echocardiogram in the absence of cardiac arrhythmias or significant valvular disease. The Modification of Diet in Renal Disease (MDRD) equation was used to estimate the glomerular filtration rate (GFR) among eligible subjects.

Results: The mean estimated GFR among patients with diastolic dysfunction was 49.16 ml per minute per 1.73 m2. Despite the average serum creatinine level of 1.43 mg/dl, 91 (78.4%) patients met the estimated GFR criteria for CKD with an estimated GFR of <60 ml per minute per 1.73 m2. The average GFR among non-diabetic patients was 53.7 ml per minute per 1.73 m2, while the average GFR among diabetics was 45.7 ml per minute per 1.73 m2.

Conclusions: A disproportionately high number of patients with diastolic dysfunction met the criteria for CKD. Cardiovascular disease is more prevalent with declining renal function. The pathophysiology of volume overload may be more than simple restrictive filling of the heart. A breakdown in the RAAS causes increased salt and water reabsorption which is directly linked to volume overload seen in patients with characteristics of diastolic dysfunction on echocardiogram. Also, erythropoietin deficiency and increased levels of angiotensin II seen in CKD leads to LVH and is the primary reason for non-compliance of the left ventricle and the resultant symptoms of diastolic HF. The symptoms of volume overload seen in diastolic dysfunction may, in fact, be primarily related to CKD.

C03
Duloxetine and the Control of Pain
J.A. Hall, MD,¹ S. Brecht, MD,² F. Lewis, DO,³ M. Detke, MD¹; ¹Eli Lilly and Company, Indianapolis, IN; ²Boehringer Ingelheim; ³Global Therapeutic Development in Neurology and Psychiatry PPD

Background/Aims: Serotonin (5-HT) and norepinephrine (NE) have been implicated in the etiology and treatment of depression. However, these two monoamines are present in descending pathways in the spinal cord that are involved in the perception of pain, particularly chronic pain, that may be the result of central sensitization. Duloxetine, a potent and selective dual 5-HT and NE reuptake inhibitor (SNRI), has been approved for treatment of major depressive disorder (MDD) and management of diabetic peripheral neuropathic pain (DPNP). This presentation reviews the data from all randomized placebo-controlled clinical studies of duloxetine in MDD, with a focus on pain symptoms, and in DPNP and fibromyalgia syndrome (FMS), to elucidate duloxetine's therapeutic potential in reducing pain.

Methods: Review of data from 11 clinical trials in patients with MDD, 3 trials in DPNP, and 2 trials in FMS. The primary outcome measure was HAMD17 total score for 10/11 MDD studies. In the additional MDD study, involving elderly patients, the primary outcome measure was a prespecified composite cognitive score based on 5 cognitive tests that measured verbal learning and memory, selective attention, and executive functioning. Primary pain measures were used for DPNP and FMS studies.

Results: Duloxetine was superior to placebo on the a priori primary outcome measure(s) in 7/11 MDD studies, 3/3 DPNP studies, and 1/2 FMS studies. Outcomes on multiple secondary measures were positive in 3/4 remaining MDD studies and the other FMS study.

Conclusions: Duloxetine is effective for treatment of MDD, including painful physical symptoms, for management of DPNP, and treatment of FMS. This is consistent with its mechanism of action as an SNRI, presumably working on emotional symptoms within forebrain regions and pain symptoms within the spinal cord.

C04
Prevalence of Abnormal Findings on Knee MRI in Asymptomatic NBA Basketball Players
B.E. Walczak,¹ R. Kang, MS,² P.C. McCulloch, A.M. Zelazny, B. Cole; ¹Midwestern University/CCOM, Downers Grove, IL; ²Department of Orthopaedic Surgery & Anatomy and Cell Biology, Rush University Medical Center

Variations in the prevalence of knee abnormalities in asymptomatic elite basketball players exist. The purpose of this study was to evaluate the knees of asymptomatic National Basketball Association (NBA) players via magnetic resonance imaging (MRI) and confirm or dispute findings reported in previous literature. It is believed that a variety of significant abnormalities affecting the knee exist despite an asymptomatic patient and these findings can be accurately identified on MRI. Two months prior to the 2005 season, bilateral knee MR imaging examinations of fourteen asymptomatic NBA players (28 knees) were evaluated for abnormalities of the articular cartilage, menisci, patellar and quadriceps tendons. The presence of joint effusion, subchondral edema, cystic lesions and the integrity of the collateral and cruciate ligaments were also assessed. Twenty-five knees had evidence of one or more abnormality (89%). Fourteen knees demonstrated chondromalacia (50%) and corresponding subchondral edema in 7 knees (25%). One knee had evidence of a mensical tear (3.6%). Tendonosis of either the patellar or quadriceps tendon was evident for 13 knees (46%). The results support a high incidence of articular cartilage abnormalities primarily involving the patellofemoral joint of professional basketball players with a low incidence of meniscal tears. This emphasizes the potential hazards involving the knee joint in professional basketball players and the importance of using clinical correlation when assessing the knee of an injured athlete.

