Reported biological effects following Osteopathic Manipulative Treatment: A comprehensive mapping review.

BACKGROUND AND PURPOSE: Osteopathic Manipulative Treatment (OMT) is a therapeutic whole-body approach mainly focused on correcting somatic dysfunctions. The aim of this scoping review is to systematically map the literature regarding the documented biological effects observed following OMT. METHODS: The 2020 JBIRM version and the PRISMA-ScR were followed for the conceptualization and reporting of this review. The protocol was registered on the "Open Science Framework Registry" (https://doi.org/10.17605/OSF.IO/MFAUP). We searched for original articles published on Medline, Embase, and Scopus, from inception to the present. RESULTS: Overall, 10,419 records were identified. After duplicate removal, screening for title and abstract, and specific exclusions with reasons, a total of 146 studies were included. Wide differences were detected among studies in their geographical localization, study design, temporal distribution, participants' condition, OMT protocols, and documented biological effects. Such variety in frequency distribution was properly described through descriptive statistics. CONCLUSIONS: Biological modifications that appear to be induced by OMT have been detected in several body systems, but mostly in neurophysiological correlates and musculoskeletal changes. Results suggest a growing interest over the years on this topic, especially in the last two decades. More efforts in research are recommended to highlight whether such changes specifically depend on OMT, and to demonstrate its specific contribution to clinical practice.

Reliability and Validity of the Variability Model Testing Procedure for Somatic Dysfunction Assessment: A Comparison with Gait Analysis Parameters in Healthy Subjects.

Somatic dysfunction (SD) is an altered body function involving the musculoskeletal system. However, its clinical signs-tissue texture abnormalities, positional asymmetry, restricted range of motion, and tissue tenderness-did not achieve satisfactory results for reliability. A recent theoretical model proposed a revision assessing the movement variability around the joint rest position. The asymmetry and restriction of motion may characterize functional assessment in osteopathic clinical practice, demonstrating the reliability required. Hence, this study investigated the reliability of the new variability model (VM) with gait analysis (GA). Three blind examiners tested 27 young healthy subjects for asymmetry of motion around rest position and the SD grade on six body regions. The results were compared to the VICON procedure for 3D-GA. The inter-rater agreement for the detection of reduced movement variability ranged from 0.78 to 0.54, whereas for SD, grade ranged from 0.64 to 0.47. VM had a sensitivity and specificity of 0.62 and 0.53, respectively, in SD detection compared to step length normality. Global severity grade of SD demonstrated moderate to good correlation with spatial-temporal parameters. The VM showed palpatory reliability and validity with spatial-temporal parameters in GA. Those findings contribute to the innovation for SD examination with implications for the clinical practice.

Effectiveness of Osteopathic Manipulative Treatment in Adults with Irritable Bowel Syndrome: A Systematic Review and Meta-Analysis.

The aim of this systematic review and meta-analysis was to evaluate the effectiveness of the osteopathic manipulative treatment (OMT) in adults with irritable bowel syndrome (IBS). A literature resview was carried out on the following databases: PubMed, Embase, Cochrane, Cinahl, Scopus, PEDro and ClinicalTrials.gov. 350 articles were recovered. Eligibility criteria were evaluated by two independent reviewers, including randomized controlled trials (RCTs), quasi-RCTs, or ongoing RCTs with OMT compared to any kind of control in patients diagnosed with IBS. Six studies (five RCTs and one ongoing RCT) were considered eligible. Four RCTs were classified as some concerns and one as high risk of bias. In the meta-analysis, OMT compared to sham/no intervention showed statistically significant results for abdominal pain (effect size ES = -1.14 [-1.66, -0.62]; p < 0.0001) and constipation (ES = -0.66 [-1.12, -0.20]; p = 0.005). Instead, OMT was not superior to the control for the IBS symptoms measured with the IBS Severity Score and the Likert scale (ES = -0.34 [-0.83, 0.16]; p = 0.19), and diarrhea (ES = -1.20 [-2.84, 0.43]; p = 0.15). The quality of evidence was "low" for IBS symptoms in general for abdominal pain and constipation, while it was judged as "very low" for diarrhea. OMT turns out to be safe in the treatment of IBS without major adverse effects. OMT may be effective in IBS patients, however the results must be interpreted carefully due to the low methodological quality of the studies.

