Osteopathic manipulative treatment of back pain and related symptoms during pregnancy: a randomized controlled trial.

OBJECTIVE: To study osteopathic manipulative treatment of back pain and related symptoms during the third trimester of pregnancy. STUDY DESIGN: A randomized, placebo-controlled trial was conducted to compare usual obstetric care and osteopathic manipulative treatment, usual obstetric care and sham ultrasound treatment, and usual obstetric care only. Outcomes included average pain levels and the Roland-Morris Disability Questionnaire to assess back-specific functioning. RESULTS: Intention-to-treat analyses included 144 subjects. The Roland-Morris Disability Questionnaire scores worsened during pregnancy; however, back-specific functioning deteriorated significantly less in the usual obstetric care and osteopathic manipulative treatment group (effect size, 0.72; 95% confidence interval, 0.31-1.14; P = .001 vs usual obstetric care only; and effect size, 0.35; 95% confidence interval, -0.06 to 0.76; P = .09 vs usual obstetric care and sham ultrasound treatment). During pregnancy, back pain decreased in the usual obstetric care and osteopathic manipulative treatment group, remained unchanged in the usual obstetric care and sham ultrasound treatment group, and increased in the usual obstetric care only group, although no between-group difference achieved statistical significance. CONCLUSION: Osteopathic manipulative treatment slows or halts the deterioration of back-specific functioning during the third trimester of pregnancy.

Comparison of sequence-specific oligonucleotide probe vs next generation sequencing for HLA-A, B, C, DRB1, DRB3/B4/B5, DQA1, DQB1, DPA1, and DPB1 typing: Toward single-pass high-resolution HLA typing in support of solid organ and hematopoietic cell transplant programs.

Many clinical laboratories supporting solid organ transplant programs use multiple HLA genotyping technologies, depending on individual laboratory needs. Sequence-specific primers and quantitative polymerase chain reaction (qPCR) serve the rapid turnaround necessary for deceased donor workup, while sequence-specific oligonucleotide probe (SSOP) technology is widely employed for higher volumes. When clinical need mandates high-resolution data, Sanger sequencing-based typing (SBT) has been the "gold standard." However, all those methods commonly yield ambiguous typing results that utilize valuable laboratory resources when resolution is required. In solid organ transplantation, high-resolution typing may provide critical information for highly sensitized patients with donor-specific anti-HLA antibodies (DSA), particularly when DSA involve HLA alleles not discriminated by SSOP typing. Arguments against routine use of SBT include assay complexity, long turnaround times (TAT), and increased costs. Here, we compare a next generation sequencing (NGS) technology with SSOP for accuracy, effort, turnaround time, and level of resolution for genotyping of 11 HLA loci among 289 specimens from five clinical laboratories. Results were concordant except for SSOP misassignments in eight specimens and 21 novel sequences uniquely identified by NGS. With few exceptions, SSOP generated ambiguous results while NGS provided unambiguous three-field allele assignments. For complete HLA genotyping of up to 24 samples by either SSOP or NGS, bench work was completed on day 1 and typing results were available on day 2. This study provides compelling evidence that, although not viable for STAT typing of deceased donors, a single-pass NGS HLA typing method has direct application for solid organ transplantation.

Lymph flow in the thoracic duct of conscious dogs during lymphatic pump treatment, exercise, and expansion of extracellular fluid volume.