C05
A Fixed Dose Study of the Efficacy and Safety of Duloxetine for the Treatment of Generalized Anxiety Disorder
J. Russell, MD,¹ H. Koponen,² C. Allgulander,³ Y. Pritchett,¹ J. Erickson,¹ M. Detke,¹ S. Ball,⁴ F. Lewis, DO⁵; ¹Eli Lilly and Company, Indianapolis, IN; ²University of Kuopio; ³Karolinska Institutet; ⁴Indiana University School of Medicine; ⁵Global Therapeutic Development in Neurology and Psychiatry PPD

Purpose: We examined the efficacy and safety of duloxetine, a reuptake-inhibitor of serotonin and norepinephrine, for treatment of generalized anxiety disorder (GAD).

Methods: In a 9-week, double-blind study, patients with DSM-IV defined GAD were randomized to receive duloxetine 60mg/day (DLX-60mg, N=168), duloxetine 120mg/day (DLX-120mg, N=170), or placebo (PBO, N=175). Primary efficacy outcome the Hamilton Anxiety Scale (HAMA) total score. Secondary measures included response rate (50% HAMA reduction), Sheehan Disability Scale Global Functional Impairment score (SDS), and HAMA Psychic and Somatic Subscales.

Results: Compared with PBO, both DLX groups demonstrated significantly greater reduction in HAMA scores (Mean decrease DLX-60mg=12.8, DLX-120mg=12.5, PBO=8.4, P<.001), greater response rates (DLX-60mg=58%, DLX-120mg=56%, PBO=31%, P<.001), greater improvements in SDS global scores (Mean decrease DLX-60mg=7.8, DLX-120mg=7.0, PBO=3.8, P<.001), and greater reductions in HAMA Psychic (Mean decrease DLX-60mg=7.6, DLX-120mg=7.1, PBO=4.5, P<.001) and HAMA Somatic subscales (Mean decrease DLX-60mg=5.2, DLX-120mg=5.3, PBO=3.8, P<.001) Discontinuation rates due to adverse events were 11.3% for DLX-60mg, 15.3% for DLX-120mg, vs. 2.3% for PBO (P<.001). The three most frequent adverse events associated with duloxetine were nausea, dizziness, and dry mouth.

Conclusion: Duloxetine 60mg and 120mg once daily was a safe, effective treatment resulting in clinically significant improvements in symptom severity and disability associated with GAD.

C06
Time Needed for Diabetes Self Care
J.H. Shubrook, DO, F.L. Schwartz, DO; Ohio University College of Osteopathic Medicine, Athens OH

Background: Diabetes mellitus has reached epidemic proportions in the US. Nearly 7% of the US population has diabetes. Diabetes educators serve in the trenches to help people learn the skills and habits necessary to successfully manage their diabetes. Self-management is central to controlling this disease. A previous study by Russell et al showed that in focus groups with DM educators that time demands for diabetes self-management were substantial if patients followed educators' recommendations. In this study, the authors attempt to quantify the necessary time needed to complete all of the tasks for self-management by enrolling a larger sample of diabetes educators.

Methods: The modal patient for this study was an adult with type 2 diabetes on oral medications alone. This study was completed using a questionnaire administered to diabetes educators and dieticians to estimate time demands for self-care as directed by the ADA and the CDE.

Results: At the time of submission 42 questionnaires have been completed. The time needed for the required elements as directed by the ADA was 190 minutes (3 hours and 10 minutes). Ninety-two minutes were for home glucose monitoring, record keeping, medication management, oral and foot care, problem solving and exercise. An additional 98 minutes/day were needed for meal planning, shopping and preparation. There was substantial variation in the estimates of each component of self-care.

Conclusions: The recommendations for DM self-care are likely too time intensive for most people to successfully complete. To make the demands more realistic we will need to find ways to combine tasks, or, alternatively, develop a cultural change so that all adults can build self care into their daily lives. [Russell LB, Suh DC, Safford MA. Time requirements for diabetes self-management: too much for many? J Fam Pract. 2005 Jan;54(1):52–56.]

