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1.  OSTEOPAThic Health outcomes In Chronic low back pain: The OSTEOPATHIC Trial 
Background
Osteopathic manipulative treatment (OMT) and ultrasound physical therapy (UPT) are commonly used for chronic low back pain. Although there is evidence from a systematic review and meta-analysis that OMT generally reduces low back pain, there are no large clinical trials that specifically assess OMT efficacy in chronic low back pain. Similarly, there is a lack of evidence involving UPT for chronic low back pain.
Methods
The OSTEOPAThic Health outcomes In Chronic low back pain (OSTEOPATHIC) Trial is a Phase III randomized controlled trial that seeks to study 488 subjects between August 2006 and June 2010. It uses a 2 × 2 factorial design to independently assess the efficacy of OMT and UPT for chronic low back pain. The primary outcome is a visual analogue scale score for pain. Secondary outcomes include back-specific functioning, generic health, work disability, and satisfaction with back care.
Conclusion
This randomized controlled trial will potentially be the largest involving OMT. It will provide long awaited data on the efficacy of OMT and UPT for chronic low back pain.
Trial registration
, NCT00315120
doi:10.1186/1750-4732-2-5
PMCID: PMC2386783  PMID: 18439282
2.  Osteopathic manipulative treatment for pneumonia 
The pneumonias due to infection continue to be a meaningful threat to the health and viability of persons, particularly those in high risk groups: children, the aged and the debilitated. Noll and colleagues provide us with the results of a well-designed and well-executed multi-institutional controlled clinical trial to evaluate the efficacy of osteopathic manipulative treatment (OMT) in the treatment of pneumonia. The data obtained indicate that by intention-to-treat analysis, the addition of OMT to conventional care did not improve the designated outcomes when compared to conventional care only. A disappointing but important finding. However, by per-protocol analysis, the addition of OMT or of light touch decreased length of hospital stay, the duration of intravenous antibiotics and the incidence of respiratory failure and death relative to conventional care only. Further study is called for to explain these surprising results.
Meeting the need for randomized clinical trials of the role and efficacy of OMT is a responsibility of high priority for the osteopathic profession in this age of evidence-based medicine. The American Osteopathic Association (AOA) needs to consider reinstating a dues-generated financial set-aside both to increase its support of osteopathic research and to initiate a program of physician-investigator career development awards to recruit and help establish osteopathic clinical investigators in a career in translational and clinical research.
doi:10.1186/1750-4732-4-3
PMCID: PMC2845139  PMID: 20302620
3.  Osteopathic manipulative treatment for low back pain: a systematic review and meta-analysis of randomized controlled trials 
Background
Osteopathic manipulative treatment (OMT) is a distinctive modality commonly used by osteopathic physicians to complement their conventional treatment of musculoskeletal disorders. Previous reviews and meta-analyses of spinal manipulation for low back pain have not specifically addressed OMT and generally have focused on spinal manipulation as an alternative to conventional treatment. The purpose of this study was to assess the efficacy of OMT as a complementary treatment for low back pain.
Methods
Computerized bibliographic searches of MEDLINE, EMBASE, MANTIS, OSTMED, and the Cochrane Central Register of Controlled Trials were supplemented with additional database and manual searches of the literature.
Six trials, involving eight OMT vs control treatment comparisons, were included because they were randomized controlled trials of OMT that involved blinded assessment of low back pain in ambulatory settings. Data on trial methodology, OMT and control treatments, and low back pain outcomes were abstracted by two independent reviewers. Effect sizes were computed using Cohen's d statistic and meta-analysis results were weighted by the inverse variance of individual comparisons. In addition to the overall meta-analysis, stratified meta-analyses were performed according to control treatment, country where the trial was conducted, and duration of follow-up. Sensitivity analyses were performed for both the overall and stratified meta-analyses.
Results
Overall, OMT significantly reduced low back pain (effect size, -0.30; 95% confidence interval, -0.47 – -0.13; P = .001). Stratified analyses demonstrated significant pain reductions in trials of OMT vs active treatment or placebo control and OMT vs no treatment control. There were significant pain reductions with OMT regardless of whether trials were performed in the United Kingdom or the United States. Significant pain reductions were also observed during short-, intermediate-, and long-term follow-up.
Conclusion
OMT significantly reduces low back pain. The level of pain reduction is greater than expected from placebo effects alone and persists for at least three months. Additional research is warranted to elucidate mechanistically how OMT exerts its effects, to determine if OMT benefits are long lasting, and to assess the cost-effectiveness of OMT as a complementary treatment for low back pain.
doi:10.1186/1471-2474-6-43
PMCID: PMC1208896  PMID: 16080794
4.  Osteopathic research: elephants, enigmas, and evidence 
Background
The growth and acceptance of osteopathic physicians as conventional medical practitioners in the United States has also raised questions about the distinctive aspects of osteopathic medicine. Although the use of osteopathic manipulative treatment (OMT) and a focus on primary care are most often cited as rationales for the uniqueness of osteopathic medicine, an osteopathic professional identity remains enigmatic.
