Context: Acute lateral ankle sprain (ALAS) is responsible for short-term disability, increased risk for future acute ankle sprain, and chronic ankle instability. Several studies highlighted that manipulative therapy may reduce pain and increase the range of motion (ROM) of the injured ankle, but not all of them targeted acute injuries. Some studies focused their interest on a specific manipulative technique or utilized either physiotherapy or chiropractic techniques.
Objectives: The objectives of this study were to evaluate the effectiveness of osteopathic care in ALAS, to assess pain, edema, and functional stability of the injured ankle, and to assess and comparing mobility between the injured and noninjured ankle.
Methods: We conducted an interventional randomized controlled trial (RCT) in the emergency department (ED) of a French University Hospital. Fifty patients were enrolled in this study. They had to be ≥18 years old, consulting in the ED for a single ALAS (<72 h) stage 1 or 2, and must have had preliminary consultation with an emergency physician. Patients with an ALAS stage 3 or fractured, or with history of homolateral ankle surgery, were excluded. Patients were randomized either in the medical treatment (MT) group or in the medical and osteopathic treatment (MOT) group and had a 3-week follow-up. In the MOT group, the intervention consisted of a single osteopathic treatment (manual intervention) at Day 0, depending on the tissue affected and on the intensity of the tissular tension found, and individualized advice provided at Days 0, 7, and 21. Comparisons between groups were investigated utilizing the chi-square or Fisher's exact test, or Student's t-test or Mann Whitney U-test, as appropriate.
Results: Forty-five patients completed the study. The patients' median age was 29.5 years old (23-40 years). At Day 21, 95.7 % of patients in the MOT group had equivalent capacity of unloaded dorsal flexion between the injured and noninjured ankle, vs. 50.0 % of patients in the MT group (p=0.0005). Between Day 0 and Day 21, the pain with the injured ankle loaded and unloaded decreased more significantly in the MOT group (p=0.001 and p=0.0007, respectively), while the loaded and unloaded dorsal flexion, and the unloaded plantar flexion, increased (p=0.003, p<0.0001 and p=0.02, respectively). Between Day 0 and Day 0 postosteopathic treatment, all judgment criteria showed improvement in the MOT group. At Day 7, all the functional stability tests were performed better by patients in the MOT group.
Conclusions: Early osteopathic treatment associated with usual MT, delivered to patients with an ALAS, may improve mobility and functional stability, and may reduce pain and edema, in the 3 weeks postintervention. These promising findings require confirmation in a larger controlled trial.
Context: Osteopathic manipulative treatment (OMT) encompasses a wide range of diagnostic and treatment techniques for many conditions, but few studies have evaluated OMT use on injured patients.
Objectives: We aimed to describe the use of OMT on injured patients from a nationwide sample of emergency department (ED) encounters.
Methods: We performed a retrospective analysis of the 2018-2022 Nationwide Emergency Department Sample (NEDS) datasets. We included all ED encounters with an injury diagnosis as well as an osteopathic diagnosis or treatment, including International Classification of Diseases - Tenth Revision (ICD-10) Clinical Modification (CM) codes M9900-M9909, ICD-10 Procedure Coding System (PCS) codes 7W00X07-7W09X9Z, and Current Procedural Terminology/Healthcare Common Procedure Coding System (CPT/HCPCS) codes 98925-98929. We calculated the Injury Severity Score (ISS) and the predicted probability of injury-related in-hospital mortality for each encounter utilizing the ROCmax method. Except for counts, all statistics at the encounter level are weighted to account for the complex survey design.
Results: Among 29,966,447 ED encounters with an injury diagnosis within the study period, we identified 1,686 with at least one osteopathic diagnosis or treatment code, 6.0 per 100k injury encounters (95 % confidence interval [CI] 4.2 to 8.2). A minority of encounters (574 [35.5 %]) were at level 1 or 2 trauma centers. Although 677 (39.7 %) were admitted, the median ISS was only 1 (interquartile range [IQR 1, 4]), and only 62 (2.9 %) had computed tomography (CT) orders. The predicted probability of injury-related mortality was low, 1.5 % (IQR 1.3, 2.0). Most encounters had a somatic dysfunction diagnosis without an osteopathic treatment code, 1,239 (75.9 %). The most common site of injury, as well as the body area with somatic dysfunction diagnosis and osteopathic treatment, was the thorax.
Conclusions: In this nationwide sample, few injured ED patients received OMT, the majority only received a somatic dysfunction diagnosis without osteopathic treatment, and most had minor injuries. These results offer real-world insights into the use of OMT among injured ED patients and may inform efforts to promote its adoption.