Fast improvements in functional status after osteopathic manipulative treatment based on myofascial release in patients with moderate or severe fibromyalgia: a retrospective study.

OBJECTIVES: Fibromyalgia (FM) is a chronic pain syndrome characterized by a large variety of symptoms. Evidence suggests that an alteration of central nervous system processing of pain could be involved. The purpose of this study is to analyze clinical records of patients affected by FM who underwent osteopathic manipulative treatment (OMT), predominantly based on a myofascial release approach (MFR). METHODS: This retrospective study considered records of 21 FM patients with moderate or severe functional impact, who consented to OMT in addition to their usual care. The assessment considered the following measures: FIQ (functional status), SF36 (quality of life), VAS (pain), TSK (kinesiophobia) and PSQI (quality of sleeping). Patients were preliminarily assessed over a 1 month run-in phase, then after 1, 2 and 4 months; a 1 month follow-up was also considered. RESULTS: After one month, 71% of patients reported a decrease in functional impact and scores remained stable until follow-up (from 69.8 to 52.37, p≤0.001). Overall, after four months, patients improved their quality of life, with a score ranging from 33.47 to 42.6 (p≤0.05). We also observed a reduction of pain (p≤0.05). CONCLUSIONS: A series of OMT sessions based on MFR could play a therapeutic role in improving functional status, pain and quality of life over a period of 4 months.

Model-Base Estimation of Non-Invasive Ventilation Weaning of Preterm Infants Exposed to Osteopathic Manipulative Treatment: A Propensity-Score-Matched Cohort Study.

Ventilation weaning is a key intensive care event influencing preterm infants' discharge from a neonatal intensive care unit (NICU). Osteopathic manipulative treatment (OMT) has been recently introduced in some Italian NICUs. This retrospective cohort study tested if OMT is associated with faster non-invasive ventilation (NIV) weaning. The time to NIV weaning was assessed in very preterm and very low birth weight infants who either received or did not receive OMT. The propensity score model included gender, antenatal steroids, gestational age (GA), birth weight (BW), and Apgar score 5'. Out of 93 infants, 40 were included in the multilevel survival analysis, showing a reduction of time to NIV weaning for GA (HR: 2.58, 95%CI: 3.91 to 1.71, p < 0.001) and OMT (HR: 3.62, 95%CI: 8.13 to 1.61, p = 0.002). Time to independent ventilation (TIV) was modeled with GA and BW as dependent variables and OMT as the factor. A negative linear effect of GA and BW on TIV was shown. OMT exposure studied as the factor of GA had effects on TIV in infants born up to the 32nd gestational week. Preterm infants exposed to OMT were associated with earlier achievement of NIV weaning. This result, together with the demonstrated OMT safety, suggests the conduct of clinical trials in preterm infants younger than 32 weeks of GA.

Correlation between diminished vagal tone and somatic dysfunction severity in very and extremely low birth weight preterm infants assessed with frequency spectrum heart rate variability and salivary cortisol.

Osteopathic manipulative treatment (OMT) is evolving in the neonatal intensive care unit (NICU) setting. Studies showed its efficacy in length of stay and hospitalization costs reduction. Moreover, it was suggested that OMT has a modulatory effect on the preterm infants' autonomic nervous system (ANS), influencing saturation and heart rate. Even if OMT is based on the palpatory examination of the somatic dysfunctions (SD), there are controversies about its identification and clinical relevance. The objective of this study was to evaluate the inter-rater reliability, clinical characteristics, and functional correlation of the SD Grade score with the heart rate variability (HRV) and the salivary cortisol (sCor) using a multivariate linear model approach. To evaluate those features, we implemented an ad hoc SD examination for preterm infants that was performed by 2 trained osteopaths. It was based on the new variability model of SD that includes an SD Grade assessment procedure. The ANS features were assessed by frequency parameters of HRV studying high frequency (HF), low frequency (LF), and HF/LF, whereas sCor was tested with a radioimmunoassay. The ANS assessment was standardized and performed before SD testing. Sixty-nine premature infants were eligible. SD Grade showed excellent concordance between the blinded raters. Using SD Grade as a grouping variable, the infants presented differences in GA, Apgar, pathological findings, length of stay, and ventilatory assistance. In our multivariate model, HF, LF, and LF/HF resulted linearly correlated with SD Grade. Instead, sCor presented a linear correlation with 5' Apgar and respiratory distress syndrome but not with SD Grade. SD Grade was in line with the natural history of the underdevelopment due to prematurity. Our models indicate that the cardiac vagal tone is linearly related with SD Grade. This finding may improve the multidisciplinary decision making inside NICU and the management of modifiable factors, like SD, for cardiac vagal tone regulation.

