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Context: Sixty thousand people are diagnosed with Parkinson's disease (PD) each year, making it the second most common neurodegenerative disorder. PD results in a variety of gait disturbances, including muscular rigidity and decreased range of motion (ROM), that increase the fall risk of those afflicted. Osteopathic manipulative treatment (OMT) emphasizes the central role of the musculoskeletal system, which could be ideal for addressing the somatic dysfunction associated with neurodegeneration in PD. The close anatomical relationship of structures implicated in PD within the skull and the increased frequency of strain patterns raise the question of whether osteopathic cranial manipulative medicine (OCMM) can improve gait performance by improving circulation to the affected nervous tissue. However, there have been few studies in recent years that explore the effects of a standardized OMT protocol on Parkinsonian gait characteristics, and there have been few studies that include OCMM techniques., Objectives: This study aims to determine whether a single session of OMT or OMT + OCMM can improve the gait of individuals with PD by addressing joint restrictions in the sagittal plane and by increasing ROM in the lower limb., Methods: The following study is a two-group, randomized controlled trial in which individuals with PD (n=45) and age-matched healthy control participants (n=45) were recruited from the community. PD participants were included if they were otherwise healthy, able to stand and walk independently, had not received OMT or physical therapy (PT) within 30 days of data collection, and had idiopathic PD in Hoehn and Yahr stages 1.0-3.0. PD participants were randomly assigned to one of three experimental treatment protocols: a 'whole-body' OMT protocol (OMT-WB), which included OMT and OCMM techniques; a 'neck-down' OMT protocol (OMT-ND), including only OMT techniques; and a sham treatment protocol. Control participants were age-matched to a PD participant and were provided the same OMT experimental protocol. An 18-camera motion analysis system was utilized to capture 3-dimensional (3D) position data in a treadmill walking trial before and after the assigned treatment protocol. Pretreatment and posttreatment hip, knee, and ankle ROM were compared with paired t-tests, and joint angle waveforms during the gait cycle were analyzed with statistical parametric mapping (SPM), which is a type of waveform analysis., Results: Individuals with PD had significantly reduced hip and knee extension in the stance phase compared to controls (32.9-71.2% and 32.4-56.0% of the gait cycle, respectively). Individuals with PD experienced a significant increase in total sagittal hip ROM (p=0.038) following a single session of the standardized OMT-WB treatment protocol. However, waveform analysis found no significant differences in sagittal hip, knee, or ankle angles at individual points of the gait cycle following OMT-WB, OMT-ND, or sham treatment protocols., Conclusions: The increase in hip ROM observed following a single session of OMT-WB suggests that OCMM in conjunction with OMT may be useful for improving gait kinematics in individuals with PD. Longitudinal studies over multiple visits are needed to determine the long-term effect of regular OMT and OMT+OCMM treatments on Parkinsonian gait characteristics., (© 2022 Zachary T. Terrell et al., published by De Gruyter, Berlin/Boston.)

Background: The technique for the compression of the fourth ventricle (CV4) in the brain has been described as a method of reaching the physiologic centers that reside in its floor and of restoring optimal flow of the cerebrospinal fluid. However, a study published as an abstract in 1992 questioned whether CV4, when applied to pregnant women, could induce uterine contractions and possibly labor., Objective: To further examine whether CV4 could induce uterine contractions and labor as part of the osteopathic manipulative treatment (OMT) protocol used in the Pregnancy Research in Osteopathic Manipulation Optimizing Treatment Effects (PROMOTE) study., Methods: Labor and delivery data collected during the PROMOTE study from 2007-2011 were analyzed. The PROMOTE study was funded by the National Institutes of Health and was a randomized controlled clinical trial that measured the primary outcomes of back-specific functioning and pain in pregnant women aged 18 to 34 years. Participants were randomly divided into 3 groups-usual obstetric care only, placebo ultrasound treatment plus usual obstetric care, and OMT plus usual obstetric care. Study participants were scheduled for 7 treatment visits. Presented data were gathered from labor and delivery records., Results: Four hundred participants were included. No significant differences were identified between treatment groups for the development of high-risk status (P=.293) or preterm delivery (P=.673). Evaluation of high-risk status by preterm delivery for the groups also showed no significant differences between groups (P=.455)., Conclusion: The application of CV4 as part of an OMT protocol during the third trimester caused neither a higher incidence of preterm labor nor the development of high-risk status.

Background: Few quality data exist on the safety of osteopathic manipulative treatment (OMT) during pregnancy. The Pregnancy Research on Osteopathic Manipulation Optimizing Treatment Effects (PROMOTE) study was a randomized controlled clinical trial that studied the application of an OMT protocol to manage pain and dysfunction in pregnant patients during their third trimester., Objective: To evaluate the safety of an OMT protocol applied during the third trimester of pregnancy by analyzing incidence of high-risk status and labor and delivery outcomes., Methods: In the PROMOTE study, 400 pregnant patients were randomly assigned to 1 of 3 study groups: usual care plus OMT (OMT), usual care plus placebo ultrasound treatment (PUT), or usual care only (UCO). The incidence of high-risk status of participants and outcomes of labor and delivery, including length of labor, fever in mother during labor, operative vaginal delivery, conversion to cesarean delivery, need for forceps or vacuum device, need for episiotomy, incidence of perineal laceration, meconium-stained amniotic fluid, and infants' Apgar scores, were analyzed., Results: Data from 380 participants were studied. High-risk status was less likely to develop in participants who received OMT (95% CI, 0.16-0.91; P=.03). The OMT protocol also did not increase risk of precipitous labor, operative vaginal delivery, conversion to cesarean delivery, need for forceps or vacuum device, need for episiotomy, incidence of perineal laceration, or meconium-stained amniotic fluid when compared with participants in the other 2 groups (P>.05). Of all other maternal outcomes examined, no difference was reported among the 3 treatment groups with the exception of incidence of prolonged labor in the OMT group. Participants receiving OMT had longer durations of labor than participants in the other groups (P=.002)., Conclusion: These results suggest that the OMT protocol given during the third trimester of pregnancy as applied in the PROMOTE study is safe with regard to labor and delivery outcomes. The increased duration in labor in the OMT group needs further study. (ClinicalTrials.gov number NCT00426244).

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.

Objective: The purpose of this study was to evaluate the efficacy of osteopathic manipulative treatment (OMT) to reduce low back pain and improve functioning during the third trimester in pregnancy and to improve selected outcomes of labor and delivery., Study Design: Pregnancy research on osteopathic manipulation optimizing treatment effects was a randomized, placebo-controlled trial of 400 women in their third trimester. Women were assigned randomly to usual care only (UCO), usual care plus OMT (OMT), or usual care plus placebo ultrasound treatment (PUT). The study included 7 treatments over 9 weeks. The OMT protocol included specific techniques that were administered by board-certified OMT specialists. Outcomes were assessed with the use of self-report measures for pain and back-related functioning and medical records for delivery outcomes., Results: There were 136 women in the OMT group: 131 women in the PUT group and 133 women in the UCO group. Characteristics at baseline were similar across groups. Findings indicate significant treatment effects for pain and back-related functioning (P < .001 for both groups), with outcomes for the OMT group similar to that of the PUT group; however, both groups were significantly improved compared with the UCO group. For secondary outcome of meconium-stained amniotic fluid, there were no differences among the groups., Conclusion: OMT was effective for mitigating pain and functional deterioration compared with UCO; however, OMT did not differ significantly from PUT. This may be attributed to PUT being a more active treatment than intended. There was no higher likelihood of conversion to high-risk status based on treatment group. Therefore, OMT is a safe, effective adjunctive modality to improve pain and functioning during the third trimester., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Context: Randomized controlled trials (RCTs) are considered the standard for establishing practice guidelines; however, they are expensive and time-consuming, and often the generalizability of the results is limited., Objectives: To conduct an observational study using the findings of the American Osteopathic Association's Clinical Assessment Program (AOA-CAP) low back pain module, and to compare these findings with those of a major back pain-related RCT to determine the validity and generalizability of this pseudoexperimental model., Methods: Data were abstracted from the AOA-CAP for Residencies platform from April 1, 2006, through October 5, 2007, with a diagnosis code consistent with low back pain. Process and outcome measures were compared after segregating a similar patient population to an RCT that compared "osteopathic spinal manipulation" with standard care., Results: A total of 1013 medical records were abstracted and entered into the AOA-CAP low back pain module. Mean (standard deviation [SD]) age was 44.7 (15.9) years, and body mass index was 29.6 (8.1). The eligible patients comprised 415 men (41.0%) and 598 women (59.0%), and common comorbid disease was found in 69 patients (6.8%). Activities of daily living were limited in 402 patients (42.4%), whereas 546 (57.6%) had no limitations. Previous exacerbations of low back pain occurred in 653 patients (65.9%). Most patients had no sensory or proprioception deficit (729 [87.7%]), and motor function was normal in 636 patients (74.5%). Normal ankle and knee reflexes were found in 744 of 814 (91.4%) and 755 of 829 (89.0%) patients, respectively. Osteopathic manipulative treatment (OMT) was performed on the lumbar spine (576 patients [56.9%]), thoracic spine (411 [40.6%]), sacrum/pelvis (440 [43.4%]), rib (261 [25.8%]), and lower extremity (256 [25.3%]). A segregated patient cohort (n=539) showed statistically significant differences between patients who received OMT and those who did not with the use of analgesics, steroids, spinal injections, straight-leg raising, and days off or limited work duties., Conclusion: The observational findings of the present study, which suggest that analgesic medication use is lower in patients who receive OMT, align with previous findings of RCTs and support the generalizability of these findings.

