A randomized, controlled trial of osteopathic manipulative treatment for acute low back pain in active duty military personnel.
ABSTRACT: 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.
Project description: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.
Project description:Chronic pain is a common condition that often interferes with work or other activities. Guidelines support the use of non-pharmacological treatments, such as spinal manipulation, in patients with chronic pain. Osteopathic physicians in the United States are uniquely positioned to manage chronic pain because their professional philosophy embraces the biopsychosocial model and they are trained in the use of osteopathic manipulative treatment (OMT) to complement conventional medical care. This narrative review provides current perspectives on the osteopathic approach to chronic pain management, including evidence for the efficacy of OMT based on systematic searches of the biomedical literature and the ClinicalTrials.gov database. Men, persons with low levels of education, and non-White and Hispanic patients are significantly less likely to have received OMT during their lifetime. Patients with low back and neck pain are most likely to be treated with OMT, and osteopathic manipulative medicine specialty physicians and family medicine physicians most often use OMT. However, many osteopathic physicians report using OMT infrequently. Although OMT is considered safe, based on millions of patient encounters over more than a century, there is limited evidence on its efficacy in treating chronic pain. The lone exception involves chronic low back pain, wherein there is evidence from systematic reviews, a large clinical trial, and observational studies. There is lesser evidence to support cost effectiveness and patient satisfaction associated with OMT for chronic pain. The only clinical practice guideline established by the American Osteopathic Association recommends that OMT should be used to treat chronic low back pain in patients with somatic dysfunction. Given the philosophy of osteopathic medicine, universal training of osteopathic physicians to use OMT, and national guidelines supporting non-pharmacological treatments for chronic pain, it is unclear why OMT use is reported to be remarkably low in physician surveys.
Project description: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.
Project description: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.
Project description: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."
Project description:Low back pain is highly prevalent and one of the most common causes of disability in U.S. armed forces personnel. Currently, no single therapeutic method has been established as a gold standard treatment for this increasingly prevalent condition. One commonly used treatment, which has demonstrated consistent positive outcomes in terms of pain and function within a civilian population is spinal manipulative therapy provided by doctors of chiropractic. Chiropractic care, delivered within a multidisciplinary framework in military healthcare settings, has the potential to help improve clinical outcomes for military personnel with low back pain. However, its effectiveness in a military setting has not been well established. The primary objective of this study is to evaluate changes in pain and disability in active duty service members with low back pain who are allocated to receive usual medical care plus chiropractic care versus treatment with usual medical care alone.This pragmatic comparative effectiveness trial will enroll 750 active duty service members with low back pain at three military treatment facilities within the United States (250 from each site) who will be allocated to receive usual medical care plus chiropractic care or usual medical care alone for 6 weeks. Primary outcomes will include the numerical rating scale for pain intensity and the Roland-Morris Disability Questionnaire at week 6. Patient reported outcomes of pain, disability, bothersomeness, and back pain function will be collected at 2, 4, 6, and 12 weeks from allocation.Because low back pain is one of the leading causes of disability among U.S. military personnel, it is important to find pragmatic and conservative treatments that will treat low back pain and preserve low back function so that military readiness is maintained. Thus, it is important to evaluate the effects of the addition of chiropractic care to usual medical care on low back pain and disability.The trial discussed in this article was registered in ClinicalTrials.gov with the NCT01692275 Date of registration: 6 September 2012.
Project description: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.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.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.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.
Project description:Objective: To investigate the action of osteopathic manipulative treatment on the muscular activity of the stomatognathic apparatus by using surface electromyography (sEMG). Material and Methods: Surface electromyography (sEMG) was performed on the masseter and anterior temporalis muscles of 120 subjects (73 F; 47 M), both at time T0 and T2. The sample was divided into three randomized groups of 40 subjects each: control, placebo, and osteopathic manipulative treatment (OMT). In the T1 interval between the two evaluations, the control group was not treated, the placebo group underwent a placebo treatment, and the OMT group underwent manipulative treatment. The mean value of each measurement and its coefficient of variation, between time T0 and T2, were calculated for both the intragroup (OMT, placebo, control) and the intergroup (OMT-placebo, OMT-control). Outcomes: In 40% of the subjects, statistically significant improvements were highlighted in the OMT. Whereas, the statistically significant results of the placebo and control groups were 7.5% and 17.5%, respectively, of which more than 75% moved away from the physiological range, showing a worsening of the muscular activity. This analysis showed statistically significant variations (p ? 0.05) in the OMT group compared to the placebo and the control groups. Conclusions: OMT determines variations of the activity of masticatory muscles.
Project description:The purpose of the present case study was to explore the efficacy of osteopathic manipulative treatment (OMT) in patient with pulmonary fibrosis (PF) in the critical care outpatient department. Here, we present a 48-year-old male case with breathlessness, increased frequency of defecation, and pain in and around the nape of neck with diagnosed pulmonary fibrosis. He scored 3 on a patient-reported modified Medical Research Council (mMRC) dyspnea scale. Osteopathic examination reveals multiple somatic findings across the chest and abdominal region and treated by OMT. Pre- and post-intervention changes were assessed by the 13-item shortness of breath with daily activities (13iSOBDA). 27.2, 22, 16.4, and 11.8 were noted at the end of 1st, 2nd, 3rd, and 4th week of intervention, respectively, on 13iSOBDA while mMRC decreased from 3 to 1. OMT may be a feasible option in decreasing the symptoms of the PPF in the critical care outpatient department.
Project description:PURPOSE:The aim of present study was to study the effect of osteopathic manipulation on pain relief and quality of life improvement in hospitalized oncology geriatric patients. METHODS:A nonrandomized controlled clinical trial was performed in the Oncology Rehabilitation Unit, Milan, Italy, from September 2015 to March 2016. Twenty-three older cancer patients were enrolled and allocated in 2 experimental groups: the study group (OMT group, N = 12) underwent osteopathic manipulative treatment in addition to physiotherapy, and the control group (PT group, N = 12) underwent only physiotherapy. At enrollment (T0), 24 recruited oncology patients completed the sociodemographic forms and were evaluated for pain intensity and quality of life by an external examiner. All patients were revaluated every week (T1, T2, T3, and T4) for pain intensity and at the end of the study treatment (T4) for quality of life. A standard level of significance was set at ? < .05. RESULTS:The 2 groups did not significantly differ in age ( P = .682), body mass index ( P = .413), or gender ( P = 1). The osteopathic manipulative treatment added to physiotherapy produced a significant reduction in Numeric Rating Scale (NRS) scores both at T2 ( P = .004) and T4 ( P = .002). The difference in quality of life improvements between T0 and T4 was not statistically significant. NRS improved in the PT group at T4. Between-group analysis of NRS and quality of life with the Mann-Whitney test did not show any significant difference between the 2 treatments. CONCLUSIONS:Our study showed a significant improvement in pain relief and a nonsignificant improvement in quality of life in hospitalized geriatric oncology patients during osteopathic manipulative treatment. TRIAL REGISTRATION:Protocol registered on Clinicaltrials.gov (NCT03142386).