Discussion
The fledgling basic osteopathic research efforts of the early and mid-twentieth century have not been sustained and expanded over time. Thus, there is presently a scarcity of basic mechanistic and translational research that can be considered to be uniquely osteopathic. To be sure, there have been advances in osteopathic clinical trials, particularly those involving OMT for low back pain. Meta-analysis of these low back pain trials has provided evidence that: (1) OMT affords greater pain reduction than active or placebo control treatments; (2) the effects of OMT are comparable regardless of whether treatment is provided by fully-licensed osteopathic physicians in the United States or by osteopaths in the United Kingdom; and (3) the effects of OMT increase over time. However, much more clinical research remains to be done. The planning and implementation of a large longitudinal study of the natural history and epidemiology of somatic dysfunction, including an OMT component, represents a much-needed step forward. Osteopathic medicine's use of OMT and its focus on primary care are not mutually exclusive aspects of its uniqueness. The intersection of these fundamental aspects of osteopathic medicine suggests that the profession may successfully adopt a generic strategy of "focused differentiation" to attain a competitive advantage in the health care arena. While there are both requisite demands and risks for the osteopathic profession in adopting such a strategy, these are reasonable in relation to the potential rewards to be attained. To help promote an osteopathic identity, "omtology" and its derivative terms are recommended in referring to the study of OMT.
Conclusion
The osteopathic profession should adopt a coherent strategy for developing and promoting its identity. Failure to do so will likely ensure that osteopathic medicine remains "stuck in the middle."
doi:10.1186/1750-4732-1-7
PMCID: PMC1808471  PMID: 17371583
5.  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.
doi:10.1186/1750-4732-4-2
PMCID: PMC2848182  PMID: 20302619
6.  Educating osteopaths to be researchers – what role should research methods and statistics have in an undergraduate curriculum? 
Evidence-based medicine (EBM) involves using research data to enhance the diagnosis and treatment of clinical disorders. Somatic dysfunction and osteopathic manipulative treatment (OMT) are two unique aspects of osteopathy that will benefit from a greater emphasis on scientific evidence. Most evidence in osteopathy is based on expert opinions, case reports, case series, and observational studies. Only one systematic review of randomized controlled trials, involving OMT for low back pain, has been published. Although this study demonstrates the efficacy of OMT for low back pain, other clinical trials are needed to expand the evidence base in osteopathy. Undergraduate osteopathy curricula should ensure that students acquire the tools necessary to become knowledgeable consumers of the research and statistics presented in biomedical journals. Such curricula need to be supplemented with graduate training programs and research funding mechanisms to ensure that young osteopathic researchers are able to produce the research needed to practice and advance evidence-based osteopathy in the future.
doi:10.1016/j.ijosm.2008.03.003
PMCID: PMC2574521  PMID: 19122835
osteopathy; osteopathic medicine; osteopathic manipulative treatment (OMT); somatic dysfunction; low back pain; evidence-based medicine; evidence-based osteopathy; research methods; biostatistics
7.  Osteopathic Manipulative Treatment of Back Pain and Related Symptoms during Pregnancy: A Randomized Controlled Trial 
Objective:
To study osteopathic manipulative treatment (OMT) of back pain and related symptoms during the third trimester of pregnancy.
Study design:
A randomized, placebo-controlled trial was conducted to compare usual obstetrical care (UOBC) and OMT (UOBC+OMT), UOBC and sham ultrasound treatment (UOBC+SUT), and UOBC only. Outcomes included average pain levels and the Roland Morris-Disability Questionnaire (RMDQ) to assess back-specific functioning.
Results:
Intention-to-treat analyses included 144 subjects. The RMDQ scores worsened during pregnancy; however, back-specific functioning deteriorated significantly less in the UOBC+OMT group (effect size, 0.72; 95% CI, 0.31-1.14; P=.001 vs. UOBC only; and effect size, 0.35; 95% CI, −0.06-0.76; P=.09 vs. UOBC+SUT). During pregnancy, back pain decreased in the UOBC+OMT group, remained unchanged in the UOBC+SUT group, and increased in the UOBC 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.
doi:10.1016/j.ajog.2009.07.057
PMCID: PMC2811218  PMID: 19766977
osteopathic manipulative treatment; pregnancy; back pain; physical functioning; randomized controlled trial
8.  Osteopathic manipulative treatment and its relationship to autonomic nervous system activity as demonstrated by heart rate variability: a repeated measures study 
Background
The relationship between osteopathic manipulative treatment (OMT) and the autonomic nervous system has long been acknowledged, but is poorly understood. In an effort to define this relationship, cervical myofascial release was used as the OMT technique with heart rate variability (HRV) as a surrogate for autonomic activity. This study quantifies that relationship and demonstrates a cause and effect.
