Osteopathic Manipulative Treatment Effects on High Frequency Parameters in Healthy Subjects

Study Overview
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Brief Summary
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The aim of the present study is to determine the extend to which osteopathic manipulative treatment (OMT) is effective on a sample of healthy subjects in changing high frequency (HF) parameters.

Conditions
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Healthy Subject, Heart Rate Variability

Intervention / Treatment
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* Other: Osteopathic manipulative treatment
* Other: SHAM
* Other: CONTROL


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18 and 45; No chronic symptomatology; No acute symptomatology during the last 72 hours before intervention; No pathologies Exclusion Criteria: Age below 18 or over 45; Pregnancy; Menopause; Abuse of alcool during the last 48 hours; Chronic pain; Acute pain during the last 72 hours; Conclamate pathologies; Use of drugs during the last 72 hours ; Use of ortothic devices during the last 3 months; Any type of surgery; Osteopathic treatment during the last 3 months.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: OMT<br>Each osteopathic session is based on structural evaluation and treatment using indirect techniques. | Other: Osteopathic manipulative treatment<br> <br> |
| Other: SHAM<br>Sham therapy was administered with subjects lying supine on the treatment table while the operator used light manual contact to treat the subject. A pre-determined protocol has been used. The practitioner's attention was distracted by subtracting calculation in silence. | Other: SHAM<br> <br> |
| Other: CONTROL<br>No intervention | Other: CONTROL<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline high frequency (HF) value at 1 week |  | baseline and 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in low frequency (LF) value at 1 week |  | baseline and 1 week | 
| Change from baseline LF/HF ratio value at 1 week |  | baseline and 1 week | 
| Change from baseline very low frequency (VLF) value at 1 week |  | baseline and 1 week | 
| Change from baseline standard deviation beat-to-beat (SDNN) value at 1 week |  | baseline and 1 week | 
| Changes from baseline square root of the mean squared difference of successive beat-to-beat (RMSSD) at 1 week |  | baseline and 1 week | 
| Change from baseline proportion of beat-to-beat50 divided by total number of beat-to-beats in (pNN50) at 1 week |  | baseline and 1 week | 
| Change from baseline detrended fluctuation scaling exponent (DFAa1) value at 1 week |  | baseline and 1 week | 
| Change in LF value |  | during treatment session | 
| Change in LF/HF ratio value |  | during treatment session | 
| Change in VLF value |  | during treatment session | 
| Change in SDNN value |  | during treatment session | 
| Change in RMSSD value |  | during treatment session | 
| Change in pNN50 value |  | during treatment session | 
| Change in DFAa1 value |  | during treatment session | 
| Change from baseline intrasubject HF value at 1 week |  | baseline and 1 week | 
| Change from baseline heart rate variability parameters between smokers and no-smokers at 1 week |  | baseline and 1 week | 
| Change from baseline 15D questionnaire at 1 week |  | baseline and 1 week | 
| Differences in skin conductance value between groups |  | 1 week |