Tissutal and Fluidic Aspects in Osteopathic Manual Therapy: A Narrative Review.

Over the years, several authors have discussed the possibility of considering somatic dysfunction (SD) as a "nosological element" detectable on palpation. There are many aspects to consider regarding the etiology and diagnosis of SD, and the literature on osteopathic issues provides details on physiological signs that characterize it, including tissue texture changes. Recent knowledge suggests that how tissue and, in particular, connective tissue, responds to osteopathic treatment may depend on the modulation of the inflammation degree. Low-grade inflammation (LGI) may act on the extracellular matrix (ECM) and on cellular elements; and these mechanisms may be mediated by biological water. With its molecules organized in structures called exclusion zones (EZ), water could explain the functioning of both healthy and injured tissues, and how they can respond to osteopathic treatment with possible EZ normalization as a result. The relationship between inflammation and DS and the mechanisms involved are described by several authors; however, this review suggests a new model relating to the characteristics of DS and to its clinical implications by linking to LGI. Tissue alterations detectable by osteopathic palpation would be mediated by body fluids and in particular by biological water which has well-defined biophysical characteristics. Research in this area is certainly still to be explored, but our suggestion seems plausible to explain many dynamics related to osteopathic treatment. We believe that this could open up a fascinating scenario of therapeutic possibilities and knowledge in the future.

Osteopathic Manipulative Treatment in Neonatal Intensive Care Units.

The aim of this study was to assess the impact of osteopathic manipulative treatment (OMT) on newborn babies admitted at a neonatal intensive care unit (NICU). This was an observational, longitudinal, retrospective study. All consecutive admitted babies were analyzed by treatment (OMT vs. usual care). Treatment group was randomly assigned. Between-group differences in weekly weight change and length of stay (LOS) were evaluated in the overall and preterm populations. Among 1249 babies (48.9% preterm) recorded, 652 received usual care and 597 received OMT. Weight increase was more marked in the OMT group than in the control group (weekly change: +83 g vs. +35 g; p < 0.001). Similar trends were found in the subgroup of preterm babies. A shorter LOS was found in the OMT group vs. the usual care group both in overall population (average mean difference: -7.9 days, p = 0.15) and in preterm babies (-12.3 days; p = 0.04). In severe preterm babies, mean LOS was more than halved as compared to the control group. OMT was associated with a more marked weekly weight increase and, especially in preterm babies, to a relevant LOS reduction: OMT may represent an efficient support to usual care in newborn babies admitted at a NICU.

The paradox of sham therapy and placebo effect in osteopathy: A systematic review.

BACKGROUND: Placebo, defined as "false treatment," is a common gold-standard method to assess the validity of a therapy both in pharmacological trials and manual medicine research where placebo is also referred to as "sham therapy." In the medical literature, guidelines have been proposed on how to conduct robust placebo-controlled trials, but mainly in a drug-based scenario. In contrast, there are not precise guidelines on how to conduct a placebo-controlled in manual medicine trials (particularly osteopathy). The aim of the present systematic review was to report how and what type of sham methods, dosage, operator characteristics, and patient types were used in osteopathic clinical trials and, eventually, assess sham clinical effectiveness. METHODS: A systematic Cochrane-based review was conducted by analyzing the osteopathic trials that used both manual and nonmanual placebo control. Searches were conducted on 8 databases from journal inception to December 2015 using a pragmatic literature search approach. Two independent reviewers conducted the study selection and data extraction for each study. The risk of bias was evaluated according to the Cochrane methods. RESULTS: A total of 64 studies were eligible for analysis collecting a total of 5024 participants. More than half (43 studies) used a manual placebo; 9 studies used a nonmanual placebo; and 12 studies used both manual and nonmanual placebo. Data showed lack of reporting sham therapy information across studies. Risk of bias analysis demonstrated a high risk of bias for allocation, blinding of personnel and participants, selective, and other bias. To explore the clinical effects of sham therapies used, a quantitative analysis was planned. However, due to the high heterogeneity of sham approaches used no further analyses were performed. CONCLUSION: High heterogeneity regarding placebo used between studies, lack of reporting information on placebo methods and within-study variability between sham and real treatment procedures suggest prudence in reading and interpreting study findings in manual osteopathic randomized controlled trials (RCTs). Efforts must be made to promote guidelines to design the most reliable placebo for manual RCTs as a means of increasing the internal validity and improve external validity of findings.

Quality of life in patients referring to private osteopathic clinical practice: a prospective observational study.

BACKGROUND: Health improvement is one of the main priorities of both public and private health systems. In recent years, more attention has been given to the use of complementary and alternative medicines, including osteopathic manipulative treatment (OMT), as possible effective interventions in increasing patients' health reported outcomes. With regard to OMT, very little research was focused on its effectiveness in enhancing health in the general population. OBJECTIVES: To explore the extent to which OMT is effective in improving quality of life in referring patients. DESIGN: Cohort study. SETTING: Private osteopathic clinical practices in Italy. INTERVENTIONS: 25 osteopaths from Central and Southern Italy participated in the study. Self-referred patients, with a diagnosed musculo-skeletal disorder and older than 18 years of age, who did not undergo any OMT session in the previous 12 months and/or contemporarily additional manual therapies were enrolled. MAIN OUTCOME MEASURES: Changing from baseline SF36 general health sub-domain scores was used as the study primary outcomes. RESULTS: 1000 patients with primary diagnosis of musculo-skeletal disorder were initially enrolled. 988 patients completed the study. After 4 weeks, mean general health score was 14.7 points higher (95% CI 13.9-15.6; Cohen's d=0.84). Similarly, physical and mental component scores increased (11.5; 95% CI 10.8-12.1; d=0.87 and 9.6; 95% CI 8.6-10.5; d=0.61 respectively). No association between SF36 domains and socio-demographic exposures was found to be statistically significant. CONCLUSIONS: Positive changes on various quality of life dimensions were reported by patients receiving osteopathic treatment. The trial was registered on clinicaltrials.gov (identifier NCT01965678).