Beliefs and Use of Palpatory Findings in Osteopathic Clinical Practice: A Qualitative Descriptive Study among Italian Osteopaths.

The Italian government has started the regulatory process of osteopathy to include it among the healthcare professions mentioning terms, such as "perceptual palpation" and "somatic dysfunction" within the professional profile. 'Palpatory findings' are one of the multidimensional aspects that can inform osteopathic clinical reasoning. The non-regulated educational system has led to heterogenic professionals working in Italy, thus, the aim of this study was to investigate how Italian experts use palpatory findings in their clinical practice. A total of 12 experts were selected to participate in four virtual focus groups. A qualitative inductive approach with a constructivist paradigm was chosen to describe the results. The themes that emerged were: osteopathic identity; evaluation; osteopathic diagnosis; and sharing with different recipients. Participants agreed on the peculiarity and distinctiveness of osteopathic palpation, but there was some disagreement on the clinical significance of the findings, highlighting a complex multidimensional approach to diagnosis and treatment. The results seem to reflect the history of the profession in Italy, which has evolved quickly, leading professionals to seek new paradigms blending tradition and scientific evidence. The authors suggest further investigation to verify the state of art among osteopaths not involved in research or a broader consensus of the results.

Osteopathic Treatment for Gastrointestinal Disorders in Term and Preterm Infants: A Systematic Review and Meta-Analysis.

The aim of this systematic review and meta-analysis is to evaluate the effectiveness of osteopathic manipulative treatment (OMT) for gastrointestinal disorders in term and preterm infants. Eligible studies were searched on PubMed, Scopus, Embase, Cochrane, Cinahl, and PEDro. Two reviewers independently assessed if the studies were randomized controlled trials (RCTs) and retrospective studies with OMT compared with any kind of control in term or preterm infants to improve gastrointestinal disorders. Nine articles met the eligibility criteria, investigating OMT compared with no intervention, five involving term infants, and the remaining treating preterm infants. Five studies showed low risk of bias. In the meta-analysis, two studies were included to analyze the hours of crying due to infantile colic, showing statistically significant results (ES = −2.46 [−3.05, −1.87]; p < 0.00001). The quality of evidence was "moderate". The other outcomes, such as time to oral feeding, meconium excretion, weight gain, and sucking, were presented in a qualitative synthesis. OMT was substantially safe, and showed efficacy in some cases, but the conflicting evidence and lack of high-quality replication studies prevent generalization. High-quality RCTs are recommended to produce better-quality evidence.

Effectiveness of osteopathic interventions in patients with non-specific neck pain: A systematic review and meta-analysis.