C07
Diabetes Management in Multiple Extended Care Facilities in the Midwest
L.R. Bertheau, DO,¹ J.H. Shubrook, DO²; ¹Firelands Regional Medical Center, Sandusky, OH; ²Department of Family Medicine, Ohio University College of Osteopathic Medicine, Athens, OH

Diabetes is a chronic disease of epidemic proportions. The elderly in the US are experiencing the greatest increase in diabetes incidence. Guidelines have been published for adults and children with diabetes, but there has been a lack of studies evaluating diabetes control and treatment in extended care facilities. The ADA treatment guidelines have not addressed different treatment goals in these facilities. Experience demonstrates that providing intensive control for these patients can be challenging and even dangerous at times. In this study, the investigators used a retrospective chart review to identify areas of strength and weakness of current diabetes treatment in multiple extended care facilities in the Midwest. Adults who have lived at the facility for at least 3 of the previous 12 months and were admitted for long term care met the inclusion criteria. At the time of submission 44 charts had been reviewed. Seventy percent of the people were women, 95% Caucasian and 77% had type 2 DM. Preliminary results show that 100% had some glucose monitoring, but schedules for monitoring were very erratic. The mean HgA1c was 6.9%, yet only 21% were meeting ADA finger stick glucose goals. Thirty-two percent had a blood pressure of <130/90, and only 14% were at a LDL goal of 100 mg/dl. Forty-three percent were taking aspirin, and only 5% were getting screened for nephropathy with a microalbuminuria evaluation. Podiatry evaluations and influenza vaccination were almost universal. Many of the ADA recommendations were not utilized in this population. It appears that greater intensity of care was focused on glucose control as compared to blood pressure and lipid control. However, in large clinical trials there is greater mortality benefit with blood pressure and lipid control in the elderly. Glucose monitoring was sporadic and not uniformly performed. Glucose goals were not being met despite excellent HgA1c levels. This raises concern for unidentified hypoglycemia. Further studies are needed to evaluate current levels of care. Evidenced-based guidelines should be developed to guide treatment for this population.

C08
Assessment of Community Knowledge of HIV/AIDS in a Rural Village of Tanzania
K. Marcovis, OMS II,¹ S. Eyyunni, OMS II,¹ S. Brown Kunin, OMS III,¹ S. Brown Kunin, OMS III,¹ W.O. Maira, MD,² E. Kaweerah, MD,² E. Mahmoud, MD, MPH¹; ¹Touro University School of Osteopathic Medicine, Vallejo, CA; ²Shirati Hospital Medical Research Center

Objective: To conduct a survey in a rural village of Tanzania in order to determine ways to prevent the spread of HIV/AIDS and increase testing and knowledge about the disease.

Methods: From the Shirati Village of Eastern Tanzania, 141 people were surveyed. The survey was written by two medical students, in conjunction with a local HIV doctor, and translated into Swahili. Surveys were handed out to people attending church and in the center of town. After surveys were collected, an educational pamphlet was given out with the correct answers.

Results: The average age of individuals surveyed was 25. Approximately 60% of people surveyed were single and 78% were men. The average number of sexual partners was 11. In terms of knowledge, 88% of individuals surveyed believe that a virus causes AIDS and it can't be cured; 91% believe you can contract HIV thru contact with blood and the birth process. Only 26% believe that you can tell if someone is HIV+ just by looking at them or contract HIV by holding hands, hugging, or sitting on a toilet. In terms of prevention, 2/3 of people believe that using a new condom properly every time can prevent HIV and 78% said they would use a condom if they were readily available. In terms of testing, 85% said they would be more likely to get tested if it were free and they would change their sexual behavior if they found out they were HIV+. In terms of social stigma, nearly half said their relationships and/or opinions of others would change if they found out their friends and/or family members were HIV+.

Conclusions: Overall, individuals' knowledge of transmission, methods of prevention and testing were high; however, the stigma associated with the disease also remains high. In addition, making condoms and testing free and separate from the church would increase the likelihood that people protect themselves.

Future directions: Of all new infections in Tanzania, 60% are among 15–24 year old females. Focus groups may help to assess this group's knowledge and gain input into designing effective prevention programs. Community support groups designed to reduce the stigma associated with HIV/AIDS is also paramount. Lastly, creating a welcoming place to distribute free condoms, in addition to holding educational workshops, will be critical to preventing the spread of disease.

C09
First-Dose Success of Vardenafil 10 Mg in Men with Erectile Dysfunction and Comorbidities in the RELY-I Trial
L. Gilderman, DO; University Clinical Research, Inc, Pembroke Pines, FL

Hypothesis: First-dose success is an important consideration when treating men with erectile dysfunction (ED), which often presents with comorbidities that may mitigate the effectiveness of phosphodiesterase-5 (PDE5) inhibitor therapies. The objective of the Reliability – Vardenafil for Erectile Dysfunction-I (RELY-I) study was to assess first-dose success and reliability of vardenafil (Var) (10 mg) in men with ED and its comorbidities.