BACKGROUND: This investigation examined interactions between expansion of the extracellular fluid volume (ECE), osteopathic lymphatic pump treatment (LPT), and exercise on lymph flow in the thoracic duct of eight instrumented, conscious dogs. METHODS AND RESULTS: After recovery from surgery, LPT was performed for 8 min before and after ECE with normal saline, i.v., 4.4+/-0.3% of body weight. Baseline lymph flow was 1.7+/-0.5 mL/min. LPT rapidly increased lymph flow to 5.0+/-1.1 mL/min at 1 min, and lymph flow remained above baseline for 4 min (p<0.05). LPT produced a net increase in lymph flow of 15.4+/-1.1 mL. Following ECE, baseline lymph flow was 4.8+/-0.6 mL/min (p<0.05). LPT increased lymph flow to 9.9+/-1.1 mL/min at 1 min (p<0.05), and lymph flow remained above baseline for 4 min (p<0.05); all flow values after ECE were greater than corresponding values before ECE. However, the net increase in lymph flow produced by 8 min of LPT (18.3+/-3.8 mL) was not significantly greater than that observed before ECE. Moderate treadmill exercise increased lymph flow for 4 min before ECE and for 6 min after ECE. All lymph flows during exercise were greater after ECE than before ECE. The net increase in lymph flow produced by 8 min of exercise was 24.9+/-5.5 mL before ECE and 39.6+/-5.1 mL after ECE (p<0.05). CONCLUSIONS: Expansion of the extracellular fluid volume produced large increases in thoracic duct lymph flow, that were further augmented by lymphatic pump treatment and by moderate treadmill exercise.

Technical Aspects of Crossmatching in Transplantation.

The presence of antibodies directed against HLA molecules expressed on the donor's cells is one the most important risk factor for serious clinical complications after transplantation. The lymphocyte crossmatch is one of the most important tests available to the laboratory as this assay detects the presence of donor-specific anti-HLA antibodies in potential allograft recipients. Early crossmatch methods used a complement-dependent cytotoxicity test, which was useful for detecting anti-HLA antibodies responsible for hyperacute graft rejection but lacked adequate sensitivity and specificity. Consequently, more sensitive and specific crossmatch methods were developed ultimately leading to the flow cytometry crossmatch as the preferred methodology.

Abdominal lymphatic pump treatment increases leukocyte count and flux in thoracic duct lymph.

BACKGROUND: Previous studies suggest that rhythmic compression of the abdomen (abdominal lymphatic pump techniques, LPT) enhances immunity and resistance to infectious disease, but direct evidence of this has not been documented. In this study, the thoracic duct of eight anesthetized mongrel dogs was catheterized, so the immediate effects of LPT on lymph flow and leukocyte output could be measured. METHODS AND RESULTS: Lymph flow was measured by timed collection or ultrasonic flowmeter, and lymph was collected over ice under 1) resting (baseline) conditions, and 2) during application of LPT. The baseline leukocyte count was 4.8 +/- 1.7 x 10(6) cells/ml of lymph, and LPT significantly increased leukocytes to 11.8 +/- 3.6 x 10(6) cells/ml. Flow cytometry and differential cell staining revealed that numbers of macrophages, neutrophils, total lymphocytes, T cells and B cells were similarly increased during LPT. Furthermore, LPT significantly enhanced lymph flow from 1.13 +/- 0.44 ml/min to 4.14 +/- 1.29 ml/min. Leukocyte flux, computed from the product of lymph flow and cell count, was increased by LPT from 8.2 +/- 4.1 x 10(6) to 60 +/- 25 x 10(6) total cells/min. Similar trends were observed in macrophages, neutrophils, total lymphocytes, T cells and B cells during LPT. CONCLUSIONS: LPT significantly increased both thoracic duct lymph flow and leukocyte count, so lymph leukocyte flux was markedly enhanced. Increased mobilization of immune cells is likely and important mechanism responsible for the enhanced immunity and recovery from infection of patients treated with LPT.

Pregnancy Research on Osteopathic Manipulation Optimizing Treatment Effects: The PROMOTE Study Protocol.

The structural and physiologic changes in a woman's body during pregnancy can predispose pregnant women to low back pain and its associated disability, as well as to complications of pregnancy, labor, and delivery. Anecdotal and empirical evidence has indicated that osteopathic manipulative treatment (OMT) may be efficacious in improving pain and functionality in women who are pregnant. Based on that premise, the Pregnancy Research on Osteopathic Manipulation Optimizing Treatment Effects (PROMOTE) study was designed as a prospective, randomized, placebo-controlled, and blinded clinical trial to evaluate the efficacy of an OMT protocol for pain during third-trimester pregnancy. The OMT protocol developed for the PROMOTE study was based on physiologic theory and the concept of the interrelationship of structure and function. The 12 well-defined, standardized OMT techniques used in the protocol are commonly taught at osteopathic medical schools in the United States. These techniques can be easily replicated as a 20-minute protocol applied in conjunction with usual prenatal care, thus making it feasible to implement into clinical practice. This article presents an overview of the study design and treatment protocols used in the PROMOTE study.