Methods
Seventeen healthy subjects, nine males and eight females aged 19–50 years from the faculty, staff, and students at Oklahoma State University Center for Health Sciences College of Osteopathic Medicine, acted as their own controls and received interventions, administered in separate sessions at least 24 hours apart, of cervical myofascial OMT, touch-only sham OMT, and no-touch control while at a 50-degree head-up tilt. Each group was dichotomized into extremes of autonomic activity using a tilt table. Comparisons were made between measurements taken at tilt and those taken at pre- and post-intervention in the horizontal.
The variance of the spectral components of HRV, expressed as frequencies, measured the response to change in position of the subjects. Normalized low frequency (LF) and high frequency (HF) values, including LF/HF ratio, were calculated and used to determine the effect of position change on HRV.
Results
Predominantly parasympathetic responses were observed with subjects in the horizontal position, while a 50-degree tilt provided a significantly different measure of maximum sympathetic tone (p < 0.001). Heart rate changed in all subjects with change in position; respirations remained constant. When OMT was performed in a sympathetic environment (tilt), a vagal response was produced that was strong enough to overcome the sympathetic tone. There was no HRV difference between sham and control in either the horizontal or tilt positions.
Conclusion
The vagal response produced by the myofascial release procedure in the maximally stimulated sympathetic environment could only have come from the application of the OMT. This demonstrates the association between OMT and the autonomic nervous system. The lack of significance between control and sham in all positions indicates that HRV may be a useful method of developing sham controls in future studies of OMT.
Trial registration
clinicaltrials.gov NCT00516984.
doi:10.1186/1750-4732-2-7
PMCID: PMC2442110  PMID: 18534024
9.  Overcoming Barriers to the Use of Osteopathic Manipulation Techniques in the Emergency Department 
Background:
Osteopathic Manipulation Techniques (OMT) have been shown to be effective therapeutic modalities in various clinical settings, but appear to be underutilized in the emergency department (ED) setting.
Objective:
To examine barriers to the use of OMT in the ED and provide suggestions to ameliorate these barriers.
Methods:
Literature review
Results:
While the medical literature cites numerous obstacles to the use of OMT in the ED setting, most can be positively addressed through education, careful planning, and ongoing research into use of these techniques. Recent prospective clinical trials of OMT have demonstrated the utility of these modalities.
Conclusion:
Osteopathic Manipulation Techniques are useful therapeutic modalities that could be utilized to a greater degree in the ED. As the number of osteopathic emergency physicians increases, the opportunity to employ these techniques should increase.
PMCID: PMC2729220  PMID: 19718381
10.  Echinacea purpurea and osteopathic manipulative treatment in children with recurrent otitis media: a randomized controlled trial 
Background
Recurrent otitis media is a common problem in young children. Echinacea and osteopathic manipulative treatment have been proposed as preventive measures, but have been inadequately studied. This study was designed to assess the efficacy of Echinacea purpurea and/or osteopathic manipulative treatment (OMT) for prevention of acute otitis media in otitis-prone children.
Methods
A randomized, placebo-controlled, two-by-two factorial trial with 6-month follow-up, conducted 1999 – 2002 in Tucson, Arizona. Patients were aged 12–60 months with recurrent otitis media, defined as three or more separate episodes of acute otitis media within six months, or at least four episodes in one year. Ninety children (44% white non-Hispanic, 39% Hispanic, 57% male) were enrolled, of which 84 had follow-up for at least 3 months. Children were randomly assigned to one of four protocol groups: double placebo, echinacea plus sham OMT, true OMT (including cranial manipulation) plus placebo echinacea, or true echinacea plus OMT. An alcohol extract of Echinacea purpurea roots and seeds (or placebo) was administered for 10 days at the first sign of each common cold. Five OMT visits (or sham treatments) were offered over 3 months.
Results
No interaction was found between echinacea and OMT. Echinacea was associated with a borderline increased risk of having at least one episode of acute otitis media during 6-month follow-up compared to placebo (65% versus 41%; relative risk, 1.59, 95% CI 1.04, 2.42). OMT did not significantly affect risk compared to sham (44% versus 61%; relative risk, 0.72, 95% CI 0.48, 1.10).
Conclusion
In otitis-prone young children, treating colds with this form of echinacea does not decrease the risk of acute otitis media, and may in fact increase risk. A regimen of up to five osteopathic manipulative treatments does not significantly decrease the risk of acute otitis media.
