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Variations of high frequency parameter of heart rate variability following osteopathic manipulative treatment in healthy subjects compared to control group and sham therapy: randomized controlled trial.

ABSTRACT: CONTEXT:Heart Rate Variability (HRV) indicates how heart rate changes in response to inner and external stimuli. HRV is linked to health status and it is an indirect marker of the autonomic nervous system (ANS) function. OBJECTIVE:To investigate the influence of osteopathic manipulative treatment (OMT) on cardiac autonomic modulation in healthy subjects, compared with sham therapy and control group. METHODS:Sixty-six healthy subjects, both male and female, were included in the present 3-armed randomized placebo controlled within subject cross-over single blinded study. Participants were asymptomatic adults (26.7 ± 8.4 y, 51% male, BMI 18.5 ± 4.8), both smokers and non-smokers and not on medications. At enrollment subjects were randomized in three groups: A, B, C. Standardized structural evaluation followed by a patient need-based osteopathic treatment was performed in the first session of group A and in the second session of group B. Standardized evaluation followed by a protocoled sham treatment was provided in the second session of group A and in the first session of group B. No intervention was performed in the two sessions of group C, acting as a time-control. The trial was registered on clinicaltrials.gov identifier: NCT01908920. MAIN OUTCOMES MEASURES:HRV was calculated from electrocardiography before, during and after the intervention, for a total amount time of 25 min and considering frequency domain as well as linear and non-linear methods as outcome measures. RESULTS:OMT engendered a statistically significant increase of parasympathetic activity, as shown by High Frequency power (p < 0.001), expressed in normalized and absolute unit, and possibly decrease of sympathetic activity, as revealed by Low Frequency power (p < 0.01); results also showed a reduction of Low Frequency/High Frequency ratio (p < 0.001) and Detrended fluctuation scaling exponent (p < 0.05). CONCLUSIONS:Findings suggested that OMT can influence ANS activity increasing parasympathetic function and decreasing sympathetic activity, compared to sham therapy and control group.

SUBMITTER: Ruffini N

PROVIDER: S-EPMC4523739 | biostudies-literature | 2015

REPOSITORIES: biostudies-literature

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Variations of high frequency parameter of heart rate variability following osteopathic manipulative treatment in healthy subjects compared to control group and sham therapy: randomized controlled trial.

Ruffini Nuria N D'Alessandro Giandomenico G Mariani Nicolò N Pollastrelli Alberto A Cardinali Lucia L Cerritelli Francesco F

Frontiers in neuroscience 20150804

<h4>Context</h4>Heart Rate Variability (HRV) indicates how heart rate changes in response to inner and external stimuli. HRV is linked to health status and it is an indirect marker of the autonomic nervous system (ANS) function.<h4>Objective</h4>To investigate the influence of osteopathic manipulative treatment (OMT) on cardiac autonomic modulation in healthy subjects, compared with sham therapy and control group.<h4>Methods</h4>Sixty-six healthy subjects, both male and female, were included in ...[more]

PMID: 26300719

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Project description:BackgroundThe relationship between osteopathic manipulative treatment (OMT) and the autonomic nervous system has long been acknowledged, but is poorly understood. In an effort to define this relationship, cervical myofascial release was used as the OMT technique with heart rate variability (HRV) as a surrogate for autonomic activity. This study quantifies that relationship and demonstrates a cause and effect.MethodsSeventeen healthy subjects, nine males and eight females aged 19-50 years from the faculty, staff, and students at Oklahoma State University Center for Health Sciences College of Osteopathic Medicine, acted as their own controls and received interventions, administered in separate sessions at least 24 hours apart, of cervical myofascial OMT, touch-only sham OMT, and no-touch control while at a 50-degree head-up tilt. Each group was dichotomized into extremes of autonomic activity using a tilt table. Comparisons were made between measurements taken at tilt and those taken at pre- and post-intervention in the horizontal.The variance of the spectral components of HRV, expressed as frequencies, measured the response to change in position of the subjects. Normalized low frequency (LF) and high frequency (HF) values, including LF/HF ratio, were calculated and used to determine the effect of position change on HRV.ResultsPredominantly parasympathetic responses were observed with subjects in the horizontal position, while a 50-degree tilt provided a significantly different measure of maximum sympathetic tone (p < 0.001). Heart rate changed in all subjects with change in position; respirations remained constant. When OMT was performed in a sympathetic environment (tilt), a vagal response was produced that was strong enough to overcome the sympathetic tone. There was no HRV difference between sham and control in either the horizontal or tilt positions.ConclusionThe vagal response produced by the myofascial release procedure in the maximally stimulated sympathetic environment could only have come from the application of the OMT. This demonstrates the association between OMT and the autonomic nervous system. The lack of significance between control and sham in all positions indicates that HRV may be a useful method of developing sham controls in future studies of OMT.Trial registrationclinicaltrials.gov NCT00516984.