Increased lymphatic flow in the thoracic duct during manipulative intervention.

The thoracic pump and the abdominal pump are osteopathic manipulative (OM) lymphatic pump techniques frequently used by osteopathic physicians to treat patients with infections (eg, pneumonia, otitis media). Although there is a widely accepted belief among the osteopathic medical profession that increasing lymphatic flow is beneficial, no measurements of lymph flow during osteopathic manipulative treatment have been reported. The authors surgically instrumented five mongrel dogs to record lymphatic flow in the thoracic duct (TDF) and cardiac variables during three intervention protocols. After recovery from surgery, canine subjects were placed in a standing-support sling, and TDF, cardiac output, mean aortic blood pressure, and heart rate were recorded during two randomized 30-second sessions of manipulative intervention using the osteopathic thoracic pump and abdominal pump techniques on two successive days. Lymph flow in the thoracic duct increased from 1.57+/-0.20 mL x min(-1) to a peak TDF of 4.80+/-1.73 mL x min(-1) during abdominal pump, and from 1.20+/-0.41 mL x min(-1) to 3.45+/-1.61 mL x min(-1) during thoracic pump. Lymph flow in the thoracic duct and cardiac variables were also recorded for canine subjects during physical activity (ie, treadmill exercise at 3 miles per hour at 0% incline). During physical activity, TDF increased from 1.47+/-0.33 mL x min(-1) to 5.81+/-1.30 mL x min(-1). Although cardiac variables did not change significantly during manipulative intervention with lymphatic pump techniques, cardiac output and heart rate did increase during physical activity. The authors conclude that physical activity and manipulative intervention using thoracic pump and abdominal pump techniques produced net increases in TDF (P<.05).

Hemodynamic effects of osteopathic manipulative treatment immediately after coronary artery bypass graft surgery.

CONTEXT: Coronary artery bypass graft (CABG) surgery is a common procedure for patients with coronary artery disease. The physiologic effects of postoperative osteopathic manipulative treatment (OMT) following CABG have not been documented previously. OBJECTIVE: To determine the effects of OMT on cardiac hemodynamics post-CABG surgery. DESIGN: Pilot prospective clinical study (N=29). SETTING AND PATIENTS: Treatment subjects (n=10) undergoing CABG surgery were recruited for postoperative OMT. The primary assessment compared, pre-OMT versus post-OMT, measurements of thoracic impedance, mixed venous oxygen saturation (SvO2), and cardiac index. Records of control subjects (n=19) who underwent CABG surgery--but who did not receive OMT--were assessed for SvO2 and cardiac index at 1 hour and 2 hours postsurgery. INTERVENTION: Immediately following CABG surgery (< or = 2 h), OMT was provided to subjects to alleviate anatomic dysfunction of the rib cage caused by median sternotomy and to improve respiratory function. This adjunctive treatment occurred while subjects were completely anesthetized. RESULTS: A post-OMT increase in thoracic impedance (P < or = .02) in OMT subjects demonstrated that central blood volume was reduced after OMT, suggesting an improved peripheral circulation. Mixed venous oxygen saturation also increased (P < or = .005) after OMT. These increases were accompanied by an improvement in cardiac index (P < or = .01). Comparisons of postoperative measurements in OMT subjects versus those in control subjects revealed statistically significant differences for SvO2 (P < or = .005) and cardiac index (P < or = .02) between the two groups. CONCLUSION: The observed changes in cardiac function and perfusion indicated that OMT had a beneficial effect on the recovery of patients after CABG surgery. The authors conclude that OMT has immediate, beneficial hemodynamic effects after CABG surgery when administered while the patient is sedated and pharmacologically paralyzed.