Trial registration
ClinicalTrials.gov Identifier: NCT00010465
doi:10.1186/1472-6882-8-56
PMCID: PMC2573879  PMID: 18831749
11.  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.
doi:10.1179/2042618611Y.0000000016
PMCID: PMC3267441  PMID: 23372389
Low back pain; Manual medicine; Manipulation
12.  Responding to the challenge of clinically relevant osteopathic research: efficacy and beyond 
The osteopathic profession has been challenged over the past decade to provide clinically relevant research. The conduct of evidence-based osteopathic research is imperative not only for scientific, economic, and professional reasons, but also to drive health care policy and clinical practice guidelines. This paper summarizes recent studies in response to the osteopathic research challenge, including clinical trials registered with ClinicalTrials.gov and a systematic review and meta-analysis of osteopathic manipulative treatment (OMT) for low back pain. The concept of the OMT responder is introduced and supported with preliminary data. Within the context of a pain processing model, consideration is given to genomic (e.g., the catechol-O-methyltransferase gene) and psychological (e.g., depression and somatization) factors that are associated with pain sensitivity and pain progression, and to the role that such factors may play in screening for OMT responders. While substantial progress has been made in osteopathic research, much more needs to be done.
doi:10.1016/j.ijosm.2007.01.002
PMCID: PMC2084062  PMID: 18311324
osteopathy; osteopathic medicine; osteopathic manipulative treatment (OMT); low back pain; genomics; catechol-O-methyltransferase (COMT); pain processing
13.  A randomized control trial on the effectiveness of osteopathic manipulative treatment in reducing pain and improving the quality of life in elderly patients affected by osteoporosis 
Summary
Introduction
In the elderly population, a decrease in bone mineral density (osteoporosis) is often associated with a decrease in quality of life and an increase in self reported body pain. This pain originates from the musculoskeletal system and can potentially affect different areas of the body.
Aim
The aim of this study was to investigate the effect of osteopathic manipulative treatment (OMT) on self reported pain and quality of life in an elderly population.
Design
Randomized placebo controlled trial.
Methods
Patients were recruited from the Geriatric Department, Bassini Hospital (Milan, Italy). Patients were randomly assigned to either 6 sessions of OMT (n = 37 patients) or an equivalent number of sham manipulative treatment (SMT) (n = 35 patients). The main outcome variables were QOL measured by QUALEFFO -41 and overall bodily pain measured using a visual analog scale (VAS). Data were analyzed using a two factor ANOVA (treatment × time) for repeated measurements with an α level set at p ≤ 0.05.
Results
Main result of this study was that OMT compared to SMT showed a significant decreased of disability. This effect was demonstrated by a significant interaction in the overall disability score (p =0.001) and the Mental wellbeing (p =0.058), Health perception (p =0.005) and Pain (p =0.003) QUALEFFO -41 subscales, while no significant difference (no interaction) for pain as measured by VAS and for the Daily activities, Walking, Household cleaning and Leisure time activities QUALEFFO -41 subscales (p > 0.05) was found. No adverse effects were recorded during the study.
Discussion
This study demonstrated that, in a group of elderly subjects affected by osteoporosis OMT was able to increase self reported QOL while the effect on body pain perception is unclear. This overall improvement in QOL appears to be caused by an improvement in psychological factors (i.e Mental wellbeing and Health perception) rather than physical factors. In fact, all QUALEFFO -41 subscales related to physical function demonstrated no significant interaction. The effect of OMT on Pain perception is less clear. In fact, there was no effect on pain as assessed by VAS while a significant improvement was observed when the QUALEFFO -41 subscale was used. This could be due to the metric properties of the two pain measurement methods; an alternative explanation could be that VAS measures mainly pain quantity while QUA-LEFFO -41 subscales measures mainly pain quality. The lack of effect of OMT on physical function needs to be confirmed by more direct measurements of this variable.
PMCID: PMC3535995  PMID: 23289034
osteoporosis; osteopathic treatment; quality of life; pain
14.  Effectiveness of osteopathic manipulative treatment in neonatal intensive care units: protocol for a multicentre randomised clinical trial 
BMJ Open  2013;3(2):e002187.
Introduction
Neonatal care has been considered as one of the first priorities for improving quality of life in children. In 2010, 10% of babies were born prematurely influencing national healthcare policies, economic action plans and political decisions. The use of complementary medicine has been applied to the care of newborns. One previous study documented the positive effect of osteopathic manipulative treatment (OMT) in reducing newborns’ length of stay (LOS). Aim of this multicentre randomised controlled trial is to examine the association between OMT and LOS across three neonatal intensive care units (NICUs).
Methods and analysis
690 preterm infants will be recruited from three secondary and tertiary NICUs from north and central Italy and allocated into two groups, using permuted-block randomisation.
The two groups will receive standard medical care and OMT will be applied, twice a week, to the experimental group only. Outcome assessors will be blinded of study design and group allocation. The primary outcome is the mean difference in days between discharge and entry. Secondary outcomes are difference in daily weight gain, number of episodes of vomit, regurgitation, stooling, use of enema, time to full enteral feeding and NICU costs. Statistical analyses will take into account the intention-to-treat method. Missing data will be handled using last observation carried forward (LOCF) imputation technique.