Materials and Methods: The trial consisted of: 1) a 4-week treatment-free run-in period during which 4 attempts at intercourse were made on 4 separate days with 50% unsuccessful attempts; 2) an open label, 1-week, single-dose, challenge period; and 3) a 12-week, double-blind, randomized phase during which responders were given Var 10 mg or placebo (PL). First-dose success rates for penetration and maintenance of erection to completion of intercourse were assessed using the Sexual Encounter Profile (SEP) 2 and SEP3, respectively, for 6 hours postdose during the challenge period. Through weeks 0–12, SEP2 and SEP3 success rates were assessed. Safety was assessed using adverse events (AEs).

Results: A total of 600 men with ED >6 months received a single 10 mg dose of Var during the 1-week challenge period. Of these patients, 32% had hypertension (HTN), 19% had dyslipidemia, and 16% had diabetes mellitus (DM). Least squares mean first-dose SEP2 and SEP3 success rates in the challenge phase were 87% and 74%, respectively. First-dose results by specific comorbidities in the challenge phase are provided in the table. For reliability of insertion (SEP2) over weeks 0–12, Var was statistically (P<0.001) and clinically superior compared with PL (83% vs 56%); for reliability of maintenance of erection to completion of intercourse (SEP3), Var also showed superiority (77% vs 42%, P<0.001). The most frequently reported AEs for Var were flushing (3.5%) during the challenge phase, and flushing (5.4%) and headache (5.0%) in the randomized phase.

Conclusions: Var 10 mg is efficacious, safe, and well tolerated, providing first-dose success and reliability in men with ED and frequently associated comorbidities.

C10
Efficiency of Low Molecular Weight AGE Clearance During Hemodialysis Predicts Increases in Paraoxonase Activity in Chronic Renal Failure Patients
K. Melhalff,¹ S. Kimura,² H. Ogata,³ A. Gugliucci, MD, PhD⁴; ¹Touro University – CA, Vallejo, CA; ²Department of Clinical Pathology, Showa University Northern Yokohama Hospital; ³Department of Internal Medicine, Showa University Northern Yokohama Hospital; ⁴Glycation, Oxidation, Disease Laboratory, Dept. of Basic Sciences, TUCOM – CA, Vallejo, CA

Background: Patients with chronic renal failure show the highest increases in circulating AGEs due to a clearance defect. They also show low levels of paraoxonase activity.

Hypothesis: We hypothesized that paraoxonase activity is inhibited in the uremic milieu and that contributes to the lower activity seen in ESRD patients. We reasoned that PON-1 activity should rise after a successful hemodialysis intervention, irrespective of changes in HDL concentration or subclass distribution. Our second hypothesis was that low molecular weight substances in ESRD patients' serum but not in control subjects serum inhibit PON-1 activity.

Methods: We conducted an intervention study with 22 ESRD patients undergoing hemodialysis in whom paired pre- and postdialysis samples were studied along with 30 age-matched control subjects. We measured PON-1 activities, as well as lipid peroxidation, apoA, lipid profiles, HDL-subclasses and AGE products (both >10 kDa and <10 kDa) in each of the patients and evaluated the correlations of uremia-associated substances (urea, creatinine) with paraoxonase activity. Ultrafiltrates (cut-off 10 kDa) of both pooled control serum and ESRD serum were incubated with PON-1.

Results: Dialysis produces a 5–40% increment in PON-1 activity (average 20±8%) while no significant changes in either apoA-I or HDL subclasses distribution was observed. This change correlates (r=0.86. P<0.001) with the efficiency of dialysis as determined by either creatinine or urea rate of change. It also correlates (r=0.87. P<0.001) with changes in 350/440 fluorescence and pentosidine fluorescence in the <10 kDa serum fraction. These fractions produce a time and dose dependent inhibition of PON-1 activity (25±3% vs 10±2% for control, P<0.005).

Conclusions: Our data give both in vitro and in vivo support to an inhibition of PON-1 by uremic toxins that are partially removed by dialysis and suggest that, at least in part, these toxins are low molecular weight AGE adducts. This research lends support to another mechanism for AGE-related pathogenicity, that would act synergistically with the prevalent HDL, LDL and hemodynamics changes in this disease.

Acknowledgment: Supported by Showa and Touro Universities.