Physicians' and patients' attitudes toward manual medicine: implications for continuing medical education.

INTRODUCTION: Manual medicine (MM) is a physical modality infrequently used in primary care clinics. This study examines primary care physicians' experience with and attitudes toward the use of MM in the primary care setting, as well as patients' experience with and attitudes toward MM. METHODS: Surveys were distributed to a convenience sample of physicians (54.3% response rate) attending a 1-week primary care continuing medical education (CME) conference in Kentucky. Similar surveys were also mailed to a random sample of primary care patients (35.3% response rate) living in a service region in which most conference attendees practiced. RESULTS: Similar responses were obtained from physicians and patients. A majority (81% and 76%, respectively) of physicians and patients felt that MM was safe, and over half (56% of physicians and 59% of patients) felt that MM should be available in the primary care setting. Although less than half (40%) of the physicians reported any educational exposure to MM and less than one-quarter (20%) have administered MM in their practice, most (71%) respondents endorsed desiring more instruction in MM. The majority of those seeking additional educational exposure (56%) were willing to pay for MM training that included CME credit. DISCUSSION: This survey suggests that primary care physicians feel that there is currently insufficient education in MM. The majority of physicians and patients feel that MM is beneficial, safe, and appropriate for use in a primary care setting. Thus, there may be a rising demand for quality instruction in MM from physical medicine doctors and other licensed therapists who currently practice MM.

Development of the Attitudes Toward Osteopathic Principles and Practice Scale (ATOPPS): preliminary results.

Little empirical work has been done to examine how osteopathic medical students' attitudes toward osteopathic principles and practice (OPP) develop and evolve over the course of their medical education. A major obstacle to conducting this research is the absence of reliable and sensitive instruments to measure students' attitudes toward OPP. The purpose of this project is to develop a sensitive and reliable instrument to measure students' attitudes toward OPP. Face-to-face and telephone interviews were conducted with osteopathic medical students, osteopathic manipulative medicine (OMM) residents, OMM undergraduate fellows, and three board-certified OMM specialists. These interviews were summarized in a 39-item instrument administered to 127 students at the completion of their core OMM rotation at the University of North Texas Health Science Center at Fort Worth-Texas College of Osteopathic Medicine. Factor analysis of student responses to the 39 candidate items yielded two interpretable factors. Factor 1 contained 24 items and accounted for 33% of the item response variance, and factor 2 contained four items and accounted for 5.6% of the item response variance. Based on these results, 14 of the original 39 statements were eliminated and the smaller second factor was dropped. Factor 1 contained items reflecting both positive and negative attitudes toward the application of OPP in patient care, the importance of OPP in medical education, and professional distinctiveness. One of the original 39 candidate items was returned to factor 1 because it was judged by the investigators to be consistent with the underlying construct of the scale and helped balance the number of forward-scored and reversed-scored items in the final instrument. Two internal consistency estimates of reliability were computed for the revised 25-item Attitudes Toward Osteopathic Principles and Practice Scale (ATOPPS): the Spearman-Brown unequal-length corrected coefficient alpha and the split-half reliability coefficients. Estimates for the split-half coefficients were .89 for part 1 and .87 for part 2. The Spearman-Brown coefficient alpha was .93, indicating substantial internal consistency. The 25-item ATOPPS seems to reflect a continuum of positive and negative attitudes toward OPP. This preliminary report documents reliability for the 25-item ATOPPS. With continued support for its construct validity, ATOPPS provides investigators with a reliable tool to assess the development of attitudes toward OPP.

A randomized controlled trial of osteopathic manipulative treatment following knee or hip arthroplasty.