Ethics and dissemination
Written informed consent will be obtained from parents or legal guardians at study enrolment. The trial has been approved by the ethical committee of Macerata hospital (n°22/int./CEI/27239) and it is under review by the other regional ethics committees.
Results
Dissemination of results from this trial will be through scientific medical journals and conferences.
Trial registration
This trial has been registered at http://www.clinicaltrials.org (identifier NCT01645137).
doi:10.1136/bmjopen-2012-002187
PMCID: PMC3586056  PMID: 23430598
Complementary Medicine; Paediatrics; Preventive Medicine
15.  Osteopathic intervention in chronic non-specific low back pain: a systematic review 
Background
Chronic Non Specific Low Back Pain (CNSLBP) is a common, complex and disabling condition that has been present for longer than three months and is not caused by a serious pathology. Osteopaths are health practitioners who commonly diagnose and treat CNSLBP patients using a complex set of interventions that includes manual therapy. The study aimed to complete a Systematic Review of clinical research into osteopathic intervention in CNSLBP using a rigorous assessment of study quality.
Methods
The literature was searched to August 2011 using the following databases: AMED, CINAHL Plus, Cochrane Central Register of Clinical Trials, MEDLINE Plus, EMBASE, MANTIS, OSTMED, PEDro, ScienceDirect. Multiple search terms were used in various combinations: osteopathy/osteopathic, osteopathic manipulative technique, OMT, Spinal Manipulative Therapy, SMT, clinical trial, back pain, chronic back pain. The inclusion criteria were papers that: reported clinical trials; had adult participants; tested the effectiveness and/or efficacy of osteopathic manual therapy intervention applied by osteopaths, and had a study condition of CNSLBP. The quality of the papers was assessed using the Cochrane Back Review Risk of Bias criteria. A meta-analysis would proceed if the studies had adequate clinical and methodological homogeneity.
Results
Initial searches revealed 809 papers, 772 of which were excluded on the basis of abstract alone. The remaining 37 trial papers were subjected to a more detailed analysis of the full text, which resulted in 35 being excluded. The two remaining trials had a lack of methodological and clinical homogeneity, precluding a meta-analysis. The trials used different comparators with regards to the primary outcomes, the number of treatments, the duration of treatment and the duration of follow-up.
Conclusion
There are only two studies assessing the effect of the manual therapy intervention applied by osteopathic clinicians in adults with CNSLBP. One trial concluded that the osteopathic intervention was similar in effect to a sham intervention, and the other suggests similarity of effect between osteopathic intervention, exercise and physiotherapy. Further clinical trials into this subject are required that have consistent and rigorous methods. These trials need to include an appropriate control and utilise an intervention that reflects actual practice.
doi:10.1186/1471-2474-14-129
PMCID: PMC3623881  PMID: 23570655
Systematic review; Osteopathy; Osteopathic manipulative treatment; Low back pain; Chronic low back pain; Non-specific low back pain; Manual therapy; Clinical trial methodology
16.  Osteopathic Manipulative Therapy Induces Early Plasma Cytokine Release and Mobilization of a Population of Blood Dendritic Cells 
PLoS ONE  2014;9(3):e90132.
It has been claimed that osteopathic manipulative treatment (OMT) is able to enhance the immune response of individuals. In particular, it has been reported that OMT has the capability to increase antibody titers, enhance the efficacy of vaccination, and upregulate the numbers of circulating leukocytes. Recently, it has been shown in human patients suffering chronic low back pain, that OMT is able to modify the levels of cytokines such as IL-6 and TNF-α in blood upon repeated treatment. Further, experimental animal models show that lymphatic pump techniques can induce a transient increase of cytokines in the lymphatic circulation. Taking into account all these data, we decided to investigate in healthy individuals the capacity of OMT to induce a rapid modification of the levels of cytokines and leukocytes in circulation. Human volunteers were subjected to a mixture of lymphatic and thoracic OMT, and shortly after the levels of several cytokines were evaluated by protein array technology and ELISA multiplex analysis, while the profile and activation status of circulating leukocytes was extensively evaluated by multicolor flow cytometry. In addition, the levels of nitric oxide and C-reactive protein (CRP) in plasma were determined. In this study, our results show that OMT was not able to induce a rapid modification in the levels of plasma nitrites or CRP or in the proportion or activation status of central memory, effector memory or naïve CD4 and CD8 T cells. A significant decrease in the proportion of a subpopulation of blood dendritic cells was detected in OMT patients. Significant differences were also detected in the levels of immune molecules such as IL-8, MCP-1, MIP-1α and most notably, G-CSF. Thus, OMT is able to induce a rapid change in the immunological profile of particular circulating cytokines and leukocytes.