OBJECTIVE: The aim of this systematic review and meta-analysis is to evaluate whether osteopathic manipulative interventions can reduce pain levels and enhance the functional status in patients with non-specific neck pain (NS-NP). METHODS: A systematic review and meta-analysis was conducted following the 2020 PRISMA statement. Randomized controlled trials (RCTs) were searched in five databases, assessed through a standardized form, and evaluated using the "13 items Cochrane risk of bias (RoB) tool". Effect sizes (ES) were calculated post-treatment, and the quality of evidence was assessed through GRADE criteria. RESULTS: Five articles were included in the review, and none of these was completely judged at low RoB. Four of these were included in the meta-analysis. Osteopathic interventions compared to no intervention/sham treatment showed statistically significant results for pain levels (ES = -1.57 [-2.50, -0.65]; P = 0.0008) and functional status (ES = -1.71 [-3.12, -0.31]; P = 0.02). The quality of evidence was "very low" for all the assessed outcomes. Other results were presented in a qualitative synthesis. CONCLUSIONS: Osteopathic interventions could be effective for pain levels and functional status improvements in adults with NS-NP. However, these findings are affected by a very low quality of evidence. Therefore, further high-quality RCTs are necessary to improve the quality of evidence and generalize the results.

Definition and classification for adverse events following spinal and peripheral joint manipulation and mobilization: A scoping review.

INTRODUCTION: Spinal and peripheral joint manipulation and mobilization are interventions used by many healthcare providers to manage musculoskeletal conditions. Although there are many reports of adverse events (or undesirable outcomes) following such interventions, there is no common definition for an adverse event or clarity on any severity classification. This impedes advances of patient safety initiatives and practice. This scoping review mapped the evidence of adverse event definitions and classification systems following spinal and peripheral joint manipulation and mobilization for musculoskeletal conditions in adults. METHODS: An electronic search of the following databases was performed from inception to February 2021: MEDLINE, EMBASE, CINAHL, Scopus, AMED, ICL, PEDro, Cochrane Library, Open Grey and Open Theses and Dissertations. Studies including adults (18 to 65 years old) with a musculoskeletal condition receiving spinal or peripheral joint manipulation or mobilization and providing an adverse event definition and/or classification were included. All study designs of peer-reviewed publications were considered. Data from included studies were charted using a standardized data extraction form and synthesised using narrative analysis. RESULTS: From 8248 identified studies, 98 were included in the final synthesis. A direct definition for an adverse event and/or classification system was provided in 69 studies, while 29 provided an indirect definition and/or classification system. The most common descriptors to define an adverse event were causality, symptom severity, onset and duration. Twenty-three studies that provided a classification system described only the end anchors (e.g., mild/minor and/or serious) of the classification while 26 described multiple categories (e.g., moderate, severe). CONCLUSION: A vast array of terms, definition and classification systems were identified. There is no one common definition or classification for adverse events following spinal and peripheral joint manipulation and mobilization. Findings support the urgent need for consensus on the terms, definition and classification system for adverse events related to these interventions.

Expert consensus on a standardised definition and severity classification for adverse events associated with spinal and peripheral joint manipulation and mobilisation: protocol for an international e-Delphi study.

INTRODUCTION: Spinal and peripheral joint manipulation (SMT) and mobilisation (MOB) are widely used and recommended in the best practice guidelines for managing musculoskeletal conditions. Although adverse events (AEs) have been reported following these interventions, a clear definition and classification system for AEs remains unsettled. With many professionals using SMT and MOB, establishing consensus on a definition and classification system is needed to assist with the assimilation of AEs data across professions and to inform research priorities to optimise safety in clinical practice. METHODS AND ANALYSIS: This international multidisciplinary electronic Delphi study protocol is informed by a scoping review and in accordance with the 'Guidance on Conduction and Reporting Delphi Studies'. With oversight from an expert steering committee, the study comprises three rounds using online questionnaires. Experts in manual therapy and patient safety meeting strict eligibility criteria from the following fields will be invited to participate: clinical, medical and legal practice, health records, regulatory bodies, researchers and patients. Round 1 will include open-ended questions on participants' working definition and/or understanding of AEs following SMT and MOB and their severity classification. In round 2, participants will rate their level of agreement with statements generated from round 1 and our scoping review. In round 3, participants will rerate their agreement with statements achieving consensus in round 2. Statements reaching consensus must meet the a priori criteria, as determined by descriptive analysis. Inferential statistics will be used to evaluate agreement between participants and stability of responses between rounds. Statements achieving consensus in round 3 will provide an expert-derived definition and classification system for AEs following SMT and MOB. ETHICS AND DISSEMINATION: This study was approved by the Canadian Memorial Chiropractic College Research Ethics Board and deemed exempt by Parker University's Institutional Review Board. Results will be disseminated through scientific, professional and educational reports, publications and presentations.