CONTEXT: Preliminary study results suggest that osteopathic manipulative treatment (OMT) may reduce pain, improve ambulation, and increase rehabilitation efficiency in patients undergoing knee or hip arthroplasty. OBJECTIVE: To determine the efficacy of OMT in patients who recently underwent surgery for knee or hip osteoarthritis or for a hip fracture. DESIGN: Randomized controlled trial involving hospital and postdischarge phases. SETTING: Hospital-based acute rehabilitation unit. PATIENTS: A total of 42 women and 18 men who were hospitalized between October 1998 and August 1999. INTERVENTION: Patients were randomly assigned to groups that received either OMT or sham treatment in addition to standard care. Manipulation was individualized and performed according to study guidelines regarding frequency, duration, and technique. MAIN OUTCOME MEASURES: Changes in Functional Independence Measure (FIM) scores and in daily analgesic use during the rehabilitation unit stay; length of stay; rehabilitation efficiency--defined as the FIM total score change per rehabilitation unit day; and changes in Medical Outcomes Study Short Form-36 scores from rehabilitation unit admission to 4 weeks after discharge. RESULTS: Of 19 primary outcome measures, the only significant difference between groups was decreased rehabilitation efficiency with OMT (2.0 vs 2.6 FIM total score points per day; P = .01). Stratified analyses demonstrated that poorer OMT outcomes were confined to patients with osteoarthritis who underwent total knee arthroplasty (length of stay, 15.0 vs 8.3 days; P = .004; rehabilitation efficiency, 2.1 vs 3.4 FIM total score points per day; P < .001). CONCLUSION: The OMT protocol used does not appear to be efficacious in this hospital rehabilitation population.

A randomized, controlled trial of osteopathic manipulative treatment for acute low back pain in active duty military personnel.

OBJECTIVE: Acute low back pain (ALBP) may limit mobility and impose functional limitations in active duty military personnel. Although some manual therapies have been reported effective for ALBP in military personnel, there have been no published randomized controlled trials (RCTs) of osteopathic manipulative treatment (OMT) in the military. Furthermore, current military ALBP guidelines do not specifically include OMT. METHODS: This RCT examined the efficacy of OMT in relieving ALBP and improving functioning in military personnel at Fort Lewis, Washington. Sixty-three male and female soldiers ages 18 to 35 were randomly assigned to a group receiving OMT plus usual care or a group receiving usual care only (UCO). RESULTS: The primary outcome measures were pain on the quadruple visual analog scale, and functioning on the Roland Morris Disability Questionnaire. Outcomes were measured immediately preceding each of four treatment sessions and at four weeks post-trial. Intention to treat analysis found significantly greater post-trial improvement in 'Pain Now' for OMT compared to UCO (P = 0·026). Furthermore, the OMT group reported less 'Pain Now' and 'Pain Typical' at all visits (P = 0·025 and P = 0·020 respectively). Osteopathic manipulative treatment subjects also tended to achieve a clinically meaningful improvement from baseline on 'Pain at Best' sooner than the UCO subjects. With similar baseline expectations, OMT subjects reported significantly greater satisfaction with treatment and overall self-reported improvement (P<0·01). CONCLUSION: This study supports the effectiveness of OMT in reducing ALBP pain in active duty military personnel.

Effect of cranial osteopathic manipulative medicine on cerebral tissue oxygenation.

CONTEXT: The use of cranial osteopathic manipulative medicine (OMM) to alter cerebral tissue oxygen saturation could play a role in the maintenance of cerebral homeostasis. OBJECTIVE: To examine the effects of cranial OMM on cerebral tissue oxygen saturation (S(CT)O(2)) and cardiac autonomic function in healthy adults. METHODS: Cranial OMM augmentation and suppression techniques and sham therapy were randomly applied to healthy adults. During cranial OMM and sham therapy, S(CT)O(2) of the prefrontal cortex was determined bilaterally by using near-infrared spectroscopy. Heart rate, blood pressure, and systemic arterial blood oxygen saturation (SaO(2)) were also measured. Power spectral analysis was applied to continuous 4-minute R-R intervals. Measurements were made during 2-minute baseline periods, during 4-minute applications of the techniques, and during 5-minute recovery periods. RESULTS: Twenty-one adults (age range, 23-32 y) participated in the present study. Differences in mean baseline measurements for the augmentation technique, suppression technique, and sham therapy were not statistically significant for heart rate, blood pressure, SaO(2), left S(CT)O(2), or right S(CT)O(2). During the suppression technique, there was a statistically significant decrease in both left (slope [standard deviation]= -0.33 [0.08] %/min, R(2)=0.85, P=.026) and right (slope [standard deviation]=-0.37 [0.06] %/min, R(2)=0.94, P=.007) S(CT)O(2) with increased cranial OMM time. However, neither the augmentation technique nor the sham therapy had a statistically significant effect on S(CT)O(2). Decreases in normalized low-frequency power of R-R interval variability and enhancements of its high-frequency power were statistically significant (P=.05) during cranial OMM and sham therapy, indicating a decrease in cardiac sympathetic influence and an enhanced parasympathetic modulation. CONCLUSION: The cranial OMM suppression technique effectively and progressively reduced S(CT)O(2) in both prefrontal lobes with the treatment time.