Project description:Objective: Measurements of heart rate variability (HRV) during sleep have become increasingly popular as sleep could provide an optimal state for HRV assessments. While sleep stages have been reported to affect HRV, the effect of sleep stages on the variance of HRV parameters were hardly investigated. We aimed to assess the variance of HRV parameters during the different sleep stages. Further, we tested the accuracy of an algorithm using HRV to identify a 5-min segment within an episode of slow wave sleep (SWS, deep sleep). Methods: Polysomnographic (PSG) sleep recordings of 3 nights of 15 healthy young males were analyzed. Sleep was scored according to conventional criteria. HRV parameters of consecutive 5-min segments were analyzed within the different sleep stages. The total variance of HRV parameters was partitioned into between-subjects variance, between-nights variance, and between-segments variance and compared between the different sleep stages. Intra-class correlation coefficients of all HRV parameters were calculated for all sleep stages. To identify an SWS segment based on HRV, Pearson correlation coefficients of consecutive R-R intervals (rRR) of moving 5-min windows (20-s steps). The linear trend was removed from the rRR time series and the first segment with rRR values 0.1 units below the mean rRR for at least 10 min was identified. A 5-min segment was placed in the middle of such an identified segment and the corresponding sleep stage was used to assess the accuracy of the algorithm. Results: Good reproducibility within and across nights was found for heart rate in all sleep stages and for high frequency (HF) power in SWS. Reproducibility of low frequency (LF) power and of LF/HF was poor in all sleep stages. Of all the 5-min segments selected based on HRV data, 87% were accurately located within SWS. Conclusions: SWS, a stable state that, in contrast to waking, is unaffected by internal and external factors, is a reproducible state that allows reliable determination of heart rate, and HF power, and can satisfactorily be detected based on R-R intervals, without the need of full PSG. Sleep may not be an optimal condition to assess LF power and LF/HF power ratio.

Project description:BackgroundRecent evidence proved the necessity to improve health care and pain management in newborns. Osteopathic manipulative treatment (OMT) has been largely used to treat painful syndromes as well as term and preterm newborns. Recent studies have demonstrated positive results of osteopathy in reducing length of stay and costs. However, no trials were carried out on pain in newborns. The aim of the present clinical trial is to explore the effectiveness of osteopathic treatment in reducing pain in a sample of preterms.Methods/designA three-armed single blinded placebo-control randomised controlled trial protocol has been designed to primarily evaluate the extent to which OMT is effective in reducing pain in preterms. One hundred and twenty newborns will be enrolled from one tertiary neonatal intensive care unit in central Italy and randomised in three groups: study, sham and control. The study group will be further prospectively randomised in two subgroups: experienced osteopaths and students. All preterms will receive standard medical care. Osteopathic treatment will be applied to the study group only whilst 'soft touch' will be administer to the sham group only. Newborns will undergo manual sessions once a week for the entire period of hospitalisation. Blinding will be assured for neonatal staff and outcome assessor. Primary outcome will be the mean difference in baseline score changes of PIPP questionnaire between discharge and entry among the three groups. Secondary outcomes will be: mean difference in length of stay and costs between groups. Statistical analyses will use per-protocol analysis method. Missing data will be handled using last observation carried forward imputation technique.DiscussionThe present single blinded randomised controlled trial has been designed to explore potential advantages of OMT in the management of newborns' pain. Currently, based on a patient-centred need-based approach, this research will be looking at the benefit of osteopathic care rather than the efficacy of a specific technique or a pre-determined protocol.Trial registrationThe protocol has been registered on ClinicalTrials.gov ( NCT02146677 ) on 20 May 2014.

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Variations of high frequency parameter of heart rate variability following osteopathic manipulative treatment in healthy subjects compared to control group and sham therapy: randomized controlled trial.

Publications

Variations of high frequency parameter of heart rate variability following osteopathic manipulative treatment in healthy subjects compared to control group and sham therapy: randomized controlled trial.

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