doi:10.1371/journal.pone.0090132
PMCID: PMC3948629  PMID: 24614605
17.  Osteopathic Manipulative Treatment 
Dermatological diseases, such as dysesthesia syndromes, stasis dermatoses, and hyperhidrosis are difficult to treat due to their complex etiologies. Current theories suggest these diseases are caused by physiological imbalances, such as nerve impingement, localized tissue congestion, and impaired autonomic regulation. Osteopathic manipulative therapy targets these physiological dysfunctions and may serve as a beneficial therapeutic option. Osteopathic manipulative therapy techniques include high velocity low amplitude, muscle energy, counterstrain, myofascial release, craniosacral, and lymphatic drainage. An osteopathic manipulative therapy technique is chosen based on its physiological target for a particular disease. Osteopathic manipulative therapy may be useful alone or in combination with standard therapeutic options. However, due to the lack of standardized trials supporting the efficacy of osteopathic manipulative therapy treatment for dermatological disease, randomized, well-controlled studies are necessary to confirm its therapeutic value.
PMCID: PMC3486778  PMID: 23125887
18.  Muscle functional magnetic resonance imaging and acute low back pain: a pilot study to characterize lumbar muscle activity asymmetries and examine the effects of osteopathic manipulative treatment 
Background
Muscle functional magnetic resonance imaging (mfMRI) measures transverse relaxation time (T2), and allows for determination of the spatial pattern of muscle activation. The purposes of this pilot study were to examine whether MRI-derived T2 or side-to-side differences in T2 (asymmetries) differ in low back muscles between subjects with acute low back pain (LBP) compared to asymptomatic controls, and to determine if a single osteopathic manipulative treatment (OMT) session alters these T2 properties immediately and 48-hours after treatment.
Methods
Subjects with non-specific acute LBP (mean score on 1-10 visual analog score = 3.02 ± 2.81) and asymptomatic controls (n = 9/group) underwent an MRI, and subsequently the LBP subjects received OMT and then underwent another MRI. The LBP subjects reported back for an additional MRI 48-hours following their initial visit. T2 and T2 asymmetry were calculated from regions of interest for the psoas, quadratus lumborum (QL), multifidus, and iliocostalis lumborum/longissimus thoracis (IL/LT) muscles.
Results
No differences were observed between the groups when T2 was averaged for the left and right side muscles. However, the QL displayed a significantly greater T2 asymmetry in LBP subjects when compared to controls (29.1 ± 4.3 vs. 15.9 ± 4.1%; p = 0.05). The psoas muscle also displayed a relatively large, albeit non-significant, mean difference (22.7 ± 6.9 vs. 9.5 ± 2.8%; p = 0.11). In the subjects with LBP, psoas T2 asymmetry was significantly reduced immediately following OMT (25.3 ± 6.9 to 6.1 ± 1.8%, p = 0.05), and the change in LBP immediately following OMT was correlated with the change in psoas T2 asymmetry (r = 0.75, p = 0.02).
Conclusion
Collectively, this pilot work demonstrates the feasibility of mfMRI for quantification and localization of muscle abnormalities in patients with acute low back pain. Additionally, this pilot work provides insight into the mechanistic actions of OMT during acute LBP, as it suggests that it may attenuate muscle activity asymmetries of some of the intrinsic low back muscles.
doi:10.1186/1750-4732-3-7
PMCID: PMC2744922  PMID: 19712459
19.  Introducing an osteopathic approach into neonatology ward: the NE-O model 
Background
Several studies showed the effect of osteopathic manipulative treatment on neonatal care in reducing length of stay in hospital, gastrointestinal problems, clubfoot complications and improving cranial asymmetry of infants affected by plagiocephaly. Despite several results obtained, there is still a lack of standardized osteopathic evaluation and treatment procedures for newborns recovered in neonatal intensive care unit (NICU). The aim of this paper is to suggest a protocol on osteopathic approach (NE-O model) in treating hospitalized newborns.
Methods
The NE-O model is composed by specific evaluation tests and treatments to tailor osteopathic method according to preterm and term infants’ needs, NICU environment, medical and paramedical assistance. This model was developed to maximize the effectiveness and the clinical use of osteopathy into NICU.
Results
The NE-O model was adopted in 2006 to evaluate the efficacy of OMT in neonatology. Results from research showed the effectiveness of this osteopathic model in reducing preterms’ length of stay and hospital costs. Additionally the present model was demonstrated to be safe.