Context: The clinical relationship between cardiovascular disease and deleterious surgical outcomes has been extensively examined; however, the relationship between cardiovascular risk and the association with major surgical interventions has yet to be examined at the population level. Previous use of National Health and Nutrition Examination Survey (NHANES) data has investigated the relationship between cardiometabolic risk and a history of bariatric surgery, suggesting that NHANES population data may be a useful tool to uncover a primary association and provide insight into subgroup effects.
Objectives: This study attempts to quantify the relationships between cardiovascular risk factors and the history of open-chest or abdominal surgery.
Methods: We analyzed de-identified NHANES data from January 2007 through March 2020 for US adults ≥20 years of age selected via stratified multistage sampling (participants with missing data were excluded; Institutional Review Board [IRB] not required). We extracted self-reported history of open-chest/abdominal surgery (binary), seven metabolic/cardiovascular biomarkers (hemoglobin A1c [HbA1c], low-density lipoprotein [LDL], triglycerides, total cholesterol, systolic/diastolic blood pressure [SBP/DBP], high-density lipoprotein [HDL]), and covariates (race/ethnicity, gender, education, insurance, income-to-poverty ratio). Associations were estimated as odds ratios (ORs) utilizing survey-weighted logistic regression in STATA 16 adjusted for all covariates (two-sided α=0.05), with subpopulation logistic models for subgroup analyses by HbA1c.
Results: The elevated HbA1c level was the only variable that was statistically significant, with an OR of 1.14 (95 % confidence interval [CI], 1.06-1.23). Secondary subgroup analyses demonstrated differential impacts: Non-Hispanic White, individuals without insurance, those with a lower income-to-poverty ratio, females, and individuals with less than a ninth-grade education or a high school/General Education Development (GED) equivalent were more likely to have a surgical history as HbA1c levels increased.
Conclusions: A significant association exists between elevated HbA1c levels and a history of open-chest or abdominal surgery. Specific subgroups are at greater risk and may be disproportionately affected by the downstream consequences of higher HbA1c levels.
Context: The finalization of the Single Accreditation System (SAS) in 2020 resulted in the combined residency training of both allopathic (MD) and osteopathic (DO) graduates and has raised concerns about residency position availability for DO applicants in competitive specialties.
Objectives: The purpose of this study was to evaluate formerly American Osteopathic Association (AOA) - accredited orthopaedic surgery programs to identify the prevalence of DO degrees among program directors and residents, and stratify the association of program geography, program director degree, and osteopathic recognition status on resident composition.
Methods: A retrospective review of formerly AOA orthopaedic surgery programs was performed. Database information, program websites, and social medial profiles were used to determine program director degree and degree of all residents during academic year 2023-2024. Osteopathic Recognition status and program location were recorded. Associations were analyzed using chi-square and Fisher's Exact Test.
Results: Of the 36 identified formerly AOA programs, 12 (33.3 %) had an MD program director. Among 561 residents in these programs, there were 43 MD residents. MD residents were more likely to train under an MD program director (p < 0.01). Programs with a DO program director were significantly more likely to train zero MD residents (p < 0.01). Programs located in the Midwest trained the highest proportion of DOs (97.2 %, p < 0.01). All 5 programs with Osteopathic Recognition were training zero MD residents during the study period.
Conclusions: The increase in MD leadership in formerly AOA-accredited programs and the associated increase of MD residents in those programs that has occurred since the advent of the Single Accreditation System should be of concern to osteopathic leadership, who are dedicated to matching well qualified DO graduates into increasingly competitive residency positions such as those in orthopaedic surgery.
Context: The Comprehensive Osteopathic Medical Licensing Examination of the United States (COMLEX-USA) is a three-level national standardized licensure examination designed for the practice of osteopathic medicine. Following several years of analysis and considering input from across the continuum of osteopathic medical education, training, and licensure, the National Board of Osteopathic Medical Examiners (NBOME) transitioned COMLEX-USA Level 1 (Level 1) score reporting from a numeric score with a pass/fail result to a pass/fail result only beginning with the 2022-2023 testing cycle in May 2022.
Objectives: The purpose of this study is to investigate the differences in student Level 1 self-reported stress levels, test preparation, and performance following the transition to pass/fail score reporting.
Methods: The study utilized data from Level 1, including end-of-examination survey responses from first-time test takers in the 2023-2024 administration and examination performance data from first-time test takers across the 2021-2022, 2022-2023, and 2023-2024 administrations. The analysis examined changes in three key outcomes: self-reported stress during examination preparation, perceived examination preparation, and performance on Level 1 examination.
Results: After Level 1 transitioned to pass/fail score reporting, 60 % of students responding to the 2023-2024 end-of-examination survey reported reduced stress in Level 1 examination preparation, and 75 % of respondents reported no change in preparation time. In the first testing cycle after the transition, declines were observed in several performance indicators, including pass rate and the mean, standard deviation, and maximum of z-scores (converted from Level 1 numeric scores). In the subsequent cycle, the pass rate rebounded and the mean z-score stabilized, while both the standard deviation and maximum z-score continued to decline.
Conclusions: The COMLEX-USA series is designed as a licensure examination to assess competencies essential for the practice of osteopathic medicine. Passage of Level 1 indicates that a student has demonstrated competence in the foundational biomedical sciences, osteopathic principles, and related physician competency domains to enter supervised patient care settings. The transition in score reporting for Level 1 preserves that purpose. This study provides preliminary insights into the perceived differences in students' stress level, examination preparation, and examination performance patterns following the change of score reporting. Further study will be conducted as these students transition through their osteopathic education.
Context: Osteoporosis is a prevalent chronic disease associated with fractures, reduced quality of life, and substantial healthcare costs. Randomized controlled trials (RCTs) are essential for developing effective treatments, but when trials are discontinued or unpublished, valuable data are lost. This results in unnecessary costs and exposes thousands of participants to interventions without contributing to clinical care.
Objectives: This study aims to evaluate the rates and characteristics of discontinuation and nonpublication among US-registered phase 3 and 4 RCTs investigating osteoporosis therapies from 2000 to 2022.
Methods: Phase 3 and 4 osteoporosis-related RCTs were identified through ClinicalTrials.gov. Trial completion and publication status were determined utilizing multiple databases and researcher contact. Chi-square and Fisher's exact tests assessed the associations between trial characteristics and outcomes.
Results: Of 303 trials, 29 (9.6 %) were discontinued, and 274 (90.4 %) completed. Among completed trials, 124 (45.3 %) remained unpublished. Discontinuation was significantly more common in nonindustry-funded and single-center trials (p<0.01, p=0.04). Nonpublication was more frequent among industry-funded and internationally recruited trials (p<0.01, p=0.01).
Conclusions: Nearly half of osteoporosis RCTs were either discontinued or unpublished, representing a substantial loss of clinical data, financial inefficiency, and ethical concerns. These findings mirror patterns observed in other therapeutic areas, underscoring systemic challenges in clinical research transparency. Strengthening feasibility assessments, enforcing reporting mandates, and addressing structural barriers to trial completion and publication are essential to safeguard research integrity and ensure that patient contributions meaningfully inform medical knowledge.
Context: The benefits of breastfeeding are well established, from reduced incidence of common childhood infections to decreased incidence of sudden infant death syndrome and infant mortality. Offering support to breastfeeding mothers should be a key aspect of care in the perinatal period.
Objectives: The purpose of this study was to evaluate whether utilization of a standardized osteopathic manipulative treatment (OMT) protocol as an adjunct to lactation support improves feeding dysfunction in breastfed newborns.
Methods: This was a single-blinded, randomized, controlled, prospective pilot study of healthy, full-term neonates identified by an International Board Certified Lactation Consultant (IBCLC) as having feeding dysfunction. Neonates were subsequently randomized in an alternating fashion into an OMT protocol treatment vs. sham treatment. Infant LATCH (Latch, Audible swallowing, Type of nipple, Comfort of birth person, and Help birthing person needs holding infant to breast) scores were assessed by nurses and IBCLCs during hospitalization assessed with mean and median score improvement between groups.
Results: Forty infants were included in the study, divided into a sham group (n=21) and OMT group (n=19). The groups had similar characteristics. The change between pre- and postintervention LATCH scores were calculated for each group, respectively. The mean LATCH score change in the OMT group was 2.0±1.8. The mean LATCH score change in the sham group was 0.9±1.2. The mean LATCH score change in the OMT group is statistically significantly greater than the mean LATCH score change in the sham group (p=0.030), indicating that the OMT group had greater improvement in their LATCH score compared to the sham group.
Conclusions: Healthy newborns with feeding dysfunction who were randomized to receive two OMT treatments during their hospitalization demonstrated a statistically significant moderate improvement in the changes in the median modified LATCH score compared with newborns randomized to the sham group. However, the effect size was moderate, at best. The LATCH score changes between groups cannot be highly attributed to the OMT interventions. However, there were no adverse effects of treatment. These findings suggest that OMT may be a safe adjunct to traditional lactation support in the care of healthy breastfed newborns with feeding dysfunction. Future studies could investigate other factors, such as the length of time that mothers breastfeed their infants after the two initial treatment sessions or potentially including a separate arm for neonates with ankyloglossia.
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