In vitro modeling of repetitive motion injury and myofascial release.

OBJECTIVE: In this study we modeled repetitive motion strain (RMS) and myofascial release (MFR) in vitro to investigate possible cellular and molecular mechanisms to potentially explain the immediate clinical outcomes associated with RMS and MFR. METHOD: Cultured human fibroblasts were strained with 8h RMS, 60s MFR and combined treatment; RMS+MFR. Fibroblasts were immediately sampled upon cessation of strain and evaluated for cell morphology, cytokine secretions, proliferation, apoptosis, and potential changes to intracellular signaling molecules. RESULTS: RMS-induced fibroblast elongation of lameopodia, cellular decentralization, reduction of cell to cell contact and significant decreases in cell area to perimeter ratios compared to all other experimental groups (p<0.0001). Cellular proliferation indicated no change among any treatment group; however RMS resulted in a significant increase in apoptosis rate (p<0.05) along with increases in death-associated protein kinase (DAPK) and focal adhesion kinase (FAK) phosphorylation by 74% and 58% respectively, when compared to control. These responses were not observed in the MFR and RMS+MFR group. Of the 20 cytokines measured there was a significant increase in GRO secretion in the RMS+MFR group when compared to control and MFR alone. CONCLUSION: Our modeled injury (RMS) appropriately displayed enhanced apoptosis activity and loss of intercellular integrity that is consistent with pro-apoptotic dapk-2 and FAK signaling. Treatment with MFR following RMS resulted in normalization in apoptotic rate and cell morphology both consistent with changes observed in dapk-2. These in vitro studies build upon the cellular evidence base needed to fully explain clinical efficacy of manual manipulative therapies.

Efficacy of osteopathic manipulation as an adjunctive treatment for hospitalized patients with pneumonia: a randomized controlled trial.

BACKGROUND: The Multicenter Osteopathic Pneumonia Study in the Elderly (MOPSE) is a registered, double-blinded, randomized, controlled trial designed to assess the efficacy of osteopathic manipulative treatment (OMT) as an adjunctive treatment in elderly patients with pneumonia. METHODS: 406 subjects aged >/= 50 years hospitalized with pneumonia at 7 community hospitals were randomized using concealed allocation to conventional care only (CCO), light-touch treatment (LT), or OMT groups. All subjects received conventional treatment for pneumonia. OMT and LT groups received group-specific protocols for 15 minutes, twice daily until discharge, cessation of antibiotics, respiratory failure, death, or withdrawal from the study. The primary outcomes were hospital length of stay (LOS), time to clinical stability, and a symptomatic and functional recovery score. RESULTS: Intention-to-treat (ITT) analysis (n = 387) found no significant differences between groups. Per-protocol (PP) analysis (n = 318) found a significant difference between groups (P = 0.01) in LOS. Multiple comparisons indicated a reduction in median LOS (95% confidence interval) for the OMT group (3.5 [3.2-4.0] days) versus the CCO group (4.5 [3.9-4.9] days), but not versus the LT group (3.9 [3.5-4.8] days). Secondary outcomes of duration of intravenous antibiotics and treatment endpoint were also significantly different between groups (P = 0.05 and 0.006, respectively). Duration of intravenous antibiotics and death or respiratory failure were lower for the OMT group versus the CCO group, but not versus the LT group. CONCLUSIONS: ITT analysis found no differences between groups. PP analysis found significant reductions in LOS, duration of intravenous antibiotics, and respiratory failure or death when OMT was compared to CCO. Given the prevalence of pneumonia, adjunctive OMT merits further study.