Conclusion
The present paper defines the key steps for a rigorous and effective osteopathic approach into NICU setting, providing a scientific and methodological example of integrated medicine and complex intervention.
doi:10.1186/2045-709X-22-18
PMCID: PMC4046173  PMID: 24904746
Complementary and alternative medicine; Integrated medicine; Neonatology intensive care unit; Newborns; Osteopathic manipulative treatment
20.  Time for the osteopathic profession to take the lead in musculoskeletal research 
Musculoskeletal conditions, such as low back pain, are prevalent in the United States. These conditions exact an enormous toll on society, both in terms of their detrimental impact on quality of life and on the costs of treatment and lost productivity. Osteopathic physicians, as common providers of primary care services and spinal manipulation, are ideally positioned to lead future research efforts in this field. The emergence of data and standards relevant to osteopathic manipulative treatment outcomes, refinement of research methodologies to enhance evidence-based medicine, and investments in developing osteopathic research infrastructure are all critical elements in moving this field of research forward.
doi:10.1186/1750-4732-3-6
PMCID: PMC2724431  PMID: 19624819
21.  Spinal and sacroiliac assessment and treatment techniques used by osteopathic physicians in the United States 
Background
Osteopathic manipulative medicine texts and educators advocate a range of approaches for physical assessment and treatment, but little is known about their use by osteopathic physicians in the United States.
Methods
A web-based survey using a 5-point Likert scale was developed and e-mailed to 777 practicing osteopathic physician members of the American Academy of Osteopathy. Responses in the "frequently" and "always" categories were combined for reporting purposes. Friedman tests were used to analyze the reported usage of each item. The effect of gender was analyzed using Mann-Whitney tests.
Results
One hundred seventy-one osteopathic physicians completed the survey (22%). For the assessment of spinal somatic dysfunction, paraspinal tissue texture (98%), transverse process asymmetry (89%), and tenderness (85%) were most commonly reported. Myofascial release (78%), soft tissue technique (77%), and patient self-stretches (71%) were most commonly used for treatment of the spine. For assessment of pelvic landmark asymmetry, the anterior superior iliac spine (ASIS, 87%), sacral base (82%), posterior superior iliac spine (81%), sacral sulci (78%), iliac crests (77%), and inferior lateral angle of the sacrum (74%) were commonly palpated. For assessment of sacroiliac joint motion, ASIS compression (68%) was most commonly used. Sacroiliac pain provocation tests were also employed although their use was less common than asymmetry or motion tests. Muscle energy (70%), myofascial release (67%), patient self-stretches (66%), osteopathy in the cranial field (59%), muscle strengthening exercises (58%), soft tissue technique (58%), and articulatory technique (53%) were most commonly used for treatment of the pelvis and sacroiliac. The effect of gender was significant for many of the treatment procedures, with females using more soft tissue and muscle energy and males more high-velocity techniques. The majority of respondents document the types of osteopathic manipulative techniques used (83%), document somatic dysfunction with Fryette nomenclature (64%), and bill for osteopathic manipulative treatment (92%).
Conclusion
Respondents reported the use of a broad range of assessment and treatment approaches. Results suggest a higher use of myofascial release and cranial technique and lower use of high-velocity techniques in this group of physicians compared to previous studies.
doi:10.1186/1750-4732-3-4
PMCID: PMC2676310  PMID: 19366458
22.  A feasibility study assessing manual therapies to different regions of the spine for patients with subacute or chronic neck pain☆ 
Abstract
Objective
The purpose of this project was to develop and test protocols for a randomized clinical trial of a combined therapeutic approach (thoracic spine and sacroiliac joint high-velocity, low-amplitude spinal manipulation [HVLA SM] + cervical spine postisometric relaxation) and cervical spine HVLA SM for patients with subacute or chronic neck pain.
Methods
Patients were recruited in the Quad Cities in Iowa and Illinois. After a baseline assessment visit, eligible patients were randomly assigned to cervical spine HVLA SM or to the combined therapeutic approach for 4 treatment visits over 2 weeks. Outcome assessments included the Neck Disability Index, visual analog scale, and posttreatment response questionnaire. Patient outcomes were not aggregated or compared by treatment group.
Results
It took approximately 8 months of planning, which included the development of forms and protocols, pretesting the forms, and training staff and clinicians in the standardized protocols. Twelve participants were screened, and 6 patients were enrolled and randomly allocated to care over a 6-week period. All patients completed 5 visits. Five of 6 patients had an improvement on the Neck Disability Index. On the visual analog scale, 2 patients improved at 2 weeks, whereas the other 4 got worse. Five patients completed the posttreatment response questionnaire; 2 of the 5 indicated they experienced discomfort or an unpleasant reaction from the study treatments.
Conclusions
Designing a successful feasibility randomized clinical trial requires considerable planning, development and pretesting of the forms and protocols, and training clinicians and staff for standardized protocols. Patients were willing to be randomized, follow treatment protocols, complete baseline and outcome assessments, and return 83% of the follow-up questionnaires.