C11
Ischemia-Modified Albumin and Advanced Oxidation Protein Products Levels in Type 2 Diabetic Patients: Complementary Biomarkers for Metabolic Control?
M. Stevens,¹ N. Lunceford,² M. Tsuji,³ J. Schulze,² S. Kimura,⁴ A. Gugliucci, MD, PhD⁵; ¹Touro University – CA, Vallejo, CA; ²Basic Science, Touro University – CA, Vallejo, CA; ³Department of Internal Medicine, Showa University, Yokohama, Japan; ⁴Department of Clinical Pathology, Showa University, Yokohama, Japan; ⁵Glycation, Oxidation, Disease Laboratory, Basic Sciences, Touro University – CA, Vallejo, CA

Background: Ischemia Modified Albumin (IMA) is a new biochemical marker of myocardial ischemia, but there is concern that IMA concentrations may be affected by ischemia occurring in tissues other than the myocardium. Advanced oxidation protein products (AOPP) are new markers of oxidative stress discovered in plasma of dialysis patients. They arise from the reaction between chlorinated oxidants and plasma proteins.

Hypothesis and aims: We had previously shown that IMA reference ranges in diabetic patients differ than those for non diabetics and that IMA may be affected by short term changes in glycemic control (Diabetes 2005, 54 A 537). Since diabetic patients have increased inflammation in parallel with oxidative and carbonyl stress, we hypothesized that AOPP levels should also be higher than in control patients. We correlated AOPP with IMA, AGEs and glycemic control.

Methods: We performed a case-control study with 41 diabetic patients (19 male and 22 female, 58±9 years of age) and their age-matched controls. Basic metabolic panels, lipid panels and HbA1c were measured using standard methods. Determination of AOPP is based on spectrophotometric detection. IMA was measured by a test based on an ischemia-induced decrease in cobalt 2+ binding to an N-terminal octapeptide in the albumin molecule, using our modification (Gugliucci et al. Clin Chim Acta. 2005;362:155–160). Determination of AGEs is based on the spectrofluorimetric detection.

Results: AOPP were 35.9±17 for control subjects vs 52±29 µmol/l for diabetic patients, which represents a 44% increase (P<0.01). IMA in diabetic patients was 0.56±0.1 AU vs 0.45 vs ±0.12, a 24% increase, P<0.0001. A significant correlation, r=0.36 was found between IMA and glycemia in diabetic patients. No correlation was found between IMA and AOPP, HbA1c, r circulating AGEs.

Conclusions: We confirm our previous data showing higher IMA levels in type 2 diabetic patients in a larger series. Our data suggest that AOPP and IMA changes in diabetic patients reflect two different altered pathways and could be complementary biomarkers of oxidative and hypoxic stress in these patients.

Acknowledgment: Sponsored by Touro and Showa Universities.

C12
Factors Affecting Maternal Choices in Home or Hospital Delivery in the Tarime District, Tanzania
K.L. Townes, S. Brown Kunin, OMS II; Touro University – CA, Mare Island, Vallejo, CA

Background: The aim of this study was to investigate the factors influencing women's choice in delivering their children at home verses in the hospital in Shirati, Tanzania.

Methods: During a period of one month, 52 randomly selected mothers were surveyed. Sites included Shirati Hospital maternity ward, antenatal clinic, as well as mobile clinics in neighboring villages. Outcomes measured include maternal age, parity, education level, poverty indicators, cultural beliefs, distance from their home to the hospital, location of all deliveries and reason why. The place of delivery for each woman's pregnancy was determined.

Results: Although many women reportedly preferred to deliver in the hospital, the most prevalent factor determining their home delivery was lack of transportation to the hospital when in labor. It was found that 24 out of the 34 women who preferred to deliver in the hospital were prevented from doing so by transportation circumstances. Education level, poverty, and cultural beliefs had little influence on women's decision to deliver at home or in the hospital.

Conclusions: Based on the data analyzed, the main factor preventing women from having their children in the hospital is lack of transportation rather than education level, poverty, or cultural beliefs. With multiple women's suggestions in mind, improvements in transportation such as providing bicycles modified to carry pregnant women from each remote village to the hospital could improve delivery outcomes.

C13
HIV/AIDS in Haiti: A Clinical Investigation
S. Coupet, OMS IV, R. Nassiri, DSc; Clinical Pharmacology and International Studies, Lake Erie College of Osteopathic Medicine, Erie, PA

Background: Heterosexual transmission of HIV in Haiti is the most common, followed by vertical transmission. It is estimated that every year there are about 13,000 pregnant women who are HIV-positive. The purpose of this study was to investigate on demographics of HIV and HIV/TB co-infections, and to assess current treatment modalities in Haiti.

Materials and methods: This study was conducted at the Hospital Albert Schweitzer (HAS) in Dechapelles, Haiti. Clinical data were collected from each patient visit as well as individual patients' files, which were made available from HAS administration. HAS is a major source of healthcare delivery in Haiti.