The National Osteopathic Research Center at the University of North Texas Health Science Center: inception, growth, and future.

The osteopathic profession has long recognized the need to carry out research in order to improve clinical care. Osteopathic physicians have a particular obligation to carry out research in areas, such as osteopathic manipulative medicine (OMM), that are unique to osteopathic medicine. OMM is similar to manual therapy that is performed by other types of practitioners, but it has some distinctive characteristics. Osteopathic doctors also use OMM to treat infectious disease-not just musculoskeletal disorders.In 2001, several osteopathic professional organizations agreed to jointly fund a national osteopathic research center at one of the osteopathic medical colleges. Five osteopathic colleges submitted research proposals in response to a request for applications. The University of North Texas Health Science Center (UNTHSC) was chosen to be the site for the Osteopathic Research Center (ORC) and was funded for four years with $1.1M. Between 2002 and 2007, the ORC received an additional $11M in research support from multiple sources including federal funds. With this support, it has made substantive contributions to science. These include oversight of the recently completed four-year, $1.5M multicenter study on the efficacy of OMM as a treatment for pneumonia in the elderly and a three-year, $1.9M National Institutes of Health-funded developmental research center to perform mechanistic studies of some OMM actions.The authors discuss the long-term costs, benefits, and sustainability of the national ORC at UNTHSC in the contexts of research accomplished, the training of new medical osteopathic researchers, and an effort to develop other successful regional osteopathic research centers.

Patient expectations for placebo treatments commonly used in osteopathic manipulative treatment (OMT) clinical trials: a pilot study.

BACKGROUND: Placebo treatments should be believable to ensure expectation of benefit, yet not provide a true treatment effect. One obstacle to conducting clinical trials with osteopathic manipulative treatment (OMT) is choosing an appropriate placebo. Various placebo treatments have been used in OMT clinical trials. The purpose of this study was to determine expectations of 3 treatments (HVLA, placebo light touch, placebo sub-therapeutic ultrasound) commonly used in OMT clinical research trials. METHODS: A randomized, cross-over design was utilized. Subjects were recruited from the Family Medicine Clinic, Texas College of Osteopathic Medicine. Participants watched a video with 2 minute demonstrations of a High Velocity Low Amplitude (HVLA), placebo light touch (LT), and placebo sub-therapeutic ultrasound (ULTRA) treatment for low back pain. The order of presentations was randomized to control for order effect bias. Subjects indicated the extent of their agreement (using a 4 point Likert scale) with 4 statements that were presented after each treatment was viewed: 1)I believe this treatment would allow me to get better quicker; 2)I believe this treatment would decrease my low back pain; 3)I believe this treatment would make me more able to do the things I want to do; 4)This seems like a logical way to treat low back pain. Repeated measures analysis of variance was performed, and a partial Eta squared was calculated for each statement. Effect sizes (Cohen's d) were calculated where appropriate. RESULTS: Thirty of 40 eligible subjects participated. Twenty-two (73%) were female, 16 (53%) were Caucasian, and 11 (37%) had completed college. The mean age was 43 (SD = 15.). Repeated measures ANOVA revealed no significant differences for statements 2 and 4. For both statements 1 (p = 0.025) and 3 (p = 0.039), post hoc analysis revealed a difference between HVLA and LT. The partial Eta squared (etap2) was 0.105, 0.072, 0.107, and 0.024 for each statement, respectively. CONCLUSION: There is a difference in treatment expectation between HVLA and LT for statements 1 and 3. Participants responded more positively after viewing the HVLA treatment than the LT treatment. This suggests that sub-therapeutic ultrasound is the better placebo because the expectations were similar to those for HVLA.

A case-control study of osteopathic palpatory findings in type 2 diabetes mellitus.