Osteopathy students profile in Italy: A cross sectional census.

INTRODUCTION: The Osteopathy Students Analysis (OSA) aims to profile osteopathy students in Italy as a target population in terms of sociodemographic characteristics, geographical distribution, health status, and previous and ongoing education specifications. MATERIALS AND METHODS: The OSA used a cross-sectional design. A Web-based survey was distributed to the Italian Osteopathic Education Institutions (OEIs). The OSA survey was composed of items organised into four sections: 1. Sociodemographic characteristics (11 items); 2. Geographical distribution (5 items); 3. Health status (3 items); 4. Previous and ongoing education specifications (16 items). A descriptive sample population analysis was performed. Dichotomous and categorical variables were presented as frequencies and percentages, and continuous variables were displayed as means and standard deviations. Some variables were analysed using a pentenary distribution. RESULTS: 49 out of the 61 OEIs identified matched the inclusion criteria, and among these, 22 accepted to propose the enrolment of their students into the study. The survey was administered to 4,720 students from all the participant OEIs. A total of 3,762 students responded to the survey, accounting for an estimated response rate of 53.7%. The majority of respondents were men (54%), with an average age of 26.9 ± 6.5 years. Almost the totality of the sample was composed of the European ethnic group (99.1%). Respondents were predominantly born in Italy (97.2%). The majority of the sample reported being in good (49.5%) to excellent (38.6%) health. To date, osteopathy students are almost evenly distributed between the two types of curricula (T1 = 46.6%; T2 = 53.4%). CONCLUSIONS: The OSA is the first study that aims to profile Italian osteopathy students as a target population in terms of sociodemographic characteristics, geographical distribution, health status, and previous and ongoing education specifications. Future studies should focus on investigating the correlation between the sociodemographic characteristics of students and their academic performance.

International Overview of Somatic Dysfunction Assessment and Treatment in Osteopathic Research: A Scoping Review.

BACKGROUND: Osteopathic manipulative treatment (OMT) is a patient-centred, whole-body intervention aimed at enhance the person's self-regulation. OMT interventions are focused on somatic dysfunctions (SD) that can be defined as an altered regulative function associated with inflammatory signs palpable in the body framework in different body regions. The conceptual model that sustains SD, as well as its usefulness for the osteopathic profession, is still being discussed by the osteopathic community. Understanding the role and the application of SD is the aim of this scoping review. METHODS: A literature search was carried out through the main biomedical databases: Pubmed (Medline), Cochrane, Central (Cochrane), Embase, PEDro and Scopus. Grey literature was considered via Google Scholar and the Osteopathic Research Web. The review was prepared by referring to the "Preferred Reporting Items for Systematic reviews and Meta-Analysis extension for Scoping Reviews" (PRISMA-ScR). RESULTS: A total of 37,279 records were identified through database searching and other sources. After the duplicates were removed, 27,023 titles and abstracts were screened. A total of 1495 full-text articles were assessed for eligibility. The qualitative synthesis included 280 studies. CONCLUSIONS: Treating SD is an important part of osteopathic practice that varies from country to country. SD should be considered as a clinical value that assists in the clinical assessment and guides the decision-making process of osteopathic practitioners. Further studies should be designed to better understand why and how to choose the different assessment and intervention modalities to approach SD and to evaluate new osteopathic models.

Effectiveness of osteopathic interventions in chronic non-specific low back pain: A systematic review and meta-analysis.