Results: On a daily average, 20 adult and 8 pediatric HIV-positive patients were presented at HAS. The average adult and pediatric CD4 counts were 128 and 188 cells/mm3 respectively. Analysis of data collection revealed 70% of HIV-positive patients also were TB-positive. Further, of the pool of patients we examined, 3.8% were HBV-positive; 1% were HCV-positive, and 1% were positive for syphilis. Patients who were admitted to the hospital commonly presented with wasting syndrome, generalized malaise, and pulmonary symptoms due to HIV/TB co-infection. The analysis of patients' data further revealed Haiti has the highest adult and pediatric HIV prevalence rate in the Caribbean region at about 5%, which is observed in Port-au-Prince and other areas of the country. Finally, our data shows malnutrition is a likely contributing factor in HIV/AIDS mortality, especially among children. Current therapy aimed at HIV-positive patient is combivir, a standard therapeutic regimen in Haiti. Since most patients in Haiti present with TB, the current guideline is to treat the TB, and then proceed to the management of HIV infection.

Conclusion: HIV/AIDS is highly prevalent in Haitian adults and pediatric populations. Majority of adult HIV-positive patients also present with TB co-infections. While combivir is currently the drug of choice, there is not any major clinical center to assess the drug's efficacy or evaluate the pattern of drug resistance. Combination of AIDS and NAIDS (nutritionally-acquired immunodeficiency syndrome) may contribute to a higher mortality rate in Haiti. Such patients would greatly benefit from osteopathic care.

C14
Controlled-release Hydrocodone and Acetaminophen Tablets Provide Significant Relief of Moderate to Severe Osteoarthritis Pain With BID Dosing
L.I. Gilderman, DO,¹ B. Rankin, DO²; ¹University Clinical Research, Inc, Pembroke Pines, FL; ²University Clinical Research, Inc, Deland, FL

Introduction: Numerous single-agent opioids are currently available in controlled-release formulations to manage chronic pain states. Despite their extensive use in pain management, combination opioid/non-opioid products are not yet available in controlled-release (CR) formulations. The objective of this Phase 2, randomized, multicenter, double-blind, placebo-controlled study was to determine the analgesic efficacy and safety of hydrocodone bitartrate 15 mg/acetaminophen 500 mg CR (HC/APAP CR) tablets compared with placebo in the management of moderate to severe osteoarthritis (OA) pain.

Hypothesis: HC/APAP CR tablets administered twice daily will significantly decrease OA pain compared with placebo.

Materials: HC 15 mg/APAP 500 mg OROS osmotic technology tablets.

Methods: The study consisted of 5 periods: 3-week screening/washout, 1-week titration (1 tablet BID), 3-week maintenance (2 tablets BID), 1-week study drug taper (1 tablet BID), 1-week Follow-Up. The primary efficacy variable was change from baseline to final evaluation (Day 29) in patient assessment of OA pain by visual analog scale (VAS) (0–100 mm).

Results: 120 subjects received at least 1 dose of study drug and comprised the ITT dataset: 58 in the HC/APAP CR group and 62 in the placebo group. Most subjects were white (79%) and female (72%), and the mean age was 57 years; no statistically significant differences were found between the treatment groups with regard to any demographic variable. Mean reduction in pain scores from baseline to final evaluation was greater for the HC/APAP CR group versus the placebo group; additionally, the differences between treatment groups were statistically significant at all scheduled evaluations, based on 1-sided tests. For the primary efficacy variable, the mean change from baseline to final visit in VAS score was –38.5 mm in the HC/APAP CR group compared with –26.7 mm in the placebo group (P=0.033). The mean percent change in VAS scores from baseline to final visit was –52.5% in the HC/APAP CR group compared with –36.0% in the placebo group (P=0.027). Overall incidence of adverse events, as well as the events of nausea, somnolence, pruritus, and lethargy were experienced by a greater proportion of subjects receiving HC/APAP compared with placebo. Discontinuations, at least in part due to adverse events, occurred in 31% of subjects (n=18) in the HC/APAP CR group and 10% of subjects (n=6) in the placebo group.

Conclusions: The HC/APAP CR group showed clinically and statistically significant reductions in VAS pain scores compared with placebo. The adverse event profile was characteristic of a mu-agonist opioid. BID dosing of HC/APAP CR tablets may provide an important and more convenient treatment alternative for subjects with moderate to severe chronic OA pain.

Acknowledgment: This study was funded by Abbott Laboratories, Inc, Abbott Park, IL.