BACKGROUND: Although type 2 diabetes mellitus is often managed by osteopathic physicians, osteopathic palpatory findings in this disease have not been adequately studied. METHODS: A case-control study was used to measure the association between type 2 diabetes mellitus and a series of 30 osteopathic palpatory findings. The latter included skin changes, trophic changes, tissue changes, tenderness, and immobility at spinal segmental levels T5-T7, T8-T10, and T11-L2 bilaterally. Logistic regression models that adjusted for age, sex, and comorbid conditions were used to compute odds ratios (ORs) and 95% confidence intervals (CIs) for the associations between type 2 diabetes mellitus and each of these findings. RESULTS AND DISCUSSION: A total of 92 subjects were included in the study. After controlling for age, sex, hypertension, and clinical depression, the only significant finding was an association between type 2 diabetes mellitus and tissue changes at T11-L2 on the right side (OR, 5.54; 95% CI, 1.76-17.47; P = .003). Subgroup analyses of subjects with type 2 diabetes mellitus and hypertension demonstrated significant associations with tissue changes at T11-L2 bilaterally (OR, 27.38; 95% CI, 1.75-428; P = .02 for the left side and OR, 24.00; 95% CI, 1.51-382; P = .02 for the right side). Among subjects with type 2 diabetes mellitus and hypertension, there was also a strong diabetes mellitus duration effect for tissue changes at T11-L2 bilaterally (OR, 12.00; 95% CI, 1.02-141; P = .05 for short duration vs. OR, 32.00; 95% CI, 2.29-448; P = .01 for long duration on the left side; and OR, 17.33; 95% CI, 1.39-217; P = .03 for short duration vs. OR, 32.00; 95% CI, 2.29-448; P = .01 for long duration on the right side). CONCLUSION: The only consistent finding in this study was an association between type 2 diabetes mellitus and tissue changes at T11-L2 on the right side. Potential explanations for this finding include reflex viscerosomatic changes directly related to the progression of type 2 diabetes mellitus, a spurious association attributable to confounding visceral diseases, or a chance observation unrelated to type 2 diabetes mellitus. Larger prospective studies are needed to better study osteopathic palpatory findings in type 2 diabetes mellitus.

Osteopathic manipulative treatment for chronic low back pain: a randomized controlled trial.

STUDY DESIGN: A randomized controlled trial was conducted. OBJECTIVE: To determine the efficacy of osteopathic manipulative treatment as a complementary treatment for chronic nonspecific low back pain. SUMMARY OF BACKGROUND DATA: Osteopathic manipulative treatment may be useful for acute or subacute low back pain. However, its role in chronic low back pain is unclear. METHODS: This trial was conducted in a university-based clinic from 2000 through 2001. Of the 199 subjects who responded to recruitment procedures, 91 met the eligibility criteria. They were randomized, with 82 patients completing the 1-month follow-up evaluation, 71 completing the 3-month evaluation, and 66 completing the 6-month evaluation. The subjects were randomized to osteopathic manipulative treatment, sham manipulation, or a no-intervention control group, and they were allowed to continue their usual care for low back pain. The main outcomes included the SF-36 Health Survey, a 10-cm visual analog scale for overall back pain, the Roland-Morris Disability Questionnaire, lost work or school days because of back pain, and satisfaction with back care. RESULTS: As compared with the no-intervention control subjects, the patients who received osteopathic manipulative treatment reported greater improvements in back pain, greater satisfaction with back care throughout the trial, better physical functioning and mental health at 1 month, and fewer cotreatments at 6 months. The subjects who received sham manipulation also reported greater improvements in back pain and physical functioning and greater satisfaction than the no-intervention control subjects. There were no significant benefits with osteopathic manipulative treatment, as compared with sham manipulation. CONCLUSIONS: Osteopathic manipulative treatment and sham manipulation both appear to provide some benefits when used in addition to usual care for the treatment of chronic nonspecific low back pain. It remains unclear whether the benefits of osteopathic manipulative treatment can be attributed to the manipulative techniques themselves or whether they are related to other aspects of osteopathic manipulative treatment, such as range of motion activities or time spent interacting with patients, which may represent placebo effects.