BACKGROUND: Chronic low back pain (CLBP) is a frequent cause of disability and it represents a medical, social and economic burden globally. Therefore, we assessed effectiveness of osteopathic interventions in the management of NS-CLBP for pain and functional status. METHODS: A systematic review and meta-analysis were conducted. Findings were reported following the PRISMA statement. Six databases were searched for RCTs. Studies were independently assessed using a standardized form. Each article was assessed using the Cochrane risk of bias (RoB) tool. Effect size (ES) were calculated at post-treatment and at 12 weeks' follow up. We used GRADE to assess quality of evidence. RESULTS: 10 articles were included. Studies investigated osteopathic manipulative treatment (OMT, n = 6), myofascial release (MFR, n = 2), craniosacral treatment (CST, n = 1) and osteopathic visceral manipulation (OVM, n = 1). None of the study was completely judged at low RoB. Osteopathy revealed to be more effective than control interventions in pain reduction (ES: -0.59; 95% CI: -0.81, -0.36; P < 0.00,001) and in improving functional status (ES: -0.42; 95% 95% CI: -0.68, -0.15; P = 0.002). Moderate-quality evidence suggested that MFR is more effective than control treatments in pain reduction (ES: -0.69; 95% CI: -1.05, -0.33; P = 0.0002), even at follow-up (ES: -0.73; 95% CI: -1.09, -0.37; P < 0.0001). Low-quality evidence suggested superiority of OMT in pain reduction (ES: -0.57; 95% CI: -0.90, -0.25; P = 0.001) and in changing functional status (ES: -0.34; 95% CI: -0.65, -0.03; P = 0.001). Very low-quality evidence suggested that MFR is more effective than control interventions in functional improvements (ES: -0.73; 95% CI: -1.25, -0.21; P = 0.006). CONCLUSION: Results strengthen evidence that osteopathy is effective in pain levels and functional status improvements in NS-CLBP patients. MFR reported better level of evidence for pain reduction if compared to other interventions. Further high-quality RCTs, comparing different osteopathic modalities, are recommended to produce better-quality evidence.

A new perspective for Somatic Dysfunction in Osteopathy: the Variability Model.

INTRODUCTION: Osteopathy uses manipulative techniques to support physiological function and adaptation. These conditions are modified by the presence of Somatic Dysfunction (SD), an altered function of the components of the body's framework system. Despite SD's widespread use in clinical practice and education, research has previously shown poor results in terms of reliability and validity. In this theoretical article, the authors' proposal is to argue for a new clinical perspective for SD, which suggests a different palpatory assessment of its clinical signs: the "Variability Model". METHODS: A double simultaneous literature search was performed between January and March 2019 in Medline's electronic database. The first one critically analysed the clinical signs most used to detect SD. The second one informed authors' hypothesis related to movement variability assessment in the Neutral Zone (NZ). DISCUSSION: The Variability Model explains how the assessment of the range of motion in the NZ is essential to detect SD, its motion asymmetry and its relative restriction. The Variability Model explains SD semeiotics which could be related to "body adaptability", thus having implications with the concept of health. Finally, this paradigm aims to establish new developments in research, especially regarding SD reliability and clinical relevance. CONCLUSIONS: Movement variability allows to interpret SD clinical signs as an attempt by the body to maintain a healthy condition. This paradigm should be included in the future context of osteopathy which could better explain SD's pathophysiological mechanism, without ignoring the accuracy of its physical examination.

Biological effects of direct and indirect manipulation of the fascial system. Narrative review.

INTRODUCTION: Osteopathic Manipulative Treatment (OMT) is effective in improving function, movement and restoring pain conditions. Despite clinical results, the mechanisms of how OMT achieves its' effects remain unclear. The fascial system is described as a tensional network that envelops the human body. Direct or indirect manipulations of the fascial system are a distinctive part of OMT. OBJECTIVE: This review describes the biological effects of direct and indirect manipulation of the fascial system. MATERIAL AND METHODS: Literature search was performed in February 2016 in the electronic databases: Cochrane, Medline, Scopus, Ostmed, Pedro and authors' publications relative to Fascia Research Congress Website. RESULTS: Manipulation of the fascial system seems to interfere with some cellular processes providing various pro-inflammatory and anti-inflammatory cells and molecules. DISCUSSION: Despite growing research in the osteopathic field, biological effects of direct or indirect manipulation of the fascial system are not conclusive. CONCLUSION: To elevate manual medicine as a primary intervention in clinical settings, it's necessary to clarify how OMT modalities work in order to underpin their clinical efficacies.