C15
Simultaneous Measurement of Glycated LDL and Glycated HDL Subclasses: a New Method
A. Gugliucci, PhD,¹ J. Schulze,¹ L. Ghitescu²; ¹Glycation, Oxidation and Disease Laboratory, Department of Basic Sciences, Touro University – CA, Vallejo, CA; ²Pathology, University of Montreal, Canada

Background: Protein modification by the Maillard reaction is involved in several disease processes, including diabetes and Alzheimer's disease, as well as in aging. The first glucose metabolite, glucose-6-phosphate (G-6-P), has been known for many years to be much more aggressive than glucose itself in studies performed in vitro. However, no studies had addressed the role of G-6-P in vivo.

Hypothesis: We hypothesized that G-6-P glycation is detectable in serum and occurs mainly intracellularly prior to secretion. Serum proteins are largely a secretion product of the hepatocyte and thus provide an accessible model for the proof of principle we aimed at in this preliminary study. Serum proteins can, moreover, be modified in the circulation throughout their life span.

Methods: We detected G-6-P modified proteins in serum from control subjects (n=10) and from type 2 diabetic patients (n=10). We employed 10% SDS-PAGE and Western blot using a specific antibody we produced and characterized previously (Nguyen et al. Biochim Biophys Acta. 2005;1762(1):94–102). This antibody does not cross-react with glucitollysine adducts in the dilutions employed here. In separate experiments we incubated serum with G-6-P to confirm the specificity in our model.

Results: Serum incubated with G-6-P for 48 h showed the adducts while none was found in control serum incubated without G-6-P or with glucose. Multiple G-6-P modified proteins are detected in both control subjects and diabetic patients. No significant differences were detected between the 2 populations.

Conclusions: Our data give both in vitro and in vivo support to glycation of serum proteins by G-6-P. It opens several questions: Is G-6-P glycation an intracellular, an extracellular process or both? The low concentrations of G-6-P in serum would indicate that the intracellular process should predominate. The ER and Golgi are rich in G-6-P which participates as donor in several glycosylation reactions. The similar pattern shown in control and diabetic subjects further supports this idea. Alternatively, G-6-P glycation would occur in the circulation as a consequence of G-6-P leaking as a byproduct of cell turnover.

C16
A Cross-Sectional Study of Somatic Dysfunction and Chronic Conditions in Older Adults
Y. Cazorla-Lancas,¹ C. Pham, DO, MPH,² D. Cruser, PhD,³ D. Cipher, PhD³; ¹Texas College of Osteopathic Medicine; ²Geriatrics, Internal Medicine, Texas College of Osteopathic Medicine; ³Osteopathic Research Center, University of North Texas Health Science Center

Purpose: The purpose of this pilot study was to investigate the relationship between somatic dysfunction and chronic conditions in adults aged 65 and older who received Osteopathic Manipulative Treatment (OMT).

Methods: This was a cross-sectional study with information collected from medical records of patients seen for OMT in a Geriatric clinic at the University of North Texas Health Science Center between January 1, 2000–May 1, 2005. Data elements included demographics, Instrumental Activities of Daily Living (IADLs), Geriatric Depression Scale-Short Form (GDS-SF) scores, trauma history, chronic conditions, and somatic dysfunction.

Results: The sample included 139 adults, 83% of whom were females. In the sample, 118 (85%) subjects were white, 61 (44%) were married, and 112 (81%) were living at home. The average age was 77.4 years (SD=8.44). The mean number of chronic conditions per subject was 6.49 (SD=2.64). The most common areas of somatic dysfunction were the pelvis (84%), the sacrum (61%), and the ribs (60%). There were significantly more subjects with sacral somatic dysfunction that had GDS-SF cutoff scores above 5. IADLs were also significantly related to somatic dysfunction. Significantly more subjects that needed moderate assistance with meal preparation had somatic dysfunction in the upper thoracic (T1–T4) region (P=.039). Subjects with a history of motor vehicle accident (MVA) had significantly less lumbar somatic dysfunction (P=.031), but significantly more upper thoracic (T1–T4) somatic dysfunction (P=.012). Subjects with pulmonary/respiratory conditions had significantly more cranial somatic dysfunction (P=.016). Significantly more subjects with neurological/psychiatric conditions had somatic dysfunction of the diaphragm (P=.043).

Conclusions: The results of this study suggest several significant relationships between somatic dysfunction and chronic conditions (pulmonary/respiratory and neurological/psychiatric conditions) as well as trauma (MVA). Future research should be directed toward the prospective investigation of the onset of traumatic events and subsequent somatic dysfunction, depression, and associated medical conditions.