doi:10.1016/j.jcme.2007.10.004
PMCID: PMC2647106  PMID: 19674713
Feasibility studies; Manipulation, Spinal; Neck pain; Musculoskeletal manipulations; Chiropractic
23.  Rediscovering the classic osteopathic literature to advance contemporary patient-oriented research: A new look at diabetes mellitus 
Patient care experiences represent opportunities for establishing theories, testable hypotheses, and data to assess the potential use of osteopathic manipulative treatment in various disease conditions. The re-analysis of Bandeen's 1949 raw data described herein summarizes the effects of osteopathic manipulative treatment involving pancreatic stimulatory and inhibitory techniques in diabetic and non-diabetic patients seen over a 25-year period of clinical practice. Bandeen's data demonstrate a reduction in blood glucose levels at 30 and 60 minutes following pancreatic stimulation in 150 diabetic patients, and an elevation in blood glucose levels at 30 and 60 minutes following pancreatic inhibition in 40 non-diabetic patients. Such patient-oriented research conducted during the classic era of osteopathy in the United States provides a foundation and data for generating hypotheses about the potential mechanisms of action of osteopathic manipulative treatment. Osteopathic investigators would be well-served to rediscover the classic osteopathic literature to help advance contemporary evidence-based medicine.
doi:10.1186/1750-4732-2-9
PMCID: PMC2503986  PMID: 18644129
24.  Biomedical research competencies for osteopathic medical students 
Background
Without systematic exposure to biomedical research concepts or applications, osteopathic medical students may be generally under-prepared to efficiently consume and effectively apply research and evidence-based medicine information in patient care. The academic literature suggests that although medical residents are increasingly expected to conduct research in their post graduate training specialties, they generally have limited understanding of research concepts.
With grant support from the National Center for Complementary and Alternative Medicine, and a grant from the Osteopathic Heritage Foundation, the University of North Texas Health Science Center (UNTHSC) is incorporating research education in the osteopathic medical school curriculum. The first phase of this research education project involved a baseline assessment of students' understanding of targeted research concepts. This paper reports the results of that assessment and discusses implications for research education during medical school.
Methods
Using a novel set of research competencies supported by the literature as needed for understanding research information, we created a questionnaire to measure students' confidence and understanding of selected research concepts. Three matriculating medical school classes completed the on-line questionnaire. Data were analyzed for differences between groups using analysis of variance and t-tests. Correlation coefficients were computed for the confidence and applied understanding measures. We performed a principle component factor analysis of the confidence items, and used multiple regression analyses to explore how confidence might be related to the applied understanding.
Results
Of 496 total incoming, first, and second year medical students, 354 (71.4%) completed the questionnaire. Incoming students expressed significantly more confidence than first or second year students (F = 7.198, df = 2, 351, P = 0.001) in their ability to understand the research concepts. Factor analyses of the confidence items yielded conceptually coherent groupings. Regression analysis confirmed a relationship between confidence and applied understanding referred to as knowledge. Confidence scores were important in explaining variability in knowledge scores of the respondents.
Conclusion
Medical students with limited understanding of research concepts may struggle to understand the medical literature. Assessing medical students' confidence to understand and objectively measured ability to interpret basic research concepts can be used to incorporate competency based research material into the existing curriculum.
doi:10.1186/1750-4732-3-10
PMCID: PMC2770523  PMID: 19825171
25.  No effect of osteopathic treatment on trunk morphology and spine flexibility in young women with adolescent idiopathic scoliosis 
Introduction
Brace treatment is the gold standard for patients with mild adolescent idiopathic scoliosis (Cobb angle 20°–40°). However, negative psychosocial impacts, physical constraints and incompliance cause many patients and parents to seek for so-called holistic and apparently less harmful approaches within the field of complementary and alternative medicine (CAM). Osteopathy—manual interventions on the viscera and locomotor system—is widely used for scoliosis. There is, however, a complete lack of evidence regarding its efficacy. We, therefore, tested the hypothesis that osteopathy alters trunk morphology, a prerequisite to unload the concave side of the scoliosis, and that it halts curve progression.
Methods
This was a prospective, controlled trial of 20 post-pubertal young women (20°–40° idiopathic scoliosis) randomly allocated to an observation (group 0) or osteopathic treatment (group 1). The latter comprised three sessions (5 weeks). Trunk morphology (clinical examination, video rasterstereography) and spine flexibility (MediMouse®) were assessed at a pre- and post-intervention with a 3-month interval (blinded examiner). We chose scoliometer measurement (rib hump, lumbar prominence) as the main outcome parameter.
Results
Two patients in the treatment group refused further treatment and the final examination, as they felt no benefit after two osteopathic treatments. Regression analysis for repeat measurements (independent statistician) revealed no therapeutic effect on rib hump, lumbar prominence, plumb line, sagittal profile and global spinal flexibility.
Conclusions
We found no evidence to support osteopathy in the treatment of mild adolescent idiopathic scoliosis. Therefore, we caution against abandoning the conventional standard of care for mild idiopathic scoliosis. As for other CAM therapies, the use of osteopathy as a treatment option for scoliosis still needs to be clearly defined.
doi:10.1007/s11832-010-0258-6
PMCID: PMC2866846  PMID: 21629373
Osteopathy; Adolescent idiopathic scoliosis; Trunk morphology; Randomised trial

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