[Show abstract][Hide abstract] ABSTRACT: 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.
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.
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.
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.
Full-text · Article · Jul 2014 · American Journal of Obstetrics and Gynecology
[Show abstract][Hide abstract] ABSTRACT: 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.
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.
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.
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.
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.
No preview · Article · Feb 2014 · The Journal of the American Osteopathic Association
[Show abstract][Hide abstract] ABSTRACT: 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.
One hundred subjects were recruited at 30 weeks gestation.
The obstetric clinics of UNTHealth in Fort Worth, TX.
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).
Blood pressure and heart rate were recorded during 5min of head-up tilt followed by 4min of intermittent heel raising.
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.
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.
No preview · Article · Dec 2013 · Complementary therapies in medicine
[Show abstract][Hide abstract] ABSTRACT: 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.
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.
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).
These data support the hypothesis that upper cervical spine manipulation can acutely affect measures of heart rate variability in healthy individuals.
No preview · Article · Sep 2012 · Journal of alternative and complementary medicine (New York, N.Y.)
[Show abstract][Hide abstract] ABSTRACT: 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.
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).
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).
This study supports the effectiveness of OMT in reducing ALBP pain in active duty military personnel.
No preview · Article · Feb 2012 · The Journal of manual & manipulative therapy
[Show abstract][Hide abstract] ABSTRACT: 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.
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.
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.
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.
Full-text · Article · Mar 2010 · Osteopathic Medicine and Primary Care
[Show abstract][Hide abstract] ABSTRACT: To study osteopathic manipulative treatment of back pain and related symptoms during the third trimester of pregnancy.
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.
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.
Osteopathic manipulative treatment slows or halts the deterioration of back-specific functioning during the third trimester of pregnancy.
Full-text · Article · Sep 2009 · American journal of obstetrics and gynecology
[Show abstract][Hide abstract] ABSTRACT: Background: Community acquired pneumonia (CAP) is a major health care issue with significant morbidity, mortality and cost. The Multicenter Osteopathic Pneumonia Study in the Elderly (MOPSE) assessed the impact of adjunctive osteopathic manual treatment (OMT) in patients ≥50 years old hospitalized with pneumonia.
Methods: MOPSE is a registered, randomized, controlled, blinded clinical trial. Seven community hospitals in 5 states participated. Subjects (N=406) ≥50 years old were randomized into a conventional care (CC), light touch (LT) plus CC, or OMT plus CC group. Standardized adjunctive OMT and LT treatments lasting 15 minutes were initiated within 24 hours of admission and administered twice daily. Treatment endpoints were hospital discharge, intubation or death. Results: Subgroup analysis examined subjects with CAP (N=306, 144 male, 162 female), 171 in the 50 - 74 years age group and 135 in the group >75 years. There were no differences between the groups on Pneumonia Severity Index. Per-protocol analysis for 50 - 74 age group (N= 141) showed a reduction in the length of hospitalization (LOH) in the OMT group compared to the LT and CC groups (median (95% CI) 2.9 days (2.7.-3.4) vs 3.5 (2.9-4.5) & 3.9 (3.2-4.5); P=.02). There was no difference in LOH in those >75 (N=112, P=.21). In the intention-to-treat (ITT) analysis, there was no difference in LOH for either age group. In the ITT analysis, mortality was decreased in the OMT and LT groups compared to CC in the >75 age group only (0% & 0% vs 9%; P= .04).
Conclusions: There was a significant reduction in LOH for the OMT group of 1 day compared to the CC group and 0.6 days compared to the LT group by per-protocol analysis of CAP patients aged 50-74. This could reduce the cost of inpatient management of CAP. ITT analysis showed a significant decrease in mortality in both the OMT and LT groups in the >75 age group. With the small sample size, conclusions are limited, but considering the prevalence of CAP, adjunctive OMT merits further study.
[Show abstract][Hide abstract] ABSTRACT: Pneumonia in elderly patients is a major public health concern because of greater morbidity and mortality and longer hospital stays relative to younger populations. Based on the premise that osteopathic manipulative treatment (OMT) is beneficial in the management of pulmonary infections, the Multicenter Osteopathic Pneumonia Study in the Elderly (MOPSE) was designed as a prospective randomized controlled trial to evaluate the efficacy of OMT as an adjunct to the current pharmacologic treatment of elderly patients hospitalized for pneumonia. The protocol developed for MOPSE has its origins in early osteopathic medical literature at a time when effective antibiotic therapy was unavailable and osteopathic physicians relied on physical examination and empiric reasoning to develop treatment strategies and OMT techniques to improve host defenses against pneumonia. The present paper reviews the early osteopathic medical literature to identify the reasoning behind the OMT techniques that are the basis for the design of the MOPSE protocol. Likewise, the contemporary medical literature relevant to the protocol is reviewed. Finally, a description of the study design and the OMT and light touch (sham) protocols used in MOPSE are provided.
No preview · Article · Oct 2008 · The Journal of the American Osteopathic Association
[Show abstract][Hide abstract] ABSTRACT: 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.
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.
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.
Full-text · Article · Feb 2008 · Osteopathic Medicine and Primary Care
[Show abstract][Hide abstract] ABSTRACT: Introduction: During pregnancy, a woman’s body is challenged by significant physiological and biomechanical changes which can adversely affect normal function, mobility and quality of life. These changes may also contribute to co-morbid conditions accompanying pregnancy. Osteopathic manipulative medicine (OMM) is theorized to facilitate the body’s adjustment to the physiological and biomechanical demands of pregnancy and improve the outcomes of pregnancy, labor and delivery. Thus, this dissertation research was designed to examine the possible effects of an acute regimen of OMM on the autonomic and hemodynamic control mechanisms and gait and mobility function in women during the third trimester of pregnancy.Methods: Two studies were performed with 60 women at the 30th week of pregnancy. Study 1: The hemodynamic and autonomic (heart rate variability) responses to head-up tilt with and without engagement of the muscle pump via toe raising were assessed before and after a regimen of either randomly assigned OMM, sub-therapeutic placebo ultrasound, or a timecontrol. Study 2: Assessment of a cadre of gait parameters and functions was performed before and after application of the same randomized treatment regimens.Results: In Study 1, the response to tilt was not affected by OMM or placebo ultrasound, however, the systolic blood pressure response to toe raising was increased after OMM and was accompanied by a lower heart rate and enhanced vagal control of heart rate. In study 2, there were no statistically significant differences between groups at baseline. In addition, there were no statistically significant differences between pre-and post-treatment values for any spatiotemporal gait parameters. However, improvements in stride width and base of support trended toward significance.Conclusions: These data suggest that OMM improved hemodynamic control during engaging of the skeletal muscle pump that was most likely due to improvement of structural impediments to venous return. The gait data fail to elucidate a significant effect of OMM on gait parameters during the third trimester of pregnancy.