C17
Chronic Obstructive Pulmonary Disease (COPD): Immediate Effects of Osteopathic Manipulative Treatment on Exercise Tolerance and Dyspnea
C. Pickett, BS¹, S.T. Stoll, DO, PhD,² D. Cruser, PhD,² D.J. Cipher, PhD; ¹Texas College of Osteopathic Medicine; ²Osteopathic Manipulative Medicine/Osteopathic Research Center, University of North Texas Health Science Center at Fort Worth

Purpose: Contribute to our knowledge of the effects of OMT on breathing and exercise tolerance in patients with COPD. Hypothesis 1: One OMT intervention will have an immediate effect of improving dyspnea in a stable COPD subject, as measured by response to the Borg scale. Hypothesis 2: One OMT intervention will improve exercise tolerance in a stable COPD subject, as measured by distance in the six-minute walk test.

Methods: After obtaining informed consent, initial plethysmography and spirometry test were performed by a respiratory technician to verify that subjects met the pulmonary function test inclusion criteria. After acceptance into the study protocol, subjects were randomly assigned to either the Osteopathic Manipulative Treatment group or the no treatment (ie, rest) group. Demographics were then recorded and questionnaires were completed. Subjects filled out the St. George Respiratory Questionnaire, The American Thoracic Society Dyspnea Index and Borg Scale. The entire study took place in the Internal Medicine Department at UNTHSC-TCOM.

Results: Exploratory data analyses revealed equal variances in all descriptive measures. Between group differences were not statistically significant for any demographics or for the Quality of Life measures. No immediate effects of OMT were statistically significant following exercise for any of the outcomes of interest. Examination of individual cases within the sample provides clinically important information to contribute to our knowledge of how OMT versus rest may affect the six-minute walk and the Borg Scale for COPD patients.

Conclusions: Current OMT literature does not provide standards for dosage and frequency; therefore, this pilot study took the first step of looking at immediate effects. It is not possible to conclude appropriate dosage and frequency based on the findings of this study. Future studies with larger number of subjects and varying dosage and frequency will aid in determining these factors. Clinically important differences in the experimental groups provides information needed to design a larger study with improvements in design.

C18
Addition of Laminin and Fibronectin to SIS Used as Conduits in Peripheral Nerve Repair
Jacqueline C. Oxenberg, MS III,¹ Ryan Smith, DO, MBA,² Douglas Troutman, MS III,¹ Richard Kriebel, PhD,¹ Charlotte Greene, PhD¹; ¹Philadelphia College of Osteopathic Medicine, Philadelphia, PA 19131; ²Tripler Army Medical Center, Honolulu, HI

This is a pilot study using laminin and fibronectin as an additive to small intestine submucosa (SIS) grafts used to repair transected sciatic nerve in a rat model. Previous studies in our lab have shown sciatic nerve regeneration to be successful using SIS grafts without growth factors. SIS is a biological material that may be used to correct problems of larger peripheral nerve gap injuries and improve regrowth by acting as a natural guide between the proximal and distal segments of the nerves, providing the proper growth environment with minimal antigenicity, thus decreasing chances of rejection. Other studies have shown the addition of fibronectin to various types of grafts further enhanced nerve regeneration by promoting Schwann cell growth. The goal of this study is to determine whether adding laminin and/or fibronectin to SIS grafts improves sciatic nerve regeneration. The experimental group had a 10 mm segment of the right sciatic nerve resected followed by placement and suturing of and SIS graft plus laminin and/or fibronectin laced in the gap as a conduit for nerve regeneration. The control group had the right sciatic nerve resected and reattached directly. Schwann cell growth and nerve regeneration were assessed using anti-s100 antibody, and fast cresyl violet stain to assess Schwann cell migration and neuron regeneration respectively. Preliminary results indicated that:

1. Schwann cell migration and accompanying neuron infiltration occurred up to approximately 2.5 cm over the 6-month healing time in experimental animals.
   
2. Healing in control animals was observed to be inhibited by the formation of collagen scar tissue.
   
3. Gait analyses show increased sciatic function in experimental groups of laminin and/or fibronectin compared to control groups.
   

These results exceed previously reported rates of peripheral nerve regeneration using non-SIS graft materials and show addition of laminin and/or fibronectin improve both sciatic nerve regeneration and sciatic function in gait analyses.

C19
Improving Symptoms, Pain, Functioning, and Strength for Persons with Carpal Tunnel Syndrome
P. Meyer, DO,¹ S.T. Stoll, DO, PhD,² D. Cruser, PhD,² H.D. White, DO,³ R. Whitesell, MPH⁴; ¹UNTHSC at Fort Worth; ²Osteopathic Manipulative Medicine/Osteopathic Research Center, UNTHSC at Fort Worth; ³Scott and White Memorial Hospital, Texas A&M University; ⁴University of Texas San Antonio