Objectives: The physiological changes that occur during pregnancy, including increased blood volume and cardiac output, can affect hemodynamic control, most profoundly with positional changes that affect venous return to the heart. By using Osteopathic Manipulative Treatment (OMT), a body-based modality theorized to affect somatic structures related to nervous and circulatory systems, we hypothesized that OMT acutely improves both autonomic and hemodynamic control during head-up tilt and heel raise in women at 30 weeks gestation., Design: One hundred subjects were recruited at 30 weeks gestation., Setting: The obstetric clinics of UNTHealth in Fort Worth, TX., Intervention: Subjects were randomized into one of three treatment groups: OMT, placebo ultrasound, or time control. Ninety subjects had complete data (N=25, 31 and 34 in each group respectively)., Main Outcome Measures: Blood pressure and heart rate were recorded during 5 min of head-up tilt followed by 4 min of intermittent heel raising., Results: No significant differences in blood pressure, heart rate or heart rate variability were observed between groups with tilt before or after treatment (p>0.36), and heart rate variability was not different between treatment groups (p>0.55). However, blood pressure increased significantly (p=0.02) and heart rate decreased (p<0.01) during heel raise after OMT compared to placebo or time control., Conclusions: These data suggest that OMT can acutely improve hemodynamic control during engagement of the skeletal muscle pump and this was most likely due to improvement of structural restrictions to venous return., (Copyright © 2013 Elsevier Ltd. All rights reserved.)

Objectives: Osteopathic manipulative treatment (OMT) focused on the upper cervical spine is theorized to affect the function of the vagus nerve and thereby influence the parasympathetic branch of the autonomic nervous system. This study was designed to determine the acute effect of upper cervical spine manipulation on cardiac autonomic control as measured by heart rate variability., Design: Nineteen healthy, young adult subjects underwent three different experimental interventions administered in random order: cervical OMT, sham manipulation, and time control. Six minutes of electrocardiographic data were collected before and after each intervention, and heart rate variability was assessed by both time-domain and frequency-domain measures., Results: No differences in resting heart rate or any measure of heart rate variability were observed between the baseline periods prior to each intervention. The OMT protocol resulted in an increase in the standard deviation of the normal-to-normal intervals (0.12±0.082 seconds, p<0.01), an increase in the high frequency spectral power (p=0.03), and a decrease in the low/high frequency spectral ratio (p=0.01) relative to the sham and time control conditions. No significant differences between sham and time control were observed (p>0.11 for all variables)., Conclusions: These data support the hypothesis that upper cervical spine manipulation can acutely affect measures of heart rate variability in healthy individuals.

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., (2010 Mosby, Inc.)

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 x 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: http://www.clinicaltrials.gov